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PerkinElmer Announces Collaboration with Korea’s Sangmyung University for Drug Discovery Research

WALTHAM, Mass. & CHEONAN, South Korea–(BUSINESS WIRE)–PerkinElmer, Inc., a global leader focused on the health and safety of people and the environment, today announced that it has entered into a drug discovery research collaboration with Sangmyung University (Republic of Korea), based on applying PerkinElmer’s AequoScreen® aequorin assay technology to cutting-edge G-protein coupled receptor (GPCR) research.

It is estimated that GPCRs are associated with at least 30% percent of addressable diseases, and continue to be a key focus in drug discovery. Aequorin assays are a sensitive and flexible cell-based assay technology used to detect GPCR activation with several advantages over conventional fluorescence based dyes, including fewer false positives, much simpler protocol and significantly increased assay windows.

AequoScreen will be used by Sangmyung University as part of its efforts to establish an academic GPCR screening facility together with the Korea Chemical Bank, a national repository library of over 100,000 small molecule compounds. The aequorin technology will be used as part of nationwide GPCR screening campaigns and drug discovery programs in Korea.

“We are very pleased to be working with the distinguished faculty of Sangmyung University in providing our AequoScreen technology in support of their Korea-wide GPCR screening campaign implementation,” said Richard M. Eglen, Ph.D., president, Bio-discovery, PerkinElmer, Inc. “Given the wide range of potential drug targets linked to GPCR research, the University’s project presents tremendous promise in terms of advancing potential new drugs.”

According to Professor Sunghou Lee, Ph.D., of the Department of Biomedical Technology at Sangmyung University, “Screening programs have begun to increase in Korea, partly through the support of institutions such as the Center for Biological Modulators (CBM), the Frontier R&D Program for drug discovery research. For a nationwide academic screening research laboratory such as ours, the ability to reliably and accurately deploy a sensitive, flexible and easy-to-use GPCR detection platform like AequoScreen is of prime importance. This is especially true when dealing with small molecules, where conventional technologies such as fluorescence techniques tend to result in issues such as artifacts and interference that distort results.”

Professor Lee added, “We are delighted to be working with a partner of PerkinElmer’s caliber in this effort, and look forward to compelling results in our screening program.”

BIO-Europe Spring 2009 Presenter and Exhibitor Profiles

MILAN, Mar 12, 2009 (BUSINESS WIRE) — BIO-Europe Spring 2009 takes place March 16-18, 2009 at the Milano Convention Centre in Milan, Italy.
Business Wire is the official news wire for BIO-Europe Spring 2009. Breaking news releases, advisories, photos, and multimedia are available at Tradeshownews.com, Business Wire’s trade show, conference, and event news resource.
Listed below are the BIO-Europe Spring 2009 exhibitor and presenter profiles.
Company:                          Addex Pharmaceuticals
Ticker Symbol & Exchange:         ADXN
Media Contact:                    Chris Maggos
Phone:                            41 22 884 15 11
E-mail:                           chris.maggos@addexpharma.com
Web:                               www.addexpharma.com
Addex Pharmaceuticals discovers and develops allosteric modulators
for human health. Allosteric modulators are a different kind of
orally available small molecule therapeutic agent, which we
believe will offer patients better results than classical drugs.
The lead product in our pipeline, ADX10059, has achieved clinical
proof of concept and is in Phase IIb testing for the treatment of
GERD (e.g. heartburn) and, separately, migraine headache. ADX10059
is a first-in-class mGluR5 inhibitor, a therapeutic strategy that
also is being pursued for multiple indications by large pharma
competitors.
ADX10059 is not yet partnered but we have established drug
development deals with Merck & Co., Inc. (2 deals: schizophrenia &
Parkinson's) and Ortho McNeil Pharmaceuticals, a J&J company
(anxiety/schizophrenia). Roche Ventures and SR One
(GlaxoSmithKline's VC investing unit) have invested in Addex.
Company:                          Allon Therapeutics Inc.
Ticker Symbol & Exchange:         TSX:NPC
Media Contact:                    Aaron Keay, Director, Investor Relations
Phone:                            604-742-2540
E-mail:                           akeay@allontherapeutics.com
Web:                               www.allontherapeuticsc.com
Allon Therapeutics Inc. is a clinical-stage biotechnology company
developing treatments for major neurodegenerative conditions.
Allon's drug AL-108 (davunetide) has demonstrated human efficacy in
amnestic mild cognitive impairment, a precursor to Alzheimer's
disease. Allon has Phase II human efficacy programs pursuing large
underserved markets: Alzheimer's disease, frontotemporal dementia,
and schizophrenia-related cognitive impairment.
Company:                          Almac Group
Stand:                            10
Media Contact:                    Carl Whyte (Stakeholder Communicati)
Phone:                            44(0)28 3833 2200
E-mail:                           info@almacgroup.com
Web:                               www.almacgroup.com
Almac's integrated development services extend from research to
commercialisation of product. Our extensive facilities in Europe
and North America offer the following:
-Route design & synthesis of APIs (including potent, peptide and
chiral compounds);
-Synthesis and formulation of labelled compounds (pre-clinical and
clinical);
-Formulation development of tablets and capsules;
-Gene expression profiling & bioinformatics;
-Manufacturing/blinding, packaging, randomised labelling and
distribution of clinical supplies;
-Clinical trial technology solutions based on IVRS/Web/EDC;
-Commercial scale manufacture and distribution;
-Comprehensive analytical service;
-EU import testing and QP release for clinical and commercial
product.
Company:                          AmberCRO, ltd
Media Contact:                    Julija Gabrusenoka
Phone:                            37129340168
E-mail:                           gabrusenokaj@amber-cro.com
Web:                               www.amber-cro.com
AmberCRO is a private CRO company providing Contract Research
Organization services in Baltic Countries.
Started from feasibility to Close out Visits including additional
services:
Independent Audit services
Study Design, Protocol Development, Case report Form, Design and
Preparation.
Selection process. Site and Investigator selection.
Regulatory Consultation. Preparation and submission of Regulatory
documents (clinical trial application/ Notification).
Organize Investigator meeting, qualify and train Investigators
ICH/GCP training
Site Management and Monitoring Based on SOP's and study specific
procedures.
AmberCRO is providing services for reasonable price with high
quality.
AmberCRO has established its own EDC system with High data
security, elastic database structure, easy navigation, simple data
verification system, comprehensive report system.
Company:                           FGK Clinical Research GmbH
Stand:                             18
Media Contact:                     Dr. Edgar J. Fenzl
Phone:                             49 - 89 - 893119-0
E-mail:                            edgar.fenzl@fgk-cro.de
Web:                                www.fgk-cro.de
FGK Clinical Research GmbH is a full service contract research
organization offering a complete range of clinical development and
consulting services to pharmaceutical, biotechnology and medical
device companies.
With more than 50 highly skilled and experienced people, FGK
operates out of Munich on local and global projects, covering
clinical studies from phases II to IV. FGK has extensive experience
in all major therapeutic areas and clinical research fields, which
allows it to effectively design, manage and analyze your development
programs and clinical trials.
Company:                           Hospira One 2 One
Stand:                             4
Ticker Symbol & Exchange:          HSP
Phone:                             44 (0) 1926 835 554
E-mail:                            one2one@hospira.com
Web:                                http://one2one.hospira.com
Hospira is a global specialty pharmaceutical and medication delivery
company. The company's One 2 One(R) business is a world leader in the
custom development and manufacture of parenteral products packaged
in vials, prefilled syringes, cartridges, flexible containers and
ampules.
One 2 One(R) offers development and manufacturing services at its
worldwide facilities located in North America, Europe and Australia.
Company:                           Hybrigenics
Ticker Symbol & Exchange:          ALHYG (NYSE-Euronext)
Phone:                             (33) 1 58 10 38 00
E-mail:                            contact@hybrigenics.com
Web:                                www.hybrigenics.com
Hybrigenics is a public bio-pharmaceutical company focusing its R&D
programs on innovative targets and therapeutics against cancer. Its
most advanced development program is based on inecalcitol, a vitamin
D analogue, for prostate cancer in combination with reference
treatments, for improved efficacy and better tolerance. Hybrigenics'
research program explores the role of Ubiquitin-Specific Proteases
(USPs) in the degradation of proteins involved in cancer
(oncoproteins), and the use of proprietary USP inhibitors against
various cancer types.
Hybrigenics also commercializes expert protein interaction services
dedicated to identify, validate and inhibit protein interactions for
academic and industrial researchers from all life sciences. Its
flagship technology is a unique ISO 9001-certified Yeast-Two Hybrid
(Y2H) high throughput screening platform, backed by bioinformatic
tools.
Company:                           InNexus Biotechnology Inc.
Ticker Symbol & Exchange:          IXS.V: Toronto Stock Exchange
Media Contact:                     Jeff Morhet, Chairman & CEO
Phone:                             480-862-7500
E-mail:                            jmorhet@ixsbio.com
Web:                                www.ixsbio.com
InNexus is a drug development company commercializing the next
generation of monoclonal antibodies based on its DXL(TM) technology,
which improves the potency of existing antibody products while
opening new markets and disease applications.
In a short period of time, InNexus has assembled facilities,
resources, a stellar Scientific Advisory Board, staff and milestones
yielding multiple pre-clinical candidates targeting cancer and other
commercial opportunities. InNexus has launched into pre-clinical
development its first four products, DXL625 (CD20) for non-Hodgkin's
lymphoma, DXL702 (HER-2/neu) for breast cancer, DXL1218 for
colorectal cancer and DXL1215 for endometriosis. InNexus has
numerous products and platform opportunities for antibodies.
Company:                           PEPperPRINT GmbH
Media Contact:                     Dr. Volker Stadler
Phone:                             49-6221-424744
E-mail:                            info@pepperprint.com
Web:                                www.pepperprint.com
By means of laser printing, PEPperPRINT produces high density
peptide and peptidomimetic arrays on conventional glass slides.
For the first time, tens of thousands of individual peptides are
available at moderate costs. PEPperPRINT markets customized
peptide arrays on demand for proteome research (antibody
profiling, epitope mapping, screening for enzyme substrates...).
Additionally, on a fee-for-service basis, PEPperPRINT provides
truly large scale peptide and peptidomimetic libraries for
biomarker discovery and drug development. PEPperPRINT adds speed
and throughput on your experiment.
Company:                          Resverlogix Corp.
Ticker Symbol & Exchange:         TSX:RVX
Media Contact:                    Theresa Kennedy
Phone:                            1.604.538.7072
E-mail:                           Theresa@Resverlogix.com
Web:                               www.resverlogix.com
Resverlogix Corp. is a leading biotechnology company engaged in the
development of novel therapies for important global medical markets
with significant unmet needs. The NexVas(TM) PR (plaque regression)
program is the Company's primary focus which is to develop novel
small molecules that enhance ApoA-I. These vital therapies address
the grievous burden of atherosclerosis and other important diseases
such as acute coronary syndrome, diabetes, Alzheimer's disease,
Peripheral Artery Disease and other vascular disorders. Resverlogix
Corp. trades on the Toronto Stock Exchange  (CA:RVX:
news
,
chart
,
profile
)
. For further
information please visit  www.resverlogix.com
Company:                          ViroStatics, srl
Media Contact:                    Michael Stevens
Phone:                            1 609 213-5287
E-mail:                           m.stevens@virostatics.com
Web:                              virostatics.com
Dr. Franco Lori, Chief Executive Officer of Virostatics, will
present a Company overview during BIO-Europe Spring 2009 at 09:30
AM on Wednesday, 18 March, 2009. Dr. Lori will update recent
Company advancements in drug discovery and development in the
areas of HIV/AIDS and cancer as well as the potential for the
Company's proprietary biomarker assays. Dr. Lori will review how
Anti-Viral Hyper-Activation Limiting Therapies (AV-HALT) represent
a new family of antivirals designed to not only suppress viruses
but also to preserve the immune system from chronic damage. Dr.
Lori will also discuss in-licensing and partnering opportunities
in HIV/AIDS and cancer.

