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EPA seeks broad powers to regulate chemical industry

Last Updated on Monday, 19 October 2009 03:49 Written by Editor Monday, 19 October 2009 03:49

By RANDY LEE LOFTIS / The Dallas Morning News
rloftis@dallasnews.com The Obama administration announced Tuesday that it is seeking broad new powers to regulate toxic substances in commerce, products and the environment, including clear authority to ban unsafe chemicals.

Environmental Protection Agency Administrator Lisa Jackson laid out the administration’s principles for rewriting the nation’s main toxic chemicals law, which has not been revised significantly in 33 years.

During that time, thousands of new chemicals, processes and even types of substances have entered the economy, many with little or no health and safety review by manufacturers or the government. Researchers have found the chemicals in millions of Americans’ bodies; one study found big increases in the levels of a widely used flame retardant in the blood of Dallas residents.

“Today, everything from our cars to the cellphones we all have in our pockets are constructed with plastics and chemical additives,” Jackson said. “Chemicals are ubiquitous in our economy and our products as well as our environment and our bodies.”

House and Senate Democrats are expected to introduce bills to strengthen the Toxic Substances Control Act soon. Among the anticipated changes is one that Jackson endorsed: letting the EPA act on its own to restrict or outlaw chemicals that do not meet health and safety standards.

1991 ruling on asbestos

A 1991 federal appeals court ruling on asbestos essentially gutted the agency’s power to ban chemicals under the existing law. Congress banned further use of polychlorinated biphenyls, or PCBs, when it passed the toxic substances law in 1976, but the 1991 asbestos ruling has kept the EPA from acting against other risky chemicals.

Jackson said new chemicals and scientific breakthroughs had rendered the law weak and obsolete. Those include the discovery that some chemicals can disrupt the human endocrine system, new knowledge of the risks of some flame retardants, and increasing production of extremely small nanoscale materials that have undergone virtually no health screening.

While some substances might be proved harmless, Jackson said, the widespread discovery of many synthetic chemicals in virtually the world’s entire population demands safety assurances that an outdated law cannot provide.

“Over the years, not only has [the toxics law] fallen behind the industry it’s supposed to regulate, it’s been proven an inadequate tool for providing the protection against chemical risks that the public rightly expects,” she said in remarks prepared for delivery in San Francisco on Tuesday evening.

The administration wants to change the current chemical safety system, which puts new chemicals under more scrutiny than the 80,000 already believed to be in use, Jackson said. Sorting through all existing chemicals could take decades at the current pace, with the public possibly facing undue risk while the process drags on.

Jackson said the EPA would prioritize reviews of existing chemicals by requiring more information from industry on health and safety, use and human exposure. She added, however, that the agency would not skip over possible risks in the interest of speed.

“None of the 80,000 should be exempt,” Jackson said. “I think industry understands that.”

Texas is the heart of the U.S. chemical industry, especially along the Gulf Coast from Beaumont-Port Arthur to Corpus Christi. The federal toxics law regulates chemicals as they come into contact with people through products or industrial uses. Risks from chemical emissions into the air fall under the Clean Air Act.

Industry seeking validation

The chemical industry has endorsed reform of the toxics law along the general lines that Jackson mentioned, in part to boost confidence among consumers worried about compounds in their bodies and their children’s. The industry said its principles include imposing more stringent requirements for health and safety information from manufacturers and giving more weight to risks for children and other vulnerable groups, both mirroring the EPA’s goals

“We are convinced today, through our own testing in the industry, that our products are safe,” Cal Dooley, president and CEO of the American Chemistry Council, the trade group that represents most Texas chemical manufacturers, told reporters. “But we need that validation by the government regulatory agency that is doing the scientific assessments.”

While Congress works to rewrite the law, Jackson said, the EPA plans special reviews of chemicals that have raised particular human health concerns since the law was passed. They include bisphenol A, or BPA, used in polycarbonate plastics and epoxy resins; polybrominated diphenyl ether (PBDEs), used as flame retardants; perfluorinated compounds, used in soil- and water-repellant coatings on many consumer products; and phthalates, used in many plastics.

The EPA will issue action plans for managing risks from four of the compounds in December and will publish others in four-month intervals, Jackson said.

