PHARMACY

Express Scripts spins off Rx Outreach as a nonprofit

BY Allison Cerra

ST. LOUIS A pharmacy benefit manager is gearing up to create a new independent, nonprofit charitable organization to improve access to prescription medicines for low-income, uninsured Americans and working families.

Express Scripts said Tuesday it will restructure Rx Outreach into a nonprofit organization, which will then partner with healthcare professionals and other entities committed to assisting Americans who are unable to obtain prescription drugs. In addition, the opportunity to develop expanded partnerships with branded and generic pharmaceutical manufacturers, community health centers, rural and frontier clinics, and faith-based charities will allow Rx Outreach the potential to offer a broader level of service.

Express Scripts chairman and CEO, George Paz, said he is confident the new venture “will play a new and expanding role in providing these benefits.”

The organization will be located in St. Louis and led by Michael Holmes, EVP of Express Scripts. Holmes will remain with Express Scripts until a replacement is identified, at which time he will lead the new venture. “While I am sorry to be leaving Express Scripts, this is a tremendous opportunity to make a sustainable difference on the healthcare landscape,” stated Holmes. “I applaud Express Scripts for its creativity and vision, and personally am thrilled to lead such a noble effort.”

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PHARMACY

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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