Dainippon Sumitomo Pharma and Intercept Pharmaceuticals have today announced that they have entered into an exclusive licensing agreement for the development and commercialization of Intercept’s FXR agonist obeticholic acid (OCA, also known as INT-747). DSP will advance OCA in Japan and China for the treatment of chronic liver diseases, with an initial focus on primary biliary cirrhosis and nonalcoholic steatohepatitis. Intercept is currently preparing for the initiation of a Phase III PBC program in the US and Europe and, under the company’s cooperative research and development agreement with the National Institute of Diabetes and Digestive and Kidney Diseases, a large placebo-controlled trial of OCA in NASH patients recently started enrolling in the US.
Under the terms of the licensing agreement, Intercept will receive an initial payment from DSP of $15 million and will be eligible to receive approximately $300 million in additional milestone payments associated with the successful development and commercialization of OCA. Upon launch of OCA, Intercept will be entitled to receive tiered double-digit royalties from DSP based on sales in its territory. DSP has the exclusive option to add several other Asian countries to its territory, including Korea and Taiwan, and to pursue additional indications. DSP will be responsible for the costs of developing and commercializing OCA in its territory.
Takeda and Amgen have announced the top-line results from the MONET1 Phase 3 trial evaluating motesanib diphosphate administered in combination with paclitaxel and carboplatin in 1,090 patients with advanced non-squamous non-small cell lung cancer. According to the companies the trial did not meet its primary objective of demonstrating an improvement in overall survival. In 2008, as part of a larger agreement, Takeda announced that it would become Amgen’s worldwide partner for motesanib diphosphate (AMG 706). Under the agreement Takeda paid Amgen $100 million upfront, $175 million in success-based milestones for the first two indications, and double digit royalties on sales in Japan. Takeda also agreed to pay 60% of ongoing clinical development expenses outside Japan and share potential profits outside Japan 50/50.
Graffinity Pharmaceuticals has announced that it has entered into a research collaboration with Shionogi & Co. Under the terms of the agreement, Graffinity will receive technology access fees and payments for follow-up chemistry for the generation of various, novel small molecule hits against a key drug target. Financial details of the transaction were not disclosed.
Merck Serono has announced that it has entered into an agreement that broadens the scope of the collaboration with Newron Pharmaceuticals. The two companies are already collaborating on the development of safinamide in Parkinson’s disease. Under the terms of the agreement, Newron will receive a development license for two Merck clinical-stage compounds, pruvanserin and sarizotan. Merck will retain buy-back options for each compound upon completion of proof of concept trials. Should these options be exercised by Merck, Newron will have a co-development option. No further financial terms are disclosed.
Gilead Sciences has announced that it has formed a research collaboration with Yale School of Medicine to focus on discovery of novel cancer therapies. The research effort will initially span four years, with an option to renew for up to ten years. Gilead and Yale will develop a multi-disciplinary research program to search for genetic basis and underlying molecular mechanisms of many forms of cancer. During the initial period, Gilead will provide $40 million in research support and basic science infrastructure development. If the collaboration period is extended to a 10-year timeframe, the company will provide a total of up to $100 million.
Core Essence Orthopaedics, a medical device company focused on MIS arthroscopic and endoscopic procedures involving soft tissue and skeletal repair, has announced that it has closed a $11.5 million Series B financing. Participants include Baird Venture Partners, NewSpring Health Capital and Robin Hood Ventures.
Cephalon has confirmed today that it received an unsolicited proposal from Valeant Pharmaceuticals to acquire the company for $73 a share or to purchase Cephalon’s non-oncology related assets for $2.8 billion. Cephalon is reviewing the bid and plans to respond to Valeant during the week of April 4th.
GlaxoSmithKline and Valeant Pharmaceuticals have announced that European regulators approved Trobalt (retigabine) as an adjunctive treatment of partial onset seizures with or without secondary generalisation in adults with epilepsy, marking the first authorisation for the product. The decision followed a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in January. In the US, where the drug is known as Potiga (ezogabine), the FDA issued a complete response letter in December 2010 citing non-clinical reasons for its decision. The companies are working to submit a response in 2011.
Champions Biotechnology has announced the signing of a technology collaboration agreement with Cephalon, Inc. in which Champions will conduct low passage Tumorgraft studies on two proprietary chemical compounds, CEP-32496, an inhibitor of mutant B-Raf, and CEP-37440, a selective dual ALK-FAK inhibitor, provided by Cephalon to determine the activity or response in potential clinical indications. Cephalon will pay Champions an initiation fee of $1.39 million and will pay Champions various milestone payments. Potential milestone payments under the deal could total $27 million. In addition, under certain conditions, Cephalon will pay Champions royalties on any commercialized products developed under the agreement.
GlaxoSmithKline has announced that Pronova BioPharma Norge AS, which owns the patents for LOVAZA, has entered into an agreement with Apotex to settle their patent litigation in the US related to LOVAZA. GlaxoSmithKline has the marketing rights for LOVAZA in the US and Puerto Rico. The settlement grants Apotex a license to enter the US market with a generic version of LOVAZA in the first quarter of 2015, or earlier depending on certain circumstances. Other terms of the settlement are confidential.