LENZ Therapeutics and Laboratoires Théa Announce Exclusive License and Commercialization Agreement for LNZ100 in Canada
LENZ Therapeutics (NASDAQ:LENZ) has entered into an exclusive license and commercialization agreement with Laboratoires Théa for LNZ100, a presbyopia treatment, in Canada. The deal includes over $70 million in upfront and milestone payments, plus double-digit royalties on net sales.
LNZ100, the first and only aceclidine-based eye drop for presbyopia, has a FDA PDUFA date of August 8, 2025. The FDA accepted the NDA in October 2024 and does not plan to hold an Advisory Committee Meeting. The treatment targets a condition affecting 1.8 billion people globally, including 128 million in the United States.
LENZ Therapeutics (NASDAQ:LENZ) ha stipulato un accordo esclusivo di licenza e commercializzazione con Laboratoires Théa per LNZ100, un trattamento per la presbiopia, in Canada. L'accordo prevede oltre 70 milioni di dollari tra pagamenti iniziali e milestone, oltre a royalty a due cifre sulle vendite nette.
LNZ100, il primo e unico collirio a base di aceclidina per la presbiopia, ha una data PDUFA FDA fissata per il 8 agosto 2025. La FDA ha accettato la NDA nell'ottobre 2024 e non prevede di tenere una riunione del Comitato Consultivo. Il trattamento è destinato a una condizione che colpisce 1,8 miliardi di persone a livello globale, di cui 128 milioni negli Stati Uniti.
LENZ Therapeutics (NASDAQ:LENZ) ha firmado un acuerdo exclusivo de licencia y comercialización con Laboratoires Théa para LNZ100, un tratamiento para la presbicia, en Canadá. El acuerdo incluye más de 70 millones de dólares en pagos iniciales y por hitos, además de regalías de dos dígitos sobre las ventas netas.
LNZ100, el primer y único colirio basado en aceclidina para la presbicia, tiene una fecha PDUFA de la FDA para el 8 de agosto de 2025. La FDA aceptó la NDA en octubre de 2024 y no planea realizar una reunión del Comité Asesor. El tratamiento está dirigido a una condición que afecta a 1.8 mil millones de personas a nivel mundial, incluyendo 128 millones en Estados Unidos.
LENZ Therapeutics (NASDAQ:LENZ)가 캐나다에서 노안 치료제 LNZ100에 대해 Laboratoires Théa와 독점 라이선스 및 상업화 계약을 체결했습니다. 이번 계약에는 7,000만 달러 이상의 선급금 및 마일스톤 지급과 순매출에 대한 두 자릿수 로열티가 포함되어 있습니다.
노안 치료제인 LNZ100은 아세클리딘 기반의 첫 번째이자 유일한 점안제로, FDA PDUFA 날짜는 2025년 8월 8일입니다. FDA는 2024년 10월에 NDA를 수락했으며 자문위원회 회의는 개최하지 않을 예정입니다. 이 치료제는 전 세계 18억 명에 달하는 환자, 미국 내 1억 2800만 명을 대상으로 합니다.
LENZ Therapeutics (NASDAQ:LENZ) a conclu un accord exclusif de licence et de commercialisation avec Laboratoires Théa pour LNZ100, un traitement de la presbytie, au Canada. L'accord comprend plus de 70 millions de dollars en paiements initiaux et jalons, ainsi que des redevances à deux chiffres sur les ventes nettes.
LNZ100, le premier et unique collyre à base d'aceclidinium pour la presbytie, a une date PDUFA de la FDA fixée au 8 août 2025. La FDA a accepté la NDA en octobre 2024 et ne prévoit pas de réunion du comité consultatif. Le traitement cible une condition qui affecte 1,8 milliard de personnes dans le monde, dont 128 millions aux États-Unis.
LENZ Therapeutics (NASDAQ:LENZ) hat eine exklusive Lizenz- und Vermarktungsvereinbarung mit Laboratoires Théa für LNZ100, eine Behandlung der Presbyopie, in Kanada abgeschlossen. Der Deal umfasst über 70 Millionen US-Dollar an Vorauszahlungen und Meilensteinzahlungen sowie zweistellige Lizenzgebühren auf den Nettoumsatz.
LNZ100, der erste und einzige auf Aceclidin basierende Augentropfen gegen Presbyopie, hat ein FDA-PDUFA-Datum am 8. August 2025. Die FDA hat den NDA im Oktober 2024 akzeptiert und plant keine Beratungsausschusssitzung. Die Behandlung richtet sich gegen eine Erkrankung, die 1,8 Milliarden Menschen weltweit betrifft, darunter 128 Millionen in den USA.
