E-DRUG: MPP & Roche Sign Agreement; Focus on Preventing Blindness in HIV +ve
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
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
“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.
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:
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 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 firstname.lastname@example.org +41 79 825 4786
Richard Warren email@example.com +41 76 455 1847