The dwindling anti-retroviral (ARV) contribution to the overall revenues of Aurobindo Pharma
is likely to see improvement in the second half of the current financial year as the company expects to launch its new Dolutegravir (DTG) triple combination drug in the sub-Saharan Africa in the third quarter of FY18.
In August, the company had received tentative approval from the US
Food and Drug Administration(US
FDA) for its new drug application for dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets. The approval was sanctioned under the US
President's emergency plan for AIDS Relief (PEPFAR).
The company is expected to realise full revenue potential of the product once it gets the final US
FDA approval for the launch of the drug in the US
market. Aurobindo considers DTG to be a growth driver in the coming 3-4 years and expects to bag $500 million from the market in 2018. Aurobindo is the first company to sign a license agreement with ViiV Healthcare for the manufacture and marketing of the next generation inter-base inhibitor- DTG.
formed a major chunk of the formulations business in 2002, which is when Aurobindo started manufacturing formulations. Though the company continues to consider ARVs
as one of its core business segments, its share in total revenues came down to 8 per cent in FY17, from 13 per cent in the financial year 2012-13. Aurobindo Pharma's management has said the decline in year-on-year sales was due to a fall in revenues on some of the HIV
In the last financial year, Aurobindo's ARV sales stood at $177 million, as compared to $185 million in the previous year.
Entry of Indian generics into ARV production has changed the face of HIV
treatment in the world, especially in low-income countries in Africa and Asia with a dramatic fall in the cost of therapy in the past decade.
The Mumbai-based Cipla was one of the early entrants into the ARV manufacturing business. In 2001, Cipla had introduced the world's first ever recommended three-in-one fixed dosage combination of Stavudine, Lamivudine and Nevirapine to treat AIDS.
While several Indian companies
are manufacturing ARV products for the global market, the US
generics major Mylan is said to be the world's largest player in this field.
As the tender route and increased competition continue to put pressure on the margins of ARV manufacturers, the companies
are looking to enter the new generation ARV drugs
and combinations to offset the fall.