“This is very good news,” said Dr. Arnold Schecter of the University of Texas School of Public Health, Dallas, who studies persistent organic pollutants such as the ones the EPA singled out for special review. He has found PBDEs in 100 percent of American mothers’ breast milk tested, with some women carrying “orders of magnitude” more than women in Europe, where the compounds have been phased out since 2004.

A joint study by the School of Public Health, where Schecter is professor of environmental sciences, and the UT Southwestern Medical Center found a “very large increase” in the PBDEs in Dallas residents’ blood in 2003 compared with blood tested in 1993, Schecter said.

Schecter said stronger federal action on risks from persistent organic compounds was overdue.

“What a refreshing change,” he said.

Source: Dallas News

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BioFocus DPI to apply TET Technology in high-throughput screening campaigns

Last Updated on Sunday, 26 April 2009 05:10 Written by Editor Sunday, 26 April 2009 05:10

Saffron Walden, UK and Heidelberg, Germany; 24 April 2009 – BioFocus DPI, a leading provider of gene-to-candidate discovery services, and TET Systems Holding, a privately-held, German-based biotech company, announced today that they have entered into an agreement to apply TET System’s inducible gene technology in high-throughput screening campaigns performed for BioFocus DPI customers.

BioFocus DPI will offer TET Technology as part of its drug discovery screening service.  Through this technology, the activity of individual genes can be controlled quantitatively and reversibly in cellular assays.  This approach is particularly powerful in cases where the target is not well tolerated in the cells, since the protein will not be expressed until required for screening.

“The TET Technology allows us to build on the proven compound screening service that we offer clients.  This powerful approach will benefit discovery programs that are hindered by difficult to express targets.  Using this technology, we will be able to perform more efficient, extensive compound screening on these problematic targets,” commented Dr. Kate Hilyard, VP Biological Sciences, BioFocus DPI.

“We are very pleased to sign this agreement with BioFocus DPI, one of the leading drug discovery service providers worldwide.  TET Technology has been used successfully for many years by most of the major pharmaceutical companies.  Through this new partnership with BioFocus DPI, a broader range of pharmaceutical and biotechnology companies will gain access to TET System’s gene expression technology,” stated Dr. Ernst Boehnlein, CEO of TET Systems Holding and IP Merchandisers.

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AEterna Zentaris Presents Two Posters on its PI3K Inhibitor Compound, AEZS-126, at AACR Annual Meeting

Last Updated on Sunday, 26 April 2009 05:09 Written by Editor Sunday, 26 April 2009 05:09

In Vitro and In Vivo Data Show AEZS-126 as Promising Oral Compound for

Future Clinical Development in Cancer

QUEBEC CITY, April 21 /PRNewswire-FirstCall/ – AEterna Zentaris Inc. (TSX: AEZ; NASDAQ: AEZS), a global biopharmaceutical company focused on endocrine therapy and oncology, today presented two posters on AEZS-126, a promising compound for clinical intervention of the PI3K/ Akt pathway in human tumors. The posters were presented at the American Association for Cancer Research (AACR) Annual Meeting in Denver, Colorado.

Poster #3705

Entitled, “AEZS-126, a new orally bioavailable PI3K inhibitor with antitumor effects”, I. Seipelt, S. Baasner, M. Gerlach, M. Teifel, J. Fensterle, L. Blumenstein, G. Mueller and E. Guenther, the poster focuses on ADMET and safety profiling of the compound, as well as in vivo pharmacokinetic experiments and mouse xenograft antitumor studies.

Results

AEZS-126 was identified as a potent inhibitor of class I PI3Ks in biochemical and cellular assays and demonstrated favorable properties in early in vitro ADMET screening including microsomal stability, plasma stability and screening against a large safety profile composed of receptors, enzymes and cardiac ion-channels. During the course of in vivo pharmacokinetic experiments and mouse xenograft antitumor studies, the oral bioavailability in mice was determined to be about 60%, leading to micromolar plasma levels which are well above the nanomolar IC50 values in in vitro studies. Significant antitumor activity was observed at 30mg/kg daily oral administration in Hct116 and A549 models.

Conclusion

These data suggest that AEZS-126 is a promising compound for clinical intervention of the PI3K/Akt pathway in human tumors.