EPIX Pharmaceuticals Achieves Milestone from Collaboration with Cystic Fibrosis Foundation Therapeutics

LEXINGTON, Mass.–(BUSINESS WIRE)–Mar 11, 2009 – EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, today announced that it has achieved another milestone in its collaboration with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation. Under the terms of the collaboration EPIX has earned an additional $500,000, bringing the total amount of milestone payments achieved under this collaboration to $5 million. The milestone payment is part of a research, development and commercialization agreement between EPIX and CFFT that focuses on discovering potential drug therapies targeting the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) ion channel. Under the terms of the agreement, EPIX will own all worldwide rights to any compound that results from the collaboration.To earn the milestone, EPIX successfully completed in silico high throughput screening at four distinct sites in the delta F508 mutational form of CFTR for small molecules that may correct the defects in the mutation’s cellular processing and chloride channel gating. The delta F508 is the most common mutation of the key protein associated with cystic fibrosis. EPIX and CFFT believe that ligands to CFTR may act as molecular chaperones, stabilizing the folded structure and modulating CFTR activity.

“We continue to make progress in our collaboration with CFFT and believe that our research may eventually lead to significant advances in the treatment of cystic fibrosis,” said Elkan Gamzu, Ph.D., president and chief executive officer of EPIX. “This achievement, coupled with our announcement in September 2008 regarding the identification of dual-acting compounds that act as both potentiators and correctors, moves us one important step closer to lead optimization and the identification of clinical candidates.”

Early in the collaboration, EPIX became the first company to generate a 3-D model of the CFTR, a considerable step forward in the CF research field. All of these milestones resulted from EPIX’s highly efficient discovery platform which integrates proprietary in silico modeling techniques with hypothesis-driven approaches for the design and synthesis of compounds.

“Our collaboration with EPIX continues to yield important scientific advances in the field of cystic fibrosis research,” added Robert J. Beall, Ph.D., president and chief executive officer of Cystic Fibrosis Foundation. “This is the first time that a 3-D model has been used to test for compounds that may bind to multiple sites on the CFTR and play a key role in a future treatment for CF. We are pleased with the tangible results stemming from our relationship with EPIX and we look forward to continuing our work together as we focus on our goal of creating new therapies to treat CF.”

Cystic fibrosis (CF) is a life-threatening genetic disease that affects approximately 30,000 children and adults in the United States and nearly 70,000 people worldwide. It causes life-threatening lung infections and serious digestive complications. A mutation in the CFTR gene is one of the key factors that ultimately leads to the symptoms, complications and premature mortality in people with CF.

10-K: ALEXZA PHARMACEUTICALS INC.

he following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements that are based upon current expectations. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “intend,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements involve risks and uncertainties. Our actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this Annual Report on Form 10-K.

