Mylan N.V issued the following announcement on June 18.
Mylan achieves key milestone to provide U.S. multiple sclerosis patients with more affordable generic version of Biogen's Tecfidera® capsules
Biogen's asserted claims of ᾿514 method patent found invalid
Win clears legal pathway to launch upon FDA approval
Mylan N.V. (NASDAQ: MYL) announced that the U.S. District Court for the Northern District of West Virginia invalidated Biogen's Tecfidera® patent, U.S. Patent No. 8,399,514, for lack of written description. The ᾿514 patent claimed methods of treating multiple sclerosis (MS) using a dose of 480 mg/day of dimethyl fumarate delayed release capsules. Today's decision clears the way for Mylan's launch of its dimethyl fumarate product upon the receipt of FDA approval. The '514 patent could have otherwise delayed generic competition until 2028.
Mylan CEO Heather Bresch commented: "Today's win is significant in that it brings Mylan one step closer to providing expanded treatment options for the thousands of Americans living with relapsing forms of MS. The District Court decision clears the legal pathway for us to bring our dimethyl fumarate product to market, and we are working with the FDA to accelerate our regulatory approval target action date, which currently is November 16. Once approved and launched, we believe our generic Tecfidera will potentially be the first generic of any MS treatment in an oral solid dosage form available to patients in the U.S., further advancing our commitment to provide a broad portfolio of central nervous system medicines, which already includes glatiramer acetate injection."
Mylan President Rajiv Malik commented: "Mylan continues to address unmet patient needs across the value chain. Bringing a product like generic Tecfidera to market requires not only our extensive scientific and commercial expertise, but also our unwavering commitment to access through overcoming potential legal barriers to reach patients. We look forward to bringing this important medicine to market as soon as possible, pending final FDA approval."
Tecfidera (dimethyl fumarate) delayed-release capsules are used to treat adults with relapsing forms of MS. Mylan believes it is one of the first companies to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for a dimethyl fumarate product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Mylan's ANDA is pending with the U.S. Food and Drug Administration (FDA).
Biogen's total IQVIA sales in the U.S. for the 12 months ending April 30, 2020, were approximately $3.78 billion for Tecfidera.
About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.
Original source can be found here.
Alerts Sign-up