-- Patent Trial and Appeal Board Oral Hearing
Cancelled --
DUBLIN, July 29, 2019 /PRNewswire/ -- Alkermes
plc (Nasdaq: ALKS) announced today that it has entered into a
settlement and license agreement (the agreement) with Amneal
Pharmaceuticals LLC (Amneal) to resolve Amneal's inter partes
review (IPR) petition challenging U.S. Patent Number 7,919,499
('499 Patent), an Orange Book-listed patent for
VIVITROL® (naltrexone for extended-release injectable
suspension) that expires in 2029.
Under the agreement, the parties agreed to request termination
of the IPR and Alkermes granted Amneal the non-exclusive right to
market a generic formulation of VIVITROL in the U.S. beginning
sometime in 2028 or earlier under certain circumstances. Additional
terms of the agreement are confidential.
"We believe this settlement recognizes the strength of the
VIVITROL intellectual property. We are pleased to come to this
resolution which provides more clarity regarding the outlook for
VIVITROL," said Richard Pops, Chief Executive Officer of Alkermes.
"VIVITROL is a complex medicine that requires sophisticated
manufacturing expertise and capabilities, along with nuanced
commercial capabilities to successfully navigate a fragmented
treatment system."
An oral hearing with the Patent Trial and Appeal Board (PTAB) of
the U.S. Patent and Trademark Office, that was scheduled to take
place on July 29, 2019, was cancelled
by the PTAB in light of this settlement.
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 chronic 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 company's future
performance, business plans or prospects, and expected growth; the
strength of the intellectual property, including the '499
Patent, covering VIVITROL; the clarity in the outlook for VIVITROL
provided by the settlement with Amneal; and the potential
therapeutic and commercial value of VIVITROL. The company cautions
that forward-looking statements are inherently uncertain. Although
the company 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, including
the unfavorable outcome of litigation, including so-called
"Paragraph IV" litigation and other patent litigation, related
to VIVITROL, which may lead to competition from generic drug
manufacturers; and those risks and uncertainties described under
the heading "Risk Factors" in the company's most recent Annual
Report on Form 10-K and in subsequent filings made by the company
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
they are made. The information contained in this press release is
provided by the company as of the date hereof, and, 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.
Alkermes Contacts:
For Investors: Sandy Coombs, +1 781
609 6377
For Media: Sherry Feldberg, +1 781
609 6276
Logo -
https://mma.prnewswire.com/media/616416/Alkermes_plc_Logo.jpg