PHARMACY

Drugmakers pull Vytorin TV ads

BY Drew Buono

KENILWORTH and WHITEHOUSE STATION, N.J. In the aftermath of the results of the ENHANCE trial, which showed Merck and Schering-Plough’s drug Vytorin unable to reduce the buildup of plaque in the arteries, the two companies have decided to pull their “two sources” TV advertising campaign for Vytorin and one of the ingredients of Vytorin and a drug sold on its own, Zetia, according to published reports.

“We have voluntarily and temporarily suspended broadcast advertising for Vytorin and Zetia,” stated Schering-Plough spokesman Lee Davies. “Vytorin and Zetia print advertising campaigns will continue in consumer print publications and in professional trade journalism,” he said.

The drug makers spent $102 million to market Vytorin through the first nine months of last year and spent $83 million on Zetia, according TNS Media Intelligence.

In order to show that both drugs are still safe to take, the two companies have begun a print campaign for both drugs in national and select local daily news markets. There is no word yet on how long the print advertisements will run or how long the TV advertisements will stay off the air.

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PHARMACY

Ranbaxy, GSK settle over Imitrex litigation

BY Drew Buono

HARYANA, India Ranbaxy Laboratories has settled litigation with GlaxoSmithKline related to sumatriptan succinate tablets, the generic of GlaxoSmithKline’s drug Imitrex, according to published reports.

The settlement will allow Ranbaxy to exclusively sell the generic for 180 days starting December this year. Under the terms of the settlement, Ranbaxy can distribute a generic version of sumatriptan in 25 mg, 50 mg and 100 mg doses.

Analysts expect the company to make around $100 million in sumatriptan sales in the U.S. during the exclusivity period. Sumatriptan sales in the U.S. are worth $985 million, according to IMS data.

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FDA delays Kynapid decision pending final review

BY Drew Buono

VANCOUVER, Canada The Food and Drug Administration has delayed its decision on an application for the heart treatment drug Kynapid, according to published reports. The drug manufacturer Cardiome Pharma and its co-development partner Astellas Pharma US said yesterday that the FDA did not provide an action letter by the expected date of Jan. 19.

The application for Kynapid (vernakalant hydrochloride), based on a five-year clinical development program, was submitted in December 2006. In December 2007, the FDA’s cardiovascular and renal drugs advisory committee voted 6-2 in favor of recommending to the FDA that Kynapid be approved for the rapid conversion of acute atrial fibrillation to sinus rhythm.

“While we look forward to the FDA reaching a decision, we respect their need for additional time to review the Kynapid’s application,” said William Fitzsimmons, senior vice-president for research and development at Astellas.

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