Schering-Plough and
Merck withdrew the NDA for the Claritin (loratadine)/Singulair (montelukast) combination tablet. The companies also terminated the their respiratory joint venture formed in May 2000. The FDA issued a not-approvable letter in April for the proposed fixed-dose combination of the two drugs. This decision does not impact the companies' cholesterol joint venture.
As a result of the termination, Schering-Plough expects to receive payments totaling $105 million from Merck per the joint venture agreements, which Schering-Plough will recognize over the remaining three quarters of 2008.
Exelixis and
GlaxoSmithKline will end their six-year collaboration based on its success, on October 27, 2008, as scheduled. Under the terms of the collaboration, GSK has the right to select two compounds for further development and commercialization. Exelixis will have the right to develop and commercialize compounds not selected by GSK. Exelixis' exclusivity obligations will now be limited to the compounds selected by GSK. Exelixis will have the right to develop and commercialize any collaboration target or compound that does not infringe upon the intellectual property associated with compounds selected by GSK for further development and commercialization.
"This collaboration represents a successful alliance that has truly benefited both companies. With the selection of GSK089 (formerly XL880) and potentially one other compound, GSK has been able to strengthen its oncology pipeline. I am enthusiastic about the compounds remaining in the collaboration, and continue to be impressed by Exelixis' quality of science and productivity," said Paolo Poletti, M.D., senior vice president of the Oncology Medicines Development Center at GSK.
To date, Exelixis has received approximately $235 million from GSK, which includes upfront, milestone, and R&D support payments. If GSK selects a second compound, Exelixis will be entitled to receive an additional milestone payment of either $55 million or $27.5 million. Exelixis is eligible for development milestones and royalties on compounds selected for development and commercialization by GSK. Exelixis will pay GSK a small royalty on certain candidates not selected by GSK.
Centocor's BLA has been submitted to the FDA requesting approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis. Golimumab is the company's next-generation human anti-TNF-alpha monoclonal antibody. It's being studied as an every four-week subcutaneous injection and as an intravenous (IV) infusion therapy. In February 2008, the company submitted a MAA to the EMEA for golimumab as a monthly subcutaneous treatment for the same indications.
The submission is based on five Phase III trials: golimumab as the first-line option in the treatment of early onset RA before methotrexate; golimumab for patients with active RA despite methotrexate use; and golimumab administered subcutaneously in patients with active RA and previously treated with biologic anti-TNF-alpha agent.
Magazine