Overview
We are a pharmaceutical development company focused on the research, development, and commercialization of novel proprietary products for the acute treatment of central nervous system, or CNS, conditions. All of our product candidates are based on our proprietary technology, the Staccato system. The Staccato system, vaporizes an excipient-free drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery. Because of the particle size of the aerosol, the drug is quickly absorbed through the deep lung into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous, or IV, administration but with greater ease, patient comfort and convenience. We currently have six product candidates in various stages of clinical development, ranging from Phase 1 through late-stage Phase 3. In 2009, our focus will be on the continued rapid development of AZ-004.
We have identified approximately 200 drug compounds that have demonstrated initial vaporization feasibility for delivery with our technology. We believe that a number of these drug compounds, when delivered by the Staccato system, will have a desirable therapeutic profile for the treatment of acute and intermittent conditions. We are initially focusing on developing proprietary products by combining our Staccato system with small molecule drugs that have been in use for many years and are well characterized to create aerosolized forms of these drugs. We believe that we will be able to reduce the development time and risks associated with our product candidates, compared to the development of new chemical entities.
Our clinical-stage product candidates are:
AZ-004 (Staccato loxapine). We are developing AZ-004 for the acute treatment of agitation in patients with schizophrenia or bipolar disorder. In 2008 we successfully completed two pivotal Phase 3 clinical trials and we project a New Drug Application, or NDA, submission in the first quarter of 2010.
AZ-104 (Staccato loxapine). We are developing AZ-104 to treat patients suffering from acute migraine headaches. AZ-104 is a lower-dose version of AZ-004. AZ-104 has completed a Phase 2a in-clinic study and we initiated an out-patient Phase 2b clinical trial in January 2009. AZ-104 has been licensed to Symphony Allegro, and we have the right to repurchase all rights to this product candidate
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AZ-001 (Staccato prochlorperazine). We are developing AZ-001 to treat patients suffering from acute migraine headaches. During the third quarter of 2008, we conducted an end-of-Phase 2 meeting with the FDA. We believe we have a clear understanding of the development requirements for filing an NDA for this product candidate. We do not intend to conduct any AZ-001 Phase 3 studies without a partner, and we are continuing to seek partners for our Staccato migraine product candidates, AZ-001 and AZ-104.
AZ-007 (Staccato zaleplon). We are developing AZ-007 for the treatment of insomnia in patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep. AZ-007 has completed Phase 1 testing. We do not intend to conduct any AZ-007 Phase 2 studies without a partner in 2009.
AZ-003 (Staccato fentanyl). We are developing AZ-003 for the treatment of patients with acute pain, including patients with breakthrough cancer pain and postoperative patients with acute pain episodes. We have completed and announced positive results from a Phase 1 clinical trial of AZ-003 in opioid naïve healthy subjects.
In December 2007, we entered into a license, development and supply agreement, or the license agreement, with Endo Pharmaceuticals, Inc., or Endo, for AZ-003 and the fentanyl class of molecules for North America. Under the terms of the license agreement, Endo paid us an upfront fee of $10 million, and was obligated to pay potential additional milestone payments of up to $40 million upon achievement of predetermined regulatory and clinical milestones. Endo was also obligated to pay undisclosed royalties to us on net sales of the product, from which we would be required to pay for the cost of goods for the manufacture of the commercial version of the product. Under the terms of the license agreement, we had the primary responsibility for the development and costs of the Staccato Electronic Multiple Dose device and the exclusive right to manufacture the product for clinical development and commercial supply. Endo had the responsibility for future pre-clinical, clinical and regulatory development, and, if AZ-003 was approved for marketing, for commercializing the product in North America. In January 2009, we mutually agreed with Endo to terminate the license agreement, With all rights to AZ-003 reverting back to us. We recorded the $10 million upfront fee we received from Endo in January 2008 as deferred revenue and began to recognize this revenue in the third quarter of 2008 over the estimated performance period of six years, resulting in revenue of $486,000 in 2008. Our obligations under the license agreement were fulfilled upon the termination of the agreement, and we will recognize the remaining deferred revenue in the first quarter of 2009. We do not expect to pursue the development of AZ-003 without a partner.
AZ-002 (Staccato alprazolam). AZ-002 has completed a Phase 2a proof-of-concept clinical trial for the treatment of panic attacks, an indication the Company is not planning to pursue. However, given the safety profile, the successful and reproducible delivery of alprazolam, and the IV-like pharmacological effect demonstrated to date, we and Symphony Allegro are assessing AZ-002 for other possible indications and renewed clinical development. AZ-002 has been licensed to Symphony Allegro, and we have the right to repurchase all rights to this product candidate.
In December 2006, we entered into a transaction involving a series of related agreements providing for the financing of additional clinical and nonclinical development of AZ-002, Staccato alprazolam, and AZ-004/AZ-104, Staccato loxapine. Pursuant to the agreements, Symphony Capital LLC, a wholly owned subsidiary of Symphony Holdings LLC, and its investors have invested $50 million to form Symphony Allegro to fund additional clinical and nonclinical development of Staccato alprazolam and Staccato loxapine. We have exclusively licensed to Symphony Allegro certain intellectual property rights related to Staccato alprazolam and Staccato loxapine. We have retained manufacturing rights to these product candidates. We continue to be primarily responsible for the development of these product candidates in accordance with a development plan and related development budgets, and we have incurred and may continue to incur expenses that are not funded by Symphony Allegro. Pursuant to the agreements, we have received an exclusive purchase option that gives us the right, but not the obligation, to acquire all, but not less than all, of the equity of Symphony Allegro, and reacquire the intellectual property rights that we licensed to Symphony Allegro. This purchase option is exercisable at predetermined prices between $92.5 million at March 31, 2009 and $122.5 million at December 1, 2010. The purchase option exercise price may be paid for in cash or in a combination of cash and our common stock, in our sole discretion, provided that the common stock portion may not
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exceed 40% of the purchase option exercise price or 10% of our common stock issued and outstanding as of the purchase option closing date. If we pay a portion of the purchase option exercise price in shares of our common stock, then we will be required to register such shares for resale under a resale registration statement pursuant to the terms of a registration rights agreement. If we do not exercise our purchase option by December 1, 2010, then Symphony Allegro will retain its exclusive license to develop and commercialize Staccato alprazolam and Staccato loxapine for all indications, and we will maintain exclusive rights to manufacture and sell Staccato alprazolam and Staccato loxapine to Symphony Allegro or its sublicensee for those purposes. Pursuant to a warrant purchase agreement, we issued to Symphony Allegro Holdings, LLC a warrant with a five-year term to purchase 2,000,000 shares of our common stock at $9.91 per share, also paid a transaction structuring fee of $2.5 million, and reimbursed approximately $329,000 of Symphony Allegro transaction fees.
We have retained all other rights to our product candidates and the Staccato system. We are seeking a partner in the United States for our lead product candidate, AZ-004, and intend to retain co-promotion rights in the United States. We eventually plan to build a United States-based specialty sales force to commercialize our product candidates which are approved for marketing and which are intended for specialty pharmaceutical markets. We plan to enter into strategic partnerships with other companies to commercialize products that are intended for certain markets in the United States and for all of our product candidates in geographic territories outside the United States.
In March 2008, we obtained a committed equity line of credit under which we may sell, subject to certain limitations, up to $50 million of our registered common stock to Azimuth Opportunity, Ltd., or Azimuth, over a 24-month period. We are not obligated to utilize any of the $50 million equity line of credit. We will determine, at our sole discretion, the timing, the dollar amount and the price per share of each draw under this equity line of credit, subject to certain conditions. When and if we elect to use the equity line of credit, we will issue shares to Azimuth at a discount between 4.15% and 6.00% to the volume weighted average price of our common stock over a preceding period of trading days. Azimuth is not required to purchase any shares at a price below $5.00 per share. Any shares sold under this facility will be sold pursuant to a shelf registration statement declared effective by the Securities and Exchange Commission, or the SEC, on April 16, 2007. We have not sold any shares under this agreement as of December 31, 2008.
In March 2008, we sold 1,250,000 shares of our registered common stock to Biomedical Sciences Investment Fund Pte. Ltd, or Bio*One, at a price of $8.00 per share and issued a warrant to Bio*One to purchase up to $3 million of additional shares of our common stock at an exercise price of $8.00 per share. The agreement contained certain conditions, in which Bio*One was eligible to receive 135,041 additional shares of our registered common stock and an adjustment to the exercise price of the warrant, which would adjust the effective purchase price paid or payable by Bio*One to $7.22 per share. We did not meet these conditions, and in January 2009 we issued Bio*One 135,041 additional registered shares of our common stock and the warrant’s exercise price was automatically adjusted to give Bio*One the right to purchase 415,522 shares at a $7.22 per share exercise price. In addition, we committed to initiate and maintain manufacturing operations in Singapore. The warrant became exercisable only if we terminated operations in Singapore or did not achieve certain performance milestones. In December 2008, we did not achieve a specified performance milestone, at which time the warrant became fully exercisable. All securities sold to Bio*One were sold pursuant to a shelf registration statement declared effective by the SEC on April 16, 2007.
We were incorporated December 19, 2000. We have funded our operations primarily through the sale of equity securities, capital lease and equipment financings and government grants. We have generated $7.4 million in revenues from inception through December 31, 2008, substantially all of which was earned through United States Small Business Innovation Research grants and the agreement with Endo. We had $486,000 of revenues in 2008 and no revenues in 2007. In the third quarter of 2008, we began to recognize revenues related to our Endo license agreement. In prior years we have recognized governmental grant revenue and drug compound feasibility revenue, however, we expect no grant revenue or drug compound feasibility screening revenue in 2009. In January 2009, we and Endo mutually terminated the license agreement, at which time we fully fulfilled our obligations under the agreement, and will recognize the remaining $9.5 million of deferred revenues into revenues in the first quarter of 2009. We do not expect any material product revenue until at least 2011.
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We have incurred significant losses since our inception. As of December 31, 2008, our deficit accumulated during development stage was $222.6 million and total stockholders’ equity was $33.7 million. We recognized net losses of $58.5 million, $45.1 million, and $41.8 million, in 2008, 2007 and 2006, respectively. We expect our net losses to continue, however, at a lower rate than 2008, as we continue our existing and planned preclinical studies and clinical trials, reduce our research and development efforts, continue our manufacturing development, and begin commercialization development. We expect that our general and administrative expenses in 2009 to slightly decrease from 2008 levels as we reduced our headcount in January 2009 and have otherwise sought to reduce expenses for items such as travel and outside consultancy.
The process of conducting preclinical studies and clinical trials necessary to obtain FDA approval is costly and time consuming. We consider the development of our product candidates to be crucial to our long term success. If we do not complete development of our product candidates and obtain regulatory approval to market one or more of these product candidates, we may be forced to cease operations. The probability of success for each product candidate may be impacted by numerous factors, including preclinical data, clinical data, competition, device development, manufacturing capability, regulatory approval and commercial viability. Our strategy is to focus our resources on AZ-004. We expect to file an NDA for this product candidate in the first quarter of 2010. We have announced that we are seeking partnerships to continue development of our other programs. If in the future we enter into additional partnerships, third parties could have control over preclinical development or clinical trials for some of our product candidates. Accordingly, the progress of such product candidate would not be under our control. We cannot forecast with any degree of certainty which of our product candidates, if any, will be subject to any future partnerships or how such arrangements would affect our development plans or capital requirements.
As a result of the uncertainties discussed above, the uncertainty associated with clinical trial enrollments, and the risks inherent in the development process, we are unable to determine the duration and completion costs of the current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates. Development timelines, probability of success and development costs vary widely. While we are currently focused on developing our product candidates, we anticipate that we and our partners, will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to the scientific and clinical success of each product candidate, as well as an ongoing assessment as to the product candidate’s commercial potential. We do not expect any of our current product candidates to be commercially available before 2011, if at all.
In January 2009, we consolidated our operations to primarily focus our efforts on the continued rapid development of AZ-004. As part of the reorganization, we reduced our total workforce by 33% and we mutually agreed with Endo to terminate our development agreement for our AZ-003 product. We anticipate that this consolidation will reduce 2009 operating expenses by $21.5 million from the 2008 operating expenses. We anticipate that with current cash, cash equivalents and marketable securities along with interest earned thereon, expected payments from Symphony Allegro, the proceeds from option exercises, and purchases of common stock pursuant to our Employee Stock Purchase Plan, we will be able to maintain our currently planned operations into the second quarter of 2010. Changing circumstances may cause us to consume capital significantly faster or slower than we currently anticipate.
Critical Accounting Estimates and Judgments
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments related to development costs. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making assumptions about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
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While our significant accounting policies are more fully described in Note 2 of the notes to consolidated financial statements, we believe the following accounting policies are critical to the process of making significant estimates and judgments in preparation of our financial statements.
Preclinical Study and Clinical Trial Accruals
We estimate our preclinical study and clinical trial expenses based on our estimates of the services received pursuant to contracts with multiple research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on our behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Preclinical study and clinical trial expenses include the following:
fees paid to contract research organizations in connection with preclinical studies;
fees paid to contract research organizations and other clinical sites in connection with clinical trials; and
fees paid to contract manufacturers in connection with the production of components and drug materials for preclinical studies and clinical trials.
We record accruals for these preclinical study and clinical trial costs based upon the estimated amount of work completed. All such costs are charged to research and development expenses based on these estimates. Costs related to patient enrollment in clinical trials are accrued as patients are entered in the trial. We monitor patient enrollment levels and related activities to the extent possible through internal reviews, correspondence and discussions with research institutions and organizations. However, if we have incomplete or inaccurate information, we may underestimate or overestimate activity levels associated with various preclinical studies and clinical trials at a given point in time. In this event, we could record significant research and development expenses in future periods when the actual activity level becomes known. To date, we have not made any material adjustments to our estimates of preclinical study and clinical trial costs. We make good faith estimates which we believe to be accurate, but the actual costs and timing of clinical trials are highly uncertain, subject to risk and may change depending upon a number of factors, including our clinical development plan. With the our ongoing Phase 3 clinical trial and future Phase 3 clinical trials, the process of estimating clinical trial costs will become more difficult as the trials will involve larger numbers of patients and clinical sites.
Share-Based Compensation
On January 1, 2006, we adopted the fair value recognition provisions of Statement of Financial Accounting Standard No. 123R, Share-Based Payment, or SFAS 123R. As required, we adopted SFAS 123R using the prospective transition method. Under this transition method, beginning January 1, 2006, compensation cost recognized includes: (a) compensation cost for share-based payments granted prior to, but not yet vested as of December 31, 2005 related to (i) employees, based on the intrinsic value in accordance with the provisions of Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, or APB 25, and (ii) non-employees based on the options fair value in accordance with the provisions of SFAS 123, and (b) compensation cost for all share-based payments granted or modified subsequent to December 31, 2005, based on the grant-date fair value estimated in accordance with the provisions of SFAS 123R.
We currently use the Black-Scholes option pricing model to determine the fair value of stock options and purchase rights issued under the employee stock purchase plan. The determination of the fair value of share-based payment awards on the date of grant using an option-pricing model is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. These variables include our expected stock price volatility over the term of the awards, actual and projected employee stock option exercise behaviors, risk-free interest rates and expected dividends.
The estimated fair value of restricted stock unit awards is calculated based on the market price of our common stock on the date of grant, reduced by the present value of dividends expected to be paid on our common stock prior to vesting of the restricted stock unit. Our current estimate assumes no dividends will be paid prior to the vesting of the restricted stock unit.
Table of Contents
Through 2007, we estimated the expected term of options using the “simplified” method, as illustrated in SAB 107. Beginning in 2008, we estimated the expected term of options based on the historical term periods of options that have been granted but are no longer outstanding and the estimated terms of outstanding options.
As we had been operating as a public company for a period of time that was significantly shorter than our estimated expected option term, we were unable to use actual price volatility data. Therefore, we estimated the volatility of our common stock based on volatility of similar entities through 2007. In 2008 we estimated the volatility of our stock based on our actual historical volatility since our initial public offering.
We base the risk-free interest rate that we use in the option pricing model on U.S. Treasury zero-coupon issues with remaining terms similar to the expected term on the options. We do not anticipate paying any cash dividends in the foreseeable future and therefore use an expected dividend yield of zero in the option pricing model.
We are required to estimate forfeitures at the time of grant and revise those estimates in subsequent periods if actual forfeitures differ from those estimates. We use historical data to estimate pre-vesting option forfeitures and record share-based compensation expense only for those awards that are expected to vest. All share-based payment awards are amortized on a straight-line basis over the requisite service periods of the awards, which are generally the vesting periods.
If factors change and we employ different assumptions for estimating share-based compensation expense in future periods or if we decide to use a different valuation model, the expenses in future periods may differ significantly from what we have recorded in the current period and could materially affect our operating loss, net loss and net loss per share.
See Note 2 to the consolidated financial statements in this Annual Report on Form 10-K for further information regarding the SFAS 123R disclosures.
Symphony Allegro, Inc.
On December 1, 2006 we entered into a transaction involving a series of related agreements with Symphony Capital LLC, or Symphony Capital, Symphony Allegro Holdings LLC, or Holdings, and Holdings’ wholly owned subsidiary Symphony Allegro, Inc., or Allegro, to fund the clinical development of AZ-002, Staccato alprazolam, and AZ-004/104, Staccato loxapine, or the programs. Symphony Capital and other investors, together referred to as Symphony, invested $50 million in Holdings, which then invested the $50 million in Allegro. Pursuant to the agreements, Allegro agreed to invest up to the full $50 million to fund the clinical development of the programs, and we licensed to Allegro certain intellectual property rights related to these programs. We have retained manufacturing rights to these product candidates. Pursuant to the agreements, we continue to be primarily responsible for all preclinical, clinical and device development efforts as well as maintenance of the intellectual property portfolio for the programs. We and Allegro have established a development committee to oversee the programs. We participate in the development committee and have the right to appoint one of the five board of director seats of Allegro. We have incurred and may continue to incur expenses related to the programs that are not funded by Allegro. Pursuant to the agreements, we have received an exclusive purchase option, or the purchase option, that gives us the right, but not the obligation, to acquire all, but not less than all, of the equity of Allegro, and reacquire the intellectual property rights that we licensed to Allegro. The purchase option is exercisable at predetermined prices that increase over time and range from $67.5 million starting December 31, 2007 to $122.5 million through December 1, 2010. As of March 1, 2009 the purchase option is $92.5 million. The purchase option exercise price may be paid for in cash or in a combination of cash and our common stock, in our sole discretion, provided that the common stock portion may not exceed 40% of the purchase option exercise price or 10% of our common stock issued and outstanding as of the purchase option closing date. If we pay a portion of the purchase option exercise price in shares of our common stock, then we will be required to register such shares for resale under a resale registration statement pursuant to the terms of a registration rights agreement. If we do not exercise the purchase option by December 1, 2010, then Allegro will retain its exclusive license to develop and commercialize Staccato alprazolam and Staccato loxapine for all indications, and, if they are ultimately commercialized, we will . . .

