Rhizen Pharmaceuticals AG, a clinical-stage, oncology-focused biopharma company, with 50% stake owned by Alembic Pharmaceuticals and the rest by its Indian CEO Swaroop Vakkalanka, has announced that its novel, next generation PI3K-delta inhibitor Umbralisib (Ukoniq) has secured U.S. FDA accelerated approval for the treatment of blood cancer.
The drug, which has been licensed to TG Therapeutics since 2012, has bagged the approval for the U.S. market. TG Therapeutics has the global license except for the Indian market which will be handled by Rhizen and Alembic.
The drug is for treatment is of 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 least three prior lines of systemic therapy.
The drug has a peak market size potential of $1 billion to $1.5 billion. And out of this Rhizen will get royalty which is in high single digit.
Swaroop Vakkalanka, president and CEO, Rhizen Pharmaceuticals, said “Umbralisib’s approval offers MZL and FL patients a new treatment option and is a huge validation of Rhizen’s drug discovery and development capabilities.”
Pranav Amin, chairman, Rhizen Pharmaceuticals and MD of Alembic Pharmaceuticals Ltd., said, “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.”
“We are committed to working together with TG Therapeutics and Rhizen Pharma to ensure uninterrupted supply of Ukoniq. Umbralisib is the first discovery asset to come out of Rhizen’s R&D efforts and this approval heralds the promise of the rest of Rhizen’s deep pipeline and continuing efforts,” he said.
Rhizen and its affiliate Alembic Pharma will support TG Therapeutics towards Ukoniq’s commercialisation as its manufacturing & supply partner. The drug is expected to introduced in the U.S. by March 2021 and in 9 to 12 months in India.