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BioArctic announces global license agreement with Bristol Myers Squibb for BioArctic's PyroGlutamate-amyloid-beta antibody program

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BioArctic AB has entered into a global exclusive license agreement with Bristol Myers Squibb for its PyroGlutamate-amyloid-beta antibody program, including BAN1503 and BAN2803. The deal includes a $100 million upfront payment and up to $1.25 billion in milestone payments, plus tiered low double-digit royalties on global product sales.

The agreement covers BioArctic's novel antibodies targeting pyroglutamate modified amyloid-beta, which forms harmful aggregates causing Alzheimer's disease symptoms. BAN2803 incorporates BioArctic's BrainTransporter™ technology, designed to enhance brain drug delivery through the blood-brain barrier using the transferrin receptor. BioArctic retains co-commercialization rights in the Nordic region and all other rights for the BrainTransporter platform in different therapy areas.

BioArctic AB ha stipulato un accordo di licenza globale esclusiva con Bristol Myers Squibb per il suo programma di anticorpi contro l'amyloide-beta modificata da pyroglutammato, inclusi BAN1503 e BAN2803. L'accordo prevede un pagamento iniziale di 100 milioni di dollari e fino a 1,25 miliardi di dollari in pagamenti legati a traguardi, oltre a royalty gradualizzate a due cifre basse sulle vendite globali dei prodotti.

L'accordo copre gli anticorpi innovativi di BioArctic che mirano all'amyloide-beta modificata da pyroglutammato, la quale forma aggregati dannosi che causano sintomi della malattia di Alzheimer. BAN2803 incorpora la tecnologia BrainTransporter™ di BioArctic, progettata per migliorare la somministrazione di farmaci al cervello attraverso la barriera emato-encefalica mediante il recettore della transferrina. BioArctic mantiene i diritti di co-commercializzazione nella regione nordica e tutti gli altri diritti per la piattaforma BrainTransporter in diverse aree terapeutiche.

BioArctic AB ha firmado un acuerdo de licencia global exclusivo con Bristol Myers Squibb para su programa de anticuerpos contra el amiloide-beta modificado por pyroglutamato, que incluye BAN1503 y BAN2803. El acuerdo incluye un pago inicial de 100 millones de dólares y hasta 1,25 mil millones de dólares en pagos por hitos, además de regalías escalonadas de dígitos dobles bajos sobre las ventas globales del producto.

El acuerdo abarca los novedosos anticuerpos de BioArctic dirigidos al amiloide-beta modificado por pyroglutamato, que forma agregados perjudiciales que causan síntomas de la enfermedad de Alzheimer. BAN2803 incorpora la tecnología BrainTransporter™ de BioArctic, diseñada para mejorar la entrega de medicamentos al cerebro a través de la barrera hematoencefálica utilizando el receptor de transferrina. BioArctic retiene derechos de co-comercialización en la región nórdica y todos los demás derechos de la plataforma BrainTransporter en diferentes áreas terapéuticas.

BioArctic ABBristol Myers Squibb와 pyroglutamate-amyloid-beta 항체 프로그램인 BAN1503 및 BAN2803에 대한 글로벌 독점 라이센스 계약을 체결했습니다. 이 계약에는 1억 달러의 선불금과 최대 12억 5천만 달러의 이정표 지급이 포함되며, 전 세계 제품 판매에 대한 저수익의 계층화된 로열티도 포함됩니다.

이 계약은 알츠하이머 병의 증상을 유발하는 유해한 집합체를 형성하는 pyroglutamate 변형 아밀로이드-beta를 표적으로 하는 BioArctic의 새로운 항체를 포함합니다. BAN2803은 혈액-뇌 장벽을 통한 뇌 약물 전달을 개선하도록 설계된 BioArctic의 BrainTransporter™ 기술를 통합합니다. BioArctic는 북유럽 지역에서의 공동 상업화 권리를 유지하며, 다양한 치료 영역에서 BrainTransporter 플랫폼에 대한 모든 다른 권리를 보유합니다.

BioArctic AB a conclu un accord de licence exclusif mondial avec Bristol Myers Squibb pour son programme d'anticorps anti-amyloïde-bêta pyroglutamé, y compris BAN1503 et BAN2803. L'accord comprend un paiement initial de 100 millions de dollars et jusqu'à 1,25 milliard de dollars de paiements par étapes, ainsi que des redevances à deux chiffres basses évolutives sur les ventes mondiales de produits.

