The Medicines Patent Pool Signs a Record Seven New Sub-Licences to Speed the Availability of Generic HIV Medicines to Developing Countries

July 17, 2014

GENEVA, July 17, 2014 /PRNewswire/ –

MPP forges first agreement with a Chinese manufacturer Desano; and with
Cipla, Mylan and Micro Labs; Extends Collaborations with Aurobindo, Laurus Labs and Emcure

Three days before the start of the 20th International AIDS Conference in Melbourne,
Australia, the Medicines Patent Pool (MPP) announced seven new sub-licensing agreements
for the manufacture of generic HIV medicines, atazanavir (ATV) and dolutegravir (DTG). The
United Nations-backed MPP negotiates licences with key patent holders to speed access of
low-cost, generic medicines to developing countries. To date, the MPP has signed
agreements with Bristol Myers-Squibb, Gilead Sciences, F. Hoffmann-La Roche, the US
National Institutes of Health and ViiV Healthcare for eight antiretrovirals (ARVs) and one
medicine for an HIV opportunistic infection.

http://photos.prnewswire.com/prnh/20140717/697285 )

“With licences signed today, four new manufacturers are joining us to speed the
availability of crucial medicines, ATV and DTG, to developing countries. This almost
doubles our network of generic partners to ten companies,” said Greg Perry, Executive
Director, MPP. “Increased generic competition will ultimately bring prices down and
increase availability to allow national treatment programmes to treat many more people in
their countries.”

Following its December agreement with Bristol-Myers Squibb for a licence on
atazanavir, a WHO-preferred second-line therapy, MPP has signed its first sub-licence with
a Chinese generic firm, Desano, a supplier of active pharmaceutical ingredients (API)
based in Shanghai, and with Aurobindo and Emcure, key manufacturers of generic
antiretroviral medicines, for the production of low-cost atazanavir. Increasing access of
second-line treatments for HIV is crucial as more people living with HIV develop
resistance to first-line regimens. The WHO estimates there will be more than one million
people on second-line treatment by 2016 and many more will need access to these new

“As one of the leading Chinese pharmaceutical companies dedicated to the development,
manufacturing and supply of Anti-HIV API and finished pharmaceutical products, Desano is
honored to be the first Chinese enterprise cooperating with MPP to manufacture high
quality and affordable HIV medicines,” said Dr. Jinliang Li, Vice President of Desano. “We
are ready to contribute additional efforts from China to the global fight against AIDS.”

“Aurobindo, a long-time MPP partner, is pleased to help ensure the timely introduction
of generic ATV in developing countries,” said Arvind Vasudeva, Chief Executive Officer,
Formulations at Aurobindo. “This medicine offers new options for people living with HIV
who are no longer able to take their first HIV regimens and its distribution in
resource-poor settings is crucial.”

Three months after MPP signed ground-breaking agreements with ViiV Healthcare on new
antiretroviral dolutegravir, the organisation has signed four sub-licences for the
manufacture of generic versions of the product for both adult and paediatric care. Laurus
Labs, granted an MPP licence to produce five Gilead ARVs in 2012, has been granted a new
licence for DTG. Micro Labs, a producer of generics including WHO pre-qualified ARVs,
Cipla, a global pharmaceutical company with a strong presence in the HIV field and Mylan,
a global generics and specialty pharmaceutical company, have become new MPP sublicensing

“The HIV field needs new drugs all the time due to the development of resistance and
treatment failure,” said Dr. Jaideep Gogtay, Chief Medical Officer of Cipla. “Dolutegravir
belongs to the new class of drugs – integrase inhibitors. This class of drugs brings new
options for patients, has advantages over the existing drugs in terms of high efficacy and
also brings down the viral loads rapidly. Access to the medicine in developing countries
will make a major difference to the lives of HIV/AIDS patients living there.”

“Mylan is an established leader in ARVs with a global portfolio of 43 high-quality
products. In continuation of our commitment to providing access to a comprehensive range
of high-quality, affordable ARV medicines, Mylan is pleased to work with MPP in
sub-licensing a new molecule Dolutegravir (DTG),” said Rajiv Malik, President, Mylan. “DTG
represents a significant advancement in HIV treatment as it does not require boosting when
combined with other appropriate ARVs and has a good efficacy profile at very small doses.
This addition further strengthens our portfolio of HIV/AIDS products and helps us deliver
on our mission to provide the world’s seven billion people with access to high quality

“The new sub-licensing agreements for generic DTG are a welcome development in
ensuring that we reach developing countries with a promising new ARV in record time,” said
Mr. NK Kothari, Executive Director, Micro Labs. “We hope to have a generic product
available as soon as possible to strengthen HIV treatment options in hundreds of countries
throughout Africa, Asia and Latin America.”

About the Medicines Patent Pool (MPP)

The Medicines Patent Pool is a United Nations-backed organisation founded in 2010 by
UNITAID to increase access to HIV treatment and spur new innovation worldwide. The MPP
offers a new public health approach to negotiating patent licences for the production of
low-cost versions of new and existing medicines and works with manufacturers to encourage
the development of needed new technologies such as fixed-dose combinations (FDCs) and
formulations suitable for children. To date, MPP has signed licensing agreements for eight
antiretrovirals and for one medicine for an HIV opportunistic infection. Ten generic
manufacturers have now licensed from the organisation.



SOURCE The Medicines Patent Pool

Source: PR Newswire

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