Catalyst Pharmaceuticals Enters Into an Exclusive License, Supply and Commercialization Agreement With Kye Pharmaceuticals for AGAMREE in Canada
Catalyst Pharmaceuticals Enters Into an Exclusive License, Supply and Commercialization Agreement With Kye Pharmaceuticals for AGAMREE in Canada
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.
2024年7月24日佛羅里達州CORAL GABLES(全球新聞社) - Catalyst Pharmaceuticals,Inc.(“ Catalyst”或“公司”)(納斯達克:CPRX)是一家商業化階段的生物製藥公司,專注於轉讓許可,開發和商業化用於罕見和難以治療的疾病患者的新藥。今天宣佈,公司已與Kye Pharmaceuticals Inc.(“Kye”或“Kye Pharmaceuticals”)簽訂了許可,供應和商業化協議,授予Kye AGAMREE(vamorolone)獨家加拿大的商業權,這是一種治療肌萎縮性側索硬化(“DMD”)和其他潛在適應症的新型糖皮質激素。根據協議的條款,Catalyst將向Kye提供產品,Kye將全權負責從加拿大衛生部獲得AGAMREE用於治療DMD的監管批准以及將來的全部商業化工作。Kye目前在加拿大市場上銷售FIRDAPSE,這是Catalyst用於治療蘭貝爾特伊頓肌無力綜合徵的旗艦產品。
"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."
“我們很高興與Kye Pharmaceuticals簽訂這份關於AGAMREE的協議,這是我們擴大北美產品規模戰略計劃的關鍵里程碑。這項合作利用了我們的聯合專業知識,通過爲我們在加拿大授予第二種稀有病治療產品的許可來鞏固了我們的聯盟,展示了我們對患者護理的持續承諾, ”Catalyst的CEO和總裁Richard J. Daly說道。“在美國AGAMREE獲得批准的基礎上,我們致力於幫助加拿大DMD患者及其醫療保健提供者獲得這種新型糖皮質激素治療的便利性。我們期待與我們的合作伙伴密切合作,由他們領導AGAMREE的法規批准過程,預計將於2025年初向加拿大衛生部提交申請。”
"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.
“我們與Catalyst的擴展合作強調了我們合作開發罕見病,包括DMD,以及跨美國和加拿大改善健康結果的內在價值。我們致力於提供新型療法,並填補治療領域的顯著差距。”Kye Pharmaceuticals的首席執行官兼總裁John McKendry表示。
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.
根據協議的條款,Kye Pharmaceuticals,Inc.將擁有商業化AGAMREE(vamorolone)口服懸液的加拿大專營權,並將負責在加拿大進行所有的監管,營銷和商業化活動。Catalyst將負責臨床和商業供應,並支持Kye製藥公司努力從加拿大衛生部獲得產品的監管批准。在許可,供應和商業化協議中列出的條款和條件得到滿足的前提下,Catalyst將獲得初始支付,並有資格獲得更多的補償和銷售里程碑以及對AGAMREE的銷售版稅。
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.
關於Duchenne Muscular Dystrophy
肌萎縮性側索硬化(DMD)是一種遺傳性疾病,其特徵是肌肉退化和肌肉無力。它主要影響男性,症狀通常在幼童期出現,大約在3至5歲之間。DMD由編碼肌肉纖維蛋白的基因突變引起,該蛋白在維持肌肉纖維的結構和功能方面發揮着至關重要的作用。沒有肌蛋白,肌細胞變得易碎和容易受損,導致逐漸發展的肌肉退化。DMD的症狀通常始於步態困難,經常跌倒和肌肉無力,特別是在腿部和骨盆部位。隨着疾病的發展,患者可能經歷站立困難,爬樓梯困難,最終完全失去行動能力。其他併發症可能包括由於肌肉無力而引起的呼吸和心臟問題。
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.
關於AGAMREE(vamorolone)
AGAMREE的獨特作用模式基於糖皮質激素和礦質皮質激素受體的差異效應以及進一步下游活性的修飾。因此,它被認爲是一種設計用於實現分離性質並保持有效性的新型糖皮質激素,具有可能證明與類固醇相當的療效,並具有更好的副作用耐受性潛力。這種作用機制可以使AGAMREE成爲兒童,青少年和成人患者肌萎縮性側索硬化(DMD)的有效替代當前的標準糖皮質激素治療。在關鍵的VISION-DMD研究中,AGAMREE在治療24周後滿足了時間站(TTSTAND)速率對安慰劑(p = 0.002)的主要終點,並顯示出良好的安全性和耐受性。與安慰劑相比,VISION-DMD研究中常見的不良事件包括庫欣樣特徵,精神障礙,嘔吐,重量增加和維生素D缺乏症。副作用通常是輕度至中度的。
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 .
