Adamas Announces Declaratory Judgment Action Filed by Osmotica Related to Approved OSMOLEX ER
February 19 2018 - 8:01PM
Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) announced today that it
has learned that Osmotica Pharmaceuticals LLC and Vertical
Pharmaceuticals LCC (Osmotica) filed an action in Delaware federal
court on February 16, 2018 requesting a declaratory judgment that
Osmotica’s newly-approved product OSMOLEX ER™ (amantadine)
extended-release tablets does not infringe certain of Adamas’
patents. Adamas has not received service of a summons and
complaint. The complaint does not allege patent infringement
against Adamas or otherwise pertain to Adamas’ product GOCOVRI™
(amantadine) extended release capsules.
OSMOLEX ER was approved by the U.S. Food and
Drug Administration (FDA) on February 16, 2018 for the treatment of
Parkinson’s disease and drug-induced extrapyramidal reactions in
adult patients, indications approved for immediate release
amantadine in 1972. As Osmotica states in the complaint,
drug-induced extrapyramidal reaction is a separate and distinct
disorder from dyskinesia in Parkinson’s disease patients. According
to the package insert attached to the complaint, the approval was
based on three bioavailability studies comparing OSMOLEX ER to
immediate release amantadine syrup in healthy volunteers. The
package insert does not include any new clinical safety or efficacy
data specific to OSMOLEX ER to support its use in the approved
indications. Osmotica alleges that OSMOLEX ER does not infringe
certain of Adamas’ patents covering compositions and uses of
amantadine. Adamas is evaluating Osmotica’s non-infringement
assertions based on the limited information in the complaint.
Adamas’ approved product GOCOVRI is the first
and only FDA-approved medicine for the treatment of dyskinesia in
Parkinson’s disease patients on levodopa-based therapy, with or
without concomitant dopaminergic medicines. GOCOVRI is taken at
bedtime with a pharmacokinetic (PK) profile that delivers low
concentrations of amantadine in nighttime, slowly rising to high
concentrations (1,500 ng/ml) before awakening, and throughout the
day. Use of GOCOVRI in this Parkinson’s disease patient population
is supported by robust efficacy and safety data, required by the
FDA for approval, that demonstrate statistically significant and
clinically meaningful reductions in dyskinesia and OFF time in
three controlled clinical studies and an ongoing two-year,
open-label safety study. Neither OSMOLEX ER nor any other therapy
has been approved for the treatment of dyskinesia in Parkinson’s
disease patients on levodopa-based therapy.
Investor Conference Call and
Webcast As previously announced, Adamas will report fourth
quarter and full year 2017 financial results on Thursday, February
22, 2018 after market close. Subsequently, Adamas’ management team
will host a conference call and webcast at 4:30 p.m. Eastern Time
to discuss the financial results and provide a corporate update.
The conference call can be accessed by dialing 844-215-3280 for
participants in the U.S. or Canada and 484-747-6383 for
international callers. The webcast can be accessed live via the
investor section of the Adamas website at
http://ir.adamaspharma.com/events.cfm and will be available for
replay until March 22, 2018.
About Adamas Pharmaceuticals,
Inc.Adamas is using its deep understanding of
time-dependent biology to redefine the treatment experience for
patients suffering from chronic neurological diseases. The company
is building upon the commercial launch of GOCOVRI™ (amantadine)
extended release capsules (previously ADS-5102), the first and only
FDA-approved medicine for the treatment of dyskinesia in patients
with Parkinson’s disease, with a pipeline of differentiated
investigational programs, which includes ADS-5102 in development
for the treatment of multiple sclerosis walking impairment; and
ADS-4101, a high-dose, modified release lacosamide in development
for the treatment of partial-onset seizures in patients with
epilepsy. Adamas’ goal is to create and commercialize a new
generation of neurological medicines intended to lessen the burden
of disease on patients, caregivers and society. For more
information about Adamas and its unique approach to developing
medicines based on time-dependent biology, please visit
www.adamaspharma.com.
Contact:
Media:
Kim Kraemer
415-939-9033
kkraemer@waterhousebrands.com
Investors:
Ashleigh Barreto
Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.
510-450-3567
ir@adamaspharma.com
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