- Deal worth over $70 million plus double-digit royalties on net sales
- Third commercialization partnership outside the United States for LNZ100
- FDA PDUFA date set for August 8, 2025 with no Advisory Committee Meeting planned
- Large market opportunity with 1.8 billion people affected globally
- Product still pending FDA approval
- Pre-commercial stage company with no current revenue from LNZ100
Insights
LENZ's $70M+ Canadian licensing deal for LNZ100 strengthens commercialization strategy ahead of potential FDA approval.
LENZ Therapeutics has secured a strategic licensing agreement with Laboratoires Théa to commercialize LNZ100 in Canada, marking their third international commercialization partnership for this presbyopia treatment. The deal structure includes
This agreement comes at a pivotal time as LENZ approaches its FDA PDUFA date of August 8, 2025 for LNZ100, their aceclidine-based eye drop for presbyopia. The FDA has already accepted the New Drug Application and isn't planning an Advisory Committee meeting, which typically signals a smoother approval pathway.
Théa represents a strategic partner choice given their specialized expertise in eye-care products and established Canadian market presence. This partnership allows LENZ to focus resources on their anticipated US launch while still capturing value from international markets.
The deal targets a substantial market opportunity - presbyopia affects approximately 1.8 billion people globally, including 128 million in the United States. While specific Canadian market numbers weren't disclosed, the significant milestone payment structure suggests meaningful commercial potential.
For LENZ, a pre-commercial stage company, these types of agreements provide critical non-dilutive capital and validate their technology ahead of their first potential product approval. The company appears to be executing a measured global strategy, maintaining US rights while partnering internationally to maximize the therapy's reach and shareholder value.
Exclusive agreement includes over
SAN DIEGO and CLERMONT-FERRAND, France, July 07, 2025 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ) and Laboratoires Théa (“Théa”) announced an exclusive license and commercialization agreement for Théa to register and commercialize LNZ100 for the treatment of presbyopia in Canada. LENZ Therapeutics is a pre-commercial stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, which has a US FDA PDUFA date of August 8, 2025. Théa is an independent pharmaceutical company specialized in the research, development and commercialization of eye-care products.
Under the terms of the licensing and commercialization agreement, LENZ will be eligible to receive over
“Théa is a leading company in eyecare in key markets around the world and was a natural choice for LENZ when looking for a highly capable commercial partner in Canada. With its strong position in commercializing eye drops, Théa is uniquely positioned to bring the benefits of LNZ100 to patients in this key market,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “This agreement represents our third commercialization partnership outside the United States for LNZ100, as we continue to be focused on maximizing patient access to this important therapy worldwide.”
Jean-Frédéric Chibret, President of Théa, commented: “Canada is an important part of Théa’s international development, and we have been active in the country for several years. Our local team plays an essential role in supporting both patients and eye care professionals. This partnership with LENZ will expand our portfolio with a promising therapy targeting a prevalent condition that affects millions of adults. We see strong potential for LNZ100 in Canada and look forward to initiating the registration process and making the treatment available to Canadian healthcare providers and their patients.
In October 2024, LENZ announced that the FDA accepted the NDA for LNZ100 for the treatment of presbyopia, a condition that impacts an estimated 1.8 billion people globally and 128 million people in the United States. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100, and noted it is not planning to hold an Advisory Committee Meeting to discuss this application.
About LENZ Therapeutics
LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in patients with presbyopia. LENZ’s product candidate LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day”. LENZ is headquartered in San Diego, California. For more information, visit: LENZ-Tx.com.
About Théa
Théa is the leading independent European pharmaceutical company specializing in the research, development, and commercialization of ophthalmic products. Headquartered in Clermont-Ferrand, France, this family-owned company employs over 2,000 people and has built a strong international presence through a network of more than 35 independent subsidiaries and offices across Europe, North Africa, the Americas, and the Middle East. All products are manufactured in Europe—
| Contacts: | |
| Dan Chevallard LENZ Therapeutics IR@LENZ-Tx.com | Julie Ahmed Laboratoires Théa julie.ahmed@theapharma.com |
FAQ
What are the financial terms of LENZ Therapeutics' agreement with Théa for LNZ100?
When is the FDA PDUFA date for LENZ Therapeutics' LNZ100?
What is the market size for LENZ Therapeutics' presbyopia treatment?
What rights does Théa receive under the LENZ agreement?
How many commercialization partnerships does LENZ have for LNZ100 outside the US?
