Impax Pharmaceuticals (Branded)
Our Branded Pharmaceuticals Division
In 2008, Impax Laboratories launched Impax Pharmaceuticals as the Company’s branded products division. Impax Pharmaceuticals is a neurology-focused, specialty pharmaceutical company, dedicated to developing products for unmet needs in the treatment of Central Nervous System (CNS) disorders.
Experience in Neurology Research
The executive management team of Impax has extensive experience developing and marketing products for CNS disorders. The branded business is currently focused on internally developing CNS products where we can deliver meaningful patient benefits and develop strong intellectual property positions. The long-term strategy is to build a strong pipeline through both internal R&D and external business development.
Commercial CNS Products
In February 2012, we licensed from AstraZeneca the exclusive U.S. commercial rights to Zomig® (zolmitriptan) tablet, orally disintegrating tablet, and nasal spray formulations pursuant to the terms of the AZ Agreement and began sales of the Zomig® products under our label through our specialty sales force. As part of the AZ Agreement, we also have non-exclusive rights to develop new products containing zolmitriptan and to exclusively commercialize these products in the U.S. in connection with the Zomig® brand.
Zomig® and Zomig-ZMT® are registered trademarks of the AstraZeneca group of companies and are exclusively licensed in the U.S. to Impax in connection with Impax’s commercialization of Zomig®. For more information about Zomig®, go to www.zomig.com.
The Company has one late-stage branded pharmaceutical product candidate which we are developing internally, RYTARY™ (IPX066), an extended release capsule formulation of carbidopa-levodopa for the treatment of symptomatic Parkinson’s disease, for which an NDA was accepted for filing by the FDA in February 2012. In January 2013, the FDA issued a Complete Response Letter regarding the NDA for RYTARY™. We are working with the FDA on the appropriate next steps for the RYTARY™ NDA.
The Company currently has four additional neurology products in various stages of development and review by its R&D team.