Le contrat couvre les nouveaux anticorps de BioArctic ciblant l'amyloïde-bêta modifié par le pyroglutamate, qui forme des agrégats nuisibles causant des symptômes de la maladie d'Alzheimer. BAN2803 intègre la technologie BrainTransporter™ de BioArctic, conçue pour améliorer l'administration des médicaments au cerveau à travers la barrière hémato-encéphalique en utilisant le récepteur de transferrine. BioArctic conserve les droits de co-commercialisation dans la région nordique et tous les autres droits pour la plateforme BrainTransporter dans différentes zones thérapeutiques.

BioArctic AB hat einen globalen exklusiven Lizenzvertrag mit Bristol Myers Squibb für sein Pyroglutamat-Amyloid-beta-Antikörperprogramm, einschließlich BAN1503 und BAN2803, abgeschlossen. Der Deal umfasst eine Vorauszahlung von 100 Millionen Dollar sowie bis zu 1,25 Milliarden Dollar an Meilensteinzahlungen und gestaffelte, niedrige zweistellige Lizenzgebühren auf den globalen Produktverkauf.

Der Vertrag betrifft die neuartigen Antikörper von BioArctic, die auf pyroglutamathaltiges Amyloid-beta abzielen, das schädliche Aggregate bildet, die Symptome der Alzheimer-Krankheit verursachen. BAN2803 integriert die BrainTransporter™ Technologie von BioArctic, die darauf ausgelegt ist, die Medikamentenabgabe ins Gehirn durch die Blut-Hirn-Schranke über den Transferrinrezeptor zu verbessern. BioArctic behält die Rechte zur gemeinsamen Vermarktung in der nordischen Region und alle anderen Rechte an der BrainTransporter-Plattform in verschiedenen Therapiegebieten.

Positive
  • Secured $100 million upfront payment
  • Potential for up to $1.25 billion in milestone payments
  • Tiered low double-digit royalties on global sales
  • Retained co-commercialization rights in Nordic region
  • Maintained rights to BrainTransporter platform for other applications
Negative
  • Loss of global development and commercialization control over BAN1503 and BAN2803
  • Deal subject to US antitrust clearance

Insights

The $100M upfront payment with potential milestone payments of up to $1.25B plus double-digit royalties represents a transformative deal for BioArctic. The partnership with Bristol Myers Squibb validates their PyroGlu-Aβ antibody program and proprietary BrainTransporter™ technology. The deal structure, combining substantial upfront cash with significant milestone potential, provides both immediate value and long-term upside.

The BrainTransporter technology addresses a critical challenge in CNS drug development - crossing the blood-brain barrier. This platform technology could generate additional partnership opportunities across multiple therapeutic areas. The retention of Nordic co-commercialization rights and broader platform rights demonstrates skilled deal negotiation and maintains future value creation potential.

The PyroGlu-Aβ antibody program represents an innovative approach in Alzheimer's treatment. Targeting pyroglutamate-modified amyloid-beta is particularly promising as these modified proteins are highly prone to aggregation and are a key driver of pathology. The inclusion of BAN2803 with the BrainTransporter technology could potentially improve brain penetration and efficacy while reducing required doses and side effects.

Bristol Myers Squibb's expertise in bringing complex biologics to market, combined with BioArctic's innovative technology, positions this program well for success. The transferrin receptor-mediated transport mechanism is a validated approach for crossing the blood-brain barrier, potentially offering superior drug delivery compared to conventional antibodies.

This agreement significantly de-risks BioArctic's business model and strengthens their financial position. The immediate $100M cash infusion represents about 65% of their current market cap, providing substantial runway for continued R&D. The deal validates their technology platform and could catalyze additional partnerships.

For retail investors, this transformative deal reduces development risk while maintaining significant upside through milestone payments and royalties. The retention of Nordic commercial rights and broader platform applications creates multiple potential value drivers. This positions BioArctic as an attractive investment in the neuroscience space with both near-term catalysts and long-term growth potential.

STOCKHOLM, Dec. 19, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that it has entered into a global exclusive license agreement with Bristol Myers Squibb (NYSE: BMY) for BioArctic's PyroGlutamate-amyloid-beta (PyroGlu-Aβ) antibody program, including BAN1503 and BAN2803, whereof the latter includes BioArctic's BrainTransporter™ technology. As part of the agreement, BioArctic will receive a USD 100 million upfront payment and up to USD 1.25 billion in milestone payments. BioArctic is also entitled to tiered low double-digit royalties on global product sales.