關於Kye Pharmaceuticals
Kye Pharmaceuticals是一家快速增長的加拿大專業製藥公司,致力於通過識別,許可和商業化可能不會爲加拿大患者提供的新型處方藥物,爲加拿大人帶來價值。由勇氣和敏捷性激發,我們的企業哲學根植於追求創新,驅動我們的企業精神。憑藉日益增長的新型藥物管道,Kye的產品組合涵蓋了各種治療領域,包括心臟病學,精神病學,兒科學,罕見病,血液學和神經病學。 Kye Pharmaceuticals是一家總部位於多倫多的私人公司,專注於爲加拿大市場帶來填補重要未滿足需求的藥物。Kye致力於通過向我們的合作伙伴,加拿大醫療保健專業人員以及最重要的加拿大患者提供更好的成果,來執照和推出有意義的藥物。更多信息請訪問網站。
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.
關於Catalyst Pharmaceuticals, Inc.
Catalyst注重患者,致力於開發和商業化創新的一類治療罕見和難以治療疾病的藥物。 Catalyst的旗艦美國商業產品是FIRDAPSE(Amifampridine)10毫克片,獲得批准用於治療成人和6歲及以上的小兒Lambert-Eaton肌無力綜合症(“LEMS”)。在2023年1月,Catalyst獲得了FYCOMPA(Perampanel)CIII的美國商業權,這是一種處方藥,用於治療年齡超過4歲的癲癇患者,單獨或與其他藥物一起治療具有或不具有次生廣泛發作和其他藥物治療原發性肌陣攣大發作的癲癇患者,年齡爲12歲及以上。此外,加拿大的國家衛生保健監管機構Health Canada已批准使用FIRDAPSE治療加拿大成年患者的LEMS。在2023年7月18日,Catalyst收購了AGAMREE(Vamorolone)口服懸液40毫克/毫升的北美專有許可證,這是一種用於杜氏肌肉萎縮症的新型皮質類固醇治療藥物。 AGAMREE(先前獲得FDA有孤兒藥和快速通道認證)在2023年10月26日獲得了FDA進行商業化的批准。 AGAMREE於2024年3月13日通過處方在美國上市。
For more information about Catalyst, please visit the Company's website at . For Full Prescribing and Safety Information for FIRDAPSE, please visit . For Full Prescribing Information, including Boxed WARNING for FYCOMPA, please visit . For Full Prescribing Information for AGAMREE, please visit .
有關Catalyst的更多信息,請訪問該公司的網站。有關FIRDAPSE的完整處方和安全信息,請訪問。有關FYCOMPA的完整處方信息(包括帶框警告),請訪問。有關AGAMREE的完整處方信息,請訪問。
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.
前瞻性聲明
本新聞稿包含前瞻性陳述。前瞻性陳述涉及已知和未知的風險和不確定性,可能導致Catalyst在未來時期的結果與預期結果不符。包括(i)Catalyst的被許可方Kye Pharmaceuticals,Inc.®是否成功獲得在授權加拿大領土內商業化AGAMREE產品所需的批准,(ii)如果獲批,Kye Pharmaceuticals是否成功在授權領土內商業化AGAMREE產品,以及(iii)在Catalyst的年度報告中提到的那些因素,2023年10-K,其2024年第一季度10-Q以及其提交給美國證券交易委員會(“SEC”)的其他文件可能會對Catalyst產生不利影響。 Catalyst的拷貝提交給SEC的文件可從SEC處獲取,可從Catalyst的網站上找到,或可從Catalyst索取。Catalyst不承擔任何更新此處所述信息的義務,該信息僅作本日期。
Source: Catalyst Pharmaceuticals, Inc.
來源:catalyst pharmaceuticals
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
投資者關係聯繫人:
Mary Coleman,Catalyst Pharmaceuticals
(305)420-3200
mcoleman@catalystpharma.com
媒體聯繫人:
David Schull,Russo Partners
(858) 717-2310
david.schull@russopartnersllc.com
Source: Catalyst Pharmaceuticals, Inc.
來源:catalyst pharmaceuticals