Experience Is Our Strength
At Impax Laboratories we have created a strong platform for growth built on a broad base of drug delivery expertise, formulation technology and experience in product development.
Our generic division, Global Pharmaceuticals, has a wealth of experience and a track record of product approvals. Investing in our people is a key ingredient to our success and a benefit in building a strong organization.
Within our generics division:
- As of August 2, 2013, we marketed 133 generic pharmaceutical products representing dosage variations of 39 different pharmaceutical compounds through our Global Division, and 14 other generic pharmaceutical products, representing dosage variations of four different pharmaceutical compounds, through our alliance and collaboration agreement partners. Our marketed generic products include, but are not limited to, authorized generic Adderall XR®, Fenofibrate (generic to Lofibra®) and Oxymorphone HCl ER (generic to Opana® ER).
- 44 products pending at the FDA
- 25 products under development
In our brand division, Impax Pharmaceuticals, we have assembled a strong research and development team with the direct collective experience of 17 approved New Drug Applications (NDA). They are applying our formulation expertise to develop differentiated, modified, or controlled-release versions of currently marketed drug products focused on significant unmet needs in the Central Nervous System (CNS) market.
Within our branded division:
- Our branded portfolio consists of commercial CNS products and development stage projects. In February 2012, we licensed from AstraZeneca the exclusive U.S. commercial rights to Zomig® (zolmitriptan) tablet, orally disintegrating tablet (ODT), 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 of May 2013, the specialty sales force is commercializing only the nasal spray following patent expiration on the Zomig® tablet and ODT product.
- We currently have one late-stage branded pharmaceutical product candidate which we are developing internally, RYTARY™ (IPX066) 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.