Adamas Pharmaceuticals Issued Six Additional U.S. Patents

Adamas Pharmaceuticals, Inc.

announced the issuance of six additional US patents (US 8,889,740; US 8,895,614; US 8,895,615; US 8,895,616; US 8,895,617 and US 8,895,618), bringing the total number of issued patents for amantadine-based controlled-release products owned by Adamas to nine, with 12 more applications pending. The newly issued patents include both composition of matter claims and claims covering methods for treatment of neurological diseases, including Parkinson's disease, related to the pharmacokinetic profile of amantadine HCl. "Pursuing a comprehensive intellectual property portfolio is an important element of our corporate strategy," said Gregory T. Went, Ph.D., Adamas' founder, CEO and a co-inventor on these patents. "At Adamas, we develop and patent pharmaceutical products and methods of administration that are based on our pharmacokinetic-pharmacodynamic discoveries. We believe that these discoveries could provide the foundation for new medical treatments of individuals with serious CNS disorders, such as Parkinson's disease, as well as a broader set of movement disorders." Dr. Went continued, "This additional series of patents is based upon patent applications initially filed in 2004. Importantly, these patents cover product candidates that we believe would enable once-daily dosing over a wide range of strengths and formulations, as well as combination formulations." Pharmacokinetics is the study of the absorption, distribution, metabolism, and excretion of a drug after administration. Pharmacokinetic profiles are quantitative representations of drug levels in the body over time. Pharmacokinetics is often studied in conjunction with pharmacodynamics, the study of a drug's pharmacological effect on the body. About ADS-5102 Adamas' most advanced wholly-owned product candidate is ADS-5102 (amantadine HCl), a high dose, controlled-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 movement disorder 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. Derived from Adamas' clinical study data for patients taking ADS-5102, the amantadine plasma concentration achieved from the early morning through mid-day was substantially higher than that reached following administration of immediate-release amantadine, providing symptomatic relief to patients as they engaged in their daily activities. Further, there were no changes in sleep patterns, a common concern for Parkinson's disease patients taking immediate-release amantadine. Parkinson's Disease and Levodopa-induced Dyskinesia (LID) Parkinson's disease is a chronic, progressive motor disorder that causes 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. By properly managing the timing of levodopa administration, patients with early-stage Parkinson's disease can largely avoid "OFF" time during the day. Over time, as Parkinson's disease progresses, most patients require increasing doses of levodopa to achieve equivalent therapeutic benefit. Even with increased doses of levodopa, patients may begin to exhibit unpredictable "OFF" episodes throughout the day. In the later stages of the disease, 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.