Bio Screening Industry News

The Symposium is focused on the new modality of multiple sclerosis treatment– immunosuppressive therapy followed by autologous stem cell transplantation. Centers in Europe, North and South America, Russia, China, Israel and Australia have successfully performed this procedure, and, to date, more than 600 stem cell transplantations in multiple sclerosis have been performed worldwide.

Along with promising results there are a number of unclear and challenging issues that are worth studying.

The Symposium intends to share the newly acquired knowledge in the field, to discuss the challenges and perspectives of the method, and to develop collaborative projects. The topics to be covered within the symposium include:

• Regimens of conditioning: Immunoablation or immunosupression?
• Types of transplantation: autologous or allogenic?
• Posttransplant immunological reconstitution
• Side effects
• Outcome measures: clinical, imaging, patient-reported outcomes
• Posttransplant neurorehabilitation
• Long-term follow-up results
• Proposal for cooperative studies

We invite the submission of abstracts on the above aspects of stem cell transplantation in multiple sclerosis. All abstracts will be reviewed by an international committee and a number of abstracts will be selected for oral presentation within the Symposium.

www.stemcellms.ru

Munich, Germany, Jan 20th, 2009; Nanion is again nominated for a prestigious
innovation award, due its impressive product portfolio of automated patch clamp
systems. More than 350 companies competed in this year’s Innovation Award and
Nanion is finalist in the category “Start-Up Companies”.

The German Industry’s Innovation Award, also the world’s first innovation award, has since 1980 annually nominated and rewarded the nation’s most important scientific and technical innovations. Nanion is one of the five remaining candidates for the award and the winner will be announced on January 24th, 2009.

“To remain a profitable and leading provider of advanced and high quality ion channel drug screening systems, we constantly seek new inventions and solutions that are attractive to industrial and academic institutions.” says Michael George, CTO of Nanion. Dr. Niels Fertig, CEO of Nanion, continues “Our three product families for sophisticated cell analysis are
being used in the development of new medicines as well as in academic research. With the latest introduction of our high throughput patch clamp system, the SyncroPatch 96, the screening of ion channel drugs is revolutionized in terms of time and cost efficiency. We are happy and honoured that our products and technology are receiving such recognition by the nomination for this award.”

The SyncroPatch 96 is Nanion’s next generation screening platform, capable of highly parallel
recordings from up to 96 cells at a time. It will be launched at the Biophysical Society’s Annual Meeting in Boston, MA, USA, in the end of February, 2009. The SyncroPatch 96 is the first platform on the market to date that supports giga-seal recordings at a throughput of 5000 data points per day.
About Nanion:
Nanion Technologies GmbH is a German Private Limited Company and was founded in 2002 as a spinoff from the Center for Nanoscience (CeNS) of the University of Munich. Nanion’s team has developed and globally established two highly successful automated patch clamp instruments as enabling tools for sophisticated and high throughput applications for ion channel research and drug discovery. Nanion’s instruments use planar patch clamp chips which replace the traditional glass pipette used in the technique of patch clamping. Nanion was nominated in 2007 for Germany’s most prestigious innovation award the Deutscher Zukunftspreis (German Future Prize, Federal President’s Award for Technology and Innovation).

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.

International symposium “Stem Cell Transplantation in Multiple Sclerosis: Sharing the Experience” will be held  on October 5th, 2009 in  Moscow, Russia. Symposuim Organizers are Pirogov National Medical Surgical Center, National Center for Research and Treatment of Autoimmune Diseases, Russian Cooperative Group for Cellular Therapy, New Jersey Center for Quality of Life and Health Outcomes Research.

The symposium will be the first special meeting fully meant to discuss the state-of-the-art and perspectives of the new and quite promising method of multiple sclerosis treatment - high dose immunosuppressive therapy + autologous hematopoietic stem cell transplantation. It intends to share the newly acquired knowledge in the field, to discuss challenges and perspectives of the method, and to develop collaborative projects. The topics to be covered within the symposium include:
“    Regimens of conditioning: Immunoablation or immunosupression?
“    Types of transplantation: autologous or allogenic?
“    Posttransplant immunological reconstitution
“    Side effects
“    Outcome measures: clinical, imaging, patient-reported outcomes
“    Posttransplant neurorehabilitation
“    Long-term follow-up results
“    Proposals for cooperative studies

Neurologists, immunologists, transplantologists, hematolosits, specialists in stem cell research are invited to participate in the Symposium.

Key dates:

1 March 2009 -   Deadline for abstract submission
1 April 2009   -   Deadline for early registration

Symposium Organizers Contact Information:

Tel: +7 495 463 4923 or +7 962 710 17 11

Web-site: http://www.stemcellms.ru

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.

