The price of the drug in the US will be close to $16,000 for one month for a patient
Drug firm Alembic Pharma said its associate company Rhizen Pharmaceuticals’ novel drug Umbralisib has received accelerated approval from the US health regulator for treatment of cancer of the lymphatic system.
In a regulatory filing, Alembic Pharma said, Rhizen Pharmaceuticals’ Umbralisib, which was licensed to TG Therapeutics has secured United States Food and Drug Administration (US FDA) accelerated approval for the treatment of adult patients, with relapsed or refractory marginal zone lymphoma (MZL) and follicular lymphoma (FL)”.
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, the company added.
In 2014, Rhizen Pharmaceuticals and TG Therapeutics entered into a licensing agreement as a part of which TG Therapeutics obtained worldwide rights and Rhizen has retained commercialisation rights for India while also being the manufacturing and supply partner for Umbralisib.
“Umbralisib is a product invented by Rhizen Pharmaceuticals and then we out-licensed it to TG Therapeutics…,” Rhizen Pharmaceuticals President and CEO Swaroop Vakkalanka said in a virtual media conference. 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, he added.
“We are keen to bring Umbralisib to Indian patients and we plan to initiate activities towards registration and approval there soon,” Vakkalanka said.
The company plans to reach out to the Drug Controller General of India (DCGI) once it gets the approval documents from TG Therapeutics in the US. This process is likely to take 9 to 12 months, then “we have to reach out to the Indian regulator in due course of time,” he added.
At peak sales, the product is expected to reach to about between $ 1 to 1.5 billion in the US, as per guidance given by TG Therapeutics. The launch in the US by TG Therapeutics is expected very soon, either later this month or early part of March, Vakkalanka said.
The price in the US will be close to $16,000 for one month for a patient, he added.
On the development, Rhizen Pharmaceuticals Chairman and Alembic Pharma MD Pranav Amin said 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 its deep pipeline and continuing efforts.