Poster #3706

Entitled, “In vitro profiling of the potent and selective PI3K inhibitor, AEZS-126″, I. Seipelt, M. Gerlach, L. Blumenstein, G. Mueller, M.Teifel, E. Polymeropoulos and E. Guenther, the poster outlines the key in vitro characteristics of this compound that led to its selection for in vivo development.

Results

AEterna Zentaris has identified a new generation of low molecular weight pyridopyrazine compounds as highly potent and selective inhibitors of class I PI3Ks. Presented here, are the key in vitro characteristics of AEZS-126 that led to its selection for in vivo development. AEZS-126 inhibits PI3Ka with an IC50 value of 10nM and proved to be a potent inhibitor of Akt phosphorylation in cellular assays. Mode-of-action studies showed that AEZS-126 acts as an ATP competitive compound. The in vitro antiproliferative activity against different human tumor cell lines (MDA-MB 468, U87, Hct116, PC-3, A549 and others) was determined, with EC50 values in the nanomolar range.

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Institute of Microbiology of the Chinese Academy of Sciences and TB Alliance Announce Partnership to Develop New Tuberculosis Drugs from Natural Sources

Last Updated on Wednesday, 1 April 2009 12:44 Written by Editor Wednesday, 1 April 2009 12:44

BEIJING & NEW YORK–(BUSINESS WIRE)–The Institute of Microbiology (IMCAS), a member institute of the Chinese Academy of Sciences, and the Global Alliance for TB Drug Development (TB Alliance), a not-for-profit product development partnership accelerating the discovery and development of new TB drugs, today announced a partnership to discover and develop promising, novel anti-tuberculosis agents from natural sources, including microbial metabolites and traditional Chinese medicines.

A pilot screen conducted by IMCAS identified 24 natural product extracts as having potential anti-tubercular activity. IMCAS and the TB Alliance will collaborate to further test these extracts, purify and identify the active components, and develop those that prove most promising. Additionally, IMCAS and the TB Alliance will work together to investigate traditional Chinese herbal medicines and purified compounds for biological activity against the Mycobacterium tuberculosis (M.tb) organism. Scientists in China have made significant contributions in developing new drugs from natural sources, as exemplified by the identification of Artemisinin, one of the most effective anti-malarial drugs, first isolated from a traditional Chinese medicinal plant. The deficiency in natural product screening directly against M.tb combined with China’s strong track record of successfully developing new drugs from traditional Chinese medicines, suggests such screenings are likely to yield novel active compounds.

Previously, a group of scientists including Professors Lixin Zhang, Deborah Hung and Eric Rubin of IMCAS, Broad Institute and Harvard University, respectively, worked together to investigate underlying mechanisms of M.tb, the bacterium that causes TB, with the intent to develop new TB drugs from natural sources to treat both drug-susceptible and drug-resistant TB. Modern technologies including high-throughput chemical screening, total genome sequencing, and the construction of systematic, comprehensive arrayed bacterial libraries were utilized in this process.

“This partnership reflects China’s increasing commitment to address the deadly TB epidemic, which has had such a devastating effect on so much of the world for so many years,” said Dr. Mel Spigelman, President and CEO, TB Alliance. “Bringing the best science in China together with the expertise of the TB Alliance is an example of the pooling of global resources necessary to save the millions of lives needlessly lost to TB every year.”

Novel drugs are needed to work against drug-resistant TB, the more deadly and difficult-to-treat form of TB that is on the rise across the globe, including Asia. Drug resistance oftentimes emerges as a result of patients not completing the burdensome regimen currently used to treat drug-susceptible TB. The last class of new TB drugs was developed and approved in the 1960s. While the current treatment regimen for drug-susceptible TB is effective when administered properly, it must be administered over six to nine months. Treatment for multidrug-resistant tuberculosis (MDR-TB) usually takes a minimum of 18 months and only cures approximately half of those infected. New, faster-acting TB treatments can improve treatment of both drug-sensitive and drug-resistant TB, enhance compliance, lower relapse rates, reduce the growth of drug resistant TB, reduce health care costs and save millions of lives. The partnership between IMCAS and the TB Alliance is a fitting precursor to the three-day ministerial meeting of high MDR-/XDR-TB burden countries beginning tomorrow in Beijing.

