Adamas Announces Agreement to Settle Patent Litigation with Osmotica
December 02 2020 - 6:50AM
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to
developing and delivering medicines that make a meaningful
difference to people affected by neurological diseases,
today announced it has signed an agreement
to settle its ongoing patent litigation with
Osmotica Pharmaceutical US LLC, a subsidiary of
Osmotica Pharmaceuticals plc. As a result of this
agreement, both parties will drop their respective
claims relating to the patent litigation, and
Adamas will acquire the global
rights to OSMOLEX ER® for $7.5
million. The agreement is expected to close early
in 2021.
Adamas’ current portfolio consists of GOCOVRI®
(amantadine) extended-release capsules for the treatment of
dyskinesia in patients with Parkinson’s disease receiving
levodopa-based therapy. OSMOLEX ER (amantadine) extended-release
tablets is FDA-approved for the treatment for Parkinson’s disease
and drug-induced extrapyramidal reactions in adult patients.
“This settlement agreement removes any further
litigation costs and related distraction for Adamas. The
acquisition of OSMOLEX ER also expands our presence in Neurology
which is part of our long-term growth strategy,” said Neil F.
McFarlane, Chief Executive Officer. “The different FDA-approved
indications and pharmacokinetic profiles for GOCOVRI and OSMOLEX ER
allow for the treatment of distinct patient populations. We intend
to leverage our commercial expertise to unlock the full potential
of both products and serve more patients in the wider neurology
community.”
As part of the acquisition, Adamas will
receive existing inventory and
all rights to OSMOLEX ER. Parties also entered
a supply agreement in which Osmotica will be
the sole manufacturer of OSMOLEX ER. Both parties
are working together to ensure continuity
of product supply to patients.
About GOCOVRI®
GOCOVRI® (amantadine) extended-release
capsules is the first and only FDA-approved medicine
indicated for the treatment of dyskinesia in patients with
Parkinson’s disease receiving levodopa-based therapy, with or
without concomitant dopaminergic medications. It is also the only
medicine clinically proven to reduce both dyskinesia and
OFF.
Taken once daily at bedtime, GOCOVRI provides an
initial lag and a slow rise in amantadine concentration during the
night, resulting in a high concentration from the morning and
throughout the waking day. Additionally, in the clinical trials,
the adjunctive use of GOCOVRI did not require dose changes to
dopaminergic therapies. The most commonly
observed adverse reactions with GOCOVRI were hallucinations,
dizziness, dry mouth, peripheral edema, constipation, falls and
orthostatic hypotension.
For more information about GOCOVRI, please
visit www.GOCOVRI.com.
About
OSMOLEX ER®
OSMOLEX
ER®, (amantadine) extended-release tablets, is
FDA-approved for the treatment of Parkinson’s disease and
drug-induced extrapyramidal reactions in adult
patients. OSMOLEX ER is contraindicated in patients with
end-stage renal disease (i.e., creatinine clearance below 15
mL/min/1.73 m2). The most common adverse reactions reported in ≥5%
of patients at the recommended dosage of immediate-release
amantadine were nausea, dizziness/lightheadedness, and
insomnia.
For more information about OSMOLEX ER, including
the full Prescribing Information, please visit
www.OSMOLEX.com
About Adamas
At Adamas our vision is clear - to deliver
innovative medicines that reduce the burden of neurological
diseases on patients, caregivers and society. We are a fully
integrated company focused on growing a portfolio of therapies to
address a range of neurological diseases. For more information,
please visit www.adamaspharma.com.
Forward-looking
statements
Statements contained in this press release
regarding matters that may occur in the future are “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, including but not limited to, statements
contained in this press release regarding Adamas’
expectations regarding the expected timing of the closing of
the transaction with Osmotica. Such statements are subject to risks
and uncertainties, and actual results may differ materially from
those expressed or implied by such forward-looking statements.
For example, the completion of the transaction is subject to
closing conditions, which if not met or waived, would cause the
transaction not to close. Other risks relating to Adamas may
be found in Adamas’ Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission on November 5, 2020,
particularly under the caption “Risk Factors.” Investors are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this release. Adamas
undertakes no obligation to update any forward-looking statement in
this press release, except as required by law.
Contact:
MediaSarah MathiesonVice
President of Corporate
Communications510-450-3528smathieson@adamaspharma.com
InvestorsPeter VozzoManaging
Director, Westwicke443-213-0505peter.vozzo@westwicke.com
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