European Molecular Biology Laboratory (EMBL) Signs Agreement to License Themis and Surflex-Dock Technologies from Tripos

ST. LOUIS, Mo.–(BUSINESS WIRE)–Triposâ„¢, a leading provider of drug discovery informatics products and services, today announced an agreement with the European Molecular Biology Laboratory (EMBL), Europe’s leading research institution for molecular biology, to license Tripos’ Themisâ„¢ and Surflex-Dockâ„¢ software to support their efforts in Chemical Biology. According to Dr. Joe Lewis, Head of the Chemical Biology Core Facility, a collaboration between EMBL, the DKFZ [German Cancer Research Center, Heidelberg] and the University of Heidelberg to provide the infrastructure and expertise to enable small molecule development to research groups at these institutions. “Anytime we can reduce the amount of time it takes to advance our drug discovery efforts, we are very pleased. Tripos’ Surflex-Dock, and new Themis product have enabled us to do exactly that.”

In a benchmark study at EMBL, Surflex-Dock was installed on EMBL’s Linux Grid of 1,400 CPUs. Five million structures of EMBL’s virtual database of commercially available compounds were then docked into a binding site of a project’s receptor structure. The computation was completed in about two days and yielded a promising pool of candidates for experimental testing.

“Virtual screening has become a key technique in Chemical Biology to identify small molecules as tool compounds to help address biological questions. Our testing of Surflex-Dock’s capabilities in this area convinced us that its high speed and accuracy will enable us to quickly find the most promising compounds,” said Dr. Lewis.

Dr. Lewis added, “In first experiments performed at EMBL, Tripos’ Themis already provided interesting new chemical ideas contributing to new drug discovery projects, so in parallel, the Themis technology will enable us to search vast chemical fragment space, as composed and implemented into the Themis database by our medicinal chemists.”

“The decision by the European Molecular Biology Laboratory to select our new Themis technology together with Surflex-Dock is very significant,” said Jim Hopkins, Tripos’ Chief Executive Officer. He added, “The vigorous EMBL study demonstrated that the powerful combination of these two Tripos offerings can effectively enhance the success of discovery efforts.”

Ligand Pharmaceuticals Inc. (LGND) Enters into Screening Agreement with Trevena

SAN DIEGO–(BUSINESS WIRE)–Ligand Pharmaceuticals Incorporated (NASDAQ:LGND – News) and Trevena Inc. today announced the initiation of a joint research and license alliance to screen targets using Trevena’s novel biological platform against Ligand’s combinatorial library of compounds, to identify active compounds with potential for development as novel G-protein coupled receptor (GPCR) therapeutics.

Under the terms of the agreement, Trevena has been granted exclusive worldwide rights to sublicense active compounds resulting from the collaboration. Ligand expects to screen 24 targets over two years and receive payments triggered by a tiered screening paradigm for each target.

“We are delighted to enter into this collaboration that allows us to generate cash flow from the combinatorial chemistry technology we gained through our acquisition of Pharmacopeia,” said John L. Higgins, President and Chief Executive Officer of Ligand. “Working closely with the Trevena team, we hope to rapidly identify and advance novel drug candidates using their unique insight into GPCR signaling pathways.”

Maxine Gowen, President and CEO of Trevena said, “We are excited to work with these exceptional scientists and get access to this proven chemistry platform. We believe that this collaboration will accelerate our drug discovery efforts and the validation of our biological platform.”

About Trevena, Inc.

Trevena, Inc. is a Philadelphia-based drug discovery company focused on developing pharmaceutical products targeting GPCRs. Pharmaceutical products that target GPCRs represent up to 40% of marketed drugs today. Trevena’s drug discovery platform, licensed from Duke University Medical Center, is based on extensive research from the laboratories of scientists Robert J. Lefkowitz, M.D. and Howard A. Rockman, M.D. The company’s drug discovery portfolio is currently focused on programs for cardiovascular and CNS indications. Trevena, Inc. is privately held. (www.trevenainc.com)

About Ligand Pharmaceuticals

Ligand discovers and develops new drugs that address critical unmet medical needs of patients with muscle wasting, frailty, hormone-related diseases, osteoporosis, inflammatory diseases and anemia. Ligand’s proprietary drug discovery and development programs are based on its leadership position in gene transcription technology. In December 2008, we acquired Pharmacopeia in a transaction that provides Ligand rights to numerous collaborations with pharmaceutical companies, pipeline programs and the world’s largest combinatorial chemistry library.

Richter-Helm and Athera Biotechnologies Partner in Development of Recombinant Protein to Treat Cardiovascular Disease

Hamburg, Germany and Stockholm, Sweden, January 21st, 2009 — Richter-Helm BioLogics GmbH & Co. KG and Athera Biotechnologies AB have signed an agreement for the development and manufacturing of Athera’s novel product for prevention of plaque rupture and athero-thrombosis through binding of the protein, Annexin A5, to endothelium. The recombinant protein Annexin A5 is intended for the treatment of patients with Acute Coronary Syndrome and who are at imminent risk for Myocardial Infarction.

This agreement secures a highly cost efficient long-term development and manufacturing plan for Athera, including possible future large volume commercial production. Annexin A5 is a biotechnology product produced using Richter-Helm’s proprietary E. coli based expression system. Richter-Helm will initiate strain and process development of the new process, reaching a 1000 litre production scale.

“The Annexin A5 project fits well with the competence and experience of our company. We are confident that our collaboration will be as efficient and constructive as our negotiations were. Our state-of-the-art facilities are ideal for producing the high-quality Annexin A5 required to comply with the standards of the regulatory agencies.”, stated Dr. Bert Behnke, Managing Director of Richter-Helm.

“We are very pleased to get Richter-Helm as our development partner, they have an excellent reputation. We have now secured cost competitive and high quality production for clinical and commercial use”, said Carina Schmidt, CEO of Athera Biotechnologies.

Galapagos enters strategic alliance in diabetes and obesity with Merck & Co., Inc.

Galapagos NV (Euronext: GLPG) announced today that it has entered into a multi-year global strategic alliance with Merck & Co., Inc. to develop potential new therapies in obesity and diabetes.

Galapagos will be responsible for the discovery and pre-clinical development of new small molecule candidate drugs based on novel Galapagos targets. Merck will have the exclusive option to license each candidate for clinical development and commercialization on a worldwide basis. The alliance will make use of Galapagos’ proprietary SilenceSelect(R: 36.098, -1.882, -4.96%) target discovery platform for identification of novel targets in obesity and diabetes. After validation, targets will be selected by a joint steering committee and entered into screening and chemistry by Galapagos. Merck has the option to acquire an exclusive license to each candidate drug and upon exercise of such an option, Merck will be responsible for the development and commercialization of the candidate drug. Galapagos may execute phase I clinical studies and will have the right to further develop and commercialize certain compounds for which Merck does not exercise its exclusive option.

Under the terms of the agreement, Galapagos will receive an upfront fee of EUR 1.5 million from Merck. In addition Galapagos is eligible to receive discovery, development and regulatory milestone payments that could potentially exceed EUR 170 million total for multiple products, as well as specific sales milestones and royalties upon commercialization of any products covered under the agreement.

“The alliance with Merck in obesity and diabetes further demonstrates Galapagos’ ability to expand into new therapeutic areas,” said Onno van de Stolpe, CEO. “Galapagos has a proven track record of delivering on its alliance programs, making us attractive to potential pharma partners seeking to fill their pipelines with medicines based on novel modes of action. Galapagos has been successful through careful management of its R&D programs; this early stage alliance with Merck fits nicely into our alliance infrastructure as other programs advance into later stages.”

“By combining Galapagos’ novel target identification strategy with Merck’s drug development expertise this collaboration provides a unique opportunity to discover and develop potential new therapies for diabetes and obesity,” said Catherine Strader, Vice President, External Basic Research, Merck Research Laboratories.

Conference call and webcast presentation

Galapagos will conduct a conference call open to the public today at 11.30 Central European Time (CET: 14.7001, -0.06, -0.41%), which will also be webcast. To participate in the conference call, please call +31 20 794 8504, ten minutes prior to commencement. A question and answer session will follow the presentation. Click here to access the live audio webcast. The archived webcast also will be available for replay shortly after the close of the call.

About diabetes and obesity

Diabetes mellitus is a disorder in which blood sugar (glucose) levels are abnormally high because the body does not produce enough insulin to meet its needs. Patients with diabetes type 1 (10% of diabetes patients) have lost the ability to produce insulin themselves. In type 2 diabetes, patients develop resistance to the effects of insulin; obesity is the chief risk factor in developing this type, as 80-90% of patients with type 2 diabetes are obese. Diabetes symptoms include increased urination, thirst, and weight loss. Diabetes also can lead to nerve damage, blood vessel damage, and increased risk of heart attack, stroke, and kidney failure. About 15% of people over the age of 70 develop Type 2 diabetes. Treatment of diabetes involves diet, exercise, education, and, for most people, drugs. Global sales of diabetes drugs totaled $15 billion in 2005[1].

Obesity is the excess accumulation of body fat and is defined as having a Body Mass Index[2] > 30. Being obese increases the risk of many disorders, such as diabetes, heart disease, and certain cancers, and can result in high blood pressure and early death. Increasing activity and reducing caloric intake are essential to treating obesity, but some people also need to take drugs. Around 10% of the world population is obese[3], and sales of obesity drugs in the world’s largest markets are expected to grow from $500 million in 2006 to more than $2 billion by 2016[4].

About Galapagos

Galapagos (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA; OTC: GLPYY) is a drug discovery company with pre-clinical programs in bone and joint diseases and bone metastasis. Its BioFocus DPI division offers a full suite of target-to-drug discovery products and services to pharmaceutical and biotech companies, encompassing target discovery and validation, screening and drug discovery through to delivery of pre-clinical candidates. BioFocus DPI also provides adenoviral reagents for rapid identification and validation of novel drug targets, compound libraries for drug screening as well as chemogenomics and ADMET database products to select targets and compounds. Galapagos currently employs about 460 people and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More information about Galapagos can be found at www.glpg.com.

