Once approved, this product could represent a significant
milestone for patients with relapsing-remitting multiple
sclerosis
Mapi Pharma has completed an open-label Phase II clinical
trial and is preparing to commence a pivotal Phase III clinical
trial to support marketing applications
HERTFORDSHIRE, England
and PITTSBURGH and NESS ZIONA, Israel, April 10,
2018 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL), one of
the world's leading pharmaceutical companies, and Mapi Pharma Ltd.,
a fully integrated, clinical late stage biopharmaceutical company,
today announced that the two companies will partner on the
development and commercialization of GA Depot, a long-acting
Glatiramer Acetate product. Mylan is acquiring global marketing
rights to the product.
GA Depot is a proposed once-monthly injection for the treatment
of patients with relapsing-remitting multiple sclerosis, or RRMS.
Multiple sclerosis (MS) organizations have estimated that 2.3
million individuals are living with MS worldwide. In the U.S.,
preliminary results of an MS prevalence study by the National MS
Society estimate that nearly 1 million people are living with MS.
Relapsing-remitting MS accounts for approximately 85% of initial MS
diagnoses.
Mylan President
Rajiv Malik commented:
"Improving the lives of MS patients around the world is one of
Mylan's primary goals. We recognize that medication convenience is
very important to the MS community, and we believe that GA Depot,
once approved, will provide an important and welcomed treatment
option. GA Depot also will add to our already-strong portfolio of
central nervous system products. We appreciate the opportunity to
work with Mapi Pharma and its successful and proven founder,
Ehud Marom, and we believe that our
teams are well poised for a successful collaboration as we work
through the remaining clinical and regulatory phases to bring this
important product to market."
Mylan Chairman Robert J.
Coury commented: "Over the past several years, I have
observed firsthand the strength and resilience of Israel's business and scientific community as
well as its strong workforce. The country's scientific research
leadership is renowned worldwide, and Mylan's partnership and
collaboration with Mapi Pharma represents the most recent example
of our continued commitment to invest and maintain strong
relationships in Israel. I am
particularly grateful for Mapi Pharma CEO and Chairman Ehud Marom's leadership in this transaction. I
look forward to the positive impact this MS product will have for
patients worldwide."
Ehud Marom, CEO and Chairman
of Mapi Pharma Ltd, commented, "As one of Israel's leading biotech companies, we are
pleased and excited to have partnered and collaborated with Mylan
in bringing this very important new product to the millions of MS
patients around the globe. GA Depot is expected to significantly
improve the mode of treatment for patients with MS by reducing the
number of injections, easing the treatment burden and increasing
patient compliance. We look forward to working with Mylan to bring
this important drug to MS patients."
Mapi Pharma has strong research capabilities in the development
of long-acting depot injections. Mylan brings to this collaboration
its regulatory expertise, unique global commercial platform and
significant experience in launching other Glatiramer Acetate
injection products. The partnership is subject to approval by the
Israeli Innovation Authority.
Mapi Pharma has completed a prospective one-year, open-label
Phase II clinical trial. Mapi Pharma and Mylan are in the process
of preparing to submit an investigational new drug application to
the U.S. Food and Drug Administration, as well as other global
health authorities, and to commence a pivotal Phase III clinical
trial to support a new drug marketing application under the
505(b)(2) regulatory pathway.
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 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 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.
About MAPI Pharma
Mapi Pharma is a clinical
stage pharmaceutical company, engaged in the development of
high barrier to entry products that target large markets and
generic drugs that include complex active pharmaceutical
ingredients ("APIs") and formulations. GA Depot is the first in a
series of depot long-acting injections in the company's pipeline.
Mapi is built on strong chemical and pharmaceutical R&D
capabilities, deep understanding of the global market and of
regulatory needs and its ability to foster local cooperation and
enduring relationships in all of the countries in which it
operates. Mapi is headquartered in Israel. It has R&D facilities in
Israel and China. Mapi has a strong IP position, filing
numerous patent applications for APIs and formulations. For more
information, please visit: www.mapi-pharma.com
Forward-Looking Statements: Mylan
This press
release includes statements that constitute "forward-looking
statements", including with regard to: the development and
commercialization of a once-monthly Glatiramer Acetate injection;
that once approved, this product could represent a significant
milestone for patients with relapsing-remitting multiple
sclerosis; that Mapi Pharma has completed an open-label Phase
II clinical trial and is preparing to commence a pivotal Phase III
clinical trial to support marketing applications; that Mylan
believes that GA Depot, once approved, will provide an important
and welcomed treatment option; that GA Depot also will add to
Mylan's already-strong portfolio of central nervous system
products; that we believe that our teams are well poised for a
successful collaboration as we work through the remaining clinical
and regulatory phases to bring this important product to market;
and that Mapi Pharma and Mylan are in the process of preparing to
submit an investigational new drug application to the U.S. Food and
Drug Administration, as well as other global health authorities,
and to commence a pivotal Phase III clinical trial to support a new
drug marketing application under the 505(b)(2) regulatory pathway.
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: that the partnership is subject to approval by the
Israeli Innovation Authority; success of clinical trials and our or
our partners' ability to execute on new product opportunities; any
regulatory, legal or other impediments to our or our partners'
ability to bring products to market; other risks inherent in
product development; the scope, timing, and outcome of any ongoing
legal proceedings, including government investigations, and the
impact of any such proceedings on our or our partners' businesses;
actions and decisions of healthcare and pharmaceutical regulators,
and changes in healthcare and pharmaceutical laws and regulations,
in the United States and abroad; the impact of
competition; strategies by competitors or other third parties to
delay or prevent product introductions; the effect of any changes
in our or our partners' customer and supplier relationships and
customer purchasing patterns; any other changes in third-party
relationships; changes in the economic and financial conditions of
the businesses of Mylan or its partners; 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 these statements for revisions
or changes after the date of this release.
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