FDA approves Avalide for combination hypertension therapy
PRINCETON, N.J. and PARIS Bristol-Myers Squibb and Sanofi-Aventis have received approval from the Food and Drug Administration for their supplemental new drug application for the antihypertensive drug Avalide, for patients with hypertension who most likely need multiple drugs to achieve their blood pressure goals.
The approval is based on data from two clinical trials involving more than 1,200 patients with moderate or severe high blood pressure. In the first study, which was double-blind, active-controlled and lasted for seven weeks, patients with severe hypertension were randomly treated with either Avalide or Avapro, a hypertension drug that makes up part of Avalide. After five weeks, the patients on Avalide had greater mean blood pressure reductions than those on Avapro alone.
Avalide is approved for patients whose blood pressure is not adequately controlled on monotherapy. In the third quarter of 2007, BMS’ sales of Avapro and Avalide totaled $309 million, a 12 percent increase from the same period last year.
IMPAX announces limited resumption of sales of oxycodone
STAMFORD, Conn. IMPAX Laboratories and its distributor DAVA Pharmaceuticals will resume sales of its oxycodone hydrochloride extended-release tablets in a limited capacity starting today.
This is in response to an agreement the companies signed with Purdue Pharma, who manufactures the brand version, Oxycontin, which is used for the management of moderate to severe pain when a continuous around-the-clock analgesic is needed for an extended period of time. The agreement said that IMPAX acknowledged that Purdue’s patents for Oxycontin were valid, enforceable and infringed on by their generic version. Purdue in return, allowed the companies to continue selling the product on the market until June 14, and to resume the distribution at a future date for a limited period of time.
The sales of the generic are expected to continue until around Jan. 28, 2008, or until the company’s sales quota under the license agreement with Purdue has been reached.
Isis grants Excaliard license for development of antisense drugs
CARLSBAD and ENCINITAS, Calif. Isis and Excaliard Pharmaceuticals have entered into an agreement to discover and develop antisense drugs for the local treatment of fibrotic diseases, including scarring. Isis has granted Excaliard an exclusive worldwide license for the development and commercialization of certain antisense drugs.
Under the agreement, Excaliard made an upfront payment in the form of equity and paid $1 million cash to Isis for the licensing of a particular gene target. Isis will also be eligible to receive development milestones and royalties on antisense drugs developed by Excaliard.
“Isis has made superb progress in the development of second-generation antisense drugs over the last few years, as evidenced by its clinical pipeline and current collaborations with companies such as Bristol-Myers Squibb, Eli Lilly and Ortho-McNeil, among others,” said Excaliard co-founder J. Gordon Foulkes, acting chief executive officer for Excaliard and managing director of RiverVest Venture Partners. “Having access to Isis’ antisense technology and expertise provides a great opportunity for Excaliard.”