Dendreon (NASDAQ: DNDN) is a classic example of how a company fares as they struggle through the arcane and sometimes bewildering process of gaining FDA approval of a new treatment protocol.

A little more than a year and a half ago, the Seattle-based company was anxiously awaiting FDA approval of its new drug treatment protocol for prostate cancer.

The company's new drug, Provenge, had completed a trial that found that the treatment extended the lives of men suffering from prostate cancer an average of 4.5 months over those who did not receive the treatment. The company felt it had adequately demonstrated the efficacy of the treatment and deserved FDA approval.

In an unexpected but somewhat typical move, the FDA chose not to approve the drug for distribution at that time. It opted to delay approval until completion of another study under way with 500 subjects. This came in spite of a finding by an FDA panel that the drug was "safe and substantially effective."

Continue reading Dendreon delays request for FDA approval of prostate cancer drug

Dendreon delays request for FDA approval of prostate cancer drug originally appeared on BloggingStocks on Fri, 16 Jan 2009 15:15:00 EST. Please see our terms for use of feeds.

Do you suffer from heartburn? Your dreams may have just been answered. Perrigo (NASDAQ: PRGO), the world's largest manufacturer of over-the-counter pharmaceutical products for the store brand market, announced that the Food & Drug Administration has granted final approval to partner Dexcel Pharma Technologies Ltd. for OTC generic heartburn tablets.

As the exclusive U.S. marketer and distributor of Omeprazole for the over-the-counter market, Perrigo said it expects to begin shipments during the first quarter, with full-year annual sales estimated between $150 million and $200 million.

While Perrigo is officially a U.S. company, Dexcel Pharma Technologies Ltd. is headquartered in Israel. This drug is poised to be the biggest drug ever for Perrigo. Perrigo's Chairman and CEO Joseph C. Papa said, "The approval from the FDA is the final regulatory step for this exclusive product launch, which we expect to be the largest product in Perrigo's 120-year history. While we are excited about the opportunity, we will obviously continue investing in research and development to add more new products to our product offering. The launch of Omeprazole is another example of Perrigo's dedication to make quality health care more affordable."

This is a huge win for the health-care supplier. The company raised guidance for 2008 to between $1.32 and $1.47 per share, between 20-25 cents higher than its previous forecast.

Perrigo has been a huge winner in 2007, and sure looks poised to continue moving upward in 2008.

Aaron Katsman is the lead Portfolio Manager and Managing Director of America Israel Investment Associates, LLC. and Senior Editor of IsraelNewsletter.com. Disclosure: Writer owns shares in PRGO and is long the stock as of 12/11/07.

Perrigo heartburn drug wins FDA approval originally appeared on BloggingStocks on Tue, 11 Dec 2007 18:15:00 EST. Please see our terms for use of feeds.