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[e-drug] MPP & Roche Sign Agreement; Focus on Preventing Blindness in HIV +ve People

E-DRUG: MPP & Roche Sign Agreement; Focus on Preventing Blindness in HIV +ve 
People 
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Dear Friends, Please see below our latest announcement. Thanks, Kaitlin

MPP and Roche Sign HIV Medicines Agreement; Focus on Preventing Blindness in 
People Living with HIV

5 AUGUST 2013, GENEVA, SWITZERLAND: The Medicines Patent Pool and Roche today 
announce an agreement to increase access in developing countries to 
valganciclovir, a key easy-to-take oral medicine to treat cytomegalovirus 
(CMV), a viral infection that can cause blindness in people living with HIV.

The agreement will significantly improve access to Roche's valganciclovir for 
people living with HIV in 138 developing countries by making it up to 90% 
cheaper than current prices. As a second step, the Medicines Patent Pool and 
Roche will also enter into licensing and technology transfer negotiations to 
encourage the development of internationally approved quality generic versions 
of valganciclovir.

The most widely used treatment for CMV in developing countries requires 
injections directly to the eye, which can be painful and also difficult to 
administer on a large scale.

“The agreement announced today will make a more affordable oral treatment for 
CMV available immediately and also catalyse the creation of a sustainable 
generic market,” said Greg Perry, Executive Director of the Medicines Patent 
Pool.

“There is a vicious cycle with CMV: since the current treatment options are 
either unaffordable or inconvenient, HIV clinics rarely screen for the disease. 
Because clinics rarely screen for CMV, there is little demand for treatment and 
therefore little demand for easier to administer, affordable solutions. As a 
result, preventable blindness continues to occur in people living with HIV, 
especially in Asia,” said Dr David Heiden, a CMV expert working with Seva and 
Pacific Vision Foundations.

“CMV infection occurs when people have severely weakened immune systems. With 
timely initiation of antiretroviral therapy, HIV-related CMV has almost 
disappeared in developed countries, but in resource-limited settings still many 
people are not getting treated or start treatment late. CMV retinitis has not 
gone away and the availability of simpler, more affordable CMV treatment to 
prevent blindness from this disease is welcome news,” said Dr Nathan Ford, of 
the World Health Organization (WHO) HIV/AIDS department.
The Medicines Patent Pool will also work with other key stakeholders to develop 
long-term treatment strategies for scaling up the use of valganciclovir for 
treatment of HIV-related CMV in developing countries. In addition, the 
Medicines Patent Pool and Roche have agreed on the licensing of the 
antiretroviral, saquinavir, if a significant medical need is identified. The 
WHO recommends saquinavir as an alternative ARV in special situations and where 
other preferred treatments are not available.
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NOTES TO THE EDITOR
CMV: Cytomegalovirus (CMV) is an opportunistic infection, which, in its most 
common form, attacks the retina of the eye in patients with suppressed immune 
systems, such as those with advanced HIV infection. Vision loss from CMV 
retinitis can be prevented through early diagnosis and treatment. HIV-related 
CMV disease is no longer a problem in developed countries, but still affects 
at-risk people living with HIV in low- and middle-income countries especially 
in Asia, and to a lesser extent in Latin America and Africa. According to new 
research that systematically reviewed 65 studies conducted in these regions. 
The new research was presented at this year’s International AIDS Society 
Conference in Kuala Lumpur 30 June – 3 July and was published in Clinical 
Infectious Diseases (Ford N, Shubber Z, Saranchuk P et al. Burden of 
HIV-related CMV retinitis in resource-limited settings: a systematic review. 
Advanced Access published 29 July 2013, doi:10.1093/cid/cit494. See: 
http://cid.oxfordjournals.org/content/early/recent).

By region, the prevalence of patients diagnosed with CMV retinitis was 14.0% 
(11.8-16.2%), 12.0% (4.2-19.9%) and 2.2% (1.3-3.1%) in Asia, Latin America and 
Africa respectively. Traditionally, the treatment of CMV is difficult to 
administer, requiring several injections to the eye. This requires 
hospitalisation of patients and highly trained staff, which may not always be 
available in resource-limited settings. An alternative is the oral treatment 
valganciclovir.

VALGANCICLOVIR: Valganciclovir is indicated for the treatment of CMV. 
Currently, the main use of valganciclovir is for organ transplant patients. Due 
to access issues, the current use in HIV-related CMV is extremely small, thus 
there is insufficient demand to generate generic competition through licensing 
agreements. This differs substantially from other HIV medicines, which the 
Medicines Patent Pool has identified for immediate in-licensing. For this 
reason, the agreement with Roche is the first agreement that the Medicines 
Patent Pool has concluded that includes both a pricing and a licensing element. 
The agreement presently covers 138 countries but may be expanded further if 
there is an unmet treatment need in other countries.

THE MEDICINES PATENT POOL (MPP): The MPP is a United Nations backed 
organisation that offers a public-health driven business model that aims to 
lower the prices of HIV medicines and facilitate the development of 
better-adapted HIV medicines – such as simplified “fixed-dose combinations” and 
special formulations for children – in developing countries. It was founded in 
2010 at the request of the international community through the WHO-based 
financing mechanism UNITAID. The MPP has been endorsed by the WHO, the 2011 UN 
High Level Meeting on AIDS, and the Group of 8 as a promising innovative 
approach to improve access to HIV medicines.

FOR FURTHER INFORMATION:
Kaitlin Mara kmara@medicinespatentpool.org +41 79 825 4786
Richard Warren rwarren@medicinespatentpool.org +41 76 455 1847



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