Lupin looks to cash in on WHO pre-qualification of TB drug

Drug firm Lupin is looking at cashing in on its generic tuberculosis (TB) drug ethambutol tablet, which has been included by the World Health Organisation in the list of pre-qualified medicines, a senior company official has said.

The Mumbai-based company, which claims to have 85 per cent market share for the tablets globally, said increasing incidence of TB globally, coupled with rising price of the drug provided it the opportunity to grow the market for the drug further both in value and volume terms.

"We are the only company which produces ethambutol from active pharmaceutical ingredients (API) to dosage form and hold nearly 85 per cent market for ethambutol globally," Lupin Group President API Satish Khanna told PTI.

The estimated market size for ethambutol is over 100 million dollars globally, he added.

"In fact, these first line drugs (Isoniazid, Rifampicin, Pyrazinamide and Ethambutol) have generally increased in price over the past 20 years. For instance, US prices for these first line drugs have increased on average 10.66 per cent over the last few year as some reports would suggest," Khanna said.

Lupin had first received WHO's nod in early 1990's. Its ethambutol tablets were included in the prequalification list by the WHO earlier this month, paving way for it to supply to various countries across the world.
    
Its US subsidiary, Lupin Pharmaceuticals had received final approval for Abbreviated New Drug Application (ANDA) for Ethambutol Hydrochloride Tablets USP, 100 mg and 400 mg from the US Food and Drug Administration (USFDA) in June 2009.
    
"Since then Lupin has gone on to garner 21.1 per cent market share in under a year," Khanna said.
    
Ethambutol tablets are usually given in combination with other tuberculosis drugs, such as isoniazid, rifampicin and pyrazinamide.
    
Lupin produces ethambutol in both active pharmaceutical ingredient (API) and formulations format in its facilities at Ankleshwar and Aurangabad respectively.
    
In the first quarter ended June, Lupin had reported 21 per cent increase in net sales of Rs 1312.1 crore and 40.11 per cent jump in net profit of Rs 196.3 crore from the same period last fiscal.