Roger Viney, Ph.D. has been named director of sales & marketing Europe and Asia for Hovione. Thomas Eisele, Ph.D. has been named general manager R&D at the company and Steve Beagle has been named director of sales & marketing, North America.

Dr. Viney will lead Hovione's sales and marketing efforts outside North America and is based at Hovione headquarters in Loures, Portugal. Steve Beagle will lead those efforts for the North America territory and is based at the Hovione's Technology Transfer Center in New Jersey. Both Dr. Viney and Mr. Beagle are responsible for the development of sales and marketing strategies in line with the strategies of Hovione's four business units: Exclusive, Particle Design, Generics and Pharma. Dr. Eisele is responsible for corporate R&D and reports to chief executive officer Guy Villax. The R&D group includes Process Chemistry, Analytical Chemistry, Particle Design, Project Management and Pilot Plant.

"We are pleased to welcome Roger, Thomas and Steve to the Hovione team," said Mr. Villax. "These three individuals have a distinguished track record in the industry and their extensive experience will be an invaluable resource to the company and broadens the executive management team at an important stage in the growth of our business."

Prior to joining Hovione, Dr. Viney held various positions at Rhone-Poulenc/Rhodia from 1993 to present, most recently in Global Business Management. Prior to that he worked in senior roles in sales, marketing and technical management.

Dr. Eisele worked in Switzerland for 13 years in the area of Custom Research and Custom Manufacturing at CarboGen-Amcis, Rohner and SynphaBase. During that time Dr. Eisele held several positions in R&D, marketing and sales, global business development, shared services and general management. He began his professional career at Nycomed in the area of Medicinal Chemistry.

Mr. Beagle has a diverse 24-year history working in global roles within the pharmaceutical industry ranging from product management to sales and marketing. He is well known in the pharmaceutical manufacturing community and brings a wealth of knowledge to this position. Most recently he was at DSM where he was senior director of Business Development. Prior to this position he was at Stiefel Laboratories where he held management positions in Business Development and Technical Service. Mr. Beagle has also worked for BASF, American Cyanamid, and R.W. Greeff.

King Pharmaceuticals has initiated the Phase II trial evaluating the efficacy and safety of T-62, an investigational drug for the treatment of neuropathic pain.

Dr. Eric Carter, chief science officer of King, remarked, “T-62, a new chemical entity, is an adenosine A1 allosteric enhancer that increases the effectiveness of the body’s endogenous adenosine to treat neuropathic pain. The successful development of this product would address a substantial unmet medical need for more effective medicines to treat this serious condition.”

The Phase II trial is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia and its associated pain. The study is expected to enroll approximately 130 patients in as many as 20 study centers and will evaluate two doses of T-62 and placebo utilizing a parallel design. Each patient will complete a seven-day screening period, a 28-day treatment period, and a 14-day post-treatment period.

Matthew K. Fust has been named executive vice president and chief financial officer of Onyx Pharmaceuticals. Mr. Fust will serve as Onyx's principal financial and accounting officer and report to N. Anthony Coles, M.D., the company's president and chief executive officer.

"Matt is a proven leader who brings extensive senior management and operational experience to Onyx, as well as a shared strategic vision to create a leading biopharmaceutical company," said Dr. Coles. "His demonstrated capabilities in implementing corporate and financial strategies and accelerating corporate growth have been reflected throughout his career. On behalf of the board and the other members of the executive team, it is a pleasure to welcome Matt."

Most recently, Mr. Fust was executive vice president and chief financial officer at Jazz Pharmaceuticals, which he joined in 2003. From 2002 until 2003, he was chief financial officer at Perlegen Sciences, a biotechnology company. Previously, he served as senior vice president and chief financial officer at Alza Corp. where he was an executive from 1996 until 2002. From 1991 until 1996, Mr. Fust was a manager in the healthcare strategy practice at Anderson Consulting.

Actavis Inc. has reached agreement with the FDA on a Consent Decree of Permanent Injunction the company’s Actavis Totowa LLC subsidiary. This agreement, in effect, settles the issues identified by the Department of Justice in its previously filed complaint against Actavis Inc., Actavis Totowa, and officers Sigurdur Oli Olafsson and Douglas Boothe.

The decree only affects operations at Actavis Totowa in NJ. These include two oral-dose manufacturing sites, and one packaging facility. Actavis has agreed to not distribute any products from the Actavis Totowa facilities until it has certified completion of certain enumerated requirements that demonstrate compliance with FDA’s cGMP and has passed follow-up FDA inspections of the facilities. The company anticipates that commercial production in the Actavis Totowa facilities will resume shortly.

“We have been working with the FDA to address compliance issues at the Totowa facilities,” said John LaRocca, Actavis Inc.’s chief legal officer. “We have an entirely new management team in place at Little Falls and have invested significantly to reinforce systems and procedures intended to better ensure robust, sustainable compliance. This agreement with the FDA is a positive step and is one we have looked forward to reaching. We will continue to work with the FDA to show that we have addressed all of the agency’s compliance and manufacturing issues.”

Prior to reaching this agreement, Actavis engaged Parexel to assess Actavis Totowa facilities. Parexel has 25 years of experience in helping companies bring safe and effective treatments to the global marketplace. Parexel will continue to work with Actavis Totowa to facilitate ongoing compliance with the Consent Decree, according to an Actavis statement.

The FDA has accepted Savient Pharmaceuticals' BLA for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients. The FDA also granted Savient's BLA a priority review status which accelerates the review period to six months. This designation is assigned to drugs that are deemed by the FDA to have the potential to provide an important advancement in treatment or provide a treatment for which there is no adequate therapy available. The target date for an FDA decision on pegloticase is April 30, 2009.

The BLA submission is based on the two replicate, six-month Phase III clinical trials, performed under the auspices of a special protocol assessment. Additionally, the BLA includes data from the open label extension (OLE) study for pegloticase, per the request of the FDA. The OLE study allowed those patients who completed the Phase III trials to continue or begin receiving pegloticase for an extended period of time. The data set includes 101 patients with at least twelve months of continuous treatment. Pegloticase was previously granted orphan drug designation by the FDA.

Treatment-failure gout occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with allopurinol at the maximum medically appropriate dose or for whom allopurinol is contraindicated.

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