SOURCE: The Bedford Report

The Bedford Report

December 01, 2011 08:16 ET

Lead Drug Candidates From Galena Biopharma and Arena Pharmaceuticals Look to Make Big Splash in 2012

The Bedford Report Provides Equity Research on Galena Biopharma & Arena Pharmaceuticals

NEW YORK, NY--(Marketwire - Dec 1, 2011) - 2012 is shaping up to be a big year for the biotechnology industry with several drug candidates facing FDA advisory panels. The drug approval rate in the United States has been falling in recent years -- studies released this year courtesy of the Biotechnology Industry Organization peg the country's overall success rate at close to ten percent -- which have led to volatile swings in shares throughout the biotechnology sector. The Bedford Report examines the outlook for companies in the biotechnology industry and provides investment research on Galena Biopharma, Inc. (NASDAQ: GALE) and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA). Access to the full company reports can be found at:

Galena BioPharma develops targeted oncology treatments that address major unmet medical needs to advance cancer care. Shares of Galena received a bump after the company announced that it will work with Genetech Inc. in a mid-stage trial of Galena's breast cancer therapy NeuVax in combination with Genentech's Herceptin.

Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival, the Food and Drug Administration granted NeuVax a Special Protocol Assessment for its Phase 3 "PRESENT" study. Galena says that the Phase 3 trial is expected to commence in the first half of 2012. According to the National Cancer Institute, Phase III trials compare a new agent or intervention (or new use of a standard one) with the current standard therapy. Phase III trials often include large numbers of people across the country.

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Arena Pharmaceuticals' most advanced drug candidate, Lorcaserin, is intended for weight management. Jack Lief, Arena's President and Chief Executive Officer stated in the company's third quarter earnings release that the company's Lorcaserin program has "the potential to provide a completely new treatment option to help patients reduce their weight and improve co-morbid conditions associated with obesity."

The company states that it is focused on submitting its "response to the FDA for the lorcaserin complete response letter around year-end." In 2010, the FDA asked for more data on the drug, and Arena met with the FDA last December to clarify the request.

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