Health and Medicines

Not long ago, Hyderabad start-up Zenotech Laboratories was contacted by lawyers to Swiss pharma major F. Hoffmann-La Roche. Zenotech founder Jayaram Chigurupati told a reporter it had cloned Roche’s anti-cancer drug Mabthera and could sell it for Rs 25,000 a vial, a quarter of its price. Roche warned that as the copycat was not on the market, Chigurupati’s claims were misleading and demanded the interview be pulled from its website. Chigurupati says this means Zenotech is serious competition: “I consider it a badge of honour.”

The drug, rituximab, is a monoclonal antibody (MAB), a class of biotech medicines previously sold in India by blue-chip MNCs. Now, Zenotech and others such as Bangalore’s Biocon are making inroads into this preserve. Biocon has a MAB licensed from Cuba-based CIMAB in the market. Last week, after good quarterly results, analysts such as Merrill Lynch’s Visalakshi Chandramouli upheld a ‘buy’ on Biocon. One of the reasons was a “sales build-up” for nimotuzumab, branded Biomab.

MABs (literally clones of a single parent cell) target sites in the body responsible for disease. Valuable in cancer treatment, where chemotherapy can destroy healthy cells, MABs are used for many indications. Mumbai’s Bharat Serums And Vaccines has one for tetanus.

Globally, costly MABs such as Genentech’s Avastin, at $49,000 (Rs 21.6 lakh) for a 10-month course in the US, are set to become the largest class of biotech drugs. Worth $15 billion (Rs 66,000 crore) a year, that is slated to double by 2010 to roughly match statins or cholesterol reducers — the largest drug class ever. But while statin copycats abound in India, MABs do not. They require biological expertise. Indian firms are chemistry experts. “The competencies are different,” says Sanjiv Kaul, managing director, ChrysCapital, a Delhi private equity firm investing in pharma companies. But this means competition may be limited. “There are probably 20 drugs that do not have generic versions — like MABs. They ought to be more affordable, but aren’t as there hasn’t been the capability,” says Cartikeya Reddy, vice-president (biologics), Dr. Reddy’s. The Hyderabad-based company will soon launch a copycat MAB of its own.




The jury is out on the size of this opportunity. Since 2005, any new drug sought to be patented globally after 1995 qualifies for an Indian patent. This limits what can be copied. Further, as MABs are large volume drugs (10 per cent of the world’s biotech medicines, but 75 per cent of the production capacity), they require large amounts of infrastrcuture investment. “Ramping up is expensive,” says Kaul. The big bucks lie in the West, where entry barriers are high. (See ‘Sticker Shock’, BW, 23 April 2007.)

Biocon has tried to avoid problems by tying up with the patent owner. “We want to be seen as partners in innovation,” says Subir Basak, general manager (oncotherapeutics). Indian regulators approved Biomab, the first drug from this partnership, before the West. This poses a challenge. Indian doctors prefer not to prescribe drugs that are not approved in the US or Europe, according to a Deutsche India Equities Research report. Basak says that oncologists wanted trial data on thousands of patients, like well-known global copycats, which Biocon did not have. This changed after experiencing the product, he claims.

At any time, there are 2.5 million cancer cases in India, but often drugs are too expensive. Purvish Parikh, chief (medical oncology), Mumbai’s Tata Memorial Hospital, says companies taking risk should mean more choice for patients. The ultimate proof, he says, is if “more patients are getting cured”.

# posted by Airavat @ 7:43 AM