Chennai-Based Firm Making Key Ingredient of Drug to Treat TB

November 13, 2007

In a world where 8.8 million new cases of tuberculosis occur each year, Chennai-based Shasun Chemicals and Drugs is manufacturing the key ingredient of a drug the World Health Organisation will use to treat a virile form of the disease, as part of a public private partnership initiative to stop TB.

Shasun is one of 14 organisations from five continents brought together by Eli Lilly to fight the emergence of drug resistant strains of TB. The disease is curable but resistance develops when normal treatment (rifampicin or isoniazid) is interrupted, not taken properly or not taken in the correct dosage.

Unless the challenges of resistance are addressed, Africa and Asia will face a health crisis, warned senior WHO officials, activists and health workers gathered here at the World Conference of the International Union Against Tuberculosis and Lung Disease, which closed on Monday.

"Multi Drug Resistant (MDR) TB and Extreme Drug Resistance (XDR) TB can't be diagnosed rapidly so it spreads rapidly ... In a worst case situation drug resistant TB will completely replace drug susceptible strains ... Today only 4 per cent of cases are drug resistant, but that could become 60, 70, 80 per cent," Dr. Mario Raviglione, Director, WHO Stop TB Department, told reporters on Thursday.

Shasun makes the active pharmaceutical ingredient in cycloserine, one of the few treatments available for MDR TB. Five hundred million kilos of the active ingredient arrived in Port Elizabeth, South Africa, where Aspen Pharmaceuticals will convert it into a finished product to be sold to the WHO at a third of the market price. The ingredient is also to be exported to SIA International, Russia.

Four-way partnership

These three companies, along with Haisun Pharmaceuticals, China, the manufacturer of capreomycin ingredients, form a four-way partnership in the world's four TB hotspots. Mike Okopski, Manufacturing Science and Technology Leader, Eli Lilly, told Hindu

Technology, formulas and trademarks for cysloserine and capreomycin were transferred over four years by the multinational following an appeal by the healthcare NGO Medecins Sans Frontieres and the WHO. The partnership will be entirely turned over to southern partners in 2009.

Important factor

President Jorge Sampaio, United Nations Special Envoy to Stop TB, told media in a pre-recorded message that while sustained country leadership was the most important factor in the fight against the disease, without the improved participation of the private sector it would be impossible. "Inaction would be a blot on our consciences and a failure of good governance," he said.

The Lilly Partnership is not the only public private initiative working to convert science into tools to fight TB. The Aeras Global TB Vaccine Foundation (Aeras), the Foundation for Innovative New Diagnostics (FIND) and the Global Alliance for TB Drug Development are using the collective resources of government industry and academics to create a pipeline of 7 new drugs, 2 new diagnostics and 3 new vaccines. All of these are now in various stages of clinical trials.

"Public private partnerships have caught on to solve the financial aspects ... where the uncertainty of the science created a barrier for industry," said Dr. Georgio Rosigno, CEO of FIND.

But more funding is urgently needed because existing drugs are cumbersome to take, require lengthy adherence, and the pace of the organism's development is outstripping scientific advances.

$2 billion needed

"We are back in the pre-antibiotics era," said Dr. Raviglione, "We need new drugs, new diagnostics, new vaccines. We have only half of the budget we need. We are far from the $2 billion required to roll out the WHO global response plan to Stop TB."