Lupin Ltd, one of the top five domestic pharmaceutical companies, plans to revamp its drug research programme and foray into novel biotech and reverse engineering of biotech drugs (or biosimilars).
The move comes after the company’s earlier development efforts failed to deliver the desired results. The foray into biotech will help it tap an emerging opportunity that is globally worth $30-40 billion.
At present, Lupin has only four drugs at the clinical trial stage, which is small when compared to other Indian players. Companies such as Glenmark and Piramal Healthcare have about a dozen new drugs under development. Companies like Glenmark, Dr Reddy’s and Ranbaxy were successful in outlicensing drugs under development to multinational companies in the past five years, resulting in milestone payments.
“We had ambitious plans in New Chemical Entity (NCE) research but they did not translate into success. Now, we are re-organising and re-orienting the focus of our NCE activities,” Kamal Sharma, managing director, told Business Standard.
The new drug development programmes will revolve around segments like diabetes, rheumatoid arthritis, next-generation tuberculosis and novel biological entities.
The company would also look at in-licensing molecules in early stages of development to build a rich pipeline that could be outlicensed after further development to earn milestone revenues, Sharma added.
The company’s anti-migraine nasal spray under development, Amigra, is in the final stages of clinical trials in India. The company is planning to conduct additional trials and generate more data to outlicense the product. A couple of multinational companies had shown interest in Amigra, Sharma said.
Lupin has two versions of herb-based anti-psoriasis drugs — Desoris and Desoside-P — in the second phase of clinical trials. An anti-tuberculosis drug candidate, Sudoterb, is in the first stage of development.
Lupin’s R&D efforts for NCEs and new drug delivery systems suffered a setback two years ago, when Himadri Sen, one of the most sought-after drug scientists in the country, left Lupin to rejoin Ranbaxy, his former employer.
A few months ago, Lupin brought in Canada-based scientist Raj Kamboj, who has executed many drug discovery collaborations and outlicensing deals, as the president of NCE research. Currently, Lupin’s pharma research and development efforts are headed by Dr Ninad Deshpanday, president, pharma R&D.
“Individuals are insignificant in a professionally-run company like Lupin and any exit will not affect our research or production capabilities,” said Sharma.
Lupin is also developing nine biosimilars in mainly three areas — oncology, auto-immune diseases and diabetes. These products, about 80 per cent of them unique and difficult to develop, are expected to be ready for launch by 2012. To optimise production facilities for biotech drugs and considering the time required for developing own drugs, the company had in-licensed a few products from overseas players to feel the market, said Sharma.
The company will invest close to Rs 250 crore for biotech research at its centre in Pune. Currently, about 480 scientists were working with the research and development division and more would be added if needed, he said.
Sharma said the R&D team had been able to develop a good generic pipeline and drug delivery platform. Of the 31 approvals in the US, eight were market leaders, with 39-65 per cent market share. Of the 80 submissions so far, a fourth are carefully selected patent litigation and Lupin estimates to get about eight first-to-market opportunities.