The Indian drug industry, the world’s third-largest in terms of volume, is set to leverage its strength in the research & development (R&D) space. Pharma-ceutical majors like Sun Pharma and Glenmark are concluding advanced trials of molecules (potential drugs) and are exploring out-licensing transactions with international companies.
Out-licensing deals are those through which the rights of a drug are licensed to a third party.
Through such deals, Indian companies would receive milestone payments at various stages of the trials, as well as marketing rights for a few regions when the drug is approved.
Sun Pharma’s R&D spin-off Sun Pharma Advanced Research Company (SPARC) has about four new chemical entities at various stages of trials. SPARC’s lead molecule, SUN-133H, an anti-allergic for seasonal allergic rhinitis, has already completed the phase-II study. Anti-inflammation SUN 597 is under phase-I B clinical trials, while SUN 09, a skeletal muscle relaxant, and phase-I clinical studies are being carried out for SUN 44 (neuropathy and seizures).
A Sun Pharma spokesperson said, “We would seek to license out these products as close to the market as possible, and for some products that address a limited specialty, we could market the product ourselves, if required.” However, she refused to disclose the market potential. “We would be in a better position to share market expectations once we are closer to the market,” she said.
If it out-licenses molecules, Sun Pharma would be the third Indian company to do so, after Dr Reddy’s and Glenmark. Glenmark’s lead molecule, Revamilast, is undergoing two phase-II studies for asthma and rheumatoid arthritis. Another molecule, GRC 17536, has successfully completed phase-I studies in the Netherlands and phase-II studies for neuropathic pain would begin this year. The potential sales for asthma indication are pegged at $2 billion worldwide, while for rheumatoid arthritis, estimated peak sales are about $1 billion globally.
So far, the company has concluded six out-licensing deals with multinational companies and received over $200 million as milestone or upfront payments. “Out-licensing remains a core part of our strategy. The objective will be to discover and develop first-in-class molecules globally, and out-license these to big pharmaceutical companies in the clinical development stage,” said Glen Saldanha, chairman & managing director, Glenmark Pharma.
However, earlier, out-licensing deals by Glenmark had seen failures. In 2010, the clinical trial of Oglemilast for chronic obstructive pulmonary disease and asthma, out-licensed to US-based Forest Labs, failed to generate positive results.
In October 2008, Eli Lilly suspended clinical trials of pain drug molecule GRC 6211, out-licensed by Glenmark.
Sujay Shetty, India leader (pharma & life sciences), PricewaterhouseCoopers, said, “It is early to predict whether any Indian molecule would hit the global market. We will have to wait for a couple of years for a possible outcome from new chemical entity developments by Indian drug firms.”
Meanwhile, another pharmaceutical R&D leader, Piramal Enterprises, is optimistic about launching drugs on its own. Two of Piramal’s cancer-treatment molecules, P276 CDKs and P276, have completed phase-II trials and phase-III trials would begin soon. Phase-II trials of another molecule for diabetes are underway in Canada.
Swati Piramal, director, Piramal Enterprises, said, “Currently, we don’t have plans to out-license our molecules to a third party. However, we are considering marketing partnership for western markets.”
