Novartis, Amgen Partner
News Sep 04, 2015
Novartis has announced that it has entered into a global collaboration with Amgen to commercialize and develop pioneering neuroscience treatments. The companies will partner in the development and commercialization of a BACE inhibitor program in Alzheimer's Disease (AD). Novartis' oral therapy CNP520 will be the lead molecule and further compounds from both company's pre-clinical BACE inhibitor programs may be considered as follow-on molecules. The collaboration will also focus on new Amgen drugs in the migraine field, including phase III AMG 334 and phase I AMG 301. For the migraine program, Novartis will have global co-development rights and commercial rights outside the U.S., Canada, and Japan.
"This Novartis collaboration with Amgen highlights our clear commitment to neuroscience and to bring multiple, new targeted therapies to patients living with Alzheimer's disease and migraine, where the unmet medical need remains high." said David Epstein, Head of Novartis Pharmaceuticals.
Alzheimer's Disease is an irreversible, progressive brain disease characterized by loss of memory and other cognitive abilities. Amyloid build-up is considered a key driver of the progressive damage of the nervous system in AD. CNP520 is an oral drug designed to prevent the production of different forms of amyloid and has the potential to prevent, slow or delay the symptoms associated with AD. It is currently in phase I/IIa trials. CNP520 is planned to be included in a pioneering prevention study in people with a genetic risk of developing AD, in collaboration with the Banner Alzheimer's Institute.
Migraine is a severe headache condition affecting more than 10% of the population worldwide and a leading cause of disability. AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine. AMG 334 inhibits the activity of Calcitonin-Gene-Related-Peptide (CGRP) by targeting its receptor. CGRP is believed to play a key role in the development of migraine. AMG 334 is currently under evaluation in several large global, randomized, double-blind, placebo-controlled phase III trials to assess its safety and efficacy in migraine prevention. In addition to AMG 334, the migraine portfolio will include the development of AMG 301 and potentially another investigational compound of Amgen. AMG 301 is a monoclonal antibody being investigated in phase I trials for the prevention of migraine.
The partnership with Amgen follows two recent developments in the Novartis neuroscience portfolio aimed at complementing Novartis' neuroscience presence and pipeline in, among others, multiple sclerosis, AD and neuromuscular diseases. In July 2015 Novartis acquired Spinifex Pharmaceuticals adding phase II compound EMA401 for the treatment of neuropathic pain to the portfolio. In August 2015 Novartis announced that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline plc (GSK) for relapsing-remitting multiple sclerosis (RRMS) and certain other autoimmune indications; closing of this transaction is subject to expiry of any waiting period under the US Hart-Scott-Rodino Act and other customary closing conditions.
Under the terms of the arrangement, Novartis and Amgen will share responsibilities for development and commercialization of the BACE inhibitor program. Amgen will pay an upfront payment and milestone payments as well as disproportional research and development costs for an agreed upon period followed by a 50/50 cost and profit share arrangement. For the compounds in the migraine field, Novartis receives global co-development rights and commercial rights outside the U.S., Canada and Japan to the investigative molecules in Amgen's migraine portfolio. This includes AMG 334 in phase III and AMG 301 in phase I as well as an option to commercialize an additional early-stage Amgen molecule in these territories. Novartis will fund disproportional global R&D expenses for an agreed period on the migraine programs and will pay Amgen double-digit royalties on sales.
The Alzheimer drug candidate PRI-002 has successfully completed Phase I of clinical research involving healthy volunteers. When administered daily over a period of four weeks, the active substance proved to be safe for use in humans. The next milestone will be the proof of efficacy in patients in clinical Phase II.READ MORE