Vanderbilt University Announces Partnership with Janssen Pharmaceutica N.V. for Schizophrenia Drug Research

Vanderbilt University is pleased to announce a licensing and research agreement with Janssen Pharmaceutica N.V., focusing on discovery of novel drugs for the treatment of schizophrenia. Under the terms of the agreement Vanderbilt University grants Janssen Pharmaceutica N.V. a worldwide exclusive license to existing compounds acting on a neurotransmitter receptor target, and provides a mechanism for the discovery and licensing of additional novel compounds over the next three years.

The licensing and research agreement provides for a total of $10 million in upfront payment and committed research funding to the laboratory of Jeffrey Conn, Ph.D., Director of Vanderbilt’s Program in Drug Discovery. Additional payments will be made based on meeting certain milestones and through royalties on product sales.

Vanderbilt will use its state-of-the-art drug discovery infrastructure, including high throughput screening, medicinal chemistry, molecular biology, and pharmacology testing, to create novel compounds with properties compatible with becoming schizophrenia drugs. In addition to carrying selected compounds from the collaboration into clinical development and through commercialization, Janssen Pharmaceutica N.V. will bring its expertise to the partnership through input on compound design, synthesis and later -stage safety and pharmacokinetic studies.

“This is another milestone for our Program in Drug Discovery and we are excited to be teaming up with one of the world’s leading developers of drugs for treatment of schizophrenia, said Conn. “It is also a testament to Vanderbilt’s commitment to new approaches to drug discovery and developing new models by which academic institutions work closely with industry partners to deliver new breakthrough medicines that have a fundamental impact on human health.”

Stef Heylen, M.D., Chief Medical Officer, CNS Research and Early Development at Janssen, said, “Academic collaborations are an important part of our drug discovery strategy. This collaboration underscores the synergies between industry and academia that can help to create solutions for addressing unmet medical needs. It is a great example of how we can work together with academia to better understand complex diseases and hopefully bring improved treatments to patients.”

Seegene Receives Approval from Health Canada for Its Respiratory Virus Multi-Pathogen Detection Tests

Seegene Receives Approval from Health Canada for Its Respiratory Virus Multi-Pathogen Detection Tests

Seeplex(R) RV5 and RV12 give Canadian caregivers an effective way to test for a broad range of respiratory viruses and pathogens in one single test.

ROCKVILLE, Maryland and SEOUL, Korea, December 3, 2008 — Seegene, Inc., a leader in multi-pathogen diagnostic testing, today announced that it has received a Medical Device License from Health Canada for its Seeplex(R) RV5 ACE (Auto Capillary Electrophoresis) Screening and RV12 ACE Detection tests. Built on the novel and proprietary Seeplex(R) molecular diagnostic platform that delivers maximum specificity, reproducibility and sensitivity, the Canadian healthcare system can now use the RV5 and RV12 diagnostic tests to further improve patient care, reduce healthcare costs and prevent inappropriate antibiotic use.

Quickly detecting the specific cause of respiratory infections, especially for children, the elderly, and patients whose conditions are compromised by asthma or immune system complications is critical due to the high incidence of these pathogens developing into serious diseases. Unfortunately, respiratory disease caused by viral infection cannot be simply determined from clinical symptoms as most viruses induce both upper and lower respiratory infections.

Using the Seeplex RV5 test, doctors can now simultaneously detect the most prevalent flu viruses such as influenza A, influenza B, and respiratory syncytial virus A/B, and screen for 11 viruses, while the RV12 test identifies 12 viruses individually.

Already permitted for use in more than 30 countries recognizing the CE Mark, the license from Health Canada will bring the RV5 ACE Screening and RV12 ACE Detection tests to North America for the first time. In the United States, more than 50 million unnecessary antibiotic prescriptions are written each year for patients outside of hospitals, according to the Centers for Disease Control and Prevention.

“The advantages of Seegene’s novel rapid diagnostic tests will be manifold. With these tests, the therapies targeting a specific pathogen causing the infection for a specific patient can be prescribed much earlier. Another benefit of the test is its ability to enable the continual monitoring of the infection status, which offers a strong potential for reducing hospital stays and freeing up scarce resources for other healthcare needs,” said Jong-Yoon Chun, Founder and Chief Executive Officer, Seegene.

The ease-of-use for caregivers administering the Seeplex RV5 and RV12 tests and the rapidity of receiving conclusive results belies the power of these multi-pathogen assays to simultaneously test for the most prevalent respiratory viruses.

Jong-Yoon Chun added, “The issuing of a Medical Device License from Health Canada is another important milestone for Seegene. In this era of viral epidemics clinicians require the ability to routinely test for a wide spectrum of respiratory pathogens in a single test. The Seeplex RV tests are uniquely performed with one multiplex PCR in a single tube and capillary electrophoresis for automated detection of pathogens providing a new standard for test reproducibility, specificity and sensitivity.”

About Seegene

Seegene, Inc. is a biotechnology company specialized in molecular diagnostics and research applications. It holds a novel detection platform named “Seeplex(R),” which sets a standard in high-throughput and simultaneous multi-pathogen detection called “multiplexing.” Seeplex(R) technology accurately detects multi-pathogens with high-throughput speed, ultimately providing the most economical basis for saving time, labor and cost. Seegene develops, manufactures and markets innovative molecular diagnostic products and services to a worldwide community. The company has more than 47 distributors in 28 countries, including 2 subsidiary offices in the US and Japan. Its mission is to maintain leadership in molecular diagnostics for infectious diseases, genetics, pharmacogenetics, and oncology, and chromosomal analyses using innovative proprietary technologies. For more information please visit www.seegene.com or call +301-762-9066.

MorphoSys and Galapagos Enter Alliance to Co-develop Novel Therapeutic Antibodies in Bone and Joint Disease


Combination of Proprietary Drug Targets and Unique Technologies to Create Range of New Therapeutic Antibodies

MUNICH, GERMANY — (Marketwire) — 11/26/08 — MorphoSys AG (FSE: MOR; Prime StandardSegment, TecDAX) and Galapagos NV (Euronext: GLPG) announced today the launch of a long term co-development alliance aimed at discovering and developing antibody therapies based on novel modes of action in bone and joint disease, including rheumatoid arthritis, osteoporosis and osteoarthritis.

The alliance spans all activities from target discovery through to completion of proof of concept clinical trials of novel therapeutic antibodies. Both companies will contribute their core technologies and expertise to the alliance. Galapagos will provide antibody targetsimplicated in bone and joint disease in addition to its adenoviral target discovery platform to discover further targets for antibody development.MorphoSys will contribute its HuCAL antibody technologies to generate fully human antibodies directed against these targets. The initial goal is to further validate the targets through disease-specific in vitro and in vivotesting of the antibodies. After successful validation, the alliance will select antibody programs for pre-clinical and clinical development.Following proof of concept in human clinical trials, programs will be partnered for subsequent development, approval and marketing.

Under the terms of the agreement, Galapagos and MorphoSys will share the research and development costs, as well as all future revenues equally.Decisions will be made by a Joint Steering Committee comprising members of both companies. An initial set of three targets implicated in bone and joint disease has been selected for the collaboration, and Galapagos isalready commencing with production of these proteins for the alliance.Generation of antibodies directed against these targets will start in2009. More targets will be selected using Galapagos’ target discovery platform to fuel the alliance in the coming years. If successful, the first antibody programs based on these novel targets could enter the clinic within four to five years.

“With this alliance, we are adding a biologics strategy to our small molecule drug discovery. Galapagos is the world leader in discovery ofnovel targets, and this alliance with MorphoSys enables us to explore the potential of proprietary antibody targets. Antibody approaches have provento be successful in developing new therapies for major diseases, including rheumatoid arthritis. Having both approaches, small molecules andantibodies, to fill our product pipeline in bone and joint disease willfurther establish Galapagos as the leader in this field,” said Onno van deStolpe, Chief Executive Officer of Galapagos. “With our cash position and revenue streams from both BioFocus DPI and our pharma alliances, we are in a good financial position to enter into this alliance to create value for our shareholders.”

“This alliance represents a major step in our efforts to gain access to novel antibody targets for proprietary drug development in disease areas with a high unmet medical need. The partnership with Galapagos combines both the scientific and financial strength of two leading companies in their space,” said Dr. Simon Moroney, Chief Executive Officer of MorphoSys. “We are excited to combine our broad antibody expertise with Galapagos’ target discovery capabilities and disease know-how to form a successful partnership. The access to novel disease-related target molecules from a renowned partner accelerates the expansion of our proprietary antibody pipeline. This alliance also complements our development efforts in the field of inflammation and arthritis includingour lead program MOR103.”

With this strategic alliance, MorphoSys gains access to a proven target discovery engine as well as to Galapagos’ expertise in bone and joint disease, to support its therapeutic antibody pipeline expansion. The threemain indications of bone and joint disease – rheumatoid arthritis,osteoporosis and osteoarthritis – all represent very significant marketopportunities with several million people affected worldwide and combinedsales of drug treatments of more than US$ 15 billion in 2006.

Through the alliance with MorphoSys, Galapagos enters the rapidly growingmarket for therapeutic antibodies. In 2007, total sales for the 20antibody drugs on the market amounted to more than US$ 25 billion andantibody sales are forecast to increase to approximately US$ 50 billion in 2013. Fully human antibodies are recognized as the next generation and the majority of therapeutic antibodies currently in development are humanized or fully human. The average industry timescale from discovery to pre-clinical development of antibody therapies is only two to three years, considerably shorter than the average six years for small molecules.Antibodies also incur lower attrition rates than small molecules.

Galapagos and MorphoSys will conduct a conference call and live audio webcast today at 02:00 p.m. CET (8:00 a.m EST) to provide detailed information on the alliance.Dial-in number for the Conference Call (listen-only):Germany & U.K. residents: +32 2 401 53 06For U.S. residents: +1 866 931 1567 Please dial in 10 minutes before the beginning of the conference.Approximately two hours after the press conference, the archived webcast will be available for replay of the conference on http://www.morphosys.comand http://www.glpg.com.

For further information please contact: Dr. Claudia Gutjahr-Löser, Head ofCorporate Communications & Investor Relations, Tel: +49 (0) 89 / 899 27-122, gutjahr-loeser@morphosys.com or Mario Brkulj, Manager CorporateCommunications & Investor Relations, Tel: +49 (0) 89 / 899 27-454,brkulj@morphosys.com

About Galapagos:

Galapagos (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA; OTC: GLPYY)is a drug discovery company with pre-clinical programs in bone and jointdiseases and bone metastasis. Its BioFocus DPI division offers a fullsuite of target-to-drug discovery products and services to pharmaceuticaland biotech companies, encompassing target discovery and validation,screening and drug discovery through to delivery of pre-clinicalcandidates. BioFocus DPI also provides adenoviral reagents for rapididentification and validation of novel drug targets, compound libraries fordrug screening as well as chemogenomics and ADMET database products toselect targets and compounds. Galapagos currently employs about 450 peopleand operates facilities in six countries, with global headquarters inMechelen, Belgium. More information about Galapagos and BioFocus DPI canbe found at www.glpg.com and www.biofocusdpi.com.

