CHMP Announces Positive Opinion for REZOLSTA™, a New Once-Daily, Fixed-Dose HIV Therapy Combining Darunavir and Cobicistat

BEERSE, Belgium, September 29, 2014 /PRNewswire/ --

  CHMP also issues two label extensions for darunavir  

Janssen-Cilag International NV (Janssen) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a Positive Opinion recommending REZOLSTA™ (darunavir/cobicistat) in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older. The CHMP also announced two label extensions for darunavir, a protease inhibitor marketed as PREZISTA^® by Janssen.

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REZOLSTA™ is a new once-daily, fixed-dose combination tablet containing darunavir and the pharmacokinetic enhancing or "boosting" agent cobicistat (marketed as Tybost™ by Gilead Sciences, Inc.). The Janssen filing was based on bioequivalence data evaluating the use of a darunavir and cobicistat fixed-dose combination tablet versus single agents, and a clinical study evaluating the safety and efficacy of cobicistat-boosted darunavir for the treatment of HIV-1 in adults with no darunavir resistance-associated mutations.

"People with HIV are living longer than ever before thanks to the development and introduction of effective HIV treatments," said Christiane Moecklinghoff, M.D Ph.D, Medical Director, Virology, Janssen EMEA. "For this reason, expanding existing treatment options, especially those which will improve patients' lives by simplifying regimens and supporting adherence are critical. If approved, this new treatment option eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir, reducing the pill burden for patients. We look forward to a final decision from the European Commission in the coming months."

The darunavir and cobicistat fixed-dose combination was approved in Canada in June 2014 under the name PREZCOBIX™, and is currently undergoing regulatory review by the FDA in the USA.

Janssen will continue to make darunavir available, as a single agent in tablets, so patients and their physicians can decide which HIV treatment regimen is best for them.

The CHMP has also issued two additional label extensions relating to darunavir. The first label extension is for the prescribing of once-daily dosing of darunavir/ritonavir in children aged 3-<12 years in those who are antiretroviral (ARV) treatment-naïve as well as treatment-experienced, provided their virus is fully sensitive to drug, in combination with other ARVