NEW DELHI: Sentynl Therapeutics, Inc. (Sentynl), a U.S. based biopharmaceutical company and a wholly owned subsidiary of Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), focused on bringing innovative therapies to patients living with rare diseases and BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, today announced the execution of an asset purchase agreement (the Agreement) for the sale of BridgeBio’s NULIBRY (Fosdenopterin) for Injection.
NULIBRY is approved by the U.S. Food and Drug Administration (USFDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening paediatric genetic disorder.
With the asset purchase of NULIBR, Zydus Lifesciences Ltd. aims at bridging unmet healthcare needs of children with rare and orphan paediatric diseases. The Company’s wholly owned subsidiary Sentynl is also facilitating early diagnosis and treatment by enhancing awareness, new-born screening, genetic testing and patient support across multiple products and rare diseases including the development of a treatment for Menkes Disease, currently under rolling review by the USFDA, for which it partnered with Cyprium Therapeutics, Inc. (Cyprium).
Under the terms of the Agreement, Sentynl will acquire global rights to NULIBRY and will be responsible for the ongoing development and commercialisation of NULIBRY in the United States
and developing, manufacturing and commercialising Fosdenopterin globally. BridgeBio will share development responsibilities for Fosdenopterin through approval of the marketing authorisation
application already under accelerated assessment with the European Medicines Agency and through approval of its regulatory submission with the Israeli Ministry of Health. Sentynl will provide cash payments upon the achievement of certain regulatory milestones. BridgeBio will be eligible to receive commercial milestone payments as well as tiered royalties on adjusted net sales of NULIBRY.
and developing, manufacturing and commercialising Fosdenopterin globally. BridgeBio will share development responsibilities for Fosdenopterin through approval of the marketing authorisation
application already under accelerated assessment with the European Medicines Agency and through approval of its regulatory submission with the Israeli Ministry of Health. Sentynl will provide cash payments upon the achievement of certain regulatory milestones. BridgeBio will be eligible to receive commercial milestone payments as well as tiered royalties on adjusted net sales of NULIBRY.
Speaking on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd., said, “We are focused on our core purpose to empower patients suffering from rare disease with the freedom to live healthier and fulfilled lives. Molybdenum cofactor deficiency (MoCD) is an unmet healthcare need affecting new-borns. With this, we aim to make a radical contribution to the lives of children suffering from this disease. This agreement further adds to our portfolio of medicines for rare and orphan diseases.”
“Sentynl is an ideal partner given its expertise in the rare paediatric neurodevelopment space and its relationships with physicians who diagnose and treat children with MoCD Type A,” said Neil Kumar, Ph.D., founder and CEO of BridgeBio. “Focused execution means reducing the scope of our internal activity. We will continue to advance high-quality programs in our pipeline while expanding our reach to patients in need of options.”