Under the agreement, Bristol Myers Squibb will become solely responsible for the development and any subsequent commercialization of BAN1503 and BAN2803 and related products worldwide. BioArctic will receive a USD 100 million upfront payment and up to USD 1.25 billion in development, regulatory and commercial milestones, as well as tiered royalties on global product sales. BioArctic will retain an option to co-commercialize the products in the Nordic region. The agreement is subject to filing and clearance under the US Antitrust legislation (the Hart-Scott-Rodino Antitrust Improvements Act of 1976).

BioArctic's PyroGlu-Aβ antibody program consists of novel antibodies targeting a specific truncated, pyroglutamate modified form of amyloid-beta. Monomers of PyroGlu-Aβ are highly prone to aggregate, leading to the formation of harmful aggregates which cause debilitating cognitive and other symptoms in Alzheimer's disease.

The agreement includes both the BAN1503 and BAN2803 antibodies. BAN2803 includes BioArctic's BrainTransporter technology. Brain uptake of biotherapeutics such as antibodies and enzymes is severely limited by the blood brain barrier (BBB) primarily due to their size. Active transport across the BBB, using one of the body's own delivery mechanisms, aims to enable better drug uptake into the brain. The BrainTransporter technology utilizes the transferrin receptor (TfR), a protein facilitating transport across the BBB, to optimize brain delivery.

"I am very excited about the agreement with Bristol Myers Squibb. They share our passion for helping patients with Alzheimer's disease and I look forward to having them as our partner for this program," said Gunilla Osswald, CEO at BioArctic. "With the BrainTransporter technology, BioArctic has the capability to lead in the design and development of the next generation of treatments for various brain disorders, offering the potential of faster uptake, improved efficacy, less side effects and lower doses for the benefit of both patients and society."

"Our agreement with BioArctic has the potential to further strengthen and diversify our growing neuroscience portfolio, reinforcing our commitment to exploring novel and potentially transformative approaches for Alzheimer's disease where high unmet needs remain," said Richard Hargreaves, Senior Vice President and Head of Bristol Myers Squibb's Neuroscience Thematic Research Center. "We look forward to building on our existing expertise and leveraging cutting edge innovations, like BioArctic's BrainTransporter technology, to advance and optimize the development of anti-amyloid-beta antibody treatments."

The agreement with Bristol Myers Squibb is the first license agreement with the BrainTransporter technology. It specifically concerns PyroGlu-Aβ antibody treatments. BioArctic has retained all other rights for use of the BrainTransporter platform. The BrainTransporter technology could be used in a number of different therapy areas for delivery of biologic molecules, giving BioArctic many potential future partnering opportunities. 

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person below, on December 19, 2024, at 07:30 CET.

For more information, please contact:
Oskar Bosson, Vice President Communications and Investor Relations
Telephone: +46 70 410 71 80
E-mail: oskar.bosson@bioarctic.com

Charlotte af Klercker, Director Communications and Sustainability
Telephone: +46 73 515 09 70
E-mail: charlotte.afklercker@bioarctic.com

About the BrainTransporter technology
BioArctic's BrainTransporter technology is a technology for facilitating the passage of biological drugs as for example antibodies into the brain using the transferrin receptor (TfR). Active transport of biotherapeutics across the blood brain barrier can result in broader brain distribution enabling better efficacy, improved safety profile and dosing convenience. The technology is being applied to several in-house drug projects and could become part of future collaborations with other pharma companies.

About BioArctic
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) - the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.

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BioArctic announces global license agreement with Bristol Myers Squibb for BioArctic’s PyroGlutamate-amyloid-beta antibody program

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SOURCE BioArctic

FAQ

What is the value of BioArctic's (BIOA) license agreement with Bristol Myers Squibb?

The agreement includes a $100 million upfront payment, up to $1.25 billion in milestone payments, and tiered low double-digit royalties on global product sales.

What products are included in BioArctic's (BIOA) deal with Bristol Myers Squibb?

The agreement includes BAN1503 and BAN2803 antibodies from BioArctic's PyroGlutamate-amyloid-beta program, with BAN2803 featuring the BrainTransporter technology.

Does BioArctic (BIOA) retain any commercialization rights after the Bristol Myers Squibb deal?

Yes, BioArctic retains an option to co-commercialize the products in the Nordic region.

What is BioArctic's (BIOA) BrainTransporter technology used in BAN2803?

BrainTransporter is a technology that utilizes the transferrin receptor to optimize drug delivery across the blood-brain barrier into the brain.

How will Bristol Myers Squibb's involvement affect BioArctic's (BIOA) PyroGlu-Aβ program?

Bristol Myers Squibb will become solely responsible for the development and commercialization of BAN1503 and BAN2803 products worldwide.

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