PHARMACY

Flu vaccine trial yields positive results, Novavax says

BY Alaric DeArment

ROCKVILLE, Md. A clinical trial of a seasonal influenza vaccine that began in May 2009 has produced positive results, the vaccine’s developer announced.

Novavax said new data from a trial of its virus-like particle vaccine in patients ages 18 to 49 years showed the vaccine matched the influenza strains for which vaccination was recommended for the 2008-2009 influenza season. The study enrolled 241 subjects, of whom 221 were randomized to receive either the vaccine or placebo and 20 who received a conventional flu vaccine.

In an evaluation of the study, Novavax tested volunteers for immune response to the H3N2/Brisbane and B/Florida strains before and after immunization, finding that 50% to 73% of those immunized with Novavax’s vaccine had a fourfold increase in the antibody against neuraminidase, an enzyme that helps the virus replicate, compared with 1-of-19 volunteers who received a conventional flu vaccine and none who received placebo.

“These are very exciting results which not only support continued development of novel VLP vaccines against influenza but also provides a cornerstone to potentially differentiate our vaccine from the current standard of care,” Novavax president and CEO Rahul Singhvi said.

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Biovail, Alexza develop inhaled mental health treatment

BY Alaric DeArment

MOUNTAIN VIEW, Calif. An inhaled mental health drug could appear on the market in the near future under a collaboration announced Wednesday by Biovail Corp. and Alexza Pharmaceuticals.

Biovail subsidiary Biovail Labs International SRL and Alexza said they would work together to develop and commercialize AZ-004 (loxapine) in the United States and Canada. The drug is based on Alexza’s proprietary Staccato technology and is an inhaled drug designed to treat agitation in patients with bipolar disorder and schizophrenia. Alexza submitted an approval application for the drug to the Food and Drug Administration in December 2009.

Under the terms of the deal, Biovail will pay Alexza $40 million upfront and up to $90 million in milestone payments, if the drug is approved, as well as royalty payments of 10% to 25%.

“We are very excited to be partnering our lead program with Biovail,” Alexza president and CEO Thomas King said in a statement. “Their key strategic focus and their [central nervous system] commercial plans match our view of an ideal partner for AZ-004. We believe that AZ-004, if approved, has the potential to change the treatment practices for acute agitation, as the only product able to meet both the patients’ desire for quickly and comfortably gaining control of their agitation and the clinicians’ goal of rapidly and reliably calming an agitated patient.”

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Novartis to develop, market hepatitis C drug

BY Alaric DeArment

BASEL, Switzerland Novartis has gained exclusive rights to develop and market a hepatitis C drug that is the first of its kind, the Swiss drug maker announced Tuesday.

Novartis acquired control of Debio 025 (alisporivir) from Debiopharm Group. The drug is the first of a drug class known as cyclophilin inhibitors, which target host proteins involved in the growth of the virus. The drug is currently in phase 2b clinical trials.

Under the terms of the agreement, Novartis will pay unspecified upfront and milestone payments to Debiopharm, as well as royalties on sales, in exchange for the exclusive right to develop and market the drug worldwide, except in Japan.

“Hepatitis C is sometimes referred to as a ‘silent epidemic’ because the virus can lie dormant in the body for years or even decades before the symptoms become apparent,” Novartis Pharmaceuticals Division CEO David Epstein said. “Novartis is dedicated to developing medicines that will reduce the impact of this disease on patients, and we believe that Debio 025 could prove an important step forward by significantly enhancing the efficacy of existing therapy that forms the standard of care for hepatitis C.”

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