PHARMACY

Sanofi-Aventis offers update on its new products

BY Allison Cerra

PARIS After two years without providing the public a research update, Sanofi-Aventis, the world’s no. 3 drugmaker, is on the hunt to develop new drugs, according to Monday’s reports.

In order to defy the patent expirations of its two top-selling products: blood-thinner Plavix and anti-thrombotic Lovenox, the company said it expects to make up to 31 proposals for new drugs by the end of 2010. The company also said it has 48 drugs in late-stage development, with 28 of them in the final stage of clinical trials before the drugs can be submitted for marketing approval.

Sanofi-Aventis said tests on the prospective successor of Lovenox showed the anti-clotting medicine might work better than the original.

In light of these reports, the company had also announced that their treatment of Alzheimer’s disease, known as Xaliproden, failed in late-stage trials. Analysts, who had previously stated that it was a hazardous product, had expected this outcome.

Sanofi-Aventis made a botched attempt to receive the FDA’s approval for its anti-obesity drug Acomplia. The marketing application was ultimately withdrawn in July, after it was linked to suicide in overweight patients.

Shares in Sanofi-Aventis were down 1.6 percent at €60.53 ($83.89) in midday trading Monday in Paris.

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Evista gets FDA approval for new use to reduce breast cancer risk

BY Drew Buono

INDIANAPOLIS The Food and Drug Administration has approved a new application for Eli Lilly’s osteoporosis drug Evista. The drug is now indicated as a way to reduce the risk of invasive breast cancer.

The drug’s new use is designed for postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer. “The FDA’s decision marks a major milestone. For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns—osteoporosis and invasive breast cancer,” said Gwen Krivi, vice president of Lilly Research Laboratories.

The approval comes less than a year after the application was submitted to the FDA and also carries a recommendation of the Oncologics Drug Advisory Committee.

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Cubist to ask for patent reissue for Cubicin

BY Drew Buono

LEXINGTON, Mass. Cubist Pharmaceuticals is planning on asking U.S. regulators to reissue a patent on the drug Cubicin to block generic competition.

Cubicin is used as a treatment for skin infections and is set to lose its patent in 2016.  Cubist is going to ask the U.S. Patent and Trademark Office to correct and reissue a patent regarding the purity level of the compound daptomycin, which is the key ingredient in Cubicin.

On Wednesday, generic manufacturers were allowed to seek approval from the Food and Drug Administration to sell generic versions of the drug.  Now, with Cubist seeing corrections from the patent office, the original patent will be removed from the FDA’s registry of information on approved drugs until the mater is handled.

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