AbbVie and Gubra Announce License Agreement to Develop an Amylin Analog for the Treatment of Obesity
AbbVie (NYSE: ABBV) and Gubra A/S have announced a license agreement to develop GUB014295, a potential best-in-class, long-acting amylin analog for obesity treatment. This partnership marks AbbVie's strategic entry into the obesity market.
The agreement includes a $350 million upfront payment to Gubra, with potential additional payments of up to $1.875 billion in development, commercial, and sales milestones, plus tiered royalties on global net sales. AbbVie will lead global development and commercialization activities.
GUB014295, currently in Phase 1 clinical trials, is an agonist that activates amylin and calcitonin receptors. The compound works by triggering appetite suppression signals to the brain, reducing food intake, and delaying gastric emptying. This development addresses a significant global health concern, with approximately 900 million adults affected by obesity.
AbbVie (NYSE: ABBV) e Gubra A/S hanno annunciato un accordo di licenza per sviluppare GUB014295, un potenziale analoghi dell'amiloide di classe superiore e a lunga durata per il trattamento dell'obesità. Questa partnership segna l'ingresso strategico di AbbVie nel mercato dell'obesità.
L'accordo prevede un pagamento iniziale di 350 milioni di dollari a Gubra, con potenziali pagamenti aggiuntivi fino a 1,875 miliardi di dollari in traguardi di sviluppo, commercializzazione e vendite, oltre a royalty scalari sulle vendite nette globali. AbbVie guiderà le attività di sviluppo e commercializzazione a livello globale.
GUB014295, attualmente in fase 1 di sperimentazione clinica, è un agonista che attiva i recettori dell'amiloide e della calcitonina. Il composto agisce attivando segnali di soppressione dell'appetito al cervello, riducendo l'assunzione di cibo e ritardando lo svuotamento gastrico. Questo sviluppo affronta una significativa preoccupazione per la salute globale, con circa 900 milioni di adulti colpiti da obesità.
AbbVie (NYSE: ABBV) y Gubra A/S han anunciado un acuerdo de licencia para desarrollar GUB014295, un potencial análogo de amiloide de clase superior y de acción prolongada para el tratamiento de la obesidad. Esta asociación marca la entrada estratégica de AbbVie en el mercado de la obesidad.
El acuerdo incluye un pago inicial de 350 millones de dólares a Gubra, con posibles pagos adicionales de hasta 1.875 millones de dólares en hitos de desarrollo, comercialización y ventas, además de regalías escalonadas sobre las ventas netas globales. AbbVie liderará las actividades de desarrollo y comercialización a nivel mundial.
GUB014295, actualmente en ensayos clínicos de fase 1, es un agonista que activa los receptores de amiloide y calcitonina. El compuesto funciona al activar señales de supresión del apetito en el cerebro, reduciendo la ingesta de alimentos y retrasando el vaciamiento gástrico. Este desarrollo aborda una preocupación significativa de salud global, con aproximadamente 900 millones de adultos afectados por la obesidad.
AbbVie (NYSE: ABBV)와 Gubra A/S는 비만 치료를 위한 잠재적인 최상급 장기 작용 아밀린 유사체인 GUB014295 개발을 위한 라이선스 계약을 발표했습니다. 이 파트너십은 AbbVie의 비만 시장 진출을 전략적으로 의미합니다.
계약에는 Gubra에 대한 3억 5천만 달러의 선불 지급이 포함되며, 개발, 상업화 및 판매 이정표에 따라 최대 18억 7천5백만 달러의 추가 지급이 있을 수 있으며, 글로벌 순매출에 대한 단계별 로열티도 포함됩니다. AbbVie는 글로벌 개발 및 상업화 활동을 주도할 것입니다.
현재 1상 임상 시험 중인 GUB014295는 아밀린 및 칼시토닌 수용체를 활성화하는 작용제입니다. 이 화합물은 뇌에 식욕 억제 신호를 전달하여 음식 섭취를 줄이고 위 배출을 지연시키는 방식으로 작용합니다. 이 개발은 약 9억 명의 성인이 비만에 영향을 받는 중요한 글로벌 건강 문제를 해결하고자 합니다.
