There are certain diseases for which prognosis is very difficult, and neurodegenerative disorder - Parkinson's disease, is one among them. There is no cure for Parkinson's disease yet. But with proper treatment, symptoms of this disease can be eased.
About 4 million to 6 million people worldwide are affected by Parkinson's disease. The market for Parkinson's disease therapeutics represents a $3 billion plus global market.
The gold standard for treating Parkinson's disease is L-Dopa, also called Levodopa, which works by increasing dopamine, an important brain chemical, which is responsible for smooth, coordinated function of the body's muscles and movement. Parkinson's disease results from the loss of dopamine-producing nerve cells in the brain and is characterized by symptoms of tremor or shaking, slowness of movement, rigidity or stiffness and difficulty with balance.
Novartis AG's (NVS) Comtan and StalevoÂ, Pfizer Inc.'s (PFE)'s Mirapex and GlaxoSmithKline plc's (GSK) Requip are some of the other FDA-approved drugs to treat Parkinson's disease.
With aging population, the number of people who suffer from Parkinson's disease is expected to grow steadily, giving ample scope to new therapeutics. One such prospective entrant in the Parkinson's disease market is IPX066, being developed by Impax Laboratories Inc. (IPXL).
IPX066 is a controlled-release formulation of Carbidopa and Levodopa, which has demonstrated potential benefits for Parkinson's disease patients, with greater control of the debilitating motor symptoms of the disease, in late-stage trials.
Impax submitted the New Drug Application for IPX066 to the FDA for the treatment of idiopathic Parkinson's disease on December 19, 2011. The regulatory agency evaluates the application within the first 60 days of its receipt to determine if it is sufficiently complete to conduct a full review.
The NDA for IPX066 is a 505(b)(2) submission. The 505(b)(2) regulatory pathway allows a company to rely, at least in part, on the FDA's findings of safety and/or effectiveness for a previously approved drug (the "reference drug").
Impax has a deal in place with GlaxoSmithKline for the development and commercialization of IPX066. The agreement involving $11.5 million in upfront payments and potential payments of up to $175 million upon the successful achievement of development and commercialization milestones was signed in December 2010. Under the terms of the deal, GlaxoSmithKline has rights to market IPX066 worldwide, except in the U.S. and Taiwan.
For readers who are new to Impax Labs, here's a brief overview of its business and clinical pipeline...
The company has a balanced business model consisting of two divisions namely, generics business - operating under the name Global Pharmaceuticals, and branded products division - operating under the name Impax Pharmaceuticals.
As of November 1, 2011, 102 generic pharmaceuticals of Impax were marketed by Global Pharmaceuticals division and another 16 of its generic pharmaceuticals were marketed by the company's alliance and collaboration agreement partners.
The Global Pharmaceuticals division has 47 products pending approval , with at least 9 ANDAs or Abbreviated New Drug Applications, having first-to-file and 10 ANDAs having first-to-market potential. In addition, this generic division has another 46 products under development. This year, the company has a goal of filing at least 10 new ANDAs with at least 3 of these being first-to-file or first-to-market opportunities.
The Impax Pharmaceuticals division is engaged in the development of proprietary brand pharmaceutical products through improvements to already approved pharmaceutical products to address CNS (central nervous system)disorders.
In April 2010, the company's brand products division amended its 2008 co-promotion agreement with Wyeth, now a wholly owned subsidiary of Pfizer. According to the amended agreement, Impax co-promotes Pfizer's Lyrica CV for use as adjunctive therapy for adult patients with partial onset seizures to neurologists.
Impax has a growing partnership portfolio, which reads like a who's who of the industry. Endo Pharmaceuticals Inc., Pfizer Inc., GlaxoSmithKline, Medicis Pharmaceutical Corp., Shire Laboratories Inc., Banner Pharmacaps Inc., Perrigo Co. and IGI Laboratories Inc. are some of Impax collaboration partners.
Last December, the Impax Pharmaceuticals division initiated a phase IIb trial of its drug candidate IPX159 in patients with moderate to severe Restless Legs Syndrome.
Restless legs syndrome, or RLS, is a neurological condition that is characterized by an irresistible urge to move the legs to relieve unpleasant feelings such as creeping, crawling, pulling, itching, tingling or burning sensations.
Dopamine agonists, which are the most common form of medication to treat restless legs syndrome, account for more than 90% share of the prescription, while gabapentin account for less than 5% share.
However, dopamine agonists are associated with some side effects including nausea, dizziness, compulsive behavior and augmentation, which results in worsening of the symptoms.
Ropinirole, marketed as Requip by GlaxoSmithKline, a dopamine agonist, approved in 2005, was the first FDA-approved drug for RLS. A year later - in 2006, Pramipexole, developed by Boehringer Ingelheim and marketed as Mirapex, was approved by the FDA and the EU for the treatment of restless legs syndrome. Requip's patent lapsed in May of 2008 and its generic versions have also been approved to treat RLS. In Japan, Pramipexole was approved in 2010 for the treatment of restless legs syndrome.
Last April, the FDA approved Horizant, developed by GlaxoSmithKline and XenoPort Inc., for the treatment of moderate-to-severe primary restless legs syndrome, or RLS, in adults.
There are about 25 million RLS sufferers in the U.S. and its market opportunity is estimated at about $800 million.
Impax drug candidate for RLS - IPX159, is a new molecular entity in the U.S. The compound has an established pharmacologic and safety profile for non-Restless Legs Syndrome use outside the U.S. The regulatory pathway for IPX159 NDA submission is 505(b)(1). Under the 505(b)(1) regulatory pathway, a drug candidate is required to demonstrate clinical meaningful treatment benefits and statistically significant safety and efficacy objectives and endpoints and is a new chemical entity, with a new indication.
The phase IIb trial is designed to randomize about 120 adult subjects who will receive either IPX159 or placebo and will be treated for up to 11 weeks. The primary endpoint of the study is the International Restless Legs Syndrome Study Group Rating Scale. Results from this study are anticipated in mid-2013.
The company has a strong balance sheet with significant cash and no debt. At the end of third quarter 2011, Impax had cash of $359.8 million.
With a well-stocked pipeline, growing partnership portfolio and a healthy balance sheet, Impax might be worth a look.
Shares of Impax have thus far hit a 52-week low of $14.46 and a 52-week high of $28.75. The stock is currently down 0.55% trading at $19.81.
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