Catalyst Pharmaceuticals Enters Into an Exclusive License, Supply and Commercialization Agreement with Kye Pharmaceuticals for AGAMREE® in Canada
Catalyst Pharmaceuticals has entered into an exclusive License, Supply, and Commercialization Agreement with Kye Pharmaceuticals for AGAMREE® (vamorolone) in Canada. This agreement grants Kye the exclusive Canadian commercial rights for AGAMREE, a novel corticosteroid for treating Duchenne Muscular Dystrophy (DMD). Catalyst will supply the product, while Kye will be responsible for obtaining regulatory approval from Health Canada and commercialization within Canada.
Key points:
- Kye already markets Catalyst's FIRDAPSE® in Canada
- Regulatory application submission to Health Canada anticipated by early 2025
- Catalyst will receive an upfront payment, potential milestones, and sales royalties
- This partnership expands AGAMREE's footprint in North America
Catalyst Pharmaceuticals ha stipulato un accordo esclusivo di licenza, fornitura e commercializzazione con Kye Pharmaceuticals per AGAMREE® (vamorolone) in Canada. Questo accordo concede a Kye i diritti commerciali esclusivi su AGAMREE in Canada, un nuovo corticosteroide per il trattamento della Distrofia Muscolare di Duchenne (DMD). Catalyst fornirà il prodotto, mentre Kye sarà responsabile per l'ottenimento dell'approvazione regolatoria da parte di Health Canada e per la commercializzazione all'interno del Canada.
Punti chiave:
- Kye commercializza già FIRDAPSE® di Catalyst in Canada
- La presentazione della domanda regolatoria a Health Canada è prevista entro la fine del 2025
- Catalyst riceverà un pagamento anticipato, potenziali traguardi e royalties sulle vendite
- Questa partnership amplia la presenza di AGAMREE in Nord America
Catalyst Pharmaceuticals ha firmado un acuerdo exclusivo de licencia, suministro y comercialización con Kye Pharmaceuticals para AGAMREE® (vamorolone) en Canadá. Este acuerdo otorga a Kye los derechos comerciales exclusivos en Canadá para AGAMREE, un nuevo corticosteroide para el tratamiento de la Distrofia Muscular de Duchenne (DMD). Catalyst proporcionará el producto, mientras que Kye será responsable de obtener la aprobación regulatoria de Health Canada y de la comercialización en Canadá.
Puntos clave:
- Kye ya comercializa FIRDAPSE® de Catalyst en Canadá
- La presentación de la solicitud regulatoria a Health Canada se anticipa para principios de 2025
- Catalyst recibirá un pago inicial, posibles hitos y regalías por ventas
- Esta asociación amplía la presencia de AGAMREE en América del Norte
Catalyst Pharmaceuticals는 Kye Pharmaceuticals와 캐나다에서 AGAMREE® (바모로론)에 대한 독점 라이선스, 공급 및 상업화 계약을 체결했습니다. 이 계약은 Kye에게 듀셴 근육 이영양증 (DMD) 치료를 위한 새로운 코르티코스테로이드인 AGAMREE에 대한 독점적인 상업적 권리를 부여합니다. Catalyst는 제품을 공급하고, Kye는 Health Canada로부터 규제 승인을 얻고 캐나다 내에서 상업화하는 책임을 집니다.
주요 사항:
- Kye는 이미 캐나다에서 Catalyst의 FIRDAPSE®를 판매하고 있습니다
- Health Canada에 대한 규제 신청서는 2025년 초에 제출될 예정입니다
- Catalyst는 선불 지급, 잠재적 마일스톤 및 판매 로열티를 받을 것입니다
- 이번 파트너십은 AGAMREE의 북미 시장 진출을 확대합니다
Catalyst Pharmaceuticals a conclu un accord exclusif de licence, de fourniture et de commercialisation avec Kye Pharmaceuticals pour AGAMREE® (vamorolone) au Canada. Cet accord accorde à Kye les droits commerciaux exclusifs pour AGAMREE, un nouveau corticostéroïde destiné au traitement de la dystrophie musculaire de Duchenne (DMD). Catalyst fournira le produit, tandis que Kye sera responsable d'obtenir l'approbation réglementaire de Santé Canada et de la commercialisation au Canada.
