Janssen, the Pharmaceutical Companies of Johnson & Johnson, Announces First-of-its-Kind Drug Donation Program for HIV Treatment-Experienced Children

CAPE TOWN, South Africa, Dec. 9, 2013 /PRNewswire/ -- Janssen, the pharmaceutical companies of Johnson & Johnson, today announced a first-of-its-kind pediatric HIV treatment donation program to improve access to the company's approved HIV medicines for children and adolescents failing HIV treatment in sub-Saharan Africa. At a symposium entitled When Children Need HIV Treatment Beyond First-Line: How Can We All Respond? at the 17^th International Conference on AIDS and STIs in Africa (ICASA), Ministries of Health (MOHs) in sub-Saharan Africa were invited to submit a formal Expression of Interest to participate in the charitable pediatric HIV treatment donation program.

Through this program, Janssen will donate its HIV medicines PREZISTA^® (darunavir) and INTELENCE^® (etravirine), including child-friendly formulations, free of charge to eligible countries with the clinical capacity and willingness to address second- and third-line pediatric HIV treatment. Each child enrolled will receive Janssen's donated HIV medicines as needed until they turn 19 at which point they will be transitioned into the adult national HIV program or other designated by the national HIV program for continued treatment.

The donation program is intended to be a first step in a broader collaborative effort to build awareness, incite action, and advance learning around second- and third-line pediatric HIV treatment in sub-Saharan Africa. Janssen is working with the Elizabeth Glaser Pediatric AIDS Foundation, the Partnership for Supply Chain Management (PFSCM), and MAP International to fully maximize the impact and reach of this initiative.

"The donation program is part of our longstanding commitment to help people living with HIV and enhance access to our medicines for those in need. Only a third of the 3 million children living with HIV are receiving medicines today, and of those children receiving treatment, a small but growing number are experiencing HIV treatment failures and are in need of new treatment options," said Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson and Worldwide Chairman, Janssen. "We hope this innovative donation program is the first step in sparking further collaborative action across sub-Saharan Africa for children who are experiencing HIV treatment failure. Our vision is that these children receive the HIV treatment and care they need to stay healthy and grow to become healthy, productive young adults."

Treatment of pediatric HIV remains significantly neglected in sub-Saharan Africa. Responding to the challenge of HIV treatment-experienced children requires a comprehensive effort to help guide countries in the provision of necessary and appropriate care for this neglected population.  This includes improving understanding of the problem, expanding national treatment guidelines beyond first-line, increasing healthcare capacity for pediatric HIV treatment and monitoring, and ensuring that availability of co-administered HIV medicines remains a priority.

The submission period for the Expression of Interest by country MOHs to participate in the drug donation initiative will run from January 15, 2014 until February 14, 2014. An independent, third-party review committee of international experts in pediatric HIV will review all applications to determine country eligibility to receive the donation.  Country approvals will be announced in March 2014. Countries interested in more information or submitting an Expression of Interest should visit: www.pedaids.org/treatmentdonation.

About Janssen, the Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., rheumatoid arthritis, IBD and psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).

Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. To learn more, visit www.janssen.com.

About Johnson & Johnson
Caring for the world, one person at a time…inspires and unites the people of Johnson & Johnson. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 128,700 employees at more than 275 Johnson & Johnson operating companies work with partners in healthcare to touch the lives of over a billion people every day throughout the world.

(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 any of the Janssen Pharmaceutical Companies 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; impact of business combinations; 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 www.sec.gov, 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