Protea Biosciences has announced it has, in partnership with Mayoly-Spindler, completed a Phase I/IIA human clinical trial for their MS1819 recombinant Lipase. The clinical trial was a randomized, placebo-controlled, parallel design conducted at Hospital la Timone in Marseille, France. The goal of the clinical trial was primarily to assess the safety profile and secondarily, to get early evidence of the clinical activity of the MS1819 recombinant lipase in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis.
Monthly Archives: May 2011
Roche and TeaRx have signed a license agreement granting TeaRx development and commercialization rights for a treatment for patients at risk of thrombosis in Russia and 12 other countries. Royalties from resulting sales in these markets will be paid to Roche and the company may negotiate rights in further territories. Under the terms of the agreement, Roche will provide TeaRx with clinical candidates belonging to a new class of oral Factor Xa inhibitors. TeaRx will develop these innovative compounds in Russia, and initiate clinical studies which are expected to begin in 2012. Roche will co-invest into the project by manufacturing the API material (active ingredient) for the early clinical studies in a high tech facility in the USA. TeaRx will produce the final formulation in Russia. TeaRx will conduct clinical studies to prevent deep venous thrombosis and pulmonary embolism in patients undergoing orthopedic and general surgery. They will also conduct clinical studies for other potential indications like the prevention of stroke in risk patients with atrial fibrillation.
Epitomics has announced that it has signed a service agreement with Bayer Schering Pharma. Under the terms of the agreement Epitomics will use its rabbit monoclonal antibody technology to produce antibodies for Bayer HealthCare’s drug target identification and validation.
A federal judge has issued a temporary restraining order that prevents Eli Lilly from proceeding with plans to use the same sales force to sell both Byetta, which both currently promote, and a rival drug made by Boehringer Ingelheim. The move follows a lawsuit filed by Amylin, which accused Lilly of anticompetitive activity and breaching their alliance agreement. Amylin and Lilly have also been collaborating on Bydureon, a once-weekly injectable that is designed to supplant the older drug.The District Court Judge also enjoined Lilly from disclosing any confidential information about Byetta to any of its employees participating in the marketing, promotion or sale of linagliptin.
Medicago has announced that it has entered into a research collaboration agreement with the US Army Medical Research Institute of Infectious Diseases for the development of a plant-based VLP vaccine candidate for the prevention of Ebola.
AMRI has announced that it will receive a $3 million milestone payment from Bristol-Myers Squibb resulting from a recently initiated Phase II clinical trial of an AMRI compound exclusively licensed to BMS. This is the sixth milestone payment originating from a 2005 agreement in which AMRI licensed to BMS its technology around CNS triple reuptake transporter inhibitors as potential improved treatments for depression and CNS diseases. This payment brings the total milestone and licensing fees earned by AMRI related to the license agreement to $22.75 million. AMRI has also received $10 million in research collaboration fees under the agreement. In addition to the compound entering Phase II clinical evaluation, BMS is continuing to evaluate other collaboration compounds for depression and other indications. AMRI is eligible to receive as much as $66 million in development and regulatory milestone payments per compound for the first two compounds and payments of as much as $22 million per compound on subsequent compounds. AMRI also will receive royalties on worldwide sales of any commercialized compounds.
Rules-Based Medicine and its subsidiary, Psynova Neurotech, has announced that it has achieved a milestone in a companion diagnostic development program with Roche. According to RBM, using samples from a Roche clinical trial, the RBM DiscoveryMAP platform, and Psynova’s biomarker database, a biomarker pattern was identified that has utility in prognosis of disease progression and/or predicting or monitoring the efficacy for a compound in the Roche CNS pipeline. Roche has exercised its option to continue commercial development based on these results, which could result in additional future milestone and royalty payments to RBM/Psynova.
Shares in Pharmaxis closed 74% lower after indications that Europe would not approve a new drug. The company said there was a negative trend vote for its Bronchitol cystic fibrosis treatment at a Committee for Medicinal Products for Human Use meeting. Pharmaxis considers it unlikely that the committee’s position will change before the formal vote is undertaken next month.
Aastrom Biosciences has announced a collaborative agreement with CPC Clinical Research, a non-profit, academic research organization. CPC will provide services related to the execution of Aastrom’s Phase 3 REVIVE clinical studies for ixmyelocel-T, the company’s expanded multicellular therapy.
Proteostasis Therapeutics and Elan have announced a strategic business relationship to advance Proteostasis’ platform for the discovery and development of disease-modifying, small molecule drugs and diagnostics for the treatment of neurodegenerative disorders and dementia-related diseases. This deal will combine Proteostasis’ discovery technology, targets and compounds that modulate key Proteostasis Network pathways with Elan’s proprietary animal models, biology, medicinal chemistry and clinical development. Under terms of the agreement, Elan invested $20 million into equity capital of Proteostasis and will have an opportunity to provide an additional $30 million in collaboration funding over five years. As part of the agreement, Elan will acquire a 24% stake in Proteostasis, obtained a right of first negotiation to exclusively license compounds emerging from the combined initiative and will have the right to a seat on the Proteostasis board of directors and its scientific advisory board.