COPENHAGEN, Denmark, April 27, 2015 (GLOBE NEWSWIRE) -- Forward Pharma A/S (Nasdaq:FWP) (the "Company") announced today that the Company received a decision to grant from the European Patent Office (EPO) regarding its patent application 14172398.1 which covers, among other things, the treatment of multiple sclerosis with 480 mg per day of dimethyl fumarate (DMF) wherein the pH controlled release compositions have an enteric coat. The EPO projects that the application will issue under the patent number EP2801355 on May 20, 2015 with the publication of the mention of grant. We expect that the patent will provide protection until October 2025, assuming the Company successfully defends the patent during any subsequent invalidation proceedings.
This projected European patent is one of several elements of the Company's intellectual property, which also includes three U.S. pending patent applications and two other European pending patent applications covering methods of treating multiple sclerosis with formulations that provide a 480 mg daily dose of DMF.
"This would be our first issued patent covering the use of 480 mg per day of DMF in MS and is further evidence of the progress we are making with our intellectual property estate," commented Peder Andersen, CEO of Forward Pharma. "We anticipate the issuance of additional patents from our five other pending patent applications covering the 480 mg daily dose of DMF."
The EPO examiner allowed our 480 mg patent claims after considering third party observations both requesting the EPO to not grant the application as well as suspend its examination. Biogen markets Tecfidera®, a product containing DMF as the active ingredient for the treatment of MS at a daily dose of 480 mg. Tecfidera® was approved by the European Commission in January 2014. Worldwide sales of Tecfidera® as reported by Biogen totalled over $3.2 billion in the last 12 months, including $614 million of ex-US sales.
EP2801355 is one of several avenues through which Forward Pharma is advancing its intellectual property, including three U.S. patent applications numbered 11/576,871, 14/213,399, and 14/212,503 and two European patent applications numbered EP14172390.8 and EP14172396.5. Each of these applications claims treating MS with 480 mg of DMF per day. In addition, the Company has a German utility model that is in litigation in Dusseldorf, Germany against Biogen.
Additional information on the projected EP2801355 patent, including the decision to grant, is available by accessing the European Patent Office website, register.epo.org. Additional information on the Company's U.S. patent applications is available by accessing the Patent Application Information Retrieval (PAIR) website http://pair.uspto.gov/.
About Forward Pharma:
Forward Pharma A/S is a Danish biopharmaceutical company (the "Company or "Forward Pharma") developing FP187, a proprietary formulation of DMF (dimethyl fumarate) for the treatment of inflammatory and neurological indications. Since our founding in 2005, we have worked to advance unique formulations of DMF, which is an immune modulator, as a therapeutic agent to improve the health and well-being of patients with immune disorders including multiple sclerosis. FP187, our clinical candidate, is a DMF formulation in a delayed and slow release oral dose.
Our principal executive offices are located at Østergade 24A, 1, 1100 Copenhagen K, Denmark and our American Depositary Shares are publicly traded on NASDAQ Stock Market (symbol: FWP). For more information about the Company's products and developments, please visit our web site at www.forward-pharma.com.
Forward Pharma A/S Media Contact:
Sharon Klahre, Director, Investor Relations
Forward Pharma USA, LLC
7 Skyline Drive
Hawthorne, NY 10532
The Ruth Group
Forward Looking Statements:
Certain statements in this press release may constitute "forward-looking statements" of the Company within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements which contain language such as "believe," "expect," "anticipate," "hope," "would" and "potential." Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: the Company's ability to obtain, maintain and defend issued patents with protective claims; the issuance and term of term of patents; the commencement of any patent interference or infringement action; the Company's ability to prevail in or obtain a favorable decision in any such action; the Company's ability to recover damages in any such action; uncertainties relating to our development plans and activities, including the results, timing, cost and location thereof; risks and uncertainties related to the scope, validity and enforceability of our intellectual property rights in general and the impact on us of patents and other intellectual property right of third parties. These and other factors are identified and described in detail in certain of our filings with the United States Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2014.