Catalyst Pharmaceuticals and KYE Pharmaceuticals Announce Agreement to Make Firdapse® (amifampridine phosphate) Available to...
August 18 2020 - 8:03AM
Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a
commercial-stage biopharmaceutical company focused on developing
and commercializing innovative therapies for people with rare
debilitating, chronic neuromuscular and neurological diseases, and
KYE Pharmaceuticals Inc. ("KYE"), a private company headquartered
in Mississauga, Ontario and focused on bringing medicines that
fulfill clinically significant unmet needs to the Canadian market,
today announced that the companies have entered into an exclusive
license agreement under which KYE will commercialize Firdapse® in
Canada. Firdapse® is indicated for the symptomatic treatment of
Lambert-Eaton myasthenic syndrome (LEMS) in adults. Under the terms
of the agreement, Catalyst will supply Firdapse® to KYE and KYE
will be responsible for promotion, sales, advertisement, marketing,
product importation and distribution. KYE will also be responsible
for the ongoing maintenance of the regulatory file and future
communications with Health Canada.
Patrick J. McEnany, Catalyst’s Chairman and CEO,
said, “Catalyst remains focused on making a meaningful impact in
the lives of those suffering from rare diseases. We are excited to
partner with the experienced team at KYE in making Firdapse®
available to LEMS patients throughout Canada.”
Doug Reynolds, KYE Co-Founder and President,
said, “Partnering with Catalyst to make Firdapse® available to LEMS
patients in Canada allows us to continue fulfilling our goal to
bring critically needed medicines to Canadian patients and the
healthcare community. We look forward to working with the
experienced and talented Catalyst team in the years ahead.”
About Lambert-Eaton Myasthenic Syndrome
(LEMS)
Lambert-Eaton myasthenic syndrome, or LEMS, is a
rare autoimmune disorder, most often characterized by muscle
weakness of the limbs. The disease is caused by an autoimmune
reaction where antibodies are formed against voltage gated
potassium channels in the connection between nerves and the muscles
they communicate with. In approximately 50% of cases, LEMS is
associated with an underlying malignancy, most commonly small-cell
lung cancer, and in some individuals, LEMS is the first symptom of
such malignancy. LEMS generally affects the extremities, especially
the legs. As the disease most affects the parts of limbs closest to
the trunk, difficulties with climbing stairs or rising from a
sitting position are commonly noted. Physical exercise and high
temperatures tend to worsen the symptoms. Other symptoms
occasionally seen include weakness of the muscles of the mouth,
throat, and eyes. Individuals affected with LEMS also may have a
disruption of the autonomic nervous system, including dry mouth,
constipation, blurred vision, impaired sweating, and/or
hypotension.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage
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), 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 approved in
November 2018 by the U.S. Food & Drug
Administration ("FDA"), and Firdapse® is now commercially
available in the United States. Further, Canada’s national
healthcare regulatory agency, Health Canada, recently approved the
use of Firdapse® (amifampridine) for the treatment of patients in
Canada with LEMS.
Firdapse® is currently being evaluated in
clinical trials for the treatment of MuSK-MG and SMA Type 3 and has
received Orphan Drug Designation from the FDA for
myasthenia gravis.
About KYE Pharmaceuticals
KYE Pharmaceuticals is a private company
headquartered in Canada focused on bringing medications
to the Canadian market which fulfill clinically significant and
unmet needs. KYE has licensed many innovative products and was
founded on an entrepreneurial spirit that optimizes our team's
strengths and brings unique value to our partners, Canadian
healthcare professionals, and most importantly, our patients. For
more information please visit www.kyepharma.com.
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 KYE can successfully
commercialize Firdapse® in Canada, (ii) whether any such
commercialization of Firdapse® in Canada will be on a profitable
basis, (iii) the impact of competition from Ruzurgi® on sales of
Firdapse® in Canada, (iv) the impact in the United States if an
amifampridine product is purchased in Canada for use in the United
States, and (v) those factors described in Catalyst's Annual Report
on Form 10-K for the fiscal year 2019 and Catalyst's 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
Solebury Trout
(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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