[Ip-health] Tibotec Signs Multiple Agreements With Generic Manufacturers to Provide Access to New HIV Treatment

Baker, Brook b.baker at neu.edu
Mon Jan 31 09:45:41 PST 2011

Like ViiV, Tibotec has decided to skip the new Medicines Patent Pool and instead provide voluntary licenses to a subset of countries needing access to a new NNRTI.  The Tibotec license goes to only a limited number of generic companies (three identified), and covered territories are limited to least developed countries, sub-Saharan Africa, and India only.

Unlike ViiV, Tibotec will collect royalties.  Although it delegates registration responsibilities and WHO pre-qualification to the generic companies, it will presumably allow reference to or reliance on data it has previously submitted in the US, Europe, Canada, Switzerland, Australia, Russia and South Korea.  On the plus side, Tibotec has specified that companies will be permitted to co-formulated with other ARVs.  It is also providing some technical know-how which should expedite quality manufacturing.

Earlier, Tibotec announced its partnership with Gilead to co-formulated with tenofovir and emtricibitine producing a powerful new ARV entry in rich and middle-income country markets.  Freezing out other pharm-emerging countries like Thailand and Brazil is obviously intended to ensure supra-competitive profits in those markets.

Professor Brook K. Baker
Health GAP (Global Access Project) &
Northeastern U. School of Law, Program on Human Rights and the Global Economy
Honorary Research Fellow, Faculty of Law, Univ. of KwaZulu Natal, SA
400 Huntington Ave.
Boston, MA 02115 USA
(w) 617-373-3217
(c) 617-259-0760
(f) 617-373-5056
b.baker at neu.edu
From: ip-health-bounces at lists.keionline.org [ip-health-bounces at lists.keionline.org] On Behalf Of Judit Rius Sanjuan [judit.rius at keionline.org]
Sent: Thursday, January 27, 2011 11:11 AM
To: Ip-health
Subject: [Ip-health] Tibotec Signs Multiple Agreements With Generic     Manufacturers to Provide Access to New HIV Treatment

Tibotec Signs Multiple Agreements With Generic Manufacturers to Provide Access to New HIV Treatment

Agreements for Investigational TMC278 Cover Sub-Saharan Africa, India and Least Developed Countries


CORK, Ireland, Jan. 27, 2011 /PRNewswire/ -- Tibotec Pharmaceuticals today
announced that it has granted multiple non-exclusive licenses to generic
manufacturers including Hetero Drugs Limited, Matrix Laboratories Limited
(a Mylan company) of India and Aspen Pharmacare of South Africa to
manufacture, market and distribute the investigational non-nucleoside
reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending
its approval for use with other antiretroviral agents in the treatment of
treatment-naive HIV-1 infected adults.  The generic pharmaceutical
manufacturers in India will have rights to market the product in
sub-Saharan Africa (SSA), Least Developed Countries (LDCs) and India. Aspen
will have rights to market the product in SSA including South Africa. Under
the agreement, the generic manufacturers will be entitled to manufacture
once-daily 25 mg TMC278 as a single agent medicine and a fixed-dose
combination (FDC) product. Fixed-dose combinations contain multiple
medicines formulated into one tablet helping to simplify HIV therapy and
are preferred by public health treatment programs. Tibotec has chosen to
collaborate with multiple manufacturers in order to ensure the widespread
and sustainable access to, and supply of, TMC278 in areas of high HIV
burden and to support generic competition.

Tibotec specializes in the research and development of new medicines for
infectious diseases including HIV. It plays a key role in the Johnson &
Johnson Global Access & Partnerships Program, which is committed to
improving and saving lives by addressing unmet medical needs and ensuring
the availability of HIV medicines to patients in need. The Program is
already working, through existing agreements with generic manufacturers
Aspen of South Africa and Emcure Pharmaceuticals Ltd of India to broaden
access to the medicines darunavir and etravirine in SSA and LDCs and to
darunavir in India.

"We believe that voluntary licensing is an important mechanism by which to
expand access to our HIV portfolio, including our newest medicines," said
Will Stephens, Vice President of Global Access & Partnerships for Janssen
Global Services, LLC. "Multiple licenses in place for TMC278 with generic
manufacturers made before final regulatory approval in the U.S. and Europe
underscore the seriousness and speed with which we're working to ensure
that all patients in need, not just those in Western markets, will have
timely access to the most current regimens."

Tibotec will provide the generic manufacturers with the technical
information and knowledge to allow them to manufacture the single agent
product. The generic manufacturers will pay royalties ranging from two to
five percent. The generic manufacturers will be responsible for timely
regulatory filing for generic TMC278 and for seeking pre-qualification from
the World Health Organization (WHO) and ANDA approvals. To keep medicines
affordable, the generic manufacturers are required to limit their gross
profit margin on the sale of TMC278. Prior to the signing of these
agreements, Tibotec submitted TMC278 for regulatory approval in the U.S.,
Europe, Canada, Switzerland, Australia, Russia and South Korea. Upon
approval, it is expected that TMC278, in combination with other
antiretroviral medicinal products, will be indicated for the treatment of
HIV-1 infection in treatment-naïve adult patients.

The agreements cover the manufacture of TMC278 as a single agent medicine
and a license to develop an FDC product using TMC278 with 300 mg tenofovir
disoproxil fumarate and 300 mg lamivudine.

In July 2009, Tibotec announced that it had entered into a license and
collaboration agreement with Gilead Sciences, Inc. for the development and
commercialization of a new, once-daily, fixed-dose antiretroviral product
containing Tibotec's investigational non-nucleoside reverse transcriptase
inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride) and Gilead's Truvada®
(emtricitabine and tenofovir disoproxil fumarate). Tibotec and Gilead are
committed to working together to make the fixed-dose combination of TMC278
and Truvada available in the developing world and are working towards a
separate agreement for these countries.

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