Acorda Therapeutics Announces Allowance of Second U.S. Patent Application

August 10, 2011 06:03 AM Eastern Daylight Time
                                                                                                                        HAWTHORNE, N.Y.--(EON: Enhanced Online News)--Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the United       States Patent and Trademark Office (USPTO) has allowed U.S. Patent       Application No. 11/102,559 entitled “Method of Using Sustained Release       Aminopyridine Compositions.” The claims of the patent application relate       to methods to improve walking, walking speed, lower extremity muscle       tone and lower extremity muscle strength in patients with multiple       sclerosis (MS) by administering 10 mg of sustained release       4-aminopyridine (dalfampridine) twice daily. This patent application is       separate from the AMPYRA® method of use patent application       which was allowed by the USPTO in April 2011.   

“The allowance of this patent application further strengthens our patent       protection for AMPRYA and enhances our ability to continue exploring       potential new uses and indications, both in MS and other diseases”

          “The allowance of this patent application further strengthens our patent       protection for AMPRYA and enhances our ability to continue exploring       potential new uses and indications, both in MS and other diseases,” said       Ron Cohen, M.D., President and CEO of Acorda Therapeutics. “The       discoveries we made during our development of AMPYRA, several of which       are reflected in this patent, were critical to receiving FDA approval       and making this therapy available to people with MS who have walking       impairment. We are pleased that the UPTO has recognized these findings       as innovative and valuable contributions to medicine.”   
          The patent issuing from Application No. 11/102,559 is currently set to       expire in April 2025, but is also eligible for patent term adjustment,       to be determined by the USPTO based on the prosecution history. This       patent is eligible for listing in the U.S. Food and Drug Administration       (FDA) Orange Book.   
          Sustained release 4-aminopyridine is marketed in the United States under       the trade name AMPRYA® (dalfampridine) Extended Release       Tablets, 10 mg. AMPYRA is an oral medication approved by the FDA as a       treatment to improve walking in patients with multiple sclerosis (MS).       This was demonstrated by an increase in walking speed.   
          Important Safety Information   
          AMPYRA can cause seizures; the risk of seizures increases with       increasing AMPYRA doses. AMPYRA is contraindicated in patients with a       prior history of seizure. Discontinue AMPYRA use if seizure occurs.   
          AMPYRA is contraindicated in patients with moderate or severe renal       impairment (CrCl≤50 mL/min); the risk of seizures in patients with mild       renal impairment (CrCl 51–80 mL/min) is unknown, but AMPYRA plasma       levels in these patients may approach those seen at a dose of 15 mg       twice daily, a dose that may be associated with an increased risk of       seizures; estimated CrCl should be known before initiating treatment       with AMPYRA.   
          AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP,       fampridine), since the active ingredient is the same.   
          Urinary tract infections were reported more frequently as adverse       reactions in patients receiving AMPYRA 10 mg twice daily compared to       placebo.   
          The most common adverse events (incidence ≥2% and at a rate greater than       the placebo rate) for AMPYRA in MS patients were urinary tract       infection, insomnia, dizziness, headache, nausea, asthenia, back pain,       balance disorder, multiple sclerosis relapse, paresthesia,       nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain.   
          For full U.S. Prescribing Information and Medication Guide for AMPYRA,       please visit: www.AMPYRA.com.   
          About AMPYRA       (dalfampridine)   
          AMPYRA is a potassium channel blocker approved as a treatment to improve       walking in patients with multiple sclerosis (MS). This was demonstrated       by an increase in walking speed. AMPYRA, which was previously referred       to as Fampridine-SR, is an extended release tablet formulation of       dalfampridine (4-aminopyridine, 4-AP), which was previously called       fampridine, and remains known by that name outside the US. In laboratory       studies, dalfampridine has been found to improve impulse conduction in       nerve fibers in which the insulating layer, called myelin, has been       damaged. AMPYRA is being developed and commercialized in the United       States by Acorda Therapeutics, and by Biogen Idec in markets outside the       U.S. based on a licensing agreement with Acorda. AMPYRA is manufactured       globally by Elan based on a supply agreement with Acorda.   
          AMPYRA is available by prescription in the United States. For more       information about AMPYRA, including patient assistance and co-pay       programs, healthcare professionals and people with MS can contact AMPYRA       Patient Support Services at 888-881-1918.   
          AMPYRA Patient Support Services is available Monday through Friday, from       8:00 a.m. to 8:00 p.m. Eastern Time at 888-881-1918. For full U.S.       Prescribing Information and Medication Guide, please visit: www.AMPYRA.com.   
          About Acorda       Therapeutics   
          Acorda Therapeutics is a biotechnology company developing therapies for       multiple sclerosis, spinal cord injury and related nervous system       disorders. The Company is commercializing and marketing AMPYRA®       (dalfampridine) Extended Release Tablets, 10 mg, in the Unites       States. AMPYRA is a potassium channel blocker approved as a treatment to       improve walking in patients with multiple sclerosis (MS); this was       demonstrated by an improvement in walking speed. AMPYRA was developed       using Elan’s Matrix Drug Absorption System (MXDAS®)       technology and is manufactured by Elan based on a supply agreement with       Acorda.   
          Acorda also markets ZANAFLEX       CAPSULES® (tizanidine hydrochloride), a short-acting drug       for the management of spasticity. The Company's pipeline includes a       number of products in development for the treatment, regeneration and       repair of the spinal cord and brain.   
          Forward-Looking Statements   
          This press release includes forward-looking statements within the       meaning of the Private Securities Litigation Reform Act of 1995. All       statements, other than statements of historical facts, regarding       management's expectations, beliefs, goals, plans or prospects should be       considered forward-looking. These statements are subject to risks and       uncertainties that could cause actual results to differ materially,       including Acorda Therapeutics' ability to successfully market and sell       Ampyra in the United States and to successfully market Zanaflex       Capsules; third party payors (including governmental agencies) may not       reimburse for the use of Ampyra at acceptable rates or at all and may       impose restrictive prior authorization requirements that limit or block       prescriptions; the risk of unfavorable results from future studies of       Ampyra; the occurrence of adverse safety events with our products;       delays in obtaining or failure to obtain regulatory approval of Ampyra       outside of the United States and our dependence on our collaboration       partner Biogen Idec in connection therewith; competition; failure to       protect Acorda Therapeutics’ intellectual property, to defend against       the intellectual property claims of others or to obtain third party       intellectual property licenses needed for the commercialization of our       products; the ability to obtain additional financing to support Acorda       Therapeutics' operations; and, unfavorable results from our research and       development programs. These and other risks are described in greater       detail in Acorda Therapeutics' filings with the Securities and Exchange       Commission. Acorda Therapeutics may not actually achieve the goals or       plans described in its forward-looking statements, and investors should       not place undue reliance on these statements. Forward-looking statements       made in this release are made only as of the date hereof, and Acorda       Therapeutics disclaims any intent or obligation to update any       forward-looking statements as a result of developments occurring after       the date of this press release.