Key Developments For CombinatoRx, Incorporated
CombinatoRx, Incorporated (CRXX.O) (Consolidated Issue listed on NASDAQ Global Market)
CombinatoRx Incorporated Announces FDA Extends NDA Review For Exalgo Extended-Release Tablets
CombinatoRx Incorporated and Neuromed Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo (hydromorphone HCl) extended-release tablets by three months. The extended Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of the Exalgo NDA has been set for February 22, 2010. The FDA stated in its letter extending the PDUFA date that the purpose for the extension is to allow the FDA more time for a full review of Neuromed`s submission, including a recent amendment by Neuromed to the Exalgo NDA. Neuromed will continue to work with Mallinckrodt Inc., who owns the commercial rights to Exalgo, to obtain FDA approval of the Exalgo NDA. The U.S. rights to Exalgo tablets were acquired from Neuromed by Mallinckrodt Inc., a Covidien company, in June, 2009. Under the agreements between Neuromed and Mallinckrodt, Neuromed has received payments totaling $15 million, and if Exalgo is approved by the FDA, Neuromed is eligible to a payment of $30 million, which could potentially increase to $40 million. CombinatoRx and Neuromed entered into a definitive merger agreement on June 30, 2009.
CombinatoRx Incorporated's Synavive (CRx-102) Maintains Efficacy Throughout 12 Month Phase 2 Knee OA Extension Trial
CombinatoRx Incorporated announced the results of a 12 month knee osteoarthritis (OA) Phase 2 extension trial for Synavive (CRx-102) at the American College of Rheumatology (ACR) 2009 Annual Meeting in Philadelphia. The data demonstrated that Synavive-treated subjects maintained efficacy levels throughout the 12 month extension trial. These findings further support the core study data, which was presented at EULAR in June 2009, in which knee OA efficacy was observed early in treatment and sustained throughout the three month core study in all WOMAC measurement subscales including pain, physical function and stiffness. Synavive is a dissociated glucocorticoid product candidate designed to enhance the anti-inflammatory benefits of glucocorticoids, without associated side effects. Synavive contains the cardiovascular agent dipyridamole and a very low dose of the glucocorticoid prednisolone and is being developed as a uniquely engineered oral, once-daily formulation. In addition to maintaining efficacy for the Synavive-treatment group, placebo-treated subjects in the core study also experienced statistically significant improvements in all WOMAC measurement subscales upon crossing over to Synavive in the extension trial. Importantly, no treatment-related increase in glucocorticoid associated adverse events were observed in Synavive-treated subjects.
CombinatoRx Incorporated Derived Combination Drug Candidate, Prednisporin, Acquired By Sanofi-Aventis Through Proposed Acquisition of Fovea Pharmaceuticals
CombinatoRx Incorporated announced that its ophthalmic collaborator, Fovea Pharmaceuticals SA, has entered into a proposed acquisition with Sanofi-Aventis. A CombinatoRx-derived combination drug candidate, Prednisporin, (FOV1101), which is a fixed dose combination of prednisolone and cyclosporine, is the most advanced product asset in the Fovea pipeline, with Phase 2b clinical studies planned for the treatment of persistent allergic conjunctivitis. Terms were not disclosed.
Clinical Data, Inc. Announces Collaboration With CombinatoRx, Inc. For Development Of Novel B-Cell Cancer Therapy
Clinical Data, Inc. announced a collaboration and licensing agreement with CombinatoRx, Inc. to develop an adenosine A2A agonist compound in a combination therapy for the treatment of multiple myeloma, and other B-cell cancers. Under the agreement, Clinical Data licensed its highly selective adenosine A2A agonist, ATL313, to CombinatoRx in exchange for the potential to receive up to $252 million in clinical, regulatory and commercial milestones, as well as royalties on product sales. Clinical Data also retains a co-development option, which is exercisable after review of any Phase IIa study results. As part of the agreement, Clinical Data will contribute ATL313, a promising late-stage, preclinical compound. Under the collaboration, CombinatoRx will be responsible for the preclinical and clinical development of ATL313 to potentially treat B-cell malignancies.
CombinatoRx Incorporated and Neuromed Pharmaceuticals, Inc Signs Merger Agreement
CombinatoRx Incorporated and Neuromed Pharmaceuticals, Inc., a privately-held biopharmaceutical company, announced that they have entered into a definitive merger agreement under which CombinatoRx and Neuromed will merge in an all-stock transaction. Under the terms of the merger agreement, CombinatoRx is expected to issue approximately 36 million new shares of its common stock to Neuromed stockholders with each party owning approximately 50% of the voting power of the merged organization upon closing. Relative ownership of CombinatoRx will then be adjusted based upon the outcome of the FDA`s review of the NDA product candidate, Exalgo. If Exalgo approval is received by December 31, 2009, pre-merger CombinatoRx stockholders will own 30% of the combined company. If approval is received between January 1, 2010 and September 30, 2010, pre-merger CombinatoRx stockholders will own 40% of the combined company. If approval is received between October 1, 2010 and December 31, 2010, pre-merger CombinatoRx stockholders will own 60% of the combined company. If approval is not received by December 31, 2010, pre-merger CombinatoRx stockholders will own 70% of the combined company.
