Companies featured in this edition of the newsletter: ACTC, CHIP, CUR, CVM, ENZ, IMUC, IWEB, SRCO, SVUL, XSNX

Markets finally snapped their winning streak last week, as weakness in housing markets and durable goods orders led to broad-based declines in all of the major indices. All told, the Dow surrendered 155 points on the week to close at 9665, down 1.6% on the week but up 10.1% on the year. The Nasdaq lost 2.0% on the week to close at 2090, up 32.6% on the year, while the S&P 500 and Russell 2000 posted losses of 2.2% and 3.1% respectively, paring their yearly gains to 15.6% and 19.9%.

Unexpectedly poor data from the housing sector was the big economic story on the week as both new and existing August home sales failed to live up to expectations. New home sales increased modestly to 429,000, falling short of estimates calling

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Last week, Regeneron Pharmaceuticals, Inc. (REGN) announced the completion of enrollment in two late stage studies of its VEGF (vascular endothelial growth factor) trap-eye treatment for age-related macular degeneration (wet AMD), a leading cause of blindness in adults. Each of the randomized, double-masked trials has enrolled more than the target of 1,200 patients. The company is developing the drug in partnership with Bayer HealthCare (BAYRY.PK). The study will be a non-inferiority comparison of the VEGF trap-eye with ranibizumab (Lucentis from Genentech, Inc- now a wholly owned subsidiary of the Roche group (RHHBY.PK)), an anti-angiogenic agent approved for use in wet AMD. The company expects one-year primary endpoint data from both studies in the fourth quarter of 2010. As a reminder, Regeneron and Bayer HealthCare entered into a collaboration agreement in Oct 2006 for the development and commercialization of the VEGF trap-Eye outside ...

On Friday, Sanofi-Aventis (SNY) and collaboration partner, Regeneron Pharmaceuticals (REGN) suffered a pipeline setback with the companies halting development of their late-stage pipeline candidate, aflibercept, for the treatment of pancreatic cancer.

Aflibercept, an anti-angiogenesis agent being developed for a variety of tumor types, was in a phase III study, which was evaluating the efficacy of the drug in combination with Eli Lilly’s (LLY) Gemzar (gemcitabine) versus placebo plus Gemzar for the first-line treatment of pancreatic cancer.

A planned interim efficacy analysis of the study, carried out by an independent data monitoring committee, showed that the addition of aflibercept to Gemzar would not lead to a statistically significant improvement in the primary endpoint of overall survival compared to the placebo plus Gemzar combination. The companies will conduct a detailed analysis of the efficacy and safety data, which will be presented at a future medical meeting.

The discontinuation of the study is

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GenVec, Inc.

(Public, NASDAQ:GNVC)

StocksHaven Investments profiles a clinical stage biopharmaceutical company developing gene-based therapeutic drugs and vaccines. Its lead product candidate, TNFerade biologic (TNFerade), is being developed for use in the treatment of cancer, and is currently undergoing Phase III trials which are expected to be completed by Q1 2010. In addition to its therapeutic product development programs, GenVec is working with collaborators to develop new applications for its technology through its vaccine development programs. The Company is developing a vaccine in animal health against foot-and-mouth disease and preventative vaccines for malaria, human immunodeficiency virus (HIV), respiratory syncytial virus, and Herpes Simplex Virus Type 2 (HSV-2). Surrounded by cash infusions through grants, mutual and institutional investors, multi-purpose products with billion dollar market potential, and an already flowing revenue stream – GenVec is one company you shouldn’t pass by.

About

Genvec

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Allos Therapeutics (ALTH) is scheduled to release its second quarter results on August 4. We expect the company to post a net loss of $16.5 million or $0.19 per share. The company does not have any marketed product; hence it does not have any revenue stream.

The current year seems to be quite crucial for Allos Therapeutics especially related to its most advanced pipeline candidate, pralatrexate. The company has submitted a new drug application (NDA) for pralatrexate to the FDA for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) in March, 2009. We expect its approval by the end of 2009 or early 2010.

Pralatrexate has an orphan drug (presently no FDA approved drug for PTCL is available) status from the FDA and European Medicines Agency (EMEA) for the treatment of patients with PTCL. This status brings with it seven years of marketing exclusivity in the US

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Early this morning, New York-based biotechnology company OSI Pharmaceuticals Inc. (OSIP) and Genentech Inc. (now a wholly owned member of the Roche Group) announced that a phase III SATURN study proved that Tarceva was successful in improving survival of advanced non-small cell lung cancer (NSCLC) patients when used directly after initial chemotherapy.

Tarceva is promoted in the U.S. by both companies and sales force costs are split equally. The significant improvement in overall survival supports the use of Tarceva as a first-line maintenance treatment for NSCLC.

SATURN (front-line maintenance therapy in NSCLC post-chemotherapy non-progressors) is a placebo-controlled, randomized, double-blind study conducted by Roche that enrolled 889 advanced NSCLC patients at more than 150 sites worldwide.

Tarceva (erlotinib), a small molecule inhibitor of the epidermal growth factor receptor (EGFR), is currently marketed for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (2nd line NSCLC)

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Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Allos Therapeutics [ALTH: 7.19, -0.13 (-1.78%)]: On 5/30/09 , ALTH updated data from the Company’s pivotal Phase 2 PROPEL study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The overall response rate for pralatrexate as evaluated by central independent

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For Immediate Release

Chicago, IL - May 18, 2009 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Bristol-Myers Squibb (BMY), Pfizer Inc (PFE), Eli Lilly (LLY), Amgen (AMGN) and Biogen (BIIB).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=4579.

Here are highlights from Friday's Analyst Blog:

Drug Cos to Present at ASCO

Bristol-Myers Squibb (BMY) will be presenting updated survival data of its melanoma candidate, ipilimumab, from several phase II and phase III trials, both as a monotherapy and in combination with chemotherapy. Bristol will also have several presentations on Erbitux, including

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We highlight Bristol-Myers Squibb Co. (BMY), Pfizer Inc (PFE), Medivation Inc (MDVN), Cougar Biotechnology Inc. (CGRB), Eli Lilly & Co. (LLY), Amgen Inc. (AMGN) and Biogen Idec Inc. (BIIB).The American Society of Clinical Oncology (ASCO) is set for May 29th - June 2nd in Orlando, Florida. ASCO is an annual forum where pharmaceutical and biotech companies come to present data on their cancer drugs in all stages of development. ASCO is a widely followed event by analysts and investors interested in new information on key pipeline and currently marketed compounds.  We list what to look for from several of the companies that will be attending and presenting at this year's ASCO event.Bristol-Myers Squibb (BMY) will be presenting updated survival data of its melanoma candidate, ipilimumab, from several phase II and phase III trials, both as a monotherapy and ...

Highlighted companies include Genentech, inc. (DNA), Amgen, Inc. (AMGN) and Wyeth (WYE).Waxman's Bill Bad for Biotech Companies (and Doctors, Patients and America)California Representative Henry Waxman (D-CA), Chairman of the House Energy and Commerce Committee, has proposed legislation, along with his colleagues, that would give the U.S. Food and Drug Administration (FDA) the authority to approve generic (bioequivalent) versions of biotech drugs. As of now, there exists no path to approval for so called follow-on biologics as there is with small-molecule pharmaceutical products.According to the Wall Street Journal, the main contention on the bill remains how many years of market exclusivity a product would receive after approval. Mr. Waxman is calling for 5 years, whereas the biotech companies and trade organizations are asking for 14 years.This is a serious issue for investors in biotechnology stocks, in our view. Allowing ...