About Galapagos’ target discovery technology:

Galapagos’ target discovery engine is based on adenoviruses thatefficiently introduce human gene sequences into a wide variety of humancells to knock-down specific proteins. High-throughput assays thatrepresent a selected human disease state are then used to functionallyselect for those proteins that have a causative effect in those models ofhuman disease. After rigorous validation of these protein targets, theyform the basis for the development of novel drugs.

About MorphoSys:

MorphoSys is a publicly traded biotechnology company focused on thegeneration of fully human antibodies as a means to discover and developinnovative antibody-based drugs against life-threatening diseases.MorphoSys’s goal is to establish HuCAL as the technology of choice forantibody generation in research, diagnostics and therapeutic applications.The Company currently has therapeutic and research alliances with themajority of the world’s largest pharmaceutical companies includingBoehringer Ingelheim, Centocor/Johnson & Johnson, Novartis, Pfizer andRoche. Within these partnerships, more than 50 therapeutic antibodyprograms are ongoing in which MorphoSys participates through exclusivelicense and milestones payments as well as royalties on any end products.Additionally, MorphoSys is active in the antibody research market throughits AbD Serotec business unit. The business unit has operations in Germany(Munich), the U.S. (Raleigh, NC) and U.K. (Oxford). For further informationplease visit http://www.morphosys.com/

HuCAL® and HuCAL GOLD® are registered trademarks of MorphoSys AG

Fragment Based Screening Service at CRELUX and ZoBio

Munich (D) and Leiden (NL), November 24, 2008 / b3c newswire /  – CRELUX and ZoBio announced today that they have successfully executed their first fragment based screening projects from a jointly established platform.

One of the first targets, which also will be made accessible to customers, was Pim1, a kinase that has been implicated in the progression of several haematological malignancies. In addition to the “off the shelf” data on Pim1, tailor made fragment based screening projects are available for customers upon request.

The joint technology platform combines ZoBio’s proprietary Target Immobilized NMR Screening (TINS) technology with CRELUX’s high performance kinase crystallography platform. In the first campaign Pim1 was screened by TINS using ZoBio’s fragment library, hits were assessed in an in vitro kinase assay and the top 50 hits have been soaked into protein crystals. 37 out of these 50 fragments showed defined binding modes. Together with this high hit rate the structural diversity within this group generated multiple points for optimization and clearly proved the power of this technology combination.

“We are delighted to have found a perfect partner for entering into high performance fragment based screening. The collaboration with ZoBio adds another crucial drug discovery technology to our service portfolio”, commented Dr. Michael Schäffer, CEO of CRELUX.

“This project demonstrates the power of the combination of TINS with top notch crystallography. I am absolutely convinced that together we can provide our customers with critical starting point to jump start their challenging or failed targets.” noted Dr. Gregg Siegal, CSO of ZoBio.

CRELUX has used its state-of-the-art structural biology platform to solve more than 270 crystal and co-crystal structures for pharma and biotech companies. This platform encompasses all steps – from target cloning and expression all the way to high-throughput protein crystallization and in-house x-ray crystallography.

ZoBio provides fragment discovery and characterization services to the pharmaceutical and biotech industries using its proprietary Target Immobilized NMR Screening (TINS) platform. TINS, with its unparalleled sensitivity and reliability, has been used to discovery highly diverse, efficient ligands for a variety of targets including kinases, protein-protein interactions, viral targets and membrane proteins.

Company and People Notes: Patheon and Solvias Form Alliance; AstraZeneca Appoints Rich Fante President of US Business; More…


Nov 20, 2008

ePT–the Electronic Newsletter of Pharmaceutical Technology

Company Notes

San Jose, CA (Nov. 14)—AnaSpec established a new facility dedicated to peptide production that complies with good manufacturing practice (GMP). The new facility is adjacent to AnaSpec’s headquarters and provides 5000 ft2 of dedicated GMP space, including two Class 10,000 cleanrooms. AnaSpec produces GMP peptides in milligram to kilogram quantities.

West Lafayette, IN (Nov. 12)—Bioanalytical Systems (BASi), a provider of contract laboratory services and manufacturer of scientific instruments, opened its new European laboratory and office in Warwickshire, United Kingdom. The new 10,000-ft2 facility offers bioanalytical capability and provides access to BASi’s preclinical and pharmaceutical analysis services. BASi Europe distributes BASi instruments and equipment and provides support for customers and distributors throughout Europe.

Rockville, MD (Nov.18)—BioReliance concluded an agreement with Provecs Medical (Hamburg, Germany) for the production of investigational quantities of “Immunalon,” a novel therapeutic agent based on an adenovirus vector that stimulates an immunological response against tumor cells.

Mechelen, Belgium (Nov. 18)—Galapagos concluded collaboration agreements with Merck Serono, a division of Merck KGaA (Darmstadt, Germany). The total value of the contracts for Galapagos is EUR 1.1 million over one year. Galapagos’s BioFocus DPI service division will provide “SoftFocus” compounds for Merck Serono’s drug-discovery programs. In a separate agreement, BioFocus DPI will perform medicinal-chemistry services on an undisclosed Merck Serono program. The latter agreement is an extension of a long-running collaboration that was last expanded in 2005.

Cambridge, MA (Nov. 17)—Genzyme and the International Center for Genetic Engineering and Biotechnology (ICGEB, Trieste, Italy), a not-for-profit research and development organization, will collaborate to advance treatments for neglected diseases. The research agreement between Genzyme and ICGEB will initially focus on the development of new treatments for malaria. The research will take place in ICGEB’s laboratories in New Dehli, India, and in Genzyme’s facilities in Waltham, Massachusetts. Scientists from Genzyme and ICGEB will sometimes work in each other’s laboratories.

Toronto, Ontario, Canada (Nov. 14)—Patheon and Solvias (Basel) formed a global alliance to offer integrated development services to pharmaceutical and biotechnology companies. This alliance combines Patheon’s formulation-development experience with Solvias’s preformulation and solid-state chemistry capabilities. The companies will provide early-development services such as active-ingredient characterization, salt selection and cocrystallization, polymorphism screening, solubility determination, excipient compatibility, and formulation.

Fairfax, VA (Nov. 17)—SRA International, a provider of technology and strategic consulting services and solutions to government organizations and commercial clients, won a contract with the Centers for Disease Control and Prevention (CDC) to provide laboratory support services to the Select Agent Program. Under the contract, SRA will continue to help CDC track the possession, use, and transfer of select agents (biological agents and toxins that could potentially threaten public health and safety if released into the environment) in the US. The company’s work includes certifying that proper biosafety and biosecurity measures are in place in laboratories, processing select agent-transfer requests, and tracking all shipments of select agents between registered facilities.

Menlo Park, CA (Nov. 18)—SRI International, an independent, nonprofit research and development organization, was awarded a $1,788,011 contract by the National Institute on Drug Abuse (NIDA). The award is a continuation of two previous NIDA contracts for which SRI has provided chemical analysis of synthetic peptides and related compounds, as well as drugs of abuse. Under the contract, SRI researchers will provide NIDA with purity, stability, and authenticity analysis of synthetic peptides and compounds in NIDA’s medications-development program.

People Notes

Watertown, MA (Nov. 17)—Howard Bernstein resigned from his position as Acusphere’s executive vice-president of research and development to pursue new opportunities. During Bernstein’s 14-year career with the company, he led the development of its lead product candidate, which is currently awaiting approval by the US Food and Drug Administration. Bernstein also was instrumental in the development of Acusphere’s core microsphere technology platform and in devising ways to apply that technology to potential new and existing drugs.

Cambridge, MA (Nov. 17)—Ascent Therapeutics completed its senior management team by appointing Frederick Jones president and chief executive officer and Stephen Hunt senior vice-president of discovery research. Ascent is an emerging biopharmaceutical company developing “Pepducin” lipopeptides, a novel class of G protein-coupled receptor modulators to treat serious illnesses.

Wilmington, DE (Nov. 18)—AstraZeneca appointed Rich Fante president of the company’s US business. Fante succeeds Tony Zook, whose role was expanded when he was named president of MedImmune (Gaithersburg, MD), AstraZeneca’s wholly owned biologics business. Fante previously served as AstraZeneca’s vice-president of brand strategy and portfolio operations. He led the development and execution of marketing strategies for all AstraZeneca brands in the US.

West Lafatyette, IN (Nov. 14)— Anthony S. Chilton is joining Bioanalytical Systems (BASi) as chief operating officer of scientific services, effective Dec. 1, 2008. Chilton will have responsibility for the scientific services provided to BASi’s customers from three locations in the US and one in the UK.

Houston, TX (Nov. 18)—CytoGenix’s board of directors appointed Lex M. Cowsert to the positions of president, chief executive officer (CEO), and director, effective immediately. Randy Moseley, who was serving as interim CEO, resigned from this position but will remain chairman of CytoGenix’s board and principal financial officer.

Galapagos and Merck Serono Enter New Collaboration Agreements


Mechelen, Belgium; 18 November 2008 – Galapagos NV (Euronext: GLPG) announced today new collaboration agreements with Merck Serono, a division of Merck KGaA, Darmstadt, Germany. Total value of the contracts for Galapagos is €1.1 million over one year.

Galapagos’ service division BioFocus DPI will provide SoftFocus© compounds for use in Merck Serono’s drug discovery programs. In a separate agreement, BioFocus DPI will perform medicinal chemistry services on an undisclosed Merck Serono program; this represents an extension of a long running collaboration which was last expanded in 2005.

“BioFocus DPI has a long relationship with Merck Serono in medicinal chemistry, which we are pleased to extend again this year,” said Onno van de Stolpe, CEO of Galapagos. “The purchase of BioFocus DPI’s SoftFocus libraries underscores our ability to grow business with clients.”

About Galapagos and BioFocus DPI

Galapagos (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA; OTC: GLPYY) is a drug discovery company with pre-clinical programs in bone and joint diseases and bone metastasis. Its BioFocus DPI division offers a full suite of target-to-drug discovery products and services to pharmaceutical and biotech companies, encompassing target discovery and validation, screening and drug discovery through to delivery of pre-clinical candidates. BioFocus DPI also provides adenoviral reagents for rapid identification and validation of novel drug targets, compound libraries for drug screening as well as ADMET database products to select compounds. Galapagos currently employs about 460 people and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More information about Galapagos and BioFocus DPI can be found at www.glpg.com and www.biofocusdpi.com.

