Last updated on April 20, 2014 at 1:20 EDT

Janssen R&D Ireland Announces Agreement with PATH for Early Development of Rilpivirine in Long-Acting Formulation for Potential Prophylactic Intervention

September 25, 2013

CORK, Ireland, September 25, 2013 /PRNewswire/ –

Janssen R&D Ireland (Janssen) announced today it has signed a license agreement with
PATH for the early development of the human immunodeficiency virus type 1 (HIV-1) medicine
rilpivirine in a long-acting injection (depot formulation) as potential pre-exposure
prophylaxis (PrEP) against HIV infection.

Under the terms of the agreement, a Drug Development program of PATH, an international
nonprofit organization that transforms global health through innovation, has the right to
develop rilpivirine long-acting formulation as a possible new way to prevent HIV
infection. PATH has the intent to conduct prophylaxis clinical trials in collaboration
with partners including the HIV Prevention Trials Network. Following the completion of the
clinical Phase 2 program, PATH and Janssen will evaluate entering into a late stage
development agreement covering the use of rilpivirine as PrEP for uninfected individuals
at high risk of acquiring HIV.

“Rilpivirine is an important treatment option for patients today and we are pleased to
work with PATH to evaluate it as an injectable depot formulation that may help to reduce
the spread of infection,” said Wim Parys, Global Head of Research & Development, Janssen
Global Health. “We believe that evaluating a long-acting formulation, which could help
improve adherence in a PrEP regimen, is an important part of the Janssen commitment to the
global fight against HIV and AIDS.”

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It is
currently commercialized by Janssen for the oral, once daily treatment of HIV-1, in
combination with other antiretroviral agents (ARVs), in ARV treatment-naive adults, and in
most countries, in patients with a viral load less than or equal to 100,000 HIV-1RNA

This license agreement with PATH does not impact the commercialization of rilpivirine
by Janssen, and does not impact the use of rilpivirine in combination treatments.

About Janssen R&D Ireland

At Janssen, we are dedicated to addressing and solving some of the most important
unmet medical needs of our time in oncology, immunology, neuroscience, infectious
diseases, and cardiovascular and metabolic diseases.

We are further committed to making a meaningful difference in global public health.
Inspired by the legacy of Dr. Paul Janssen and our commitment to patients, we work
passionately to discover and responsibly deliver innovative medicines and vaccines that
address serious unmet health needs, including HIV, tuberculosis, intestinal worms and
neglected tropical diseases.

We collaborate with members of the global healthcare community, including the Bill and
Melinda Gates Foundation, the Global TB Alliance, the Drugs for Neglected Diseases
Initiative, the International Partnership for Microbicides, and many others, to bring new
solutions that deliver years of life and quality of life for people around the world.

Janssen R&D Ireland is part of the Janssen Pharmaceutical Companies of Johnson &
Johnson. Please visit http://www.janssenrnd.com for more information.


(This press release contains “forward-looking statements” as defined in the Private
Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these
forward-looking statements. 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 the expectations and projections of
Janssen R&D Ireland, any of the other Janssen Pharmaceutical Companies and/or Johnson &
Johnson. Risks and uncertainties include, but are not limited to, general industry
conditions and competition; economic factors, such as interest rate and currency exchange
rate fluctuations; technological advances, new products and patents attained by
competitors; challenges inherent in new product development, including obtaining
regulatory approvals; challenges to patents; changes in behavior and spending patterns or
financial distress of purchasers of health care products and services; changes to
governmental laws and regulations and domestic and foreign health care reforms; trends
toward health care cost containment; and increased scrutiny of the health care industry by
government agencies. 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 December 30, 2012. Copies of this Form 10-K, as well as
subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com
or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor
Johnson & Johnson undertake to update any forward-looking statements as a result of new
information or future events or developments.)

SOURCE Janssen R&D Ireland

Source: PR Newswire