Sentynl Therapeutics and BridgeBio Pharma announce asset purchase agreement for Nulibry

Sentynl Therapeutics, the wholly-owned subsidiary of Zydus Lifesciences, and BridgeBio Pharma yesterday announced the execution of an asset purchase agreement for the sale of BridgeBio’s Nulibry (Fosdenopterin) for injection. Nulibry is approved by the US Food and Drug Administration (FDA) to reduce the risk of mortality in patients with Molybdenum Cofactor Deficiency (MoCD) Type A, an ultra-rare, life-threatening paediatric genetic disorder, the companies said in a joint statement.

Under the terms of the agreement, Sentynl will acquire global rights to Nulibry, and will be responsible for its ongoing development and commercialisation in the US, 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 (EMA) 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, the statement added.

It also said that with the asset purchase of Nulibry, Zydus Lifesciences aims at bridging the unmet healthcare needs of children with rare and orphan paediatric diseases. 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 FDA, for which it partnered with Cyprium Therapeutics.