Catalyst Pharmaceuticals Announces Expansion of Firdapse License to Include Japan
May 30 2019 - 7:03AM
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a
biopharmaceutical company focused on developing and commercializing
innovative therapies for people with rare debilitating, chronic
neuromuscular and neurological diseases, today announced that it
has amended its license agreement for Firdapse® to expand its
commercial territory. The original license was for North America,
and has been amended to include Japan. Upon the achievement
of a certain milestone in Japan, Catalyst will have the option to
expand the territory further to include most of Asia and Central
and South America.
“We are pleased to have expanded the scope of
our license to include Japan and possibly other territories, as we
believe that Japan represents an attractive strategic opportunity
for Catalyst,” said Patrick J. McEnany, Chairman and Chief
Executive Officer of Catalyst Pharmaceuticals, Inc. “The available
treatment options for LEMS patients in Japan are very limited and
without an approved evidence-based therapy. We look forward to
working with the regulatory authorities in Japan to potentially
advance Firdapse as a new treatment option for LEMS patients and
their families,” McEnany added.
There are currently no approved therapies
available to treat LEMS in Japan. In addition, Firdapse will seek
to qualify for Orphan Drug Designation in Japan. Japan has the
world’s third largest economy.
The original license was signed in October of
2012. Under the recently amended license, Catalyst will pay
royalties of a similar percentage of its net revenues derived in
Japan as in its original License Agreement.
About Catalyst
Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical
company focused on developing and commercializing innovative
therapies for people with rare debilitating, chronic neuromuscular
and neurological diseases, including Lambert-Eaton myasthenic
syndrome (LEMS), anti-MuSK antibody positive myasthenia gravis
(MuSK-MG), congenital myasthenic syndromes (CMS), and spinal
muscular atrophy (SMA) Type 3. Catalyst's new drug application for
Firdapse® (amifampridine) 10 mg tablets for the treatment of adults
with LEMS was recently approved by the U.S. Food & Drug
Administration ("FDA"), and Firdapse is now commercially available
in the United States. Prior to its approval, Firdapse for LEMS had
received breakthrough therapy designation and orphan drug
designation from the FDA.
Firdapse is currently being evaluated in
clinical trials for the treatment of MuSK-MG, CMS, and SMA Type 3
and has received Orphan Drug Designation from the FDA for CMS and
myasthenia gravis. Firdapse (amifampridine) 10 mg tablets is the
first and only approved drug in Europe for the symptomatic
treatment in adults with LEMS.
Forward-Looking Statements
This press release contains forward-looking
statements. Forward-looking statements involve known and unknown
risks and uncertainties, which may cause Catalyst's actual results
in future periods to differ materially from forecasted results. A
number of factors, including (i) whether Catalyst will be
successful in filing an application in Japan to commercialize
Firdapse; (ii) even if Catalyst is successful in obtaining approval
of an application to commercialize Firdapse in Japan, whether
Catalyst can successfully commercialize Firdapse in Japan on a
profitable basis; (iii) whether Catalyst will be successful in
commercializing Firdapse in the United States, (iv) whether, even
if Catalyst is successful in commercializing Firdapse in the United
States, Catalyst will become profitable, (v) the effect on
Catalyst’s business and future results of operations of the recent
approval by the FDA of an NDA for Jacobus Pharmaceuticals for their
version of 3,4-DAP for the treatment of pediatric LEMS patients;
(vi) whether Firdapse will ever be approved for the treatment of
MuSK-MG, CMS, SMA Type 3, or any other disease, and (vii) those
other factors described in Catalyst's Annual Report on Form 10-K
for the fiscal year 2018 and its other filings with the U.S.
Securities and Exchange Commission (SEC), could adversely affect
Catalyst. Copies of Catalyst's filings with the SEC are available
from the SEC, may be found on Catalyst's website, or may be
obtained upon request from Catalyst. Catalyst does not undertake
any obligation to update the information contained herein, which
speaks only as of this date.
Investor Contact
Brian Korb
The Trout Group LLC
(646) 378-2923
bkorb@troutgroup.com
Company Contact
Patrick J. McEnany
Catalyst Pharmaceuticals
Chief Executive Officer
(305) 420-3200
pmcenany@catalystpharma.com
Media Contact
David Schull
Russo Partners
(212) 845-4271
david.schull@russopartnersllc.com
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