Mumbai: US drug multinational Johnson & Johnson (J&J) plans to introduce its second-line HIV/AIDS drug, Prezista, in India through a local partner who will licence and manufacture the drug in the country.
The J&J move is significant because India’s more than 5.8 million AIDS patients are currently fully dependent on imports for the second- and third-line therapies.
The second-line drugs, comparatively latest discoveries, treat patients with persisting complications after the first line treatment, especially when the virus develops multi-drug resistance in patients due to improper treatments.
According to estimates of some non-government organizations (NGOs) involved with HIV/AIDS work, at least 10,000 HIV-positive people in India have developed resistance to the first line of anti-retroviral treatment and need access to second-line drugs.
This anti-retroviral drug, approved by the US Food and Drug Administration (FDA) in 2006, will be licensed to a major Indian pharmaceutical firm and manufactured locally.
About seven different molecules, including darunavir (generic name of Prezista) are currently available for second-line treatment globally. The World Health Organization’s treatment protocol recommends new drugs, such as lopinivir, retonivir, tenofovir, atezonovir, didanasone, abacavir and their combinations, as second-line therapies.
The average cost of the second-line therapy is over $225 (Rs9,225) per patient per month. This almost equals the cost of the first-line treatment for a whole year. Since most of these drugs are patented, access to them has been a major concern in developing countries.
Prezista, one of the costliest second-line drugs, costs about $20 for a day’s treatment in the US. It is a discovery of Tibotec Pharmaceuticals Ltd, an Ireland-based pharmaceutical research and development company focusing on discovery and development of innovative HIV/AIDS drugs. J&J acquired Tibotec in 2002.
In April, Tibotec signed a similar royalty-free, non-exclusive licence agreement with Aspen Pharma of South Africa for making Prezista available in sub-Saharan Africa. As per this agreement, Prezista will be made and distributed by Aspen and sold at an ex-factory price that should not exceed $3 a day.
“We will make the product available in India soon through a local partnership for manufacturing,” said Paul Stoffels, group chairman, research & development, pharmaceuticals, J&J.
Stoffels was in India recently to inaugurate the company’s new R&D lab in Mumbai. “The drug is likely to be priced in India at around the same level at which it is sold in sub-Saharan Africa,” said Stoffels. He declined to give additional details because “we have not yet finalized the Indian partner.”
“Though the global access programme for HIV/AIDS drugs by the patent holders offers hope for developing countries that are in the grip of the deadly disease, these drugs would still be beyond the reach of most patients in India,” notes Celina D’Costa of the Indian Network for People Living with HIV/AIDS, an NGO. “Most of the people who need second-line treatment at the moment are those with very low income levels.”
“Every year, approximately 10% of those who have been on first line anti-retroviral treatment for three or four years will need newer medications. This is because they either develop resistance to the first line of therapy or they are showing signs of toxicity,” says Leena Menghaney, project manager, India, of Campaign for Access to Essential Medicines, initiatied by Medicins Sans Frontiers (MSF), an international not-for-profit health access organization.
While the Indian government provides free access to first-line treatment through hospitals, it does not provide second-line drugs. Though the government has announced it plans to provide HIV-positive people with access to second-line anti-retroviral drugs as early as next year, it has not yet met its target of providing 100,000 patients with access to free first line anti-retrovirals. The government currently provides first-line drugs to only about 67,000 patients and expects to meet its target by the end of 2007.
One reason why second-line treatment is not cheap is that there aren’t too many generic alternatives to these drugs. “The foreign drug makers developed these drugs have filed patent applications in India too,” says Menghaney of MSF. Since the newer drugs could qualify for patents, generic players have not started producing them.