Catalyst Pharmaceuticals Announces Sub-Licensee DyDo Pharma Received Approval to Commercialize FIRDAPSE® in Japan
Catalyst Pharmaceuticals announced that its sub-licensee in Japan, DyDo Pharma, has received approval from the Ministry of Health, Labor and Welfare of Japan to commercialize FIRDAPSE® (amifampridine) Tablets 10 mg for treating Lambert-Eaton Myasthenic Syndrome (LEMS) in Japan. This approval marks a significant advancement in LEMS treatment, addressing unmet needs of patients in Japan.
FIRDAPSE is the only FDA-approved treatment for LEMS in the United States, indicated for adults and pediatric patients six years and older. LEMS is a rare autoimmune disorder characterized by muscle weakness and fatigue, with about 50% of LEMS patients having underlying cancer. This approval aligns with Catalyst's commitment to expanding its rare disease product portfolio globally.
Catalyst Pharmaceuticals ha annunciato che il suo sub-licensee in Giappone, DyDo Pharma, ha ricevuto l'approvazione dal Ministero della Salute, del Lavoro e del Welfare giapponese per commercializzare FIRDAPSE® (amifampridina) compresse da 10 mg per il trattamento della sindrome miastenica di Lambert-Eaton (LEMS) in Giappone. Questa approvazione segna un significativo progresso nel trattamento della LEMS, rispondendo alle esigenze insoddisfatte dei pazienti in Giappone.
FIRDAPSE è l'unico trattamento approvato dalla FDA per la LEMS negli Stati Uniti, indicato per pazienti adulti e pediatrici di sei anni e oltre. La LEMS è una rara malattia autoimmune caratterizzata da debolezza muscolare e affaticamento, con circa il 50% dei pazienti LEMS affetti da un cancro sottostante. Questa approvazione è in linea con l'impegno di Catalyst ad espandere il proprio portafoglio di prodotti per malattie rare a livello globale.
Catalyst Pharmaceuticals anunció que su sublicenciatario en Japón, DyDo Pharma, ha recibido la aprobación del Ministerio de Salud, Trabajo y Bienestar de Japón para comercializar FIRDAPSE® (amifampridina) tabletas de 10 mg para el tratamiento del Síndrome Miasténico de Lambert-Eaton (LEMS) en Japón. Esta aprobación marca un avance significativo en el tratamiento de LEMS, atendiendo las necesidades insatisfechas de los pacientes en Japón.
FIRDAPSE es el único tratamiento aprobado por la FDA para LEMS en los Estados Unidos, indicado para pacientes adultos y pediátricos de seis años en adelante. LEMS es un raro trastorno autoinmunitario caracterizado por debilidad muscular y fatiga, con aproximadamente el 50% de los pacientes LEMS teniendo cáncer subyacente. Esta aprobación se alinea con el compromiso de Catalyst de expandir su portafolio de productos para enfermedades raras a nivel global.
Catalyst Pharmaceuticals는 일본의 서브 라이센스사인 DyDo Pharma가 일본의 보건복지부로부터 FIRDAPSE® (아미팜프리딘) 10mg 정제를 일본에서 램버트-이튼 근무력증후군(LEMS) 치료를 위해 상용화할 수 있는 승인을 받았다고 발표했습니다. 이 승인은 LEMS 치료의 중요한 진전을 나타내며, 일본의 환자들이 가진 unmet needs를 해결하는 데 기여합니다.
FIRDAPSE는 미국에서 LEMS에 대해 FDA 승인된 유일한 치료제로, 6세 이상의 성인 및 소아 환자에게 적합합니다. LEMS는 근육 약화와 피로를 특징으로 하는 드문 자가면역 질환으로, LEMS 환자의 약 50%가 기저암을 가지고 있습니다. 이 승인은 Catalyst가 전 세계적으로 희귀질환 제품 포트폴리오를 확장하겠다는 의지를 반영합니다.
Catalyst Pharmaceuticals a annoncé que son sous-licencié au Japon, DyDo Pharma, a reçu l'approbation du ministère de la Santé, du Travail et du Bien-être du Japon pour commercialiser FIRDAPSE® (amifampridine) comprimés de 10 mg pour traiter le syndrome myasthénique de Lambert-Eaton (LEMS) au Japon. Cette approbation marque une avancée significative dans le traitement de la LEMS, répondant aux besoins non satisfaits des patients au Japon.
FIRDAPSE est le seul traitement approuvé par la FDA pour la LEMS aux États-Unis, indiqué pour les patients adultes et pédiatriques âgés de six ans et plus. La LEMS est une maladie auto-immune rare, caractérisée par une faiblesse musculaire et de la fatigue, avec environ 50 % des patients LEMS ayant un cancer sous-jacent. Cette approbation s'inscrit dans l'engagement de Catalyst d'élargir son portefeuille de produits pour les maladies rares à l'échelle mondiale.
Catalyst Pharmaceuticals gab bekannt, dass ihr Sublizenznehmer in Japan, DyDo Pharma, die Genehmigung des Ministeriums für Gesundheit, Arbeit und Soziales von Japan erhalten hat, FIRDAPSE® (Amifampridin) Tabletten zu 10 mg zur Behandlung des Lambert-Eaton-Myasthenie-Syndroms (LEMS) in Japan zu vermarkten. Diese Genehmigung stellt einen bedeutenden Fortschritt in der LEMS-Behandlung dar und adressiert die unerfüllten Bedürfnisse der Patienten in Japan.