Emerging Diagnostic Index: Average loss of 63.2%, including 39 companies with average market cap of $50M

Emerging Bio-Pharma Index: Top 40 Rated Companies

Emerging Bio-Pharma Index: 36 Additional Companies

Micro-Cap Bio-Pharma Index: 130 companies with an average loss of 43.6% in past year and average market cap of $58M

AspenBio Pharma (APPY) – APPY has pending results for the world’s first blood-based appendicitis screening test, AppyScore, which will support a 510(k) filing with the FDA for marketing clearance if positive.

BioDelivery Sciences (BDSI) – Onsolis approval is possible by mid-2009 and the Company recently raised $6M in cash from partner Meda AB, representing a $3M expanded licensing agreement + a $3M advance of the $30M milestone payment upon FDA approval.

Momenta Pharma (MNTA) – MNTA represents a pure-play on the future of bio-generics and is developing a mix of proprietary compounds, follow-on-biologics, and has pending ANDAs for blockbuster, complex products including Lovenox and Copaxone in partnership with Sandoz division of Novartis (NVS).

Electro-Optical Sciences (MELA) – MELA has pending clinical trial results for MelaFind diagnostic screening test for melanoma, which will support a FDA application if positive.

OraSure Technologies (OSUR) – OSUR is a leader in oral fluid diagnostic testing, with a pending FDA application for its hepatitis C (HCV) test with Schering-Plough (SGP) and is also developing an over-the-counter oral fluid test for HIV.

Discovery Labs (DSCO) – DSCO has a mid-April PDUFA decision date for Surfaxin after several previous delays due to manufacturing issues raised by the FDA.

Cytori Therapeutics (CYTX) – An innovator in the field of regenerative medicine which is already marketing its products in Asia and Europe based on the Celution System for breast reconstruction procedures and stem cell banking applications from a patient’s own fat tissue.

Caraco Pharma (CPD) – CPD has more than doubled from its low around 3 bucks, but is still cheap at current levels and is poised to return into double digits once resolving the manufacturing issues outlined in a FDA warning letter last year.

Dendreon (DNDN) – DNDN represents the ultimate biotech binary trade for 2009 with Provenge clinical trial results expected around mid-year which will either send the stock soaring or tumbling.

Javelin Pharma (JAV) – JAV has surged nearly four-fold from a low of 40 cents late last year as the victim of forced liquidation and panic selling since reporting positive Phase 3 results for Dyloject, which will support an application for FDA approval in 2H09. Dyloject is already on the market in Europe and the Company is engaged in partnership discussions for the product, along with another late-stage pipeline candidate Ereska.

SuperGen (SUPG) – SUPG has more than doubled from its low of $1.11, driven down by disappointing data for cancer drug Dacogen compared to Celgene’s rival drug Vidaza. However, SUPG boasts a robust, early-stage cancer drug pipeline + discovery platform and the current price around $2.50 includes zero debt and about $1.50 per share in cash.

Clarient (CLRT) – CLRT is a play on personalized medicine through its diagnostic and clinical lab services, which are focused on improving the treatment outcomes for cancer therapeutics.

Nanosphere (NSPH) – NSPH recently filed 510(k) applications with the FDA for two new diagnostic products, including a cystic fibrosis assay and an infectious disease panel for respiratory viruses (influenza + respiratory syncytial virus or RSV).

Home Diagnostics (HDIX) – HDIX manufactures value-priced blood glucose monitors and testing supplies, which are sold through a variety of channels, including mail order, retail pharmacies, and medical wholesalers.

Osiris Therapeutics (OSIR) – OSIR is a leader in regenerative medicine, which signed a major deal with Genzyme (GENZ) last year and has pending clinical trial results later this year for Prochymal.
Cypress Bioscience (CYPB) – CYPB has attracted the attention of stock and option investors lately in anticipation of a FDA decision for milnacipran in the treatment of fibromyalgia – with no clear indication of a decision date, but 1/18/09 represents a three-month delay from the original PDUFA date.

Vivus (VVUS) – VVUS has nearly 3 bucks per share in cash, negligible debt, and is trading around 5 bucks with pending data from two Phase 3 clinical trials of weight loss drug Qnexa expected in mid-2009.

Isis Pharma (ISIS) – ISIS is expected to report Phase 3 data around mid-year for mipomersen in the treatment of patients with a genetic disorder that leads to very high levels of LDL (bad) cholesterol.

AMAG Pharma (AMAG) – AMAG received a second complete response late last year for Feraheme, but it appears that no new issues were raised by the FDA and the Company may not be required to issue another response to the agency as it may only required more time for the FDA to review AMAG’s original response last October.

Acorda Therapeutics (ACOR) – ACOR is expected to submit a NDA to the FDA during 1Q09 for fampridine SR in the treatment of walking disabilities due to multiple sclerosis.

Author: Mike Havrilla
Source: Etfinnovators.com