Applied Biosystems and Asuragen Collaborate with the Critical Path Institute to Improve Drug Toxicity Screening

FOSTER CITY, Calif., Nov 06, 2008 (BUSINESS WIRE) — Drug toxicity accounts for billions of lost dollars to the pharmaceutical industry each year and is a leading cause of pre-clinical drug failures. The U.S. Food and Drug Administration (FDA) and other regulatory organizations have called upon the pharmaceutical industry to develop more effective tools to help avoid these costly failures, reduce the number of failed compounds, and bring better drugs to market sooner. To help address this challenge, Applied Biosystems Inc. and Asuragen, Inc., a provider of pharmacogenomic services, are collaborating with the Critical Path Institute’s Predictive Safety Testing Consortium to develop a predictive gene signature panel that will allow pharmaceutical companies to quickly and easily screen potential therapeutics for toxic effects in pre-clinical samples.
As part of the collaboration, Critical Path Institute (C-Path), Applied Biosystems, and Asuragen, Inc. will partner to develop a panel of assays with gene targets determined to be associated with carcinogenicity in laboratory rats, a common model organism for pharmaceutical testing. The collaborators will also use the Applied Biosystems assays to determine and differentiate effects that are genotoxic from non-genotoxic modes of action to assist in risk assessment. The new biomarker panel will be based on Applied Biosystems’ TaqMan(R) Gene Signature Array and real-time PCR technology.
C-Path is a publicly funded, nonprofit research and education institute. The institute was established in 2005 to create and support collaborations among industry, academic, and governmental scientists that advance the FDA’s Critical Path Initiative, which is an endeavor to modernize the process for the development of medical products, including drugs, diagnostics and medical devices. The Critical Path Opportunities List, published by the FDA in March 2006, presents examples of how new scientific discoveries in genomics and proteomics, imaging, and bioinformatics could be applied to improve the accuracy of the tests used to predict the safety and efficacy of investigational medical products.
“The development of robust turnkey assays to speed development of therapeutics for patients is one of the fundamental goals of the Critical Path Initiative, for which we believe we can make a difference working with partners such as Applied Biosystems and Asuragen,” said William B. Mattes, Ph.D., director of C-Path’s Predictive Safety Testing Consortium. “We expect this collaboration will facilitate broader utility of genomic biomarkers of toxicity across the industry in order to enable the early prediction and mechanistic understanding of potential carcinogens in pre-clinical research.”
The Predictive Safety Testing Consortium (PSTC) was established by C-Path to bring together major pharmaceutical companies to work in collaboration with C-Path and in coordination with the FDA. Its objective is to enable the exchange of knowledge and resources to speed drug development and improve drug safety. The Consortium currently has 16 members. Scientists from the FDA and its European counterpart, the European Medicines Agency, as well as academic experts also participate as advisors.
Increasingly, researchers are using Applied Biosystems comprehensive line of RNA analysis tools based on gold-standard TaqMan chemistry for the development of potential biomarkers. For this project, Applied Biosystems is providing PSTC scientists with its TaqMan Gene Signature Arrays. PSTC scientists will use this collection of RNA expression assays to develop a biomarker panel for use in screening potential therapeutics for carcinogenic effects in pre-clinical samples.
“Biomarkers that allow early prediction of toxicity will enable pharmaceutical companies to make better compound selection decisions and facilitate the early initiation of risk assessment work that would otherwise delay bringing important medicines to market,” said Peter Dansky, president of Applied Biosystems’ functional analysis division. “We are committed to continue expanding our menu of TaqMan Arrays for applications requiring a robust and highly-sensitive detection system in an easy-to-use and standardized format, such as in high-throughput drug screening.”
The development of tools that improve drug toxicity screening involves the generation and analysis of vast amounts of molecular data. Asuragen is contributing crucial laboratory services, pharmacogenomic expertise, and bioinformatics capabilities for the Predictive Safety Testing Consortium project.
“For this important project, Asuragen is committed to working with the Critical Path Institute and Applied Biosystems to help improve the drug development process,” said Matt Winkler, Ph.D., CEO and CSO of Asuragen.
About the Critical Path Institute
The Critical Path Institute (C-Path) was established in 2005 as a publicly funded, nonprofit research and education institute to serve as “neutral ground” and “trusted third party” for collaborations between scientists and others from government, industry and academia. C-Path’s mission is to help implement the FDA’s Critical Path Initiative (released in March 2004) by developing faster, safer and smarter pathways to new medical products. C-Path has offices in Tucson, Ariz. and Rockville, Md. For more information, visit www.C-Path.org.
About Applied Biosystems Inc.
Applied Biosystems Inc. (formerly known as Applera Corporation) is a global leader in the development and marketing of instrument-based systems, consumables, software, and services for academic research, the life science industry and commercial markets. Driven by its employees’ belief in the power of science to improve the human condition, the company commercializes innovative technology solutions for DNA, RNA, protein and small molecule analysis. Customers across the disciplines of academic and clinical research, pharmaceutical research and manufacturing, forensic DNA analysis, and agricultural biotechnology use the company’s tools and services to accelerate scientific discovery, improve processes related to drug discovery and development, detect potentially pathogenic microorganisms, and identify individuals based on DNA sources. Applied Biosystems has a comprehensive service and field applications support team for a global installed base of high-performance genetic and protein analysis solutions. Applied Biosystems Inc. is headquartered in Norwalk, CT. On June 12, 2008, Applera Corporation and Invitrogen Corporation announced that their Boards of Directors had approved a definitive merger agreement under which Invitrogen will acquire all of the outstanding shares of Applied Biosystems stock. The merger is subject to customary closing conditions and is targeted to close in November 2008. Information about Applied Biosystems, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.appliedbiosystems.com. All information in this news release is as of the date of the release, and Applied Biosystems does not undertake any duty to update this information unless required by law.
About Asuragen, Inc.
Asuragen is a molecular biology service provider and fully integrated diagnostic reagent company focused on molecular oncology and the early detection of cancer, with emphasis on microRNA (miRNA). The Asuragen Pharmacogenomic Services Division provides comprehensive molecular services for DNA, mRNA, and miRNA empowering commercial and academic scientists to rapidly acquire a wide range of molecular data. Our services group possesses critical expertise in biomarker discovery, assay design and validation, clinical trial design, CLIA-based testing, project management, and analysis.
Asuragen also provides a high level of expertise in diagnostic assay development, a well developed business infrastructure, and an established cGMP manufacturing facility that allow it to span the spectrum of discovery, testing, production, and commercialization. Asuragen is dedicated to developing new technologies that will lead to cutting edge clinical products. Visit our website at www.asuragen.com
Applied Biosystems Forward Looking Statements
Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as “should,” “expect,” and “planned,” among others. These forward-looking statements are based on Applied Biosystems’ current expectations. The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for such forward-looking statements. In order to comply with the terms of the safe harbor, Applied Biosystems notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to: (1) rapidly changing technology and dependence on the development and customer acceptance of new products; (2) sales dependent on customers’ spending policies; (3) other factors that might be described from time to time in Applied Biosystems’ filings with the Securities and Exchange Commission.
For Research Use Only. Not for use in diagnostic procedures. Practice of the patented 5′ Nuclease Process requires a license from Applied Biosystems. For further information on purchasing licenses contact the Director of Licensing, Applied Biosystems, 850 Lincoln Centre Drive, Foster City, California 94404, USA. The TaqMan(R) Array is covered by U.S. Patents Nos. 6,514,750 and 6,942,837. Micro Fluidic Card developed in collaboration with 3M Company.
(C)Copyright 2008. Applied Biosystems Inc. All rights reserved. Applied Biosystems, and AB (Design) are registered trademarks of Applied Biosystems Inc. or its subsidiaries in the U.S. and/or certain other countries. TaqMan is a registered trademark of Roche Molecular Systems, Inc. All other trademarks are trademarks of their respective owners.
SOURCE: Applied Biosystems Inc.

WuXi PharmaTech Inks New Three-year Deal with Pfizer

WuXi PharmaTech (NYSE: WX) has signed a new three-year CRO deal with Pfizer (NYSE: PFE) to collaborate on in vitro ADME (Absorption, Distribution, Metabolism and Excretion) services. Although WuXi has already been providing the services to Pfizer, WuXi said the new agreement “strengthens an already productive relationship.” WuXi also provides Pfizer with synthetic chemistry, parallel medicinal chemistry (PMC), and bioanalytical services.

In partnership with Pfizer, WuXi PharmaTech will establish ADME assays to provide in vitro screening services on compounds WuXi PharmaTech synthesizes for Pfizer. The goal is to improve the pharmacokinetic properties of new compounds.

The announcement did not disclose financial details of the contract.

DEFINIENS AND BIOSCAN TEAM UP FOR COOPERATIVE MARKETING EFFORTS

Morristown, New Jersey / Munich, Germany – December 2, 2008 – Definiens, the number one Enterprise Image Intelligence™ company, has signed a co-marketing agreement with Bioscan, Inc., a leading developer of advanced imaging instrumentation for radiolabeled compounds.  Under the terms of the agreement, Bioscan and Definiens will conduct cooperative marketing activities and host joint workshops and events.  Customers will benefit through integrated training and implementation programs and streamlined access to the market-leading solutions offered by both companies. 

Non-invasive in vivo animal imaging offers researchers a window into living biological systems.  It provides the means to track a range of biological processes, from metabolism to receptors and gene-expression, and enables the effects of candidate pharmaceutical treatments to be monitored more accurately.  Recent improvements in molecular imaging technologies have made in vivo preclinical imaging increasingly important to researchers, and especially to those involved in the drug development process.  However, intelligent image analysis is required to extract meaningful insight from the prodigious amounts of data generated by advanced preclinical in vivo imaging systems.

Bioscan develops advanced instrumentation for the detection, synthesis and imaging of radiolabeled compounds used in life science research, molecular imaging, pharmaceutical development and nuclear medicine.  The company’s dual modality NanoSPECT/CT and NanoPET/CT in vivo animal imaging systems provide unparalleled insight into molecular function at the nanoliter precision level.  With these nano-nuclear imagers, Bioscan allows researchers to overcome the challenge of balancing resolution and sensitivity that has hampered the advancement of non-invasive imaging in preclinical studies.  

“Definiens and Bioscan share a commitment to developing the most advanced imaging technologies on the market,” said Dr. York Hamisch, Vice President of Imaging Technologies at Bioscan.  “This cooperative agreement will provide our customers with special access to Definiens’ image analysis technology, enabling them to extract information from their imagery with a high level of automation.”


Definiens provides life science organizations with software applications for analyzing and interpreting images on every scale, from cell and tissue-based assays to in-vivo imaging systems.  The company’s proprietary Definiens Cognition Network Technology® is context-based, emulating human cognitive processes to extract intelligence from images of all modalities, sizes,  and resolutions.  Definiens image analysis software complements Bioscan’s imaging systems, enabling researchers to extract additional quantitative and anatomical information from 3D images of small animal models.

 

“Increased adoption of non-invasive imaging is indicative of the life science research community’s move toward a systems biology approach,” said Manfred Voglmaier, Vice President of Business Development, Life Sciences at Definiens.  “Partnering with Bioscan provides an opportunity for Definiens to introduce its imaging technology to an established community of molecular imaging researchers.”

Definiens and Bioscan will continue to explore further opportunities for cooperation, which may include the co-development of user interfaces to incorporate Definiens software into Bioscan hardware.  Existing Bioscan customers will also benefit from introductory offers on Definiens applications beginning in late 2008.

The German Cancer Research Center Investigates the Role of miRNAs in Carcinogenesis Using febit’s Geniom RT Analyzer

LEXINGTON, Mass. (USA), and HEIDELBERG, Germany, Oct. 20, 2008 – The German Cancer
Research Center, also known as DKFZ, in Heidelberg (Germany) chose febit´s newly
introduced Geniom® RT Analyzer to investigate the association of microRNAs (miRNAs)
and cancer.

miRNAs are small pieces of RNA with a maximum length of 23 nucleotides, which have
become an important focus of life-science research in the past couple of years.
Since they do not encode any proteins, they remained largely unappreciated for many
decades. Recently, however, scientists began to realize their crucial role in the
regulation of intracellular events such as differentiation or apoptosis of cells.
The number of miRNA being discovered is growing by the day.

