Zydus Lifesciences: Sentynl Licenses Alvelestat for US Market from Mereo

Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, has entered into an option and license agreement with Mereo BioPharma for alvelestat. Sentynl gains exclusive US commercial rights for the oral treatment of Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD). The deal includes an option fee, potential milestone payments up to $40 million, and double-digit tiered royalties on US sales, significantly expanding Sentynl’s rare disease portfolio.

Zydus Subsidiary Secures US Rights for Rare Disease Drug

Sentynl Therapeutics, Inc., a wholly-owned subsidiary of Zydus Lifesciences Limited, has entered into an option and license agreement with Mereo BioPharma Group plc for alvelestat. This agreement grants Sentynl the exclusive right to acquire the license to commercialize alvelestat, a first-in-class oral treatment for Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD), in the United States. Mereo will retain commercial rights for the rest of the world.

Deal Structure and Financials

The agreement includes a non-refundable option fee. Upon exercise of the option, Sentynl will provide Mereo with up to $40 million in upfront and R&D payments until the New Drug Application (NDA) filing. Furthermore, Mereo will be eligible to receive double-digit tiered royalties on U.S. net sales of alvelestat. Sentynl will also receive global rights to manufacture alvelestat for AATD-LD and will provide funding for the alvelestat Phase 3 development program, which could commence in early 2027.

Strategic Importance for Sentynl

Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, highlighted that this partnership is a pivotal moment for Sentynl’s rare disease strategy. Alvelestat is considered a highly promising candidate that meaningfully expands Sentynl’s portfolio and addresses a significant unmet need. AATD-LD is a rare, progressive genetic lung disease estimated to affect 50,000-80,000 individuals in the United States. If approved, alvelestat could offer a crucial new oral treatment option for patients.

About Alvelestat and the Disease

Alvelestat is a novel, oral small molecule designed to inhibit neutrophil elastase (NE), a key enzyme implicated in inflammation and lung tissue destruction. It has received Orphan Drug Designation and Fast Track designation from the European Commission and the FDA for AATD-LD. The agreement also stipulates collaboration between the companies to refine the Phase 3 study design during the option period.

Source: BSE

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