[Ip-health] MPP and Roche Sign HIV Medicines Agreement; Focus on Preventing Blindness in People Living with HIV

Kaitlin Mara kmara at medicinespatentpool.org
Sun Aug 4 23:05:05 PDT 2013

Dear Friends, Please see below our latest announcement. Thanks, Kaitlin


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

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.

³The agreement announced today will make a more affordable oral treatment
for CMV available immediately and also catalyse the creation of a
sustainable generic market,² said Greg Perry, Executive Director of the
Medicines Patent Pool. 

³There 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,² said Dr David Heiden, a CMV expert
working with Seva and Pacific Vision Foundations. 

³CMV 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,² 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.


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 year¹s 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:

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 ³fixed-dose
combinations² 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

Kaitlin Mara kmara at medicinespatentpool.org +41 79 825 4786
Richard Warren rwarren at medicinespatentpool.org +41 76 455 1847

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