DKFZ scientists therefore searched for a technology that would allow them to keep
pace with the rapidly evolving miRNA databases, continually incorporating the latest
information into their research on the role of miRNAs in carcinogenesis. The newly
developed Geniom RT Analyzer ideally meets this requirement: it exploits freely
configurable biochips produced on demand at febit for microarray analysis of miRNA
profiles in biological samples.

“Our positive experience with the flexibility of febit´s Geniom contributed to our
decision to use the new Geniom RT Analyzer,” said Joerg Hoheisel, director of the
DKFZ Functional Genome Analysis Division. “Preliminary tests indicate an excellent
quality of microarray analysis. In addition, my team is enthusiastic about the
straight-forward operation and outstanding efficiency of the instrument.”

In addition to flexibility, the Geniom RT Analyzer offers a high degree of
automation and nume­rous user-friendly features: all steps in the workflow,
including sample addition, hybridization, staining, washing, shaking and detection,
are performed in one single instrument requiring a minimum of operator time. The
efficient operation results with minimal error rates and offer consistent
experimental parameters providing highly reproducible results. Data read out by the
Geniom Wizard software may then be analyzed with standard software solutions.

In addition to miRNA analysis, the Geniom RT Analyzer offers a variety of other
high-performance applications. For example, a patented biochip protocol enables the
fragmen­tation and sorting of large genomes in smaller well-defined fractions.
Without this essential fractionation step, the complexity of the genomic DNA would
preclude any effective analysis. These may then serve as samples in mutation
analysis and high-throughput sequencing with next-generation sequencers.

febit’s new Geniom RT Analyzer combines extraordinary flexibility with a high degree
of automation for microarray analysis. (Photo: febit)

About febit

febit enables scientists to read, write and understand the code of life: DNA. With
its unique Geniom technology and services, febit is the only company that puts the
control of simplified genomic research in the hand of the user. The seamless
integration of DNA synthesis and analysis and the superior support in experiment
design and bioinformatics helps to understand data and turn it into results. febit’s
team of experienced scientists is dedicated to support customers to solve the
challenge of understanding biological processes. Geniom is a technological and
service platform successfully implemented in basic and applied research by renowned
institutions and companies. Geniom exploits cutting-edge microarray technology for
analysis and synthesis of genes and genomes, providing superior time- and
cost-efficiency combined with an unsurpassed spectrum of applications.

For more information about febit and its products please visit

www.febit.com

About the DKFZ, Division of Functional Genome Analysis

Research at the division of Functional Genome Analysis at the DKFZ (German Cancer
Research Center) aims at the development and immediate application of new
technologies for the production and processing of molecular information at a global
cellular level. The overall objectives are an analysis, assessment and description
of the realisation of cellular function from genetic information as well as the
understanding of the regulation of the relevant processes. Many projects are pursued
in national and international collaborations and programmes.

For more information on Functional Genome Analysis at the DKFZ, please visit
www.dkfz.de/funct_genome/

Hydra Biosciences Bolsters Discovery and IP Capabilities with Key Additions to Executive Management Team

CAMBRIDGE, Mass., Oct 24, 2008 (BUSINESS WIRE) — Hydra Biosciences, a privately held biopharmaceutical company focused on developing novel drugs using its expertise in Transient Receptor Potential (TRP) ion channels, announced today the expansion of its executive management team with the appointments of David Kimball, Ph.D. as Chief Scientific Officer and Christine Bellon, Ph.D. as Vice President of IP and Legal Affairs. Dr. Kimball most recently served as Senior Vice President, Discovery, at Pharmacopeia. Dr. Bellon joins Hydra from Infinity Pharmaceuticals, where she served as Assistant General Counsel, Intellectual Property.
“We are excited to add the demonstrated scientific, business and legal acumen of Christine and David to an already talented management team, and believe their appointments are indicative of the broader near-term growth potential for our organization,” said Russell Herndon, President and Chief Executive Officer of Hydra. “David and Christine will each play a key role in advancing and building upon the strong IP position of our deep and competitively differentiated pipeline of TRP ion channel antagonists and agonists in development for the treatment of pain, inflammatory disease, pulmonary dysfunction, and other indications.”
Dr. Kimball joins Hydra with 25 years of experience in the discovery and development of small molecule drug candidates. At Pharmacopeia Dr. Kimball was responsible for research alliances as well as drug discovery research from target identification through preclinical development. During his six years at Lexicon, Dr. Kimball built the company’s discovery capability with direct responsibility for Lexicon’s small molecule pipeline. Dr. Kimball grew and managed an organization of over 75 chemists, including medicinal, analytical, computational, process research and development, library synthesis and outsourcing chemistry. Prior to joining Lexicon, Dr. Kimball spent nearly 20 years at Bristol-Myers Squibb Pharmaceutical Research Institute, most recently as Research Fellow in the Division of Medicinal Chemistry. During his tenure at BMS, Dr. Kimball led several significant drug discovery and development research efforts that culminated in clinical compounds. An Associate Member of the graduate faculty at Rutgers University School of Pharmacy since 1989, Dr. Kimball received his Ph.D. in Organic Chemistry/Chemical Biology from the State University of New York at Stony Brook.
Dr. Bellon brings more than 15 years of experience in intellectual property law to Hydra. Dr. Bellon came to Hydra from Infinity Pharmaceuticals, where she held the position of Assistant General Counsel, Intellectual Property. Prior to her position at Infinity Pharmaceuticals, Dr. Bellon served as patent counsel at Wyeth Pharmaceuticals, where she was responsible for the company’s small molecule cardiovascular and metabolic disease patent portfolio and structural biology patent portfolio. Earlier in her career, Dr. Bellon was an attorney in the Boston office of Fish & Richardson P.C., where her practice focused on patent prosecution and client counseling in the areas of pharmaceuticals, chemicals, polymers, and biotechnology. Dr. Bellon received a B.S. in Chemistry from Yale University, and holds a Ph.D. in Organic Chemistry from the Massachusetts Institute of Technology and a J.D. degree from Columbia Law School.
About TRP Ion Channels
Ion channels have been implicated in many diseases, including hypertension, cardiac arrhythmias, gastrointestinal disorders, cystic fibrosis and pathological pain. Many drugs on the market today act on ion channels, either directly or indirectly, including calcium channel blockers for hypertension and angina, and sodium channel blockers for pain. Hydra’s TRP channel discovery program has identified numerous modulators predicted to impact diseases such as pain and inflammation, hypertension, and pulmonary diseases. Many of these modulators have been shown to be efficacious in animal models of disease. In addition, ion channels have been successful drug targets, with modulators of ion flux representing up to 17% of world pharmaceutical sales.
About Hydra Biosciences
Hydra Biosciences, a biopharmaceutical company based in Cambridge, Massachusetts, develops novel drugs to treat pain, inflammation, cardiovascular and other diseases using its expertise in novel ion channels. Hydra’s proprietary high throughput screening platforms enable the company to identify and develop drug candidates that address significant unmet medical needs. More information about Hydra Biosciences is available at: www.hydrabiosciences.com.

BNC Collaborators Author High-profile Paper in Nature Nanotechnology

London, UK – 17 October 2008: Research by scientists collaborating with specialist product development consultancy, Bio Nano Consulting (BNC), into the workings of vancomycin – one of the few antibiotics that can be used to combat increasingly resistant infections such as MRSA – has been published in Nature Nanotechnology (October 2008). The researchers, led by Dr Rachel McKendry and Professor Gabriel Aeppli at the London Centre for Nanotechnology, developed novel, ultra-sensitive nanomechanical probes capable of providing new insight into how antibiotics work, paving the way for the development of more effective new drugs.

Commenting on the new research, Bio Nano Consulting CEO, Dr David Sarphie said “BNC was set up specifically to help companies apply nanotechnology tools to address real-world biomedical problems such as antimicrobial resistance. Working with the BNC allows companies access scientists who have expertise in numerous ground-breaking nanotech-related research areas, and this paper in Nature Nanotechnology is a great example of the highest quality research that they are undertaking.”

During the study Dr McKendry, Joseph Ndieyira, Moyu Watari and coworkers used cantilever arrays – tiny levers no wider than a human hair – to examine the process which ordinarily takes place in the body when vancomycin binds itself to the surface of the bacteria. They coated the cantilever array with mucopeptides from bacterial cell walls and found that as the antibiotic attaches itself, it generates a surface stress on the bacteria which can be detected by a tiny bending of the levers. The team suggests that this stress contributes to the disruption of the cell walls and the breakdown of the bacteria.

The interdisciplinary team went on to compare how vancomycin interacts with both non-resistant and resistant strains of bacteria. The ‘superbugs’ are resistant to antibiotics because of a simple mutation which deletes a single hydrogen bond from the structure of their cell walls. This small change makes it approximately 1,000 times harder for the antibiotic to attach itself to the bug, leaving it much less able to disrupt the cells’ structure, and therefore therapeutically ineffective.

“There has been an alarming growth in antibiotic-resistant hospital ‘superbugs’ such as MRSA and vancomycin-resistant Enterococci (VRE),” said Dr McKendry. “This is a major global health problem and is driving the development of new technologies to investigate antibiotics and how they work.

“The cell wall of these bugs is weakened by the antibiotic, ultimately killing the bacteria,” she continued. “Our research on cantilever sensors suggests that the cell wall is disrupted by a combination of local antibiotic-mucopeptide binding and the spatial mechanical connectivity of these events. Investigating both these binding and mechanical influences on the cells’ structure could lead to the development of more powerful and effective antibiotics in future.”

Established in late 2007, BNC provides a seamless concept-to-market route for the bio-nanotechnology sector.

Image caption:
A schematic representation to show the nanomechanical detection of antibiotic-peptide interactions on multiple cantilever arrays. The blue and white structures show chemical binding interaction between vancomycin and the bacterial mucopeptide analogue, DAla. The red line represents the mechanical connectivity of the chemically reacted regions on the cantilever.

For more information please visit www.bio-nano-consulting.com

Editors’ notes

About the paper and authors:
The article ‘Nanomechanical Detection of Antibiotic Mucopeptide Binding in a Model for Superbug Drug Resistance’ by J. W. Ndieyira et al., was published in Nature Nanotechnology, October 12 2008.

About Bio Nano Consulting
The BNC is a specialist research and development consultancy operating in the convergent field of bionanotechnology. A joint venture of Imperial College London and University College London, the BNC is funded through the Technology Strategy Board (TSB) with additional support from the London Development Agency (LDA).

Along with its partner organisation, the National Physical Laboratory, the BNC offers a service to the biomedical and healthcare industries in microsystems and nanotechnology. This encompasses design, 3-D modelling and visualisation, rapid prototyping, and characterisation.