PHARMACY

Roche, Synta agree to $1 billion licensing deal

BY Alaric DeArment

NEW YORK A Lexington, Mass.-based drug maker has signed a licensing agreement with Swiss drug maker Roche to develop and market treatments for inflammatory diseases, according to published reports.

The agreement, between Roche and Synta Pharmaceuticals Corp., is potentially worth more than $1 billion. Synta will receive an upfront payment of $25 million, as well as up to $245 million for the first licensed products and up to half that amount for the other two, depending on development milestones. Synta will also receive up to $170 million for each product, depending on commercialization milestones.

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PHARMACY

FDA tentatively approves Seroquel generic

BY Alaric DeArment

JERUSALEM The Food and Drug Administration has given tentative approval to a generic version of AstraZeneca’s antipsychotic Seroquel.

Teva announced last Tuesday that the FDA had granted the tentative approval for generic Seroquel (quetiapine fumarate) in 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg strengths.

The branded version of the drug had sales of about $3.8 billion in the United States for the 12 months ending Sept. 30, according to IMS Health data.

Teva expects to receive final approval after resolving patent litigation with AstraZeneca.

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Zerit generic gets FDA approval

BY Alaric DeArment

PITTSBURGH The Food and Drug Administration has approved a generic version of Bristol-Myers Squibb’s Zerit by Mylan’s Indian subsidiary, Mylan announced Tuesday.

The FDA approved Matrix Labs? stavudine capsules USP in 15 mg, 20 mg, 30 mg and 40 mg strengths. The drug is an antiretroviral used to treat HIV infection in combination with other antiretroviral drugs. The branded version of the drug had sales of about $54 million in the 12 months ending Sept. 30, according to IMS Health data.

Mylan owns a 71.5% stake in Matrix.

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