“The fight against tuberculosis is a global endeavor. This partnership represents joint efforts by IMCAS and the TB Alliance in the development of new TB drugs from natural resources,” said Prof. Li Huang, Executive Deputy Director-General of the IMCAS. “Natural products have long been an important source of drugs for human medicine. The rich functionality and stereochemistry of natural products is without doubt one of their great strengths, providing both potency and selectivity. Taking advantage of its expertise in the exploitation of microbial resources, IMCAS has recently set up the Drug Discovery Center for Tuberculosis. The aim of the Center, led by Prof. Lixin Zhang, is to develop and deliver novel TB drugs that work quickly and can help prevent the problems of today’s drugs relating to compliance, drug resistance and TB-HIV co-infection.”

The TB Alliance is leading the development of the most comprehensive portfolio of TB drugs in history, and is accelerating discovery, preclinical and clinical research of known and novel classes of antibiotics to shorten and simplify the treatment of tuberculosis, including MDR- and XDR-TB. The TB Alliance is committed to making all drugs developed by its research partnerships affordable and available to all who need them.

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First auto carbohydrate synthesiser

Last Updated on Tuesday, 24 March 2009 12:24 Written by Editor Tuesday, 24 March 2009 12:24

German researchers have unveiled the first fully automated carbohydrate synthesiser, which they hope will advance development of carbohydrate-based vaccines for the developing world.

The new machine was announced at this week’s meeting of the American Chemical Society in Salt lake City, Utah, and could significantly reduce the amount of time it takes for researchers to build complex carbohydrates for vaccine research. Currently, synthesis of multiple carbohydrates for screening causes a bottle neck in efforts to discover new carbohydrate-based vaccines.

‘A chemical synthesis of a single carbohydrate typically takes months to years,’ explains Peter Seeberger from the Max Planck Institute of Colloids and Interfaces, Potsdam. His team has now revealed a next generation synthesiser, building on an earlier partially automated model announced in 2001, that Seeberger says is ‘entirely reliable, very fast and can be operated by somebody with no experience of chemistry at all’. And when he says fast, he means fast: ‘we have repeated a synthesis of a carbohydrate that initially took two years in the lab in less than 20 hours.’ He also claims to have fixed protection and deprotection issues, major hurdles in carbohydrate synthesis, that plagued the earlier version of the synthesiser.

The concept of the machine is very simple, solid phase chemistry. The starting point is a polystyrene bead with a single sugar attached and ‘we add to that one sugar at a time like threading beads on a necklace,’ explains Seeberger. ‘The bead’s only role is to stop the sugar from being dissolved, and using this methodology we can build up chains between six and 15 sugars. The addition of each sugar takes about two hours, meaning that in 1.5 to two days we can make pure, useable quantities of carbohydrates.’ In a single run they can make 25-50mg of carbohydrate. Seeberger also claims that the sugar building blocks can be made easily in 50-100g bulk quantities.

Carbohydrates surround every cell in humans, bacteria and viruses and play a crucial role in the body’s immune response to disease-causing viruses and bacteria. They have been used for medicinal purposes before, including in some blockbuster vaccines used to inoculate small children against bacterial diseases, such as meningitis, explains Seeberger. The current vaccines are based on isolated carbohydrates – meaning drug companies have to grow bacteria, harvest the carbohydrates, isolate mixtures of compounds and put them into a carrier protein – and Seeberger is looking to simplify this process by using carbohydrates that can be chemically synthesised and therefore help drive down the cost of these vaccines.

The 2001 version of his machine was used to develop a carbohydrate-based vaccine for malaria, scheduled to enter clinical trials in 2010. Malaria kills two million children a year in the developing world, explains Seeberger, and ‘we have a cost target of under $1 per child’. Using their technique the team now have ‘approximately 15 carbohydrates that are entering different phases of development for potential clinical purposes such as tuberculosis.’

The price is pretty attractive too – according to Seeberger the machine itself will cost somewhere in the region of $25,000 (£17,000), approximately one quarter the price of the analogous peptide synthesiser owned by most labs.

