Ascendis Pharma and Novo Nordisk Sign Collaboration for Development and Commercialization of TransCon Technology-based Products in Metabolic and Cardiovascular Diseases
Ascendis Pharma (ASND) has entered into a licensing agreement with Novo Nordisk for the exclusive worldwide rights to its TransCon technology platform. The collaboration focuses on developing products for metabolic and cardiovascular diseases, with a lead program targeting a once-monthly GLP-1 receptor agonist for obesity and type 2 diabetes. Ascendis will receive up to $285 million in upfront, development, and regulatory milestone payments for the lead program, plus sales-based milestones and tiered royalties. Additional product candidates could earn up to $77.5 million each in milestone payments plus royalties. Ascendis will handle early development while Novo Nordisk will manage clinical development, regulatory affairs, manufacturing, and commercialization.
Ascendis Pharma (ASND) ha stipulato un accordo di licenza con Novo Nordisk per i diritti esclusivi a livello mondiale sulla sua piattaforma tecnologica TransCon. La collaborazione si concentra sullo sviluppo di prodotti per le malattie metaboliche e cardiovascolari, con un programma principale che mira a un agonista del recettore GLP-1 a somministrazione mensile per l'obesità e il diabete di tipo 2. Ascendis riceverà fino a 285 milioni di dollari in pagamenti anticipati, per lo sviluppo e per i traguardi normativi per il programma principale, oltre a traguardi basati sulle vendite e royalties graduali. Ulteriori candidati di prodotto potrebbero guadagnare fino a 77,5 milioni di dollari ciascuno in pagamenti per traguardi e royalties. Ascendis gestirà lo sviluppo iniziale, mentre Novo Nordisk si occuperà dello sviluppo clinico, delle questioni regolatorie, della produzione e della commercializzazione.
Ascendis Pharma (ASND) ha llegado a un acuerdo de licencia con Novo Nordisk para los derechos exclusivos a nivel mundial de su plataforma tecnológica TransCon. La colaboración se centra en el desarrollo de productos para enfermedades metabólicas y cardiovasculares, con un programa principal que tiene como objetivo un agonista del receptor GLP-1 de administración mensual para la obesidad y la diabetes tipo 2. Ascendis recibirá hasta 285 millones de dólares en pagos iniciales, por el desarrollo y pagos por hitos regulatorios para el programa principal, además de hitos basados en ventas y regalías escalonadas. Candidatos adicionales de productos podrían generar hasta 77,5 millones de dólares cada uno en pagos por hitos y regalías. Ascendis se encargará del desarrollo inicial, mientras que Novo Nordisk gestionará el desarrollo clínico, los asuntos regulatorios, la fabricación y la comercialización.
Ascendis Pharma (ASND)는 Novo Nordisk와 TransCon 기술 플랫폼에 대한 전세계 독점 권리를 위한 라이센스 계약을 체결했습니다. 이 협력은 대사 및 심혈관 질환을 위한 제품 개발에 집중되며, 주요 프로그램은 비만 및 제2형 당뇨병을 위한 월 1회 GLP-1 수용체 작용제를 목표로 합니다. Ascendis는 주요 프로그램에 대해 최대 2억 8500만 달러의 선불금, 개발 및 규제 이정표 지급액을 받을 것이며, 판매 기반 이정표와 단계별 로열티도 받을 예정입니다. 추가 제품 후보는 각각 최대 7750만 달러의 이정표 지급과 로열티를 얻을 수 있습니다. Ascendis는 초기 개발을 담당하고, Novo Nordisk는 임상 개발, 규제 업무, 제조 및 상업화를 관리합니다.
Ascendis Pharma (ASND) a conclu un accord de licence avec Novo Nordisk pour les droits exclusifs mondiaux sur sa plateforme technologique TransCon. La collaboration se concentre sur le développement de produits pour les maladies métaboliques et cardiovasculaires, avec un programme phare visant un agoniste du récepteur GLP-1 à administration mensuelle pour l'obésité et le diabète de type 2. Ascendis recevra jusqu'à 285 millions de dollars en paiements initiaux, de développement et de jalons réglementaires pour le programme principal, ainsi que des jalons basés sur les ventes et des redevances progressives. D'autres candidats de produit pourraient gagner jusqu'à 77,5 millions de dollars chacun en paiements de jalons et en redevances. Ascendis gérera le développement précoce, tandis que Novo Nordisk s'occupera du développement clinique, des affaires réglementaires, de la fabrication et de la commercialisation.
Ascendis Pharma (ASND) hat einen Lizenzvertrag mit Novo Nordisk über die exklusiven weltweiten Rechte an seiner TransCon-Technologieplattform abgeschlossen. Die Zusammenarbeit konzentriert sich auf die Entwicklung von Produkten für metabolische und kardiovaskuläre Erkrankungen, wobei ein Hauptprogramm auf einen einmal monatlichen GLP-1-Rezeptoragonisten für Fettleibigkeit und Typ-2-Diabetes abzielt. Ascendis wird bis zu 285 Millionen Dollar an Vorauszahlungen, Entwicklungs- und regulatorischen Meilensteinzahlungen für das Hauptprogramm erhalten, sowie meilensteinbasierte Zahlungen und gestaffelte Lizenzgebühren. Zusätzliche Produktkandidaten könnten jeweils bis zu 77,5 Millionen Dollar an Meilensteinzahlungen und Lizenzgebühren verdienen. Ascendis wird die frühe Entwicklung übernehmen, während Novo Nordisk das klinische Entwicklungs-, Regulierungs- und Fertigungsmanagement sowie die Vermarktung leitet.
