PHARMACY

Pfizer Q4 profits better than dour expectations; raise 2008 predictions

BY Drew Buono

NEW YORK Pfizer released its fourth-quarter profit and even though it fell 70 percent from a year ago, the company was still happy to top expectations from Wall Street analysts and others, especially taking into consideration the number of drugs it lost this year to generic introductions, reports stated.

For the three months that ended Dec. 31, net income fell to $2.88 billion from $9.45 billion. Revenue climbed 4 percent to $13.07 billion from $12.60 billion in the 2006 period, as international sales kept up by the weaker dollar helped offset the loss of patent protection on the blood pressure drug Norvasc and the antidepressant Zoloft. The revenue was driven by sales of such drugs as the cholesterol medication Lipitor, the smoking cessation drug Chantix, pain treatment Celebrex and Lyrica and kidney cancer drug Sutent.

“With strong product performance, cost reductions, improved productivity and the benefits of foreign exchange, we achieved both revenue and adjusted earnings growth despite losing U.S. market exclusivity for Norvasc and Zoloft,” said chairman and chief executive Jeff Kindler in a statement.

The company raised its outlook for 2008 revenue to a range of $47 billion to $49 billion, from a prior estimated range of $46.5 billion to $48.5 billion. The company warned that first-quarter revenue may not top year-ago results due to the loss of patent protection on Norvasc in 2007, allergy drug Zyrtec this month and colon cancer drug Camptosar in February. These products contributed to a revenue of about $1.1 billion in the first quarter of 2007.

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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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