Geert Jan Boons, University of Georgia, Athens, US, an expert in carbohydrate synthesis, says that this technology is ‘very sophisticated and has great potential’. Explaining that there is nothing similar available, he says ‘most complex carbohydrates are made in solution, and any solid phase chemistry that is done uses manual approaches – where you add the reagents one by one yourself.’ Seeberger’s fully automated system handles everything, including cooling and warming of each step as required, he adds. Boons does however say that he is not entirely convinced that the chemistry is yet robust enough to make every type of carbohydrate, but adds that Seeberger does claim to have fixed these issues in research he is yet to publish. ‘I think the biggest hurdle will be when he tries to make a bigger molecule,’ he explains, adding that the separation of the desired product from its isomeric compounds is another hurdle that needs to be overcome.

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

Last Updated on Thursday, 19 March 2009 01:14 Written by Editor Thursday, 19 March 2009 01:14

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.”

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EPIX Pharmaceuticals Achieves Milestone from Collaboration with Cystic Fibrosis Foundation Therapeutics

Last Updated on Friday, 13 March 2009 01:31 Written by Editor Friday, 13 March 2009 01:31

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.

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10-K: ALEXZA PHARMACEUTICALS INC.

Last Updated on Friday, 13 March 2009 01:29 Written by Editor Friday, 13 March 2009 01:29

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.
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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 . . .

Posted under Biotech & Pharma Law, Collaborations, Events, North America, Press Releases, USA and Canada  |  Comments Off

BioFocus DPI Extends Drug Discovery Collaboration with Lilly Drug Discovery & Development

Last Updated on Wednesday, 25 February 2009 11:56 Written by Editor Wednesday, 25 February 2009 11:56

BioFocus DPI has extended its drug discovery agreement with Eli Lilly and Company until end 2009. Under the terms of the agreement, BioFocus DPI will identify active compounds by screening of Lilly’s library compounds.

The agreement extension announced today builds on the successful collaboration begun in March 2005. BioFocus DPI has been working with Lilly on discovering new compounds that target specific cellular signal transduction pathways. With this agreement, Lilly secures continued access to BioFocus DPI’s screening and biology expertise to identify new potential target compounds.

‘We are pleased to extend this collaboration with Lilly into its fourth year,’ said Dr. Chris Newton, Senior VP, BioFocus DPI. ‘It is satisfying to know that BioFocus DPI’s drug discovery research consistently meets the standards of large pharma companies such as Lilly and that we are successful in these long term collaborative relationships.’

Posted under Biotech & Pharma Law, Cell Analysis, Cell-based Assays, Discoveries, Innovations and Patents, Events, Industry News, News by Region, North America, Press Releases, USA and Canada  |  Comments Off

IPR story 12- Patenting a mere idea

Last Updated on Wednesday, 26 November 2008 02:14 Written by Editor Wednesday, 26 November 2008 02:14


Jaidev had joined a leading Pharmaceutical Research Institute in India, for his Ph.D work. He reviewed his research plan thoroughly and also searched patents. Based on discussions with his guide, he formulated a very innovative research plan, pertaining to development of a new screening method for diabetic compounds. He started his work and after nearly 2 years of hard work, came up with very good data. He filed a patent in India and subsequently in the USA. He was confident of grant of patent, since nobody had done the work he had done.

The examination of his patent application started in the USA. He was shocked when his application in the USA was objected owing to a provisional patent filed by a researcher in USA. The provisional application filed by the USA researcher merely discussed theoritically an innovative research plan, very similar to the one proposed by Jaidev. However, there was no follow up after that and the researcher had abandoned the patent application. Mere theoritical discussion on the idea was there, without any data. However, it had been duly published and was in public domain. The US examiner objections were based on the observation, that Jaidev’s idea was not new- it had already been disclosed by someone else. Novelty was destroyed and Jaidev could not get a patent.

Discussion:

The case gives very important lessons for researchers:

1. Don’t wait for research work to be completed before filing a patent- even at initial stage or just when preliminary encouraging results give proof to an innovative concept, file a provisional patent application in India. It is quite cheap- govt. fee is just Rs.1000/- and in case you do it yourself, no further expense. But it protects your idea! After filing, within 12 months, you must file complete patent application, duly accompanied by data and including ‘claims’. In provisional, claims are not there.

