Print（PDF/82KB） May 06, 2021 Corporate

Consolidated Subsidiary Enzyvant Transfers its RVT-801, an Investigational Therapy for Farber Disease, to Aceragen

Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President, and CEO: Hiroshi Nomura) announced today that its consolidated subsidiary, Enzyvant Therapeutics Ltd., announced on May 3, 2021 (local time), has entered into an agreement (hereinafter, "the Agreement") with Aceragen, Inc. (Head Office: North Carolina, U.S.) to transfer all rights related to development, sales, and etc. of Enzyvant's RVT-801 (development code) a recombinant human acid ceramidase under development (non-clinical stage) for Farber disease.

As consideration for concluding the Agreement, Enzyvant will receive an upfront payment, development and sales-related milestones up to $226 million, as well as tiered royalties on net sales.

RVT-801 has been granted Rare Pediatric Disease and Fast Track designations by the U.S. Food and Drug Administration (FDA), Orphan Drug designations by the FDA and European Medicines Agency (EMA), and is eligible for a priority review voucher once approved by the FDA.

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About Aceragen, Inc.
Aceragen is biopharmaceutical company headquartered in Durham, North Carolina, U.S., focused on the development of innovative therapeutics for rare and ultra-rare diseases. For more information, please visit http://www.aceragen.com/

About Enzyvant Therapeutics Ltd.
Enzyvant is a biotechnology company dedicated to developing novel, transformative regenerative therapies for people with devastating rare diseases. RVT-802, tissue-based regenerative therapy, has been submitted to the FDA (PDUFA: October 8, 2021) for congenital athymia, an ultra-rare and life-threatening pediatric immunodeficiency. RVT-802 has been granted multiple regulatory designations, including the FDA designation as a Regenerative Medicine Advanced Therapy (RMAT). Through a strategic alliance with Roivant Sciences Ltd., Sumitomo Dainippon Pharma made Enzyvant a wholly owned subsidiary in December 2019 under the umbrella of its newly established subsidiary, Sumitovant. For more information about Enzyvant, please visit https://enzyvant.com/