The Medicines Patent Pool (MPP), a United Nations-backed organisation for HIV treatment and spur new innovation worldwide, has signed new sub-licences with four Indian companies namely, Aurobindo, Cipla, Emcure and Hetero Labs to allow generic manufacture of tenofovir alafenamide (TAF) for 112 developing countries. Additionally, MPP has also signed sub-licences with Desano and Laurus Labs.
MPP’s announcement comes one day after Gilead released positive results on two of its TAF phase III studies, suggesting that the medicine has the potential to play a large role in the international community’s efforts to scale-up HIV treatment.
Greg Perry, executive director, MPP, said, “The generic companies will begin development plans for a promising, new HIV product simultaneous with the US Food and Drug Administration's review to expedite access to low and middle-income countries once the medicine is approved. This is revolutionary in its approach to ensuring more people living with HIV have access to newer options for treating the disease.”
In studies, TAF has demonstrated comparable antiviral efficacy to that of 300 milligram tenofovir disoproxil fumarate (TDF) a World Health Organization-preferred HIV therapy but at a dose that is 10 times lower. The smaller milligram dose may also allow lower production costs, as well as greater ease in developing new fixed-dose combinations and single tablet regimens.
Arvind Vasudeva, chief executive officer, Formulations at Aurobindo, said, “With this agreement Aurobindo will be collaborating with the MPP on seven HIV medicine development programmes. We have finalised developments plans for key ARVs from our first sub-licence in 2011 and appreciate our continued role in providing promising new products such as TAF to low and middle-income countries in the future.”
“Cipla is happy to sign its second agreement with MPP for TAF,” said Subhanu Saxena, MD & Global chief executive officer, “Cipla has been committed to the cause of HIV/AIDS for over two decades and this agreement emphasises our ongoing commitment to provide advanced and effective treatments. This deal affirms Cipla’s overarching goal of providing access to affordable medicines to patients using established mechanisms that allow us to put patients first.”
A K Khanna, executive director, Emcure Pharmaceuticals said, “TAF is a pioneering new medicine potentially offering ‘drug substance dose reduction’ which could decrease side effects to the patient and enhance greater access of HIV medicines through possible cost benefits.”
“Working with MPP has been a pleasure. We consider our partnership with MPP to be crucial to the company’s mission of bridging research and access, and are putting additional resources into ensuring more PLHIV have the medicines they need,” said Bhavesh Shah, director of international marketing, Hetero Drugs. “More than four million patients are currently taking Hetero Labs medicines and almost 50 per cent are on TDF-based combinations, in part as a result of our 2012 sub-licence with the MPP.” Hetero also signed a sub-licence with MPP for the development of dolutegravir, a promising new ARV recently approved by the European Medicines Agency.
“The Gilead-MPP licence paved the way for Chinese manufacturers to participate in the development of TAF and we look forward to working with the MPP on manufacturing processes,” said Jinliang Li, vice president of Desano. “We are the first Chinese enterprise to join the MPP as a sub-licensee, signing an agreement with the organisation just months ago for the manufacture of atazanavir (ATV) an important medicine for treating people who have developed resistance to their current regimens.” Additionally Desano has also received a licence to produce generic TDF, emtricitabine and cobicistat.
“Laurus Labs is a long-time MPP partner,” said C Satyanarayana, chief executive officer. “We have been working closely with the team on six projects including the production of five Gilead ARVs from its licence with MPP in 2011. Laurus Labs looks forward to continuing this collaboration on TAF with a mutual goal of ensuring that, once registered, it is distributed rapidly across low- and middle-income countries.”
In July, the MPP announced seven new sub-licences for the development of ATV and for DTG. With the agreements announced today, MPP will be managing 42 sub-licensing projects for the development of a range of ARVs for both children and adults.