2. Filing a provisional patent application can be done for a mere theoritical idea, with due discussion on the scientific and technical logic behind the concept. However, your filing date and hence PRIORITY gets protected from date of filing provisional.

Had Jaidev filed a provisionl application, well in time he might have been able to save his work. It was something very easy and simple, but because he was not aware, he waited to finish his work and lost the race to someone who was smart enough to file a provisional patent. However, the irony in this case is that even the US inventor did not get a patent, since he had not filed a complete patent application within one year. Maybe, he did not get success with experiments or some other problem. Jaidev did succeed in the Lab, but lost the patenting case, since his novelty had been destroyed by the US inventor.

Hence, do not underestimate the VALUE OF PATENTING YOUR IDEAS- THEY ARE PRECIOUS! FILE PROVISIONAL APPLICATIONS AT THE EARLIEST. DO NOT WAIT FOR YOUR RESEARCH TO FINISH.

Posted under Biotech & Pharma Law, Compound Screening, Discoveries, Innovations and Patents, Drug-Like Compounds, Industry News, News by Subject  |  Comments Off

BIO-Europe 2008: The World’s Leading Biotech Companies and Deal-Makers Get Ready for Three Days of Intense Partnering in Mannheim/Heidelberg

Last Updated on Tuesday, 2 September 2008 04:04 Written by admin Tuesday, 2 September 2008 04:04

CARLSBAD, Calif. & WASHINGTON — September 2, 2008 — The leaders of the biotechnology industry will once again gather for BIO-Europe, the world’s largest stand-alone partnering conference, in Mannheim/Heidelberg, Germany, November 17-19. With biotech deal-making still the thrill in drug development markets, this year’s BIO-Europe promises to set new standards for generating quality partnering meetings and providing the information required to successfully navigate opportunities in an era of significant biotech industry change. Many of the most respected industry thought leaders and decision makers will come to the Rhein-Neckar biotech super cluster to examine the issues, new business approaches, policy trends that are vital to biotech’s successful long-term future.

A central theme to BIO-Europe 2008 is partnering in a globalizing biotechnology market, featuring interactive workshops led by renowned industry experts on important emerging topics such as understanding the critical issues upon entering the U.S. market and partnering with U.S. companies; deal-making in China; deal-making with Japanese companies; and how to adjust to changes in U.S. patent law.

Other conference highlights include the not-to-be-missed 6th annual “A Day in the Life of Experienced Deal-makers” plenary session. Led by James Watson, Managing Director and Head of Merchant Banking, Burrill & Company and including industry notables such as Andrew Gengos, Vice President, Strategy and Corporate Development, Amgen; Mark McDade, Executive Vice President, UCB Pharma; Dr. Simon Moroney, Chief Executive Officer, Morphosys; John Goddard, Senior Vice President and Global Head of Strategic Planning and Business Development, AstraZeneca; Simon Turton, Managing Director, Warburg Pincus; and William Ringo, Senior Vice President, Strategy and Business Development, Pfizer; this highly popular and provocative forum promises to continue its tradition of lively and insightful debate over key issues of strategic deal-making by some of the biggest names in biotech partnering.

One of the more difficult tasks for the biopharmaceutical industry is to explain the value of new drugs to the wide variety of constituencies with which they interact, all of whom have a vested interest in minimizing the value of new drugs to the system. Successfully demonstrating value is critical if the industry is to obtain adequate reimbursement for its products, yet the environment in which the industry operates continues to put up more hurdles. In “Demonstrating the Value of New Drugs”, Dr. Karen Bernstein, Chairman and Editor in Chief, BioCentury Publications will lead a panel exploring how companies can best navigate emerging challenges such as a FDA that increasingly emphasizes safety in response to political pressures; a growing emphasis on comparative efficacy and comparative effectiveness; and the possibility of a new U.S. president less friendly to the industry.

Notes to Editors:
Entry to BIO-Europe 2008 is free to the media, including full access to the partnering system, sessions, press conferences, workshops, and pre-arranged partnering meetings. Visit the BIO-Europe conference Web site at http://www.ebdgroup.com/bioeurope for detailed information on this year’s conference and online registration. When you register online, please indicate in the comment field that you are requesting a complimentary press registration. Please fax a copy of your press pass to complete your complimentary media registration to fax number +49 (89) 23 88 756 – 55.

