Wyeth and Ambrx, Inc. have formed a worldwide alliance to discover, develop, and commercialize protein drug candidates for three undisclosed targets. The alliance will utilize Ambrx's recent breakthroughs in applying its protein medicinal chemistry platform to proteins produced in mammalian cells such as antibodies and antibody-toxin conjugates.

Ambrx is eligible for payments from an upfront commitment, target loading fees and research funding, as well as preclinical, clinical, regulatory and commercial milestone payments and royalties on sales of products resulting from the collaboration. Terms were not disclosed.

"This collaboration with Ambrx reinforces Wyeth's commitment to sustaining and growing our already robust capabilities in the field of biologics drug discovery through partnerships with biotech innovators," said Mikael Dolsten, M.D., Ph.D., president, Wyeth Research. "We are enthusiastic about working with Ambrx, a company with the ability to create and advance precisely engineered biologic drug candidates into clinical trials using its proprietary platform."

Stephen Kaldor, Ph.D., president and chief executive officer of Ambrx, said, "Wyeth is a long-standing leader in protein therapeutics with a strong record of successfully developing innovative products. We are pleased that Wyeth recognizes the power of the Ambrx EuCODE platform and look forward to collaborating with Wyeth's talented personnel to produce the next generation of biologic drugs."

Sign up today for Contracting & Outsourcing 2009!
contractpharma.com/2009conference

The FDA has approved Novartis’ Valturna (aliskiren and valsartan) tablets, a medicine targeting two key points within the renin system, also known as the renin angiotensin aldosterone system (RAAS), a regulator of blood pressure. This is the first approval for Valturna, which is indicated for the treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker (ARB) monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

"This unique combination brings together the powerful blood pressure lowering effects of valsartan and aliskiren," said Joe Jimenez, chief executive officer of the Novartis Pharmaceuticals Division. "It offers an important additional treatment option for physicians and hypertension patients, many of whom are not at their blood pressure goal. Valturna builds upon our strong cardiovascular franchise and is consistent with our long-term commitment to developing effective and innovative therapies. It further strengthens our growing portfolio of single-pill combinations to treat high blood pressure."

Valturna combines valsartan, the active ingredient in high blood pressure drug Diovan, and aliskiren, the active ingredient in Tekturna, a direct renin inhibitor (DRI). This approval was based on an eight-week randomized, double-blind, placebo-controlled trial in approximately 1,800 patients, which studied aliskiren 150 mg and 300 mg and valsartan 160 mg and 320 mg alone and in combination. Blood pressure reductions with the aliskiren/valsartan combination were significantly greater than with the monotherapies or placebo at the primary endpoint.

Sign up today for Contracting & Outsourcing 2009!
contractpharma.com/2009conference

Cambridge Regulatory Services (CambReg) has formed a strategic alliance with SIRO Clinpharm, a global Indian-based CRO, to provide services to pharma companies in both Asia and Europe. The alliance combines CambReg's regulatory expertise with SIRO's clinical trial services.

The alliance will offer full regulatory services for registering human medicines, including new small molecule or biopharmacetical entities, biologics, herbals and generics. Services include preparing clinical trial applications, marketing authorization (MA) applications in eCTD format, pediatric investigation plans and pediatric use MAs, as well as managing decentralized and mutual recognition procedures across the EU.

“Having come highly recommended to CambReg by the Mumbai High Commission, we are extremely pleased to be endorsing this alliance with SIRO,” said Karen James, managing director of Cambridge Regulatory Services. “This partnership will provide European pharma companies with increased confidence in accessing cost effective clinical trial solutions, hence introducing new clients to SIRO. In return, SIRO will have the benefit of offering regulatory expertise through CambReg.”

"Our alliance with CambReg would go a long way in helping small and mid-sized companies cut through the regulatory maze in Europe," said Dr. Chetan Tamhankar, chief operating officer of SIRO Clinpharm. "This alliance builds on the strength of our European clinical trial operations and allows us to offer greater value to our clients."

Sign up today for Contracting & Outsourcing 2009!
contractpharma.com/2009conference

Penn Pharma has appointed Karl Fry as director of quality. Mr. Fry joins the company from a quality management role at sterile pharmaceutical manufacturer, Patheon in Swindon. He has 16 years of pharmaceutical experience, having managed product quality for a range of clinical trial supply, packaging and pharmaceutical contract manufacturing companies. Mr. Fry will manage a QA team of 22 to further develop and grow this area of the business.

Mr. Fry said, “Having started my career with Penn Pharma, I always knew I’d return to this dynamic, forward-thinking company. I have spent the last six years broadening my QA expertise across a variety of pharma companies and sectors, and now seemed an opportune time to employ this expertise in helping to take Penn Pharma to the next stage in its ongoing global expansion plan.”

Sign up today for Contracting & Outsourcing 2009!
contractpharma.com/2009conference

News from our sister sites