SOURCE: The Bedford Report

The Bedford Report

July 19, 2011 08:16 ET

Developmental Drugs Draw Scrutiny From FDA

The Bedford Report Provides Equity Research on BioSante & AVI BioPharma

NEW YORK, NY--(Marketwire - Jul 19, 2011) - There is plenty of optimism surrounding the biotechnology industry as firmer pricing and new products have improved sales and earnings trends. Meanwhile, younger, more speculative firms continue to garner significant attention with potential blockbuster products working their way through the regulatory process. The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides investment research on BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) and AVI BioPharma, Inc. (NASDAQ: AVII). Access to the full company reports can be found at:

Citing agency officials, The Wall Street Journal reported this month that the Food and Drug Administration (FDA) has approved 20 new drugs so far this year -- just one short of the total for all of 2010. Some lawmakers in Washington have been arguing that the FDA's tougher safety stance has slowed down the pace of drug approvals and hurting the pharmaceutical and biotech industry.

Janet Woodcock, the head of the FDA's drug division, defended the FDA's role, saying challenges being faced by the biotech and pharmaceutical industry are related to high failure rates of drugs in the development process rather than FDA regulations.

A study released by BIO and BioMedTracker claims that the success rate in bringing new medicines to market in the past six years is only about half of what it had been previously. The study claims, however that biotech drugs are twice as likely to gain approval, compared to more traditional chemical drugs.

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Currently, Biosante's Cancer Vaccines are in various Phase I and Phase II cancer clinical trials and may represent the widest portfolio of cancer vaccines in development. BioSante is also working on a drug to chemically treat female sexual dysfunction. According to the company's Chief Executive Officer Stephen Simes, BPAX is in talks to partner on its sex gel to raise female libido or sell the company.

AVI BioPharma engages in the discovery and development of therapeutic products based on antisense and cancer immunotherapy technology. Last month the company announced that it initiated dosing of volunteers in a Phase 1 clinical study of AVI-7100, the Company's lead drug candidate for the treatment of influenza.

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