Indian pharma cos close to blockbuster breakthrough

KOLKATA: Indian pharma majors may manage to market their first indi-genous “blockbuster drugs” or new chemical entities (NCEs) in the next four years. The likes of Ranbaxy, Dr Reddy’s, Zydus Cadila and Nicholas Piramal have set a 4-6 year deadline to commercialise their respective lead NCE molecules.

They expect to complete the clinical and regulatory processes for the NCEs, the global industry terminology for a completely new drug, in under six years. This is necessary to sell products not only in India, but also in regulated markets like the US and Europe.

Indian pharma majors believe if they are able to deliver a single new molecule, it will transform their business outlook. Whether it is Glaxo’s Zantac, Eli Lilly’s Prozac, Pfizer’s Viagra or Lipitor, there are several examples of single blockbuster drugs changing fortunes in the global pharma realm.

Ranbaxy, which is working on 10 NCE programmes, expects to commercialise its anti-malarial drug (codenamed RBx 11160), which is being jointly developed with the Geneva-based Medicines for Malaria Venture organisation. “The drug is in an advanced stage of development, and Phase II dose range-finding studies are on in Thailand, India and Africa,” said Ranbaxy ED Ramesh Adige.

Ranbaxy’s nearest rival in NCE research, Dr Reddy’s Laboratories (DRL) has three drugs — for treatment of diabetes (named Balaglitazone), solid tumours (codenamed DRF-1042) and dyslipidemia — in advanced Phase II trials.

Incidentally, DRL is developing Balaglitazone with Denmark’s Rheoscience and DRF-1042 with UK’s ClinTec International. “Collaboration is one of our strategies. We will see one of our NCEs commercialised in five to six years,” R Rajagopalan, president (discovery research), DRL, told ET.

Nicholas Piramal has plans to apply for a “fast-track” clearance to the US FDA to launch its oncology molecule (codenamed P276) by ’10. “There are two more phyto-pharma products, for rheumatoid arthritis and dermatophytosis, which have potential to be launched earlier,” said Somesh D Sharma, chief scientific officer, Nicholas Piramal.

Ahmedabad-based Cadila Healthcare (Zydus Cadila) has a NCE portfolio of three products, with an anti-dyslipidemia drug in advanced Phase II trials. It is soon going to add another anti-obesity molecule (codenamed ZYO1) into the pipeline. “Though we cannot comment at this stage which product will hit the market first, we plan to commercialise the first product by ’11-12,” Cadila Healthcare CMD Pankaj R Patel said.

Investments on innovative drug research are at an all-time high. Sun Pharma has plans to invest about Rs 200 crore over the next 2-3 years. Cadila Healthcare wants to hike its new drug discovery research budget from 5% to 8% of turnover over the next three years. DRL will also increase its investment from 12% to 14% of total sales.

Sun Pharma will start Phase II global trials for its anti-allergic NCE, while Wockhardt’s most advanced anti-infective NCE (WCK 771) has started Phase II clinical trials. The NCE business is a high-risk one, but it also brings in high rewards. Due to patent protection, approval of an NCE ensures sustainable long-term revenues for the company.