Alembic Pharma subsidiary secures USFDA accelerated approval for its partnered asset, Umbralisib

Rhizen Pharmaceuticals, a clinical-stage oncology-focussed biopharmaceutical company and subsidiary of Alembic Pharma announced that its novel next-generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics, has secured USFDA accelerated approval.  

Umbralisib is a novel, next-generation inhibitor of Phosphoinositide 3-kinase (PI3K) delta & Casein kinase 1 (CK1) epsilon. It was discovered by Rhizen Pharma and subsequently licensed to TG Therapeutics in 2012. In 2014, both the parties entered into a licencing agreement as a part of which, TG Therapeutics obtained worldwide rights and Rhizen has retained commercialisation rights for India while also being the manufacturing & supply partner for Umbralisib.  

Rhizen and its affiliate Alembic Pharma will support TG Therapeutics towards Umbralisib’s commercialisation as its manufacturing & supply partner.  

Speaking on the announcement, Swaroop Vakkalanka, President and CEO of Rhizen Pharmaceuticals stated that Umbralisib’s approval offers MZL & FL patients, a new treatment option and is a huge validation of Rhizen’s drug discovery & development capabilities. He further stated that the company was keen to bring Umbralisib to Indian patients and also, plan to initiate activities towards registration and approval soon.  

On Tuesday, the stock of Alembic Pharmaceuticals closed at Rs 935 per share, down by 0.70 per cent or 6.55 per share. The 52-week high is recorded at Rs 1,150 while its 52-week low is Rs 436.10 on BSE.