PHARMACY

Pfizer discusses updated pipeline

BY Alaric DeArment

NEW YORK Pfizer’s acquisition of Wyeth appears to be paying off for the world’s largest drug maker.

Pfizer gave an update of its pipeline for the first time since the acquisition Wednesday, showing 133 drug-development programs in stages ranging from phase 1 to registration with regulatory authorities.

“The pipeline of investigational medicines represents the strong future of Pfizer,” president Martin Mackay of PharmaTherapeutics Research and Development, a branch of Pfizer, said in a statement. “Since the closing of the Wyeth transaction late last year, we have made strategic decisions about our R&D resources, global footprint and high-priority projects. Our focus now turns to delivery of these health solutions for patients around the world.”

The pipeline includes 30 compounds for cancer, 11 for inflammatory diseases, 10 for Alzheimer’s disease and eight for pain.

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Novartis’ Vasella to focus on being chairman, bows out from CEO role

BY Alaric DeArment

BASEL, Switzerland Daniel Vasella will step down as CEO of Novartis to focus on his position as chairman, with pharmaceutical division head Joe Jimenez taking his place, the Swiss drug maker announced Tuesday.

The leadership change comes amid news that the company had net sales of $44.3 billion in 2009, a 7% rise over the year before, along with an 8% rise in profits, to $10.3 billion. Among individual divisions, generics arm Sandoz saw a rise by 5%, when factoring in currency exchange rates, along with 12% for pharmaceuticals, 39% for vaccines and diagnostics –– driven by sales of the H1N1 vaccine –– and 5% for consumer health.

“Novartis delivered an excellent performance in 2009, driven by strong underlying growth across our entire healthcare portfolio,” Vasella said.

That includes more than 30 new product approvals in the United States, Europe and Japan, including the launch of the schizophrenia treatment Fanapt (iloperidone) and Japanese approvals of the diabetes treatment Equa (vildagliptin), the hypertension drug Exforge (valsartan and amlodipine) and the kidney cancer drug Afinitor (everolimus).

All of the divisions expect to grow in 2010 except for vaccines and diagnostics, which expects lower sales than in 2009 despite expected approval of the meningococcal meningitis vaccine Menveo. The company also expects to acquire a 77% stake in the eye-care company Alcon from Nestle and subsequently acquire the remaining 23%.

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Oral painkiller approved in line with FDA’s unapproved drugs initiative

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has given the green light to an oral painkiller as part of its unapproved drugs initiative, the agency announced Tuesday.

The FDA approved Roxane Labs’ morphine sulfate oral solution in the 100-mg-per-5 milliliter and 20-mg-per-milliliter strengths for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients.

 

The FDA granted the approval under a program that began in March 2009 to regulate so-called “grandfathered” drugs – mostly narcotics – that have long been prescribed without approval because they entered the market before the agency adopted its current regulatory policies.

“An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards,” FDA Center for Drug Evaluation and Research deputy director Douglas Throckmorton said. “Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law.”

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