Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company")
(Nasdaq: CPRX), a commercial-stage biopharmaceutical company
focused on in-licensing, developing, and commercializing novel
medicines for patients living with rare and difficult-to-treat
diseases, today announced that it has entered into a License,
Supply, and Commercialization Agreement with Kye Pharmaceuticals
Inc., ("Kye" or "Kye Pharmaceuticals") granting Kye the exclusive
Canadian commercial rights to AGAMREE® (vamorolone), a novel
corticosteroid for the treatment of Duchenne Muscular Dystrophy
("DMD") and potentially other indications. Under the terms of the
agreement, Catalyst will supply the product to Kye, which will
assume full responsibility for obtaining regulatory approval for
AGAMREE for the treatment of DMD from Health Canada and all future
aspects of commercialization of the product within Canada. Kye
currently markets FIRDAPSE®, Catalyst's flagship product for the
treatment of Lambert Eaton myasthenic syndrome, in Canada.
"We are pleased to enter into this agreement
with Kye Pharmaceuticals for AGAMREE, marking a pivotal milestone
in our strategic initiative to expand the product's footprint in
North America. This collaboration leverages our combined expertise,
fortifies our alliance by licensing our second therapeutic rare
disease product for Canada, and demonstrates our sustained
commitment to patient care," stated Richard J. Daly, CEO and
President of Catalyst. "Building upon the U.S. approval of AGAMREE,
we are committed to helping facilitate access to this novel
corticosteroid treatment to DMD patients and their healthcare
providers in Canada. We look forward to working closely with our
partner, who will spearhead the regulatory approval process for
AGAMREE, with application submission to Health Canada anticipated
by early 2025."
"Our expanded partnership with Catalyst
highlights the intrinsic value of our collaboration in developing
innovative treatments for rare diseases, including DMD, and
exemplifies our shared dedication to improving health outcomes
across the U.S. and Canada. Together, we are committed to
delivering novel therapies and bridging clinically significant
treatment gaps," stated John McKendry, CEO and President of Kye
Pharmaceuticals.
Under the terms of the agreement, Kye
Pharmaceuticals, Inc. will have the exclusive Canadian rights to
commercialize AGAMREE (vamorolone) oral suspension and will be
responsible for funding all regulatory, marketing, and
commercialization activities in Canada. Catalyst will be
responsible for clinical and commercial supply and provide support
to Kye Pharmaceuticals in its efforts to obtain regulatory approval
for the product from Health Canada. Subject to the satisfaction of
terms and conditions set forth in the License, Supply, and
Commercialization Agreement, Catalyst will receive an upfront
payment and be eligible to receive further reimbursement and sales
milestones and sales royalties for AGAMREE.
About Duchenne Muscular
Dystrophy Duchenne Muscular Dystrophy (DMD) is a genetic
disorder characterized by progressive muscle degeneration and
weakness. It primarily affects males, with symptoms typically
appearing in early childhood, around ages 3 to 5. DMD is caused by
mutations in the gene that encodes dystrophin, a protein that plays
a crucial role in maintaining the structure and function of muscle
fibers. Without dystrophin, muscle cells become fragile and easily
damaged, leading to progressive muscle degeneration. Symptoms of
DMD usually begin with difficulty in walking, frequent falls, and
muscle weakness, particularly in the legs and pelvis. As the
disease progresses, individuals may experience difficulty standing,
climbing stairs, and eventually, complete loss of mobility. Other
complications can include respiratory and cardiac issues due to
muscle weakness.
About
AGAMREE® (vamorolone)AGAMREE's unique mode of action
is based on differential effects on glucocorticoid and
mineralocorticoid receptors and modifying further downstream
activity. As such, it is considered a novel corticosteroid designed
to achieve dissociative properties while maintaining efficacy that
has the potential to demonstrate comparable efficacy to steroids,
with the potential for a better-tolerated side effect profile. This
mechanism of action may allow AGAMREE to emerge as an effective
alternative to the current standard of care corticosteroids in
children, adolescents, and adult patients with DMD. In the pivotal
VISION-DMD study, AGAMREE met the primary endpoint Time to Stand
(TTSTAND) velocity versus placebo (p=0.002) at 24 weeks of
treatment and showed a good safety and tolerability profile. The
most commonly reported adverse events versus placebo from the
VISION-DMD study were cushingoid features, psychiatric disorders,
vomiting, weight increases, and vitamin D deficiency. Adverse
events were generally of mild to moderate severity.