- Potential revenue of up to $285 million in milestone payments for lead program
- Additional revenue potential of $77.5 million per extra product candidate
- Partnership with industry leader Novo Nordisk enhances market reach
- Development costs will be covered by Novo Nordisk
- Multiple revenue streams through milestone payments and tiered royalties
- Licensing out technology platform may limit future independent development opportunities
- Deal completion subject to regulatory approvals
Insights
This strategic collaboration marks a significant milestone for Ascendis Pharma, potentially transforming its revenue outlook. The deal structure includes
The focus on once-monthly GLP-1 receptor agonists is particularly noteworthy given the explosive growth in the GLP-1 market, currently dominated by weekly injections. This could represent a significant competitive advantage in a market projected to reach
The development of a once-monthly GLP-1 receptor agonist could be a game-changer in metabolic disease treatment. Current leading GLP-1 products like Wegovy and Ozempic require weekly injections, which can impact patient compliance. The TransCon technology's potential to extend dosing intervals to monthly administration while maintaining therapeutic efficacy could significantly improve treatment adherence and patient outcomes.
The expansion into cardiovascular applications is particularly strategic, as GLP-1 medications have shown promising cardiovascular benefits beyond their metabolic effects. This versatility, combined with reduced dosing frequency, could position any resulting products as preferred options in both obesity and diabetes management.
- Collaboration leverages Ascendis’ proprietary TransCon™ technologies and Novo Nordisk’s expertise in cardiometabolic diseases
- Once-monthly GLP-1 receptor agonist will be the collaboration’s lead product candidate
COPENHAGEN, Denmark, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has granted Novo Nordisk A/S an exclusive worldwide license to the TransCon technology platform to develop, manufacture and commercialize Novo Nordisk proprietary products in metabolic diseases (including obesity and type 2 diabetes) and a product-by-product exclusive license in cardiovascular diseases. The agreement includes provisions requiring certain TransCon technology-based products to be identified and advanced in metabolic diseases to maintain exclusivity in the field and additional provisions for cardiovascular diseases. Under the terms of the agreement, Novo Nordisk also receives exclusive rights to expand any resulting metabolic disease products into other therapeutic areas. The lead program in the collaboration is a once-monthly GLP-1 receptor agonist product candidate that will initially target obesity and type 2 diabetes.
In exchange for the license, Ascendis will be eligible to receive total payments of up to
Ascendis will conduct early development of TransCon product candidates under the collaboration. Novo Nordisk will be responsible for these early development costs and for clinical development, regulatory, commercial manufacturing, and commercialization.
“We are pleased to collaborate with Novo Nordisk, an established expert in metabolic diseases, to maximize the potential of TransCon products for helping patients,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “The agreement with Novo Nordisk reflects our Vision 2030 to create value in additional large therapeutic areas outside endocrinology rare disease through collaborations with established global leaders.”
“Developing potential therapies that can be administered less frequently could benefit societies as well as individual patients, and it is a clear focus area for Novo Nordisk,” said Brian Vandahl, Senior Vice President of Global Research Technologies at Novo Nordisk. “We look forward to working with Ascendis to explore the potential of the TransCon technology platform to reduce the dosing frequency of GLP-1 receptor agonists and other treatments for cardiometabolic diseases.”
The closing of this transaction is subject to receipt of applicable regulatory approvals and the parties are seeking to close before the end of 2024.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the expected initial targets of the GLP-1 receptor agonist product candidate; (ii) Ascendis’ potential receipt of milestone and royalty payments; (iii) Ascendis’ plans to conduct early development of TransCon product candidates; (iv) Novo Nordisk’s responsibility for early development costs and for clinical development, regulatory, commercial manufacturing, and commercialization; (v) Ascendis’ collaboration with Novo Nordisk to maximize the potential of TransCon products; (vi) Ascendis’ ability to create value in additional large therapeutic areas outside endocrinology rare disease through collaborations; (vii) the potential benefits of therapies that can be administered less frequently; (viii) Ascendis’ and Novo Nordisk’s intent to explore the potential of the TransCon technology platform to reduce the dosing frequency of GLP-1 receptor agonists and other treatments for cardiometabolic diseases; (ix) the expected timing of the closing of the transaction; (x) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company; and (xi) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on collaboration partners to develop and conduct clinical studies with, obtain regulatory approvals for, market and sell product candidates; dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; and the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ prospectus supplement filed on September 20, 2024 and Ascendis’ current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 20-F filed with the SEC on February 7, 2024. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.
Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, and TransCon are trademarks owned by the Ascendis Pharma group. © November 2024 Ascendis Pharma A/S.
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