KYE Pharmaceuticals and Catalyst Pharmaceuticals Challenge Health Canada’s Decision to Overlook Firdapse® Data Exclusivity...
26 August 2020 - 11:40PM
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 the filing of a proceeding in Canadian Federal
Court challenging Health Canada’s issuance of a Notice of
Compliance (NOC) on August 10, 2020 for Medunik’s New Drug
Submission (NDS) for the drug Ruzurgi® (amifampridine) for the
treatment of Lambert-Eaton Myasthenic Syndrome despite the fact
that Catalyst’s Firdapse® (amifampridine phosphate) was issued an
NOC on July 31, 2020 and was granted data protection as an
“innovative drug” as it was the first amifampridine product to be
approved in Canada.
The proceeding seeks judicial review of Health
Canada’s decision to issue an NOC for Ruzurgi® as incorrect and
unreasonable. Data protection, per Health Canada regulations, is
supposed to prevent Health Canada from issuing an NOC to a drug
that directly or indirectly references an innovative drug’s data,
for eight years from the date of the innovative drug’s approval.
The Ruzurgi® Product Monograph clearly references pivotal
nonclinical carcinogenicity and reproductive toxicity data for
amifampridine phosphate developed by Catalyst. As such, the
Catalyst data was relied upon to establish the nonclinical safety
profile of Ruzurgi® needed to meet the standards of the Canadian
Food and Drugs Act. Data protection had, however, been granted to
Firdapse® at the time that the NOC was issued for Ruzurgi®.
Contrary to the regulations, Health Canada approved Ruzurgi® even
though its drug submission included carcinogenicity and
reproductive toxicity data with Firdapse®. Firdapse®’s status as an
innovative drug should have prevented the marketing authorization
of Ruzurgi®.
“Innovative drugs, not previously approved in
Canada, go through a rigorous drug approval process in Canada. A
sponsor must submit clinical and nonclinical safety, tolerability,
and efficacy data, to demonstrate the safety and efficacy of the
drug,” said Patrick J. McEnany, Chairman and Chief Executive
Officer of Catalyst Pharmaceuticals, Inc. “In exchange for that
effort, and as an incentive to do that, Health Canada regulations
are supposed to prevent other pharmaceutical companies from being
able to use the innovator’s (in this case Catalyst’s) data as a
basis for approval for eight years from the date of the Notice of
Compliance. In Firdapse®’s case, Health Canada only did so for ten
days. We are compelled to bring this application to preserve the
specialized regulatory framework for new chemical entities, and the
future of drug innovation in Canada.”
“As the marketing partner for Firdapse® in
Canada,” added Douglas Reynolds, President of KYE, “it is essential
that we seek to enforce the data protection for Firdapse® as the
regulations have been designed to do. Without that incentive, the
motivation to bring new chemical entities to Canada is
significantly diminished.”
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) whether Catalyst’s action to overturn the
approval of Ruzurgi® in Canada will be successful, (v) the impact
in the United States if an amifampridine product is purchased in
Canada for use in the United States, and (vi) 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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