About BIO-Europe

BIO-Europe is the preeminent stand-alone partnering event for the biotechnology industry. Delegates from all parts of the biotechnology value-chain come to BIO-Europe to efficiently identify, engage and enter into the strategic relationships that drive their business successfully forward. The annual BIO-Europe partnering event draws over 2,200 industry attendees from almost 50 countries, representing more than 1,250 companies, for three days of high-level networking. BIO-Europe is organized by EBD Group with the support of the Biotechnology Industry Organization, in partnership with European Biopharmaceutical Enterprises.

About EBD Group

EBD Group is the leading partnering firm for the global biotechnology industry. Since 1993, firms in the life sciences have leveraged EBD Group’s partnering conferences, technology and services to identify business opportunities and develop strategic relationships that drive their business.

EBD Group’s conferences are run in collaboration with leading industry players and international trade associations. They include BIO-Europe, the world’s largest stand-alone life science partnering conference (organized with the support of the Biotechnology Industry Organization, BIO); BIO-Europe Spring(R); BioPharm America(TM) (EBD’s new North American partnering event); BioEquity Europe (co-organized with BioCentury Publications and BIO); and EuroMed Tech, the partnering event for the advanced medical technology industry.

EBD’s novel, Web-based, partnering service partneringONE(TM) is also used at numerous third-party events around the world. Outside of the conference format, EBD Group’s consultants can provide hands-on assistance for firms seeking to in- or out-license products and technologies. EBD Group has offices in the USA and Europe. For more information please visit www.ebdgroup.com.

About BIO

BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

Posted under Biotech & Pharma Law, Europe, Press Releases  |  Comments Off

FDA Issues Public Health Advisory on Chantix

Last Updated on Wednesday, 9 April 2008 11:59 Written by admin Wednesday, 9 April 2008 11:59

The U.S. Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.

On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

As the agency’s review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products’ lifecycles to keep health care professionals and patients informed of new and emerging safety data.

“Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product,” said  Bob Rappaport, M.D., director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products. “While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug.”

Chantix was approved by FDA in May 2006 as a smoking cessation drug. Chantix acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking.

In the Public Health Advisory and a Health Care Professional Sheet that was also issued today, FDA emphasized the following safety information for patients, caregivers, and health care professionals:

Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug’s approval.

Health care professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.

Patients should immediately report changes in mood and behavior to their doctor.

Vivid, unusual, or strange dreams may occur while taking Chantix.

Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

FDA will continue to update health care professionals with new information from FDA’s continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms. FDA may consider requesting further revisions to the labeling or taking other regulatory action as the agency’s continuing reviews and conclusions warrant.

For more information:

http://www.fda.gov/cder/drug/infopage/varenicline/default.htm

Posted under Biotech & Pharma Law, FDA News, North America, Press Releases  |  Comments Off

Health Care’s Silent Spring

Last Updated on Wednesday, 9 April 2008 11:50 Written by admin Wednesday, 9 April 2008 11:50

As the Intergovernmental Working Group (IGWG) of the WHO prepares to meet and discuss how to best facilitate the expropriation of intellectual property rights (in this case the IPR of pharmaceutical patents) it’s important to consider the unintended consequences — the death of medical innovation.

The global purloiners of patents — led by Jamie Love — are thrilled to point out all of the new and important medicines that are the low hanging fruit of their property theft proposals — but are far less keen to explain how the fruit tree got there in the first place — or how they are nurtured.

In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death” in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all.

In other words, the elimination of patent rights doesn’t produce greater access to medicines.

There is a reason why virtually all the world’s “miracle drugs” have been developed in Western countries. It’s called incentive.

Intellectual property rights are the fertile soil that allowed the tree to grow in the first place — and to thrive. To borrow an over-used adjective from the world of global climate change — we must protect “sustainable” innovation.

Jamie Love and Company may very well say, “A world without patents, amen.” And they’re right, because minus pharmaceutical IPR we’d all better start saying our prayers — because that’s the only way we’re going to battle disease and improve the health of our global fraternity.