AbbVie (NYSE: ABBV) et Gubra A/S ont annoncé un accord de licence pour développer GUB014295, un analogue de l'amylin à longue durée d'action et potentiellement de premier plan pour le traitement de l'obésité. Ce partenariat marque l'entrée stratégique d'AbbVie sur le marché de l'obésité.
L'accord comprend un paiement initial de 350 millions de dollars à Gubra, avec des paiements supplémentaires potentiels pouvant atteindre 1,875 milliard de dollars en jalons de développement, de commercialisation et de ventes, ainsi que des redevances échelonnées sur les ventes nettes mondiales. AbbVie dirigera les activités de développement et de commercialisation à l'échelle mondiale.
GUB014295, actuellement en essais cliniques de phase 1, est un agoniste qui active les récepteurs d'amylin et de calcitonine. Le composé agit en déclenchant des signaux de suppression de l'appétit au cerveau, réduisant la consommation alimentaire et retardant la vidange gastrique. Ce développement répond à une préoccupation majeure en matière de santé mondiale, avec environ 900 millions d'adultes touchés par l'obésité.
AbbVie (NYSE: ABBV) und Gubra A/S haben eine Lizenzvereinbarung zur Entwicklung von GUB014295 angekündigt, einem potenziell besten langwirksamen Amylin-Analogon zur Behandlung von Fettleibigkeit. Diese Partnerschaft markiert AbbVies strategischen Eintritt in den Fettleibigkeitsmarkt.
Die Vereinbarung umfasst eine Vorauszahlung von 350 Millionen Dollar an Gubra, mit möglichen zusätzlichen Zahlungen von bis zu 1,875 Milliarden Dollar bei Entwicklungs-, Handels- und Verkaufsmeilensteinen sowie gestaffelten Lizenzgebühren auf den globalen Nettoumsatz. AbbVie wird die globalen Entwicklungs- und Vermarktungsaktivitäten leiten.
GUB014295, das sich derzeit in Phase 1 klinischen Studien befindet, ist ein Agonist, der Amylin- und Calcitonin-Rezeptoren aktiviert. Die Verbindung funktioniert, indem sie Signale zur Appetithemmung an das Gehirn sendet, die Nahrungsaufnahme reduziert und die Magenentleerung verzögert. Diese Entwicklung spricht ein erhebliches globales Gesundheitsproblem an, da etwa 900 Millionen Erwachsene von Fettleibigkeit betroffen sind.
- Strategic entry into large obesity market (900M adults)
- $350M upfront payment secured with $1.875B additional milestone potential
- Phase 1 trial already showing promising initial data
- Global commercialization rights secured
- Early-stage drug (only Phase 1) with significant development risks
- High upfront payment ($350M) with uncertain return
- Entering highly competitive obesity market as a late player
Insights
AbbVie's $350 million upfront payment to Gubra for their amylin analog represents a calculated strategic entry into the highly competitive obesity therapeutics market. This deal structure - with potential milestone payments reaching
The timing is significant as AbbVie continues navigating post-Humira patent cliff challenges. Obesity represents a massive addressable market with 900 million adults globally identified in the announcement. The substantial financial commitment suggests AbbVie's confidence in both the specific amylin-based mechanism and Gubra's preclinical work.
For Gubra, securing a partner with AbbVie's development infrastructure and commercialization capabilities substantially derisks their program while maintaining significant upside through the milestone structure. The GUB014295 compound's Phase 1 status indicates substantial development work remains before commercialization, with multiple clinical hurdles ahead.
The amylin analog approach targets a different biological pathway than leading GLP-1 therapies, potentially positioning this compound as either a differentiated monotherapy or future combination treatment option. AbbVie's entrance into this therapeutic area shows recognition of obesity's emergence as a treatment category with substantial growth potential and recurrent revenue characteristics.
GUB014295's mechanism as an amylin/calcitonin receptor agonist represents an alternative approach to weight management compared to GLP-1 receptor agonists. The science here is compelling - amylin's natural role in appetite suppression and delayed gastric emptying provides a physiologically-relevant target with established biological rationale.
