Medicines Patent Pool signs deal with 5 Indian companies for HIV drug

Medicines Patent Pool (MPP), an United Nations arm, has entered into sub-licencing agreement with five Indian companies - Aurobindo, Cipla, Emcure, Hetero Labs and Laurus Labs – and a Chinese firm Desano for generic manufacturing a HIV drug tenofovir alafenamide for 112 developing countries. This is two months after MPP, a UN-backed organisation founded by UNITAID to increase access to HIV treatment and spur new innovation worldwide, had signed a licencing pact with Gilead Sciences Inc for its novel investigational medicine tenofovir alafenamide (TAF).
 
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.
 
“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,” said Greg Perry, Executive Director, MPP.
 
“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,” said Arvind Vasudeva, Chief Executive Officer, Formulations at Aurobindo.
 
Subhanu Saxena, MD & Global CEO, Cipla Limited, said, “Cipla is happy to sign its second agreement with MPP for TAF. 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.”
 
“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,” said A K Khanna, Executive Director, Emcure Pharmaceuticals. 
 
Bhavesh Shah, Director of International Marketing, Hetero Drugs Limited, said,  “More than four million patients are currently taking Hetero Labs medicines and almost 50% 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.
 
C Satyanarayana, Chief Executive Officer, Laurus Labs, said, “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.