Walvax Biotechnology is reported to have ended negotiations for a collaboration with GlaxoSmithKline because China regulators decided against allowing GSK to import its measles-mumps-rubella vaccine. The vaccine was the centerpiece of a joint venture that Walvax and GSK announced two years ago. A manufacturing facility was completed one year later.
Monthly Archives: December 2011
Emergent BioSolutions has announced receipt of a notice from Abbott that it is terminating its TRU-016 co-development and co-commercialization agreement. TRU-016, Emergent’s humanized anti-CD37 mono-specific protein therapeutic, recently began a Phase 2 clinical study for chronic lymphocytic leukemia and is currently in the middle of Phase 1b clinical evaluation in non-Hodgkin’s lymphoma. Following the termination of the agreement, Emergent will retain worldwide rights for the development and commercialization of TRU-016, and Abbott will be obligated to provide certain forms of transition assistance to Emergent for a certain period of time. In a separate release, Emergent announced the initiation of patient dosing in the Phase 2 study (protocol 16201) of TRU-016 in combination with bendamustine for patients with relapsed CLL. The initiation of this clinical trial triggered a $6 million milestone payment to Emergent by Abbott. The Phase 2 portion of this study was initiated under the collaboration agreement following achievement of the Phase 1b study objectives and authorization for the commencement of the Phase 2 study by an independent data monitoring committee.
Immunomedics and UCB have announced that they have amended their collaboration agreement for the exclusive worldwide rights to develop, market and sell epratuzumab for all autoimmune disease indications. According to the companies the restructuring provides UCB with the right to select a partner to sublicense its rights for certain territories. In return for the right to sublicense, UCB returned its buy-in right for the cancer indication to Immunomedics. Immunomedics will receive a non-refundable cash payment totaling $30 million upon execution of the amendment. In the event UCB exercises its right to sublicense, Immunomedics will be entitled to receive an additional cash payment of $30 million and additional milestone payments. Immunomedics will also issue to UCB a five year warrant to purchase one million shares of Immunomedics’ common stock at an exercise price of $8.00 per share.
Alexion Pharmaceuticals has announced that it has agreed to buy Enobia Pharma. Alexion will pay $610 million upon completion of the deal, and up to $470 million on achievement of various regulatory and sales milestones. Alexion said it will acquire worldwide development and commercial rights to Enobia’s bone-targeted enzyme replacement therapy, ENB-0040, for treating hypophosphatasia. ENB-0040, which was awarded an orphan drug designation in the US and the EU in 2008 and fast track status in the US in 2009, is currently in mid-stage clinical development.
Acceleron Pharma has announced that it has raised a $30 million private financing. Celgene, one of Acceleron’s strategic partners, and all other existing investors participated in this financing. The proceeds will be used to expand and advance Acceleron’s clinical stage pipeline. George Golumbeski, Senior Vice President of Corporate Development of Celgene, has joined the Acceleron Board of Directors.
ViroPharma has paid $7.5 million for an option to acquire Meritage Pharma for $69.9 million, plus milestones. ViroPharma also agreed to pay Meritage up to an additional $12.5 million in milestones before the option is exercised. ViroPharma can exercise the option after the receipt of data from a final Phase II study of Meritage’s oral budesonide suspension to treat eosinophilic esophagitis, and agreement with FDA on an acceptable Phase III endpoint. The product has Orphan drug designation in the US for eosinophilic esophagitis.
Karo Bio has announced that it has entered into a research collaboration agreement with Pfizer to discover and develop novel small molecule RORgamma modulators for the treatment of autoimmune diseases. Under the agreement, Pfizer will provide full funding for the research costs and have the exclusive right to market any products that may be developed as a result of the collaboration. Karo Bio may receive up to $217 million in upfront and milestone payments in addition to potential royalty fees.
Marina Biotech and Mirna Therapeutics have announced that they have entered into a license agreement for the development and commercialization of microRNA-based therapeutics using Mirna’s microRNAs and Marina Biotech’s Smarticles liposomal delivery technology. Under the agreement Mirna will have full responsibility for the development and commercialization of any products arising and Marina Biotech will support pre-clinical and process development efforts. Under terms of the Agreement, Marina Biotech could receive up to $63 million in total upfront, clinical and commercialization milestone payments, as well as royalties on sales, based on the successful outcome of the collaboration. Further terms of the agreement were not disclosed.
Coronado Biosciences signs agreement with Dr. Falk Pharma and OvaMed to collaborate in the development of CNDO-201
Coronado Biosciences has announced an agreement with Dr. Falk Pharma and OvaMed to collaborate in the development of CNDO-201, or Trichuris suis ova (TSO), for Crohn’s disease. Under the agreement, Coronado, Falk and OvaMed have agreed to enter into a Collaboration Agreement under which Falk will grant Coronado exclusive rights and licenses under certain Falk patent rights, pre-clinical data and clinical data from Falk’s clinical trials of TSO in Crohn’s disease, including an ongoing Phase II clinical trial, for use in North America, South America and Japan. Coronado will grant Falk exclusive rights and licenses to Company data from planned clinical trials of TSO in Crohn’s disease for use in Europe. Under the agreement, Coronado will pay Falk €5 million during 2012 and a royalty of 1% of net sales of TSO.
Coronado and Falk have each licensed TSO, an immunomodulator that regulates T-Cells and inflammatory cytokines, from OvaMed, the manufacturer of the product, in their respective territories. A Steering Committee comprised of Coronado, Falk and OvaMed representatives will oversee the development program, under which Coronado and Falk will each be responsible for clinical testing on approximately 50% of the total number of patients required for regulatory approval of TSO for Crohn’s disease in the United States and Europe. Coronado expects to finalize the Collaboration Agreement in the first quarter of 2012.
Sanofi and Exelixis have announced that they have decided to end their cooperation on the discovery of inhibitors of Phosphoinositide 3-Kinase (PI3K) alpha and beta in cancer treatment. The agreement was signed in 2009 which was worth up to $1 billion to Exelixis. Under the deal Excelixis received upfront payments of $140 million.