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

By Tibotec Therapeutics, PRNE
Wednesday, January 26, 2011

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

CORK, Ireland, January 27, 2011 - 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(R)
(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.

About Tibotec

Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical
research and development company and one of the companies that compose the
Janssen Pharmaceutical Companies of Johnson & Johnson. Tibotec is dedicated
to the discovery and development of innovative HIV/AIDS drugs and
anti-infectives for diseases of high unmet medical need. The Company's main
research and development facilities are in Beerse, Belgium with offices in
Titusville, NJ.

Tibotec has developed a Global Access & Partnerships Program to
facilitate access to its antiretrovirals for patients living with HIV/AIDS in
developing countries. The Global Access & Partnerships Program for darunavir
and etravirine includes access pricing, registration, medical education for
appropriate use and voluntary licensing.

(This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from Tibotec Pharmaceuticals' and/or Johnson &
Johnson's expectations and projections. Risks and uncertainties include
general industry conditions and competition; economic conditions, such as
interest rate and currency exchange rate fluctuations; technological advances
and patents attained by competitors; challenges inherent in new product
development, including obtaining regulatory approvals; domestic and foreign
health care reforms and governmental laws and regulations; and trends toward
health care cost containment. A further list and description of these risks,
uncertainties and other factors can be found in Exhibit 99 of Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended January 3,
. Copies of this Form 10-K, as well as subsequent filings, are available
online at www.sec.gov, www.jnj.com or on request from Johnson &
Johnson. Neither Tibotec Pharmaceuticals nor Johnson & Johnson undertake to
update any forward-looking statements as a result of new information or
future events or developments.)

Karen Manson of Tibotec, +32-479-89-47-99 (mobile)

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