SOURCE: The Bedford Report

The Bedford Report

September 27, 2011 08:16 ET

Orexigen and Keryx Grind Though Strict Regulatory Process

The Bedford Report Provides Equity Research on Orexigen Therapeutics and Keryx Biopharmaceuticals

NEW YORK, NY--(Marketwire - Sep 27, 2011) - In recent years the FDA has been heavily scrutinized for making the approval process more difficult for drug developers. A groundbreaking 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 10 percent. The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides equity research on Orexigen Therapeutics, Inc. (NASDAQ: OREX) and Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX). 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 more than two-thirds of new drugs being approved within the six-to-10-month timeframes given to new drug applications.

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Due to the overwhelming percentage of overweight Americans, an effective and safe weight loss drug is seen to have astronomical earnings potential. The problem is that the FDA has proven to be very hesitant to approve prospective obesity drugs due to both safety and efficacy concerns.

Orexigen is looking to gain approval for Contrave for the treatment of obesity, including weight loss and maintenance of weight loss. Shares skyrocketed last week in the aftermath of a meeting with the FDA's office of new drugs (OND) regarding the development path for its obesity candidate Contrave.

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