Mylan Inc. (Nasdaq: MYL) today announced that it has received all regulatory approvals and has completed an agreement with Pfizer for the exclusive worldwide rights to develop, manufacture and commercialize a novel long-acting muscarinic antagonist (LAMA) compound for various indications.
Mylan expects that this product, which is ready to enter Phase IIb, will be submitted to the U.S. Food and Drug Administration (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 CEO Heather Bresch commented, "This acquisition further expands Mylan's growing respiratory franchise, building upon the products we already have in development, such as our generic Advair® program and our combination product for the treatment of chronic obstructive pulmonary disease (COPD). By adding a novel LAMA compound to our capabilities, we will have the opportunity to bring additional combination products to market, including triple-combination therapies, and further differentiate Mylan as a leader in this important therapeutic area."
Mylan 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.