Date: 28 January 2011
Source: keionline.org
Link: http://keionline.org/node/1068
Today, Tibotec, a subsidiary of Johnson & Johnson,
announced it has signed voluntary licensing agreements with several Indian and
South African generic companies to allow generic competition on a new HIV-AIDS
treatment, the investigational non-nucleoside reverse transcriptase inhibitor
rilpivirine hydrochloride (TMC278) (rilpivirine hydrochloride), to certain developing countries. The Tibotec press release is
available here. The release specifically mentions three firms: Hetero Drugs Limited, Matrix Laboratories Limited (a Mylan company) of India and Aspen Pharmacare of South Africa.
KEI has not seen the terms of the licenses granted, but notes from the press
release that the license is significantly limited in terms of geographical
scope. The press release announces that "the generic pharmaceutical manufacturers
in India will have rights to market the product in sub-Saharan
Africa (SSA), Least Developed Countries
(LDCs) and India" and that Aspen "will have rights to market the
product in SSA including South Africa". This excludes all countries in
Latin America outside of Haiti, all of North Africa, and many other countries in Asia. For example, countries in Asia
excluded from the announcement would include such countries as Thailand, Malaysia, the Philippines, Indonesia, and Pakistan, to
mention a few.
Some speculate the Tibotec announcement is part of a larger effort to undermine
the recently established Medicines Patent Pool.
The Medicines Patent Pool is a UNITAID-supported mechanism to accelerate the
availability of HIV-AIDS medicines by obtaining open licenses to patents for
AIDS medicines in developing countries. The Tibotec announcement focuses on a
small number of firms that have in the past collaborated with Tibotec, Gilead or GSK on voluntary licensing. It notably
excludes CIPLA and other firms that are seen as more independent.
After months of informal conversations, in December 1,
2011 during the World Aids Day, the
Medicines Patent Pool sent a letter to Johnson & Johnson/ Tibotec asking to
formally start negotiations for Tibotec to voluntary joint the Medicines Patent
Pool. In December 15, civil society from around the world sent a follow up
letter to Tibotec asking for the negotiations to be conducted with transparency
and to include all developing countries.
The Global Fund to Fight AIDS, Tuberculosis and Malaria,
the UK government and many others have asked for companies to joint the
Medicines Patent Pool without delay. In September 2010, the White House
announced that the US Government would be the first to share patents with
Medicines Patent Pool and last week, during the Executive Board of the World
Health Organization, the US government made a strong intervention in support of
the Medicines Patent Pool and generic competition to lower the price of
HIV-AIDS medicines in developing countries.
The Medicines Patent Pool asked Tibotec to provide a response before January
31, 2011. The response that Tibotec has provided today January 27, 2011, a few
days before the deadline expires, suggests Tibotec will reject the initial
Medicines Patent Pool offer.
Under the announced agreement, the generic manufacturers will be allowed to
manufacture TMC278 as a single agent medicine and a fixed-dose combination
using TMC278 with tenofovir disoproxil fumarate and lamivudine. The Tibotec
press release mentions that the licenses are pending the product "approval
for use with other antiretroviral agents in the treatment of treatment-naïve HIV-1 infected adults". The Press Release also
mentions that Tibotec and Gilead are collaborating to develop a new fixed-dose
combination containing Tibotec`s TMC278 and Gilead`s Truvada® (emtricitabine
and tenofovir disoproxil fumarate). Today, we also learned that the FDA has refused the approval for TMC278 & Truvada
fixed-dose combination.
Keywords: HIV/AIDS / KEI / India / Global Fund
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