18.12.2013 15:51:32
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Mylan Acquires Rights To Novel LAMA Respiratory Compound From Pfizer
(RTTNews) - Mylan Inc. (MYL) announced Wednesday that it has received all regulatory approvals and has completed an agreement with Pfizer Inc. (PFE) for the exclusive worldwide rights to develop, manufacture and commercialize a novel long-acting muscarinic antagonist or LAMA compound for various indications.
Mylan said it expects that this product, which is ready to enter Phase IIb, will be submitted to the U.S. Food and Drug Administration or FDA for approval as a new chemical entity, and expects the product to benefit from long-term patent protection in the U.S. through 2029.
Mylan expects to further develop this compound into combination therapies and that these products will utilize the multi-dose dry powder inhaler technology, also licensed from Pfizer.
Mylan noted that it will have exclusive commercialization rights for this compound in the U.S., Canada, Australia, New Zealand, the European Union and European Free Trade Association countries, India and Japan. In the rest of the world, Mylan and Pfizer will have co-promotion rights to the product. All other financial terms and product details remain confidential, Mylan said.
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