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 we currently have:
- 66 approved ANDAs.
- 39 products pending at the FDA.
- 79 products under development.
Our experience in controlled-release formulation is quite impressive compared to our competitors. Since our first submission in 2001, we have had 19 controlled-release approvals, a strong position versus significantly larger industry peers.
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 market.
Within our branded division we are currently developing:
- A product for Parkinson’s disease (IPX066). Completed Naive Phase III Study (APEX-PD), Advanced Phase III Study (ADVANCED-PD) and ASCEND-PD Phase III Study (IPX066 vs. carbidopa-levodopa plus entacapone). Targeting NDA filing in fourth quarter of 2011.
- A product for Restless Legs Syndrome (IPX159). Completed Phase IIa study. Filed Investigational New Drug (IND) Application in May 2011. Planning Phase IIb study in moderate to severe RLS in fourth quarter 2011 or first quarter 2012.
- A product for Spasticity in patients with Multiple Sclerosis (IPX056). Completed one Phase III study, with second Phase III study currently on hold, available for out-licensing.