Hetero Labs’ new generic Fixed Dose Combination (FDC) therapy will help minimize the disparity between the standards of HIV treatment in developed countries and those with limited resources, but the drug will be currently unavailable for sale in the US due to conflicting patent restrictions, according to healthcare industry analysts GlobalData.
On November 8, US Food and Drug Administration (FDA) gave a tentative approval for Hetero Labs’ FDC therapy of efavirenz/ lamivudine/ tenofovir disoproxil fumarate. But the current patent rights held by Bristol-Myers Squibb’s Sustiva (efavirenz) and Gilead’s Viread (tenofovir disoproxil fumarate) until 2013 and 2017, will not allow Hetero Labs to market the drug in the US. However, the treatment can be marketed outside the US through Hetero Labs’ partners, including the President’s Emergency Plan for AIDS Relief (PEPFAR). Although currently unavailable for sale in the US due to conflicting patent restrictions.
According to Dr Charalampos Valmas, analyst, GlobalData covering Infectious Diseases, Hetero Labs has placed itself in a distinctly advantageous position over competitors offering generics, as only antiretroviral drugs that have undergone a stringent review by a regulatory authority are eligible for use under PEPFAR.
Hetero’s approach to obtain the marketing rights to patent-protected drugs is different from the approach adopted by other generic manufacturers, such as the Brazil-based generic producer Cristália, which managed to legally annul Abbott’s patent on Kaletra earlier this year for use in Brazil.
“Unlike cases where branded drugs are declared of public interest, which sets the stage for compulsory licensing, Hetero Labs pursued a combination that is not currently marketed as an FDC, thereby potentially side-stepping conflict and a litigation process between the patent holders. The approach might signify a growing trend in future collaborations and technology licensing between generic manufacturers and existing pharmaceutical or biotech players,” he added.
“In employing this strategy, Hetero Labs might earn a significant share of the market in developing countries, while at the same time help bridge the gap in the disease management of HIV between the major markets and resource-limited settings,” said Dr Valmas.
The clever market positioning of Hetero Labs may prove a pioneering endeavour, both in terms of boosting company profits, but also raising the level of care in poorer countries.
“Companies employing Hetero Labs’ approach could easily find themselves in a position to not only contribute to the development and distribution of more FDCs, and by collaborating with non-governmental organizations or charities provide access to better therapies, but also be uniquely positioned to enter the market as existing drugs reach their patent expiries,” noted GlobalData analyst.