HERTFORDSHIRE, England and
PITTSBURGH, Oct. 5, 2017 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced that partner, Synthon, received
marketing authorization approval in Europe for Glatiramer Acetate Injection 40
mg/mL, a therapeutically equivalent generic version of Teva's
Copaxone® 40 mg/mL, indicated for the treatment of
patients with relapsing forms of multiple sclerosis (MS), a chronic
inflammatory disease of the central nervous system.
This approval complements last year's approval of Glatiramer
Acetate Injection 20 mg/mL, which already is available in several
European markets.
Granting of national marketing authorizations is expected to
follow in the near future.
Mylan CEO Heather Bresch
commented, "We're pleased with the approval of Glatiramer Acetate
Injection 40 mg/mL, and look forward to leading the marketing and
selling of this important product in our European markets. Mylan
recognizes the complexities of MS care and challenges faced by
patients. This approval reinforces our commitment to helping
patients and healthcare providers by providing alternative
treatment options to better serve the needs of this community. The
approval also highlights Mylan's commercial capabilities and
ability to commercialize complex products around the globe."
Mylan is partnered with Synthon, the developer and supplier of
its European Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL
products, and has exclusive distribution and supply rights for the
products for Germany, France, Spain, Portugal, Belgium, Italy, the
Netherlands, United
Kingdom, Republic of
Ireland, Switzerland,
Greece, Denmark, Sweden, Norway, Finland, Cyprus and Malta.
Forward-Looking Statements
This press release
includes statements that constitute "forward-looking statements,"
including with regard to bringing Glatiramer Acetate Injection 40
mg/mL product to market, that Mylan looks forward to leading the
marketing and selling of this important product in its European
markets and that the granting of national marketing authorizations
is expected to follow in the near future. 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 40 mg/mL; any regulatory, legal, or other impediments to
Mylan's ability to bring Glatiramer Acetate Injection 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;
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.
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
growing portfolio of more than 7,500 marketed products around the
world, including antiretroviral therapies on which approximately
50% of people being treated for HIV/AIDS in the developing world
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.
View original content with
multimedia:http://www.prnewswire.com/news-releases/mylan-in-partnership-with-synthon-receives-marketing-authorization-approval-in-europe-for-first-generic-for-copaxone-40-mgml-300531944.html
SOURCE Mylan N.V.