Points clés :
- Kye commercialise déjà FIRDAPSE® de Catalyst au Canada
- La soumission de la demande réglementaire à Santé Canada est prévue pour début 2025
- Catalyst recevra un paiement initial, des étapes potentielles et des redevances sur les ventes
- Ce partenariat étend la portée d'AGAMREE en Amérique du Nord
Catalyst Pharmaceuticals hat einen exklusiven Lizenz-, Liefer- und Vermarktungsvertrag mit Kye Pharmaceuticals für AGAMREE® (Vamorolon) in Kanada abgeschlossen. Dieser Vertrag gewährt Kye die exklusiven kommerziellen Rechte für AGAMREE, ein neuartiges Kortikosteroid zur Behandlung von Duchenne-Muskeldystrophie (DMD). Catalyst wird das Produkt liefern, während Kye dafür verantwortlich ist, die regulatorische Genehmigung von Health Canada zu erhalten und die Vermarktung in Kanada zu übernehmen.
Wichtige Punkte:
- Kye vertreibt bereits FIRDAPSE® von Catalyst in Kanada
- Die Einreichung des regulatorischen Antrags bei Health Canada wird Anfang 2025 erwartet
- Catalyst wird eine Vorauszahlung, potenzielle Meilensteine und Verkaufsroyalties erhalten
- Diese Partnerschaft erweitert die Präsenz von AGAMREE in Nordamerika
- Expansion of AGAMREE's market to Canada, potentially increasing future revenue
- Upfront payment and potential for additional milestone payments and sales royalties
- Strengthened partnership with Kye Pharmaceuticals, leveraging their existing market presence in Canada
- Catalyst retains responsibility for product supply, maintaining control over manufacturing
- Dependence on Kye Pharmaceuticals for regulatory approval and commercialization in Canada
- Potential delay in Canadian market entry, with regulatory submission not expected until early 2025
Insights
The licensing agreement between Catalyst Pharmaceuticals and Kye Pharmaceuticals for AGAMREE® is a significant development in the biopharmaceutical industry, especially for patients suffering from Duchenne Muscular Dystrophy (DMD). This strategic move leverages AGAMREE’s prior U.S. approval and aims to tap into the Canadian market, addressing a critical need for novel corticosteroids to treat DMD.
From a medical perspective, AGAMREE (vamorolone) is noteworthy because it offers a potentially safer alternative to traditional corticosteroids, which are the standard treatment for DMD but come with severe side effects over long-term use. Vamorolone’s unique mechanism aims to reduce these side effects while providing the same anti-inflammatory benefits. This makes the drug highly valuable for DMD patients who require long-term medication.
Considering that DMD is a rare and debilitating condition with limited treatment options, this agreement holds promise. It could significantly improve the quality of life for Canadian patients and may also have implications for other regions if successful.
From a financial perspective, this agreement is poised to benefit Catalyst Pharmaceuticals significantly. Licensing agreements like this one often result in substantial revenue streams through upfront payments, milestone payments and royalties. Although the specific financial terms of the deal haven't been disclosed, the structure of such agreements typically ensures a stable revenue flow for Catalyst.
Catalyst's decision to partner with Kye, which already markets FIRDAPSE® in Canada, indicates a trusted relationship and a proven commercialization pathway. This reduces the risk associated with entering a new market. Moreover, the upfront payment and potential milestone payments provide immediate financial benefits while the royalty structure offers long-term revenue potential as AGAMREE gains market traction.
Given the niche market for DMD treatments, any successful commercialization effort could lead to significant financial returns, making this deal a strategic win for Catalyst.
In terms of market strategy, the agreement aligns well with Catalyst’s broader objectives of expanding its footprint in rare disease markets. The Canadian market, though smaller than the U.S., offers a lucrative opportunity due to its advanced healthcare system and willingness to adopt innovative treatments.
Currently, the market for DMD treatments in Canada is underserved, offering AGAMREE a strong entry point. The established relationship between Catalyst and Kye Pharmaceuticals suggests a smoother regulatory approval process and faster market onboarding. Additionally, Kye’s existing marketing infrastructure for FIRDAPSE® can be leveraged to promote AGAMREE, reducing the time and cost associated with market entry.
This strategic alliance not only diversifies Catalyst's revenue streams but also strengthens its position in North American markets, reinforcing its credibility and market presence in the rare disease treatment sector.
CORAL GABLES, Fla., July 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 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 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'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.
FAQ
What is the new agreement between Catalyst Pharmaceuticals (CPRX) and Kye Pharmaceuticals?
When is Kye Pharmaceuticals expected to submit the regulatory application for AGAMREE to Health Canada?
What financial benefits will Catalyst Pharmaceuticals (CPRX) receive from this agreement?
What is AGAMREE® and what condition does it treat?
