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In a major breakthrough in cancer treatment, Alembic Pharmaceutical’s co-owned Rhizen Pharmaceuticals has received US drug regulator - US Food and Drug Administration (USFDA)’s approval for novel next generation oral inhibitor of phosphoinositide 3 kinase (PI3K) delta - Umbralisib for treatment of relapsed or refractory marginal zone lymphoma (MZL), follicular lymphoma (FL).
Umbralisib will be marketed by Nasdaq-listed TG Therapeutics, which led its clinical development, under the brand name of Ukoniq. Rhizen Pharmaceuticals co-owned by Alembic Pharmaceuticals with 50 per cent% stake and the rest by Dr Swaroop Vakkalanka, who is President & CEO of the company.
To be launched by early-next month, Umbralisib is a novel, next generation, oral, once daily, inhibitor of PI3K delta and casein kinase 1 (CK1) epsilon and and was discovered by Rhizen Pharma and subsequently licensed to TG Therapeutics at an IND stage (TGR 1202) in 2012.
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At a media concall on Tuesday, Vakkalanka, informed that the estimated market size for the drug is $7-8 billion annually. “At peak sales, Ukoniq is expected to reach between $1-1.5 billion. That is the guidance given by our partner in the US. The launch is expected latest by early March.”
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. Also Rhizen remains the manufacturing and supply partner for Umbralisib.
Pranav Amin, Managing Director of Alembic Pharmaceuticals Ltd called it a historic milestone as Umbralisib is the first new chemical entity discovered by Indian scientists to secure a US FDA approval. “Rhizen would get high single digit royalty on net sales of the product globally. We expect it will take about 9-12 months to get the data ready for launch in India,” Amin told the media.
Commenting on the R&D and trials, Vakkalanka informed that the drug took overall 8 years since the start of the Phase - 1 development in early part of 2013 and getting the regulatory approval in early 2021. The trials were conducted globally with US being the major country, followed by countries in Europe, Australia and New Zealand and others.
“Our product, Umralisib, which is a monotherapy treatment, offers the best choice for oncologists - particularly it can be a drug of choice for treatment of geriatric patients who need to be treated in the community cancer centers those who will be taking concomitant medications for other disorders such as blood-pressures, diabetes etc,” he added.
The drug approval is for the treatment 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.
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.
Alembic Pharmaceuticals shares traded at ₹944.35 on Tuesday up 0.3 per cent on BSE.