HERTFORDSHIRE, England and PITTSBURGH, Dec. 11, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that Teva has dismissed its pending district court litigation against Mylan regarding Mylan's Glatiramer Acetate Injection 40 mg/mL, the first generic version of Copaxone® 40 mg/mL. The litigation involved two non-Orange Book listed patents, U.S. Patent Nos. 9,155,775 and 9,763,993, relating to the final sterile filtration step in the manufacturing process for glatiramer acetate products.
Teva dropped litigation on these patents after the U.S. District Court for the District of Delaware issued a decision adopting Mylan's interpretation of the patents' claims. In addition, Teva has agreed to withdraw the Irish equivalent to these patents from the recently filed proceeding in Ireland.
After the dismissals, Teva's only remaining patent challenges in the U.S. and Ireland against Mylan's Glatiramer Acetate Injection 40mg/mL relate to the three-times-a-week dosing regimen, which Mylan has already successfully invalidated at the U.S. District Court for Delaware, the U.S. Patent Trial and Appeal Board and the United Kingdom's High Court of Justice. Teva is appealing these decisions.
We are extremely proud to be the first company to offer MS patients in the U.S. our Glatiramer Acetate Injection 40 mg/mL as an alternative to Teva's Copaxone three-times-a-week formulation. The ruling and case dismissal give us even greater confidence in our ability to continue providing this important product to thousands of MS patients nationwide who are living with this very difficult disease and in need of a more affordable treatment option.
In early October, Mylan received FDA approval and launched its Glatiramer Acetate Injection 40 mg/mL for three-times-a-week injection, an AP-rated, substitutable generic version of Teva's Copaxone 40 mg/mL. According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete Abbreviated New Drug Application for Glatiramer Acetate Injection, 40 mg/mL, containing a Paragraph IV certification.
Copaxone® is the most prescribed MS treatment for relapsing forms of MS in the U.S. with brand sales for the 20 mg/mL dose of approximately $667 million and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending Oct. 31, 2017, according to IQVIA. Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial MS diagnoses.
This press release includes statements that constitute "forward-looking statements," including with regard to: the launch of Mylan's Glatiramer Acetate Injection products; and the ruling and case dismissal giving Mylan even greater confidence in its ability to continue providing this important product to thousands of MS patients nationwide who are living with this very difficult disease and in need of a more affordable treatment option. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; actions and decisions of healthcare and pharmaceutical regulators; determinations by health insurance companies regarding coverage for Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL; any regulatory, legal, or other impediments to Mylan's ability to bring Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL to market, including ongoing and unresolved allegations of patent infringement around our launch of Glatiramer Acetate Injection 40 mg/mL; any changes in or difficulties with Mylan's or its partners' inventory of, and ability to manufacture and distribute, Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL to meet anticipated demand; the potential impact of any change in patient access to or demand for Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL; the scope, timing, and outcome of any ongoing legal proceedings, including but not limited to government investigations, and the impact of any such proceedings on Mylan's or its partners' business; the impact of competition; strategies by competitors or other third parties to delay or prevent product introductions, including Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL; changes in the economic and financial conditions of the businesses of Mylan or its partners; other uncertainties and matters beyond the control of management; and the other risks detailed in Mylan's filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update any statements herein for revisions or changes after the date of this release.
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 growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 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 more than 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.
SOURCE Mylan N.V.