Rifapentine, the first new anti-TB drug on the global healthcare horizon after almost 30 years, was recently approved by the US Food and Drug Administration (US FDA) for treatment of pulmonary tuberculosis. The drug has been branded Priftin in the US.

Hoechst Marion Roussel managing director, Debabrata Bhadury told The Financial Express that the company had commenced `initial activity' to bring in rifapentine though it was `far from an actual registration' of the product with the Drugs Controller General of India.

At the time of advanced clinical trials with rifapentine, the German multinational had said that it would first pursue filings in South Africa, Canada, Europeand India followed by Latin America and the Asia Pacific. It had also indicated its willingness to make the drug available at affordable prices in developing nations.

Bhadury, however, added that the new drug could certainly go a long way in bettering patient compliance, given its longer duration of action and fewer dosages required.

Effective TB treatment currently includes a dosage of three to four drugs (usually isoniazid, rifampicin, pyrazinamide and ethambutol) taken daily for around two months. This is followed by a continuation phase of four-six months wherein isoniazid and rifampicin continue to be taken daily to remove the bacilli completely.

Incomplete treatment, besides aiding the spread of the ailment, could also lead to the development of multi-drug resistant (MDR) TB.

With Priftin, patients continue to take three other drugs daily backed by rifapentine twice a week in the first two months. The number of doses is subsequently reduced to one a week in the final four months.

Industryanalysts say that rifapentine, when introduced, could have a significant impact on the Indian anti-TB market which is essentially dominated by Mumbai-based Lupin Laboratories (with a 41 per cent market share) and Swiss multinational, Novartis (with a 11 per cent share).

"Rifapentine may possibly reduce the disparities in market shares between the leaders and others in the long run. Moreover, given the wide acceptance of Hoechst's Rifater in the triple combination market, rifapentine will certainly improve the company's prospects," an analyst said.

Rifater (comprising rifampicin, isoniazid and pyrazinamide) and Rifadin-INH are both original products of Marion Merrell Dow (which was taken over by Hoechst AG). Market leader Lupin has around 30 anti-TB products and packs including recent launches like AKT FD, Ciprova 750 and Q-Pas.