Aurobindo’s AIDS cocktail drug receives USFDA nod

It is the first such drug in the world to get the approval.

HYDERABAD: In a major relief to AIDS patients the world over, the US Food & Drug Administration (FDA) has issued the world’s first tentative approval for an anti-AIDS cocktail drug for use as a single dose.

Made by Hyderabad-based bulk drugs major Aurobindo Pharma, the three-in-one fixed dose drug contains the widely used anti-retro virals (ARVs) — Epivir (lamivudine), Retrovir (zidovudine) and Viramune (nevirapine).

All the three drugs are recognised as the first line of therapy for AIDS by the World Health Organisation (WHO) and constitute about 50% of the medicines consumed to treat the disease.

Therefore, the availability of a single tablet combining all the three drugs resulting in fewer dosages and side-effects makes life much easier for patients who, otherwise, have to consume 20-30 pills a day for the Highly Active Antiretroviral Therapy (HAART), most common in treating AIDS.

What the US FDA approval means is that the drug can be sold immediately in over 15 countries as part of the $15 billion US President’s Emergency Plan for AIDS Relief (PEPFAR) programme.

Further, given that it is a new drug approval (NDA), the triple combination cocktail can be sold in the US markets, once the patents on the individual components expire.  The combined market for these three drugs is estimated at a whopping $5 billion annually in the US alone.

GlaxoSmithKline sells lamivudine and zidovudine under the brand names Epivir and Retrovir, respectively, while the 9.5 billion Euro- German pharma giant Boehringer Ingelheim sells nevirapine as Viramune. The patents for these drugs in the US market expire in 2009 and 2010.

“This is indeed a major milestone for Aurobindo and, in fact, the whole country,” Lanka Srinivas, director, Aurobindo Pharma, told DNA Money. What is further significant is that this is the first triple combination filing approved by the US FDA and, in fact, the first one ever filed, he added.

Tapping the huge anti-AIDs market has been a major strategy of the $400 million Aurobindo with 15 approvals for its anti-AIDS ARVs under the PEPFAR programme and about 10 drugs pre-approved by WHO.

While margins for supplies of ARVs under the PEPFAR can be upwards of 35%, the company stands to make substantial margins under the WHO programme, too, anywhere between 25-30%.

According to Lanka, Aurobindo is targeting upwards of $100 million in total revenues from the export of ARVs next year from the current $60 million.