PHARMACY

GAO to investigate FDA drug-review process

BY Drew Buono

WASHINGTON The Government Accountability Office will investigate the Food and Drug Administration’s drug-review process, according to the Associated Press. This is a result of the recent problems linked to two FDA approved drugs, GlaxoSmithKline’s diabetes drug Avandia and Merck and Schering-Plough’s cholesterol drug Vytorin.

The FDA approved Avandia because it helped control blood sugar, which many doctors believe decreases diabetics’ risk of heart attack. But the agency came under fire last year when an analysis showed Avandia could actually increase heart attack risk. The agency argued that it has never required diabetes drugs to show lower heart attack risk, and that lowering blood sugar alone is an important benefit.

The agency approved Vytorin, which combines Schering-Plough’s Zetia with Merck’s cholesterol drug Zocor, based on its cholesterol-lowering capability. But a study released earlier this year showed Vytorin was no more effective at limiting plaque buildup in neck arteries than Zocor alone.

At issue now is whether the FDA should approve drugs based on factors like cholesterol and blood sugar, without evidence they improve more meaningful measures like survival.

Also, the FDA has been criticized for not following up on companies when they ask for follow-up studies on drugs. In a recent report, the FDA said 900 of more than 1,200 studies required of drug makers had not even begun. To help with this, the FDA is enacting a new law next month that fines companies up to a million dollars for failing to honor drug study commitments.

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Lilly and PsychoGenics partner on neuropsychiatric disorder treatments

BY Drew Buono

TARRYTOWN, N.Y. PsychoGenics and Eli Lilly have entered into a drug discovery agreement aimed at identifying drug candidates suitable for clinical developments.

Per the agreement, Lilly will supply precandidate compounds that PsychoGenics will evaluate using its proprietary drug discovery technologies for the treatment of neuropsychiatric disorders. Upon Lilly’s further development of clinical candidates, PsychoGenics would receive research and milestone payments, as well as royalties.

Emer Leahy, president and chief executive officer of PsychoGenics, said, “We are delighted to once again work with Lilly and play an integral and expanding role in a successful drug discovery collaboration. We are confident that by combining the complementary strengths and expertise of PsychoGenics and Lilly, we may identify a new generation of treatments for neuropsychiatric disorders.”

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Roche asks for clearance to bring Mircera to market

BY Drew Buono

BASEL, Switzerland Roche is asking a U.S. judge for clearance to sell an anti-anemia drug by offering a royalty to Amgen and offering the drug at a price that is lower than what Amgen charges for its top anemia drug, according to published reports.

Roche won regulatory approval for Mircera as a treatment for anemia associated with kidney disease in November. But it hasn’t brought the drug to market because it lost a civil trial in October in which a federal jury found Mircera violated patents held by Amgen. Amgen sells drugs Aranesp and Epogen to treat anemia associated with kidney disease and cancer chemotherapy.

Although Roche lost the patent trial to Amgen, it is now seeking permission from Judge William Young to bring Mircera to the market by arguing that it would serve the public interest. Roche also has proposed selling Mircera at an initial “wholesale acquisition cost” that is about 5 percent less than the current “average selling price” of Amgen’s Aranesp. Also, it would pay Amgen a royalty 20 percent of net sales of Mircera while Amgen’s patents are still enforced, assuming the original ruling of infringement stands.

Roche said it would begin taking steps to market Mircera if the judge doesn’t rule on Amgen’s injunction request on Feb. 28, when oral arguments are scheduled in the case. Roche would be doing this even though they would be at risk to pay Amgen penalties if the infringement case isn’t overturned.

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