If the IGWG succeeds, pharmaceutical innovation dies. And that’s a Silent Spring we cannot afford.

Author: Peter Pitts
Source: DrugWonks

Posted under Asia, Biotech & Pharma Law, Business and Investment, Discoveries, Innovations and Patents, HIV Research, North America  |  Comments Off

BIO Spent $6.6 Million on Lobbying Efforts in 2007

Last Updated on Wednesday, 9 April 2008 11:41 Written by admin Wednesday, 9 April 2008 11:41

The Biotech Industry Organization (“BIO”) spent $6.6 Million on lobbying efforts in 2007, reported the Associated Press.

BIO’s lobbying efforts last year addressed a range of issues from patent reform to generics to FDA-related issues. The Associated Press reported as follows:

[BIO's] lobbying efforts went toward cloning issues ahead of the Food and Drug Administration’s ruling that cloned meat and milk is safe for consumers. Several members of Congress tried to compel the agency to do more studies before issuing a ruling, but FDA cleared the products for consumption in January.

The biotech industry also lobbied on legislation to allow the Food and Drug Administration to approve generic copies of biotech drugs. Generic drug companies already market cheaper versions of regular, chemical drugs, but the FDA does not have the authority to approve copies of biotech drugs, which are more complicated. Biotech makers opposed a bill that would have made generic biotechs medically interchangeable with the originals. The industry also argued generic biotechs should be classified as similar, but not interchangeable.

They also want biotech medicines to be guaranteed at least 12 years on the market before having to compete with generic copies. Generic drug makers say any protection beyond five years is unreasonable. Senate lawmakers attempted to pass a compromise bill last year, but negotiations broke down over the length of exclusivity.

This report raises some interesting questions about how much various industries spend today on their Washington lobbying efforts. One of the issues that has repeatedly come up in the patent reform debate is how minimal the biotech industry’s lobbying efforts are in contrast with the high tech industry. The argument has been that the proposed patent reform legislation favors the high tech industry, which has traditionally had more of a voice and presence in Washington. However, as this report makes clear, the biotech industry’s expenditures on lobbying–at least BIO’s expenditures on behalf of the industry–are not inconsequential. So, this report begs the question: if biotech’s lobbying efforts pale in comparison to high tech’s lobbying efforts on Washington, just how much is the high technology industry spending on Washington lobbying? What kind of lobbying money is considered adequate to have a voice in Washington?

Posted under Biotech & Pharma Law, Discoveries, Innovations and Patents, FDA News, North America, Press Releases  |  Comments Off

Soon-to-be Laid Off Schering-Plough Employees

Last Updated on Friday, 4 April 2008 11:50 Written by admin Friday, 4 April 2008 11:50

As reported in today’s Newark Star-Ledger, Schering-Plough’s New Jersey employees will bear the brunt of Fred Hassan’s plan to fire, terminate, let go with extreme prejudice, 5,500 people in S-P’s workforce:

“Schering-Plough’s chief executive said yesterday the budget ax will fall first and hardest in New Jersey as the drugmaker cuts more than $1 billion in spending after the abrupt collapse of its top-selling cholesterol medicines.

“Fred Hassan said the global cost-cutting plan announced late Wednesday was still under development, but workers in the United States — particularly employees at the company’s Kenilworth headquarters — would bear the brunt of the projected 5,500 layoffs.

“‘The way it’s going to fall on the U.S., unfortunately, it’s going to fall on New Jersey,’ Hassan said in a telephone interview. ‘That’s the way the situation has unfolded.’”

“That’s the way the ball bounces, the cookie crumbles! Too bad for you! But, hey, I’m OK!”

A lot of families will be in trouble at the worst possible time as the entire US economy may be heading for a recession (according to Warren Buffet, Ben Bernanke, and other “insiders”).

Not all who are axed will be seeking jobs at other pharmaceutical companies, many of which are cutting back as well, but these are qualified people who can help pharmaceutical vendors work smarter and find potential clients within the drug industry. I propose, therefore, to help these people network with vendors — ad agencies, medical communications companies, solution providers, technology companies, etc — and possibly find at least some leads to a new career.

Source: Pharma Marketing Blog 

Posted under Biotech & Pharma Law, Business and Investment, North America  |  Comments Off