FIRDAPSE ist die einzige von der FDA zugelassene Behandlung für LEMS in den Vereinigten Staaten und ist für erwachsene und pädiatrische Patienten ab sechs Jahren indiziert. LEMS ist eine seltene Autoimmunerkrankung, die durch Muskelschwäche und Müdigkeit gekennzeichnet ist, wobei etwa 50 % der LEMS-Patienten eine zugrunde liegende Krebserkrankung haben. Diese Genehmigung unterstützt das Engagement von Catalyst, sein Portfolio seltener Erkrankungen global auszubauen.
- Approval of FIRDAPSE in Japan expands market reach
- Potential for increased revenue from Japanese market
- Strengthens global presence in rare disease treatment
- None.
Insights
The approval of FIRDAPSE® in Japan represents a significant milestone for Catalyst Pharmaceuticals and its partner DyDo Pharma. This expansion into the Japanese market opens up new revenue potential for Catalyst's flagship product. The approval is particularly noteworthy given Japan's stringent regulatory environment.
Key points to consider:
- Market Expansion: This approval allows Catalyst to tap into the world's third-largest pharmaceutical market.
- Revenue Potential: While specific financial terms aren't disclosed, licensing agreements typically involve milestone payments and royalties, which could boost Catalyst's future earnings.
- Competitive Advantage: Being the first approved treatment for LEMS in Japan gives Catalyst a first-mover advantage in this niche market.
- Long-term Growth: This approval aligns with Catalyst's strategy to expand its rare disease portfolio globally, potentially leading to similar opportunities in other markets.
Investors should monitor for updates on the commercial launch in Japan and any guidance on expected financial impact. While positive, the immediate effect on Catalyst's financials may be until sales ramp up in the new market.
CORAL GABLES, Fla., Sept. 24, 2024 (GLOBE NEWSWIRE) -- 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 diseases, today announced that its sub-licensee in Japan, DyDo Pharma, Inc., ("DyDo") has reported that the Ministry of Health, Labor and Welfare of Japan has approved DyDo's New Drug Application ("NDA") to commercialize FIRDAPSE® (amifampridine) Tablets 10 mg for treatment of patients with Lambert-Eaton Myasthenic Syndrome ("LEMS") in Japan. This approval marks a pivotal advancement in the treatment of LEMS, a rare autoimmune disorder that can severely impact quality of life and represents a significant step forward in addressing the unmet needs of patients affected by LEMS in Japan.
"We are pleased that our partner, DyDo, has secured regulatory approval for FIRDAPSE in Japan. This represents a meaningful milestone, bringing renewed hope to patients and further affirming FIRDAPSE's proven effectiveness in the treatment of LEMS," said Richard J. Daly, Catalyst’s President and Chief Executive Officer. "This achievement underscores our unwavering commitment to advancing patient care. We appreciate the collaborative efforts of our partner in securing this approval, and we remain focused on expanding our innovative rare disease product portfolio beyond the U.S. to make a meaningful impact on patients' lives worldwide."
FIRDAPSE (amifampridine) is a leading therapy indicated in the United States for the treatment of LEMS in adults and pediatric patients six years of age and older. LEMS is a rare autoimmune disorder characterized by muscle weakness and fatigue. About
About FIRDAPSE® (amifampridine) Tablets 10 mg
FIRDAPSE® (amifampridine) Tablets 10 mg is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization. This action results in the opening of slow voltage-dependent calcium (Ca2+) channels, allowing for a subsequent influx of Ca2+. In turn, it induces the exocytosis of synaptic vesicles containing acetylcholine (ACh) to release more ACh into the synaptic cleft, enhancing neuromuscular transmission and providing for improved muscle function. Amifampridine phosphate was granted orphan drug designation by the Ministry of Health, Labor, and Welfare in Japan, and FIRDAPSE has previously been approved for use in the U.S. in adults and pediatric patients six years of age and older and in Europe and Canada for the treatment of adults with LEMS.
For Full Prescribing and Safety Information for FIRDAPSE, please visit www.firdapse.com.
About DyDo Pharma
DyDo Pharma is the rare disease pharmaceutical wholly-owned subsidiary of DyDo Group Holdings. DyDo Group Holdings, Inc. operates through the following segments: Domestic Beverage Business, International Beverage Business, Pharmaceutical-related Business, Food Business, and Other Businesses. The Domestic Beverage Business accounts for more than
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals, Inc., (Nasdaq: CPRX) is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence while actively seeking to expand its global commercial footprint through strategic partnerships. Catalyst is headquartered in Coral Gables, FL., and was recognized on the Forbes 2024 list as one of America's most successful small-cap companies. For more information, please visit Catalyst's website at www.catalystpharma.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 DyDo can successfully commercialize FIRDAPSE in Japan, (ii) whether Catalyst's revenues derived in future periods from its sub-license with DyDo will be profitable and cash flow positive to Catalyst, and (iii) those factors described in Catalyst's Annual Report on Form 10-K for fiscal year 2023, its Quarterly Report on Form 10-Q for the second quarter of fiscal year 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.
FAQ
What is the significance of FIRDAPSE approval in Japan for Catalyst Pharmaceuticals (CPRX)?
What condition does FIRDAPSE treat and who can use it?
Who is Catalyst Pharmaceuticals' sub-licensee for FIRDAPSE in Japan?
What percentage of LEMS patients have underlying cancer?
