SOURCE: The Bedford Report

The Bedford Report

October 04, 2011 08:16 ET

Diabetes and Cancer Treatment Becoming Most Lucrative Path for Biotech Industry

The Bedford Report Provides Equity Research on Dendreon and Biodel

NEW YORK, NY--(Marketwire - Oct 4, 2011) - In recent years the FDA has been heavily scrutinized for making the approval process more difficult for drug developers. A ground breaking study released this year by the BIO and BioMedTracker finds that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is a mere ten percent. The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides equity research on Dendreon Corporation (NASDAQ: DNDN) and Biodel, Inc. (NASDAQ: BIOD). Access to the full company reports can be found at:

Previously the rate of approval was one in five to one in six. Oncology drugs faced the toughest road to approval despite the fact that the disease area is the most closely studied in all of drug development.

Janet Woodcock, the head of the FDA's drug division, is quick to dismiss concerns regarding the FDA's approval process. This summer in testimony before the House Energy and Commerce's health subcommittee, Woodcock explained the agency meets more than 90% of deadlines that are part of the drug-review process. She also said so-called first cycle approvals are at a 20-year high with and said more than two-thirds of new drugs being approved within the six-to-10-month time frames given to new drug applications.

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Dendreon's Provenge is a therapy designed to train a patient's immune system to fight prostate cancer. Studies indicate it extended patients' lives by about four months. Recently the FDA approved a third facility where the company will make Provenge.

Biodel Inc., a development stage biopharmaceutical company, focuses on the development and commercialization of treatments for diabetes. It develops its product candidates by applying its proprietary formulation technologies to existing drugs. According to Frost & Sullivan research titled "US Diabetes Drug Delivery -- Patient Perspective," the future of diabetes treatments is in the convenient drug delivery methods. Type-1 diabetic patients are most likely to prefer a twice-a-day oral dosing regimen, while type-2 diabetic patients are also expected to prefer a twice-a-day oral dosing regimen or a twice-a-day patch.

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