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. Impax’ leadership team is made of up industry veterans whose focused development efforts have progressed IPX066, its lead product candidate for Parkinson’s Disease, from IND to Filing with the U.S. Food and Drug Agency (FDA) in less than four years.
CNS Therapeutic Category
CNS is the largest therapeutic category in the U.S. with 2010 retail sales of $77 billion, or 21% of the $367 billion U.S. retail drug market.
Source: Wolters Kluwer Health, Source Pharmaceutical Audit Suite, Retail Total Prescription Sales, Jan – Dec. 2010. CNS includes Neurology, Psychiatry and Pain categories.
Experience in Neurology Research
The executive management team of Impax has extensive experience developing and marketing products for CNS disorders. The Impax strategy is to build the product portfolio primarily through internal development, as well as licensing and acquisition. We intend to utilize our expertise in drug delivery technologies in the formulation of drug substances no longer protected by patents as differentiated, modified, or controlled-release pharmaceutical products that we will market as brand name products.
In December 2011, Impax filed a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IPX066, our lead branded pharmaceutical product candidate. IPX066 is an investigational, patented extended-release capsule formulation of carbidopa-levodopa (CD-LD) for the treatment of idiopathic Parkinson’s Disease (PD). IPX066 provides a rapid and sustained delivery of levodopa, with the goal of improving PD clinical symptom management. Impax has completed one Phase III study (APEX-PD) in patients with early PD and two Phase III studies (ADVANCE-PD and ASCEND-PD Part 1) in patients with advanced PD.
The results of these Phase III studies suggest that IPX066 improves control of PD motor symptoms, leading to clinically meaningful reductions in off-time, a key objective in the management of PD. Off-time is the functional state when patients' medication effects have worn off and there is a return of Parkinson motor symptoms. In addition, the IPX066 extended-release formulation is designed to enable a reduced dosing frequency, enhancing patient convenience.
IPX159 is being developed by Impax Pharmaceuticals for the treatment of moderate to severe Restless Legs Syndrome (RLS). IPX159 is an investigational oral controlled-release formulation of a small molecule that has an established pharmacological and safety profile for non-RLS use outside the U.S. and may represent a novel mechanism of action in RLS. Impax has completed a proof of concept study in RLS patients and started a Phase IIb study in RLS in December 2011.
RLS is a condition characterized by an irresistible urge to move ones’ limbs, most commonly the legs, to stop uncomfortable sensations. RLS symptoms generally worsen in the evening, are made worse by rest or inactivity, and commonly cause insomnia and involuntary leg movements during sleep. There are approximately 25 million Americans that experience RLS symptoms.1 Significant unmet need exists for alternative therapies to give physicians and their patients’ additional options and to help address the tolerability and safety issues with existing agents.
IPX159 Development Status
A Phase IIb study of IPX159 in moderate to severe RLS, commenced in December 2011 and results are planned to be available in mid-2013.
Our pipeline also consists of IPX056, an extended-release baclofen product for spasticity in patients with multiple sclerosis. One Phase III study has been completed and a second Phase III study is currently on hold, available for out-licensing.
Impax is also developing other programs for neurological disorders, which are in exploratory stages of development.
Co-Promotion Agreement with Pfizer (formerly Wyeth)
Impax has a specialty sales force performing physician detailing sales calls to Neurologists for Pfizer’s Lyrica product. We receive a fixed fee, subject to annual cost adjustment, for providing physician detailing sales calls within a contractually defined range of an aggregate number of physician detailing sales calls rendered on a quarterly basis.