The compound's current position in Phase 1 (with initial single ascending dose trials mentioned) places it several years from potential commercialization, assuming successful progression through clinical development. This early-stage status carries inherent development risk despite the substantial financial commitment.
The partnership leverages complementary strengths - Gubra's peptide discovery expertise combined with AbbVie's global development capabilities. From a technical perspective, amylin analogs face formulation and delivery challenges similar to other peptide therapeutics, though advances in this field have improved feasibility.
Particularly noteworthy is the opportunity for patient differentiation. The announcement specifically mentions that many patients "struggle to stay on current treatment options," suggesting AbbVie may position this compound for specific patient segments - either those with inadequate response to existing therapies or those experiencing challenging side effects. As the obesity treatment landscape evolves, having multiple mechanistic approaches increases the likelihood of personalized treatment optimization based on individual patient characteristics and response patterns.
- Partnership marks AbbVie's entrance into the obesity field
- Agreement will enable the incorporation of GUB014295, an amylin peptide discovered and developed by Gubra, into AbbVie's global infrastructure for developing and commercializing therapies for patients in need
"At AbbVie, we are focused on transforming the future of patient care in areas where significant unmet need persists," said Robert A. Michael, chief executive officer, AbbVie. "Our partnership with Gubra marks our entry into the obesity field, offering a compelling opportunity based on the potential to address patient needs while also fostering long-term growth for our company."
GUB014295 is currently in a Phase 1 clinical trial. A potential long-acting amylin analog, GUB014295 is an agonist that specifically activates amylin and calcitonin receptors. Amylin, a satiety hormone, has been identified as a potential therapeutic target for the treatment of obesity given its role in activating signals to the brain that result in appetite suppression and the reduction of food intake, while also acting as an inhibitory signal to delay gastric emptying.
"Obesity represents a significant global health concern with nearly 900 million adults with obesity, many of whom struggle to stay on current treatment options," said Roopal Thakkar, M.D., executive vice president, research & development, chief scientific officer, AbbVie. "Building on Gubra's experience in the discovery of novel peptide-based therapeutics, we look forward to advancing the development of the GUB014295 program."
"We are excited to partner with AbbVie given its strong capabilities in both the development and commercialization of life-changing medicines," said Henrik Blou, chief executive officer, Gubra. "This collaboration between Gubra and AbbVie will accelerate the development of GUB014295 and build on the promising data shown in its Phase 1 single ascending dose (SAD) trial. Our team has been extremely impressed with AbbVie and their commitment to bring this important partnership to life. We look forward to working together throughout the development of the GUB014295 program."
Under the terms of the agreement, AbbVie will lead development and commercialization activities of GUB014295 globally. Gubra will receive
Morgan Stanley & Co. International plc served as exclusive financial advisor to Gubra A/S. Goodwin Procter LLP and Plesner Advokatpartnerselskab served as legal advisors to Gubra A/S.
Gubra Investor Conference Call Information
A presentation for analysts and investors will be held today, March 3, at 10:00 am CET. The event will be hosted by the company's CEO Henrik Blou, CSO Louise S. Dalbøge and CFO Kristian Borbos. The presentation will be held in English.
To participate in the conference, please register here to receive the dial-in details:
https://palvelu.flik.fi/teleconference/?id=5003288
The conference can also be followed live via the webcast link:
https://hca.videosync.fi/2025-03-03-presentation/register
It will also be possible to access the webcast afterwards at the abovementioned link.
About the Phase 1 Clinical Trial of GUB014295
The Phase 1 clinical trial is a two-part, single center, double-blind (within cohorts), randomized, placebo-controlled, single (Part 1) and multiple (Part 2) ascending subcutaneous dose study of GUB014295. Part 1 has been completed; Part 2 is ongoing. More information on this trial can be found at https://www.clinicaltrials.gov/ (NCT: 06144684).
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience, eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
About Gubra
Gubra, founded in 2008 in
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
AbbVie Media: Lindsay Cangemi lindsay.cangemi@abbvie.com | AbbVie Investors: Liz Shea liz.shea@abbvie.com | |
Gubra Media: Sofia Pitt Boserup sbo@gubra.dk | Gubra Investors: Kristian Borbos kbo@gubra.dk |
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