About Kye Pharmaceuticals Kye
Pharmaceuticals is a growth-stage Canadian specialty pharmaceutical
company committed to bringing value to Canadians by identifying,
licensing, and commercializing novel prescription medicines that
may not otherwise be available to patients across Canada. Fueled by
courage and agility, our corporate philosophy is rooted in the
pursuit of innovation and driven by our entrepreneurial spirit.
With a growing pipeline of novel medicines, Kye's portfolio spans a
range of therapeutic areas, including cardiology, psychiatry,
pediatrics, rare diseases, hematology, and neurology. Kye
Pharmaceuticals is a private company headquartered
in Toronto focused on bringing medications to the
Canadian market which fulfill clinically significant unmet needs.
Kye is committed to licensing and launching medicines that matter
by delivering better outcomes to our partners, Canadian healthcare
professionals, and, most importantly, patients across Canada. For
more information, please visit www.kyepharma.com.
About Catalyst Pharmaceuticals,
Inc.With exceptional patient focus, Catalyst is committed
to developing and commercializing innovative first-in-class
medicines that address rare and difficult-to-treat diseases.
Catalyst's flagship U.S. commercial product is FIRDAPSE®
(amifampridine) Tablets 10 mg, approved for the treatment
of Lambert-Eaton myasthenic syndrome ("LEMS") in adults
and pediatric patients 6 years of age and older. In January
2023, Catalyst acquired the U.S. commercial rights to
FYCOMPA® (perampanel) CIII, a prescription medicine approved in
people with epilepsy aged four and older alone or with other
medicines to treat partial-onset seizures with or without
secondarily generalized seizures and with other medicines to treat
primary generalized tonic-clonic seizures for people with epilepsy
aged 12 and older. Further, Canada's national healthcare
regulatory agency, Health Canada, has approved the use of
FIRDAPSE for the treatment of adult patients
in Canada with LEMS. On July 18, 2023, Catalyst
acquired an exclusive license for North America for
AGAMREE® (vamorolone) oral suspension 40 mg/mL, a novel
corticosteroid treatment for Duchenne Muscular Dystrophy. AGAMREE
previously received FDA Orphan Drug and Fast Track designations and
was approved by the FDA for commercialization in
the U.S. on October 26, 2023. AGAMREE became
commercially available by prescription in the U.S. on March 13,
2024.
For more information about Catalyst, please
visit the Company's website at www.catalystpharma.com. For
Full Prescribing and Safety Information for FIRDAPSE®, please
visit www.firdapse.com. For Full Prescribing Information,
including Boxed WARNING for FYCOMPA®, please
visit www.fycompa.com. For Full Prescribing Information for
AGAMREE®, please visit www.agamree.com.
Forward-Looking StatementsThis
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's Licensee, Kye Pharmaceuticals, Inc., will
successfully obtain the approvals required to commercialize the
AGAMREE® product in the licensed Canadian territory, (ii) if
approved, whether AGAMREE will be successfully commercialized by
Kye Pharmaceuticals in the licensed territory, and (iii) those
factors described in Catalyst's Annual Report on Form 10-K for the
fiscal year 2023, its Quarterly Report on Form 10-Q for the first
quarter of 2024, 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.
Source: Catalyst Pharmaceuticals, Inc.
Investor Relations Contact:
Mary Coleman, Catalyst Pharmaceuticals
(305) 420-3200
mcoleman@catalystpharma.com
Media Contact:
David Schull, Russo Partners
(858) 717-2310
david.schull@russopartnersllc.com
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