Alembic Pharmaceuticals said the novel blood cancer drug Umbralisib developed by its associate company Rhizen Pharmaceuticals has got the accelerated approval under priority review from USFDA.
Umbralisib, used to treat relapsing blood cancer called marginal zone lymphoma (MZL), will be commercialised in US and globally, with exception of India by NASDAQ listed TG Therapeutics, that had entered into outlicensing agreement with Rhizen to develop and commercialise the molecule.
TG Therapeutics will be launching the drug in late February or early March this year. Umbralisib has peak market size potential to reach $1 billion - $1.5 billion, according to estimates of our partner, said Swaroop Vakkalanka, President & CEO of Rhizen Pharmaceuticals.
The launch will mark the first of its kind innovative drug successfully developed by an Indian biotech start-up backed by a large India drug company in the US market.
Alembic through its wholly owned subsidiary holds 50 percent stake in Rhizen. Rhizen is eligible to receive upfront, development, and commercialization milestone payments and high single digit royalties tied to net sales of the product, which could exceed $250 million, as per earlier agreement. Rhizen also maintain rights to manufacture and supply the product to TG Therapeutics.
“We are extremely proud of this historic milestone for Rhizen, and of the fact that Umbralisib is the first NCE discovered by Indian scientists to secure a US FDA approval," said Pranav Amin, Chairman, Rhizen Pharmaceuticals & Managing Director of Alembic Pharmaceuticals.
"We are committed to working together with TG Therapeutics and Rhizen Pharma to ensure uninterrupted supply of UKONIQ (Umbralisib)," Amin said.
The USFDA approval allows PI3K-delta inhibitor or Umbralisib as it is generically called to treat adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen, and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at leastthree prior lines of systemic therapy.
Umbralisib was earlier granted Breakthrough Therapy Designation (BTD) for the treatment of MZL and orphan drug designation (ODD) for the treatment of MZL and FL.
Vakkalanka said Rhizen is keen to bring Umbralisib to Indian patients and we plan to initiate activities towards registration and approval there soon.
Amin said Umbralisib is the first discovery asset to come out of Rhizen’s R&D efforts and the approval promises the rest of Rhizen’s deep pipeline and continuing efforts.
Rhizen founded by Vakkalanka, and backed by Alembic is a clinical-stage biopharmaceutical company focused on the discovery and development of novel cancer drugs.
Since its establishment in 2008, Rhizen has created pipeline of proprietary drug candidates targeting several cancers and immune associated cellular pathways. Rhizen is headquartered in Basel, Switzerland.