×

Adamas Pharmaceuticals Receives Orphan Drug Designation for ADS-5102 for the Treatment of Levodopa-Induced Dyskinesia Associated With Parkinson's Disease

EMERYVILLE, Calif., April 10, 2015 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that the Food and Drug Administration (FDA) has granted orphan drug status to ADS-5102 for the treatment of levodopa-induced dyskinesia associated with Parkinson's disease. Adamas currently has multiple Phase 3 studies underway evaluating ADS-5102 for this indication, which currently has no FDA-approved treatment options.

"People with Parkinson's disease contend with the disability associated with levodopa-induced dyskinesia multiple times a day as the disease progresses and their motor symptoms fluctuate," said Gregory T. Went, Ph.D., Chairman and CEO of Adamas Pharmaceuticals. "Adamas is committed to bringing new treatments to patients suffering with movement disorders related to neurological disorders. With positive data from our Phase 2/3 study, a pivotal Phase 3 program well underway, and 10 issued US patents, we are pleased with our ongoing momentum."

About Orphan Drugs

The Orphan Drug Act enables the FDA to grant special status to a product that treats a rare disease or condition upon request of a sponsor. For a drug to qualify for orphan drug designation, the condition must meet certain criteria, including affecting fewer than 200,000 people in the US. Once granted, orphan designation qualifies the sponsor for various incentives including: potential tax credits, a reduction in certain regulatory fees, and the potential for seven years of market exclusivity for the drug when it achieves FDA marketing approval.

About ADS-5102

Adamas' most advanced wholly owned product candidate is ADS-5102 (amantadine HCl), a high dose, extended-release version of amantadine that is administered once daily at bedtime. Adamas is initially developing ADS-5102 for the treatment of levodopa-induced dyskinesia, or LID, in patients with Parkinson's disease. LID is a complication that frequently occurs in patients after long-term treatment with levodopa, the most widely used drug for Parkinson's disease. There are no approved drugs for the treatment of LID in the United States or Europe.

Parkinson's Disease and Levodopa-induced Dyskinesia (LID)

Parkinson's disease is a chronic, progressive motor disorder that causes a variety of symptoms, such as tremors, rigidity, slowed movements and postural instability. The most commonly prescribed treatments for Parkinson's disease are levodopa-based therapies. In the body, levodopa is converted to dopamine to replace the dopamine loss caused by the disease. Patients initially receive relief from symptoms of Parkinson's disease for much of the day. This period of relief is known as "ON" time. As the effects of levodopa wear off, the symptoms of Parkinson's disease return. This is known as "OFF" time.

As Parkinson's disease progresses, most patients require increasing doses of levodopa to achieve equivalent therapeutic benefit. Patients may also experience symptoms of their disease upon waking, prior to the first dose of levodopa taking effect. Over time many patients will suffer from LID, a condition characterized by involuntary movements without purpose. LID can become severely disabling, rendering patients unable to perform routine daily tasks. As Parkinson's disease advances, the symptoms of LID worsen in frequency and severity. Eventually the total time that a patient spends either "OFF" or "ON" with LID can become a majority of his or her day.

About Adamas Pharmaceuticals

Adamas Pharmaceuticals, Inc. is a specialty pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system. The company achieves this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone or in fixed-dose combination products. Adamas is currently developing its lead wholly-owned product candidate, ADS-5102, for a complication associated with the treatment of Parkinson's disease known as levodopa-induced dyskinesia, or LID, and is evaluating other potential indications. The company's portfolio also includes two approved products with Forest Laboratories Holdings Limited (a subsidiary of Actavis plc), Namzaric™ and Namenda XR®. Forest is responsible for marketing both products in the United States under an exclusive license from Adamas. For more information, please visit www.adamaspharma.com.

Namenda XR® is a registered trademark of Merz Pharma GmbH & Co. KGaA.

Namzaric™ is a trademark of Actavis, Inc. or its affiliates.

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including, but not limited to, statements regarding bringing new treatments to patients suffering movement disorders. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "committed" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to research and development activities of ADS-5102 and other current and future products, challenges associated with clinical trials including delays in enrollment, the failure to demonstrate the safety and efficacy of ADS-5102 or other product candidates, as well as risks relating to Adamas' business in general, see Adamas' Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 3, 2015. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release.

CONTACT: Julie Wood Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc. Phone: 510-450-3528

Source:Adamas Pharmaceuticals, Inc.