Alembic partner’s anti blood cancer drug gets U.S. FDA nod

In what could further boost Alembic Pharmaceutical's oncology business, its co-owned clinical-stage biopharmaceutical firm Rhizen Pharmaceuticals AG has bagged US Food and Drug Administration (USFDA) nod for an oral drug indicated in treating lymphoma.

Umbralisib is indicated for treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

According to Alembic Pharma managing director Pranav Amin, what sets the drug apart is that the novel next generation oral inhibitor of phosphoinositide 3 kinase (PI3K) delta is the first new chemical entity discovered by Indian scientists to secure a US FDA approval.

To be launched by early-next month in the US market, Umbralisib was discovered by Rhizen Pharma and subsequently licensed to Nasdaq-listed TG Therapeutics at an investigational new drug (IND) stage in 2012. Rhizen Pharmaceuticals is co-owned by Alembic Pharmaceuticals with 50 per cent stake while the rest is held by by Dr Swaroop Vakkalanka, the President & CEO of the company.

"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," Vakkalanka explained.

In 2014, Rhizen Pharmaceuticals and TG Therapeutics entered into a licensing agreement as a part of which TG Therapeutics obtained worldwide rights while Rhizen retained commercialization rights for India. Also Rhizen remains the manufacturing and supply partner for Umbralisib.

Now, having then led the clinical development, TG Therapeutics has now bagged the regulator's nod for the US market and will now market the novel drug under the brand name 'Ukonig'. Rhizen would get high single digit royalty on net sales of the product globally, Amin stated.

Vakkalanka stated that the estimated market size for the drug is $7-8 billion per annum. "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," Vakkalanka added.

On its part, Alembic Pharma expects another 9-12 months for data to be ready for working towards a launch in India. However, it needs to be mentioned here that the company is awaiting USFDA inspection for F2, F3 and F4 plants that will manufacture oncology injectables and oral solid dosage (OSD), general injectables as well as OSDs. Alembic Pharma currently runs three API plants, one formulations plant and one plant in Sikkim for the domestic market. Apart from this, the company runs three R&D centres with one each in Vadodara, Hyderabad and New Jersey.

The drug took around eight years since inception of phase one development in early 2013 to getting USFDA nod now. The trials were conducted globally with US being the major country, followed by countries in Europe, Australia and New Zealand and others.

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.



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