LENZ Therapeutics and Laboratoires Théa Announce Exclusive License and Commercialization Agreement for LNZ100 in Canada
Rhea-AI Summary
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.
Positive
- 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
Negative
- 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
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