Sun allergy drug set for phase II US trials


Sun Pharma Advanced Research Company (Sparc), the recently demerged research entity of domestic pharma major Sun Pharmaceutical, is all set to take its lead molecule for anti-allergic treatment to the phase-II trials (trials on patient) in the US.

The investigational new drug (IND) of Sparc has already received permission from the US Food and Drug Administration to enter the phase-II trials.

The phase-II trials will be conducted in the US directly by the company, using a leading local CRO (clinical research organisation). This will mark the first IND filing and phase-II studies in the US by an Indian company working independently, that’s without a partner.

Based on pre-clinical and phase-I studies, the product appears to have a safer pharmacological profile, with a faster onset of action without major side effects

Dilip S Shanghvi, chairman and managing director of Sun Pharmaceutical Industries, said the patient trials of the new chemical entity (NCE), the first-ever lead in phase-II, should be completed on its own technical as well as financial strength.

According to industry analysts, since the NCE has already reached the phase-II in the US, it may be licensed out to global partners for further development and commercialisation on a market specific basis.

“As this is a highly market potential drug, entering the patient trials stage in the US, there will be global pharma majors eyeing the candidate for commercialisation,” they said.

For Sparc, currently conducting drug discovery research in facilities at Baroda and Mumbai, this is the first lead molecule in human trials from the company’s innovative research programme.

Sun Pharma, which had demerged its innovative R&D programmes into Sparc this year, expects to share more information about the innovative pipeline a month prior to listing the new company.

Sun Pharma, the fifth-largest and one of the fastest-growing speciality drug companies in the country, manufactures and markets a large basket of pharma formulations as branded generics as well as generics in India, the US and several other markets across the globe.

In the country, it is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology and orthopedics.

The pharma major also has skills in product development, process chemistry and manufacturing of complex active pharma ingredient, as well as dosage forms.

It is pursuing NCE and NDDS (new drug delivery system) programmes with the aim to bring products based on proprietary technology to market.