DUBLIN, Nov. 12, 2019 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced the receipt of a $150 million milestone payment from Biogen
triggered by the recent U.S. Food and Drug Administration (FDA)
approval of VUMERITY™ (diroximel fumarate), a novel oral fumarate
with a distinct chemical structure, for the treatment of relapsing
forms of multiple sclerosis, and Alkermes' transfer to Biogen Inc.
(Nasdaq: BIIB) of the New Drug Application and other regulatory
documentation related to VUMERITY.
"The receipt of this milestone payment marks an important
achievement for Alkermes and is a testament to the strategic
execution of our clinical and regulatory activities related to
VUMERITY over the past few years. This payment bolsters our solid
financial foundation and increases our flexibility to pursue
strategic business development opportunities and invest in our
internal development pipeline," commented Blair Jackson, Senior Vice President of
Corporate Planning.
Alkermes' financial expectations for 2019, provided on
Oct. 23, 2019, reflect this milestone
payment. The company will record substantially all of the milestone
payment as license revenue in the fourth quarter of 2019.
Under the terms of the license and collaboration agreement with
Biogen, Alkermes was responsible for conducting the clinical
development of VUMERITY and regulatory activities relating to its
approval, and Biogen holds the exclusive, worldwide license to
commercialize the product. Alkermes is entitled to receive a
mid-teens percentage royalty on worldwide net commercial sales of
VUMERITY, subject, under certain circumstances, to minimum annual
payments for the first five years following FDA approval and
customary reductions as set forth in the agreement.
About VUMERITY™ (diroximel fumarate)
VUMERITY is a novel oral fumarate with a distinct chemical
structure approved in the U.S. for the treatment of relapsing forms
of multiple sclerosis, to include clinically isolated syndrome,
relapsing-remitting disease and active secondary progressive
disease. Once in the body, VUMERITY rapidly converts to monomethyl
fumarate, the same active metabolite of dimethyl fumarate.
Please see the full Prescribing
Information, including Patient Information for
VUMERITY.
About Alkermes plc
Alkermes plc is a fully
integrated, global biopharmaceutical company developing innovative
medicines for the treatment of central nervous system (CNS)
diseases and oncology. The company has a diversified commercial
product portfolio and a substantial clinical pipeline of product
candidates for diseases that include schizophrenia, depression,
addiction, multiple sclerosis, and cancer. Headquartered in
Dublin, Ireland, Alkermes plc has
an R&D center in Waltham,
Massachusetts; a research and manufacturing facility in
Athlone, Ireland; and a
manufacturing facility in Wilmington,
Ohio. For more information, please visit Alkermes' website
at www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
but not limited to, statements concerning: the financial benefits
that the milestone payment may provide, including expectations
concerning the company's pursuit of business development
opportunities and investments in its internal development pipeline;
and details of other payments expected to become due under the
license and collaboration agreement with Biogen. Alkermes cautions
that forward-looking statements are inherently uncertain. Although
Alkermes believes that such statements are based on reasonable
assumptions within the bounds of its knowledge of its business and
operations, the forward-looking statements are neither promises nor
guarantees and they are necessarily subject to a high degree of
uncertainty and risk. Actual performance and results may differ
materially from those expressed or implied in the forward-looking
statements due to various risks and uncertainties. These risks and
uncertainties include, among others: whether the potential
financial benefits of the milestone payment, including those
related to the company's business development activities and
internal development pipeline, will be achieved; whether the other
payments expected to become due under the license and collaboration
agreement with Biogen will become due as anticipated; and those
risks described in the Alkermes Annual Report on Form 10-K for the
fiscal year ended Dec. 31, 2018 and
in subsequent filings made by Alkermes with the U.S. Securities and
Exchange Commission (SEC), which are available on the SEC's website
at www.sec.gov. Existing and prospective investors are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof. Except as required by law,
the company disclaims any intention or responsibility for updating
or revising any forward-looking statements contained in this press
release.
VUMERITYTM is a trademark of Alkermes Pharma Ireland
Limited used by Biogen under an exclusive license.
Alkermes Contacts:
For Investors: Sandy Coombs, +1 781
609 6377
For Media: Gretchen Murphy, +1 781
609 6419
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