PHARMACY

EpiCept gets orphan drug designation from FDA

BY Alaric DeArment

TARRYTOWN, N.Y. A topical treatment for post-herpetic neuralgia, more commonly known as shingles, has received an orphan drug designation from the Food and Drug Administration.

EpiCept Corp. announced Wednesday that the FDA had granted the designation to the drug, NP-1 (amitriptyline and ketamine). The FDA gives orphan drug designation to drugs that treat conditions affecting fewer than 200,000 Americans, offering incentives such as a market-exclusivity period of seven years rather than the five normally given to pharmaceutical drugs and potential funding for clinical studies, study design assistance and waiving of FDA user fees.

“NP-1’s orphan drug designation is another indication of the significant need that exists for new and more effective treatment options for PHN,” EpiCept president and CEO Jack Talley said. “Our recent phase 2b study of NP-1 in the PHN indication demonstrated that it has at least equivalent efficacy to the unit market leader, gabapentin, which we believe is a strong indicator of its future clinical and commercial potential.”

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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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