Alembic JV’s new drug is first US FDA-approved NCE designed by Indians

Alembic Pharmaceuticals said a new chemical developed by one of its joint ventures has become the first new chemical entity designed by Indian scientists to win approval from the US Food & Drug Administration.

Umbralisib, created by its 50% JV Rhizen Pharma, is an anti-cancer drug that works by inhibiting phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. PI3K-delta is known to play an important role in supporting cell proliferation and survival, cell differentiation, intercellular trafficking and immunity and is expressed in both normal and malignant B-cells, Alembic said.

“We are extremely proud of this historic milestone for Rhizen, and of the fact that Umbralisib is the first new chemical entity discovered by Indian scientists to secure a US FDA approval,” said Alembic MD Pranav Amin, who is also chairman of Switzerland-based Rhizen Pharmaceuticals.

“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.”

The approval marks a milestone for the Indian pharmaceutical industry, which typically manufacturers out-of-patent drugs invented by their western counterparts instead of trying to discover new chemical entities.

Umbralisib has been given accelerated approval by US FDA for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL), follicular lymphoma (FL).

The drug has already been licensed to TG Therapeutics, who led the asset’s
clinical development, for commercial exploitation in most markets.

However, Alembic and Rhizen will work as TG Therapeutics’ supply manufacturing and supply partner.

Moreover, Rhizen has the right to commercialize the drug in the Indian market.

Swaroop Vakkalanka, President & CEO of Rhizen Pharmaceuticals said umbralisib offers MZL & FL patients a new treatment option and called the approval “a huge validation” of Rhizen’s drug discovery & development capabilities.

“This is a momentous occasion in Rhizen’sjourney as a successful biotech that speaks of the true ability of our team to discover & develop safe and effective therapies that can last the rigors of drug development. Further, we are keen to bring Umbralisib to Indian patients and we plan to initiate activities towards registration and approval there soon.”

The approval was based on test results in which MZL patients showed an objective response rate (a measure of efficacy) of 49% with 16% complete responses and in FL patients showedn an ORR of 43% with 3% complete responses.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company, has been operating since 1907.