PHARMACY

Par reports increase in revenue, income and EPS for Q2

BY Alaric DeArment

WOODCLIFF LAKE, N.J. Generic drug maker Par Pharmaceutical Cos. got a jump in revenues and net income during second quarter 2009, the company announced in an earnings report Tuesday.

Par reported total revenues of $404 million, net income of $23.8 million and diluted earnings per share of 71 cents. This compared with reported revenues of $112.9 million, a net loss of $21.2 million and diluted earnings per share of 64 cents during second quarter 2008.

The company also saw increases in product sales. Sales of the heart disease drug metoprolol succinate – an authorized generic version of AstraZeneca’s Toprol XL – were $306 million during the quarter, a 173% increase over first quarter 2009. The injected migraine headache drug sumatriptan, a generic version of GlaxoSmithKline’s Imitrex, had sales of $21.8 million, compared to $16 million during the first quarter.

Meanwhile, the antihistamine meclizine, a generic version of Pfizer’s Antivert, was $8.9 million, compared with $9.8 million during first quarter, the decrease resulting primarily from trade buying patterns.

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Caraco settles patent suit over cancer generic

BY Alaric DeArment

DETROIT A generic drug maker announced Monday that it had settled patent litigation over a generic version of a cancer drug.

Caraco Pharmaceutical Labs said it reached a settlement with MedImmune over a generic version of the drug Ethyol (amifostine). MedImmune had filed the suit in the U.S. District Court for the District of Maryland.

Under the settlement, MedImmune granted Caraco a license to certain patents that permit Caraco to continue marketing its generic version of Ethyol in the United States.

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Biosimilars bill passed by House committee draws response from GPhA

BY Alaric DeArment

NEW YORK A House committee vote has brought a pathway for biosimilars one step closer to reality, but not in a way that pleases everyone.

The House Energy and Commerce Committee voted 47-11 Friday to pass an amendment to the healthcare reform bill that would give biotech drugs 12 years of market exclusivity before they face competition from biosimilars.

“We are sincerely disappointed that some members of the House Energy and Commerce Committee have decided to put brand pharmaceutical profits before patient needs,” Generic Pharmaceutical Association president and CEO Kathleen Jaeger said in a statement. “The amendment passed tosses patient needs out the window.”

In March, Reps. Henry Waxman and Anna Eshoo, both California Democrats, sponsored competing bills in Congress to allow a regulatory pathway for biosimilars. Waxman’s bill would give biotech drugs five years’ market exclusivity before facing biosimilar competition, like the Hatch-Waxman Act of 1984, which created a pathway for generic pharmaceutical drugs. Eshoo’s bill would grant 12 to 14 years of exclusivity. The short-exclusivity plan has the support of the generic drug industry, patient advocates, pharmacy trade groups and The Washington Post editorial page, though legislation to allow longer exclusivity periods has advanced further in the House and Senate.

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