Adamas Completes Acquisition of OSMOLEX ER®
January 05 2021 - 9:15AM
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 the closing of the settlement of patent litigation with
Osmotica Pharmaceutical US LLC, a subsidiary of Osmotica
Pharmaceuticals plc and completes the acquisition of the global
rights to OSMOLEX ER®. As previously disclosed, the amended
Royalty-Backed Loan Agreement with HealthCare Royalty Partners is
now effective with the closing of the acquisition of OSOMOLEX ER.
Through this acquisition, OSMOLEX ER joins the
Adamas portfolio which includes GOCOVRI® (amantadine)
extended-release capsules for the treatment of dyskinesia in
patients with Parkinson’s disease receiving levodopa-based therapy
with or without concomitant dopaminergic medications. OSMOLEX ER
(amantadine) extended-release tablets is FDA-approved for the
treatment for Parkinson’s disease and drug-induced extrapyramidal
reactions in adult patients. According to their Prescribing
Information, neither GOCOVRI nor OSMOLEX ER are interchangeable
with other amantadine immediate- or extended-release products for
their respective approved indications.
“We are pleased to begin 2021 by adding OSMOLEX
ER to our portfolio, broadening our presence in neurology and our
ability to serve more patients,” said Neil F. McFarlane, Chief
Executive Officer. “Our strategy for OSMOLEX ER is to invest in
disciplined, gated execution with the primary objective for the
product to become accretive in the near-term. We look forward to
leveraging the unique opportunities and benefits of each therapy in
our portfolio, with the growth of GOCOVRI remaining our primary
focus.”
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 benefits to it from 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. 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:
Media:Sarah MathiesonVice
President, Corporate
Communications510-450-3528smathieson@adamaspharma.com
Investors:Peter VozzoManaging
Director, Westwicke443-213-0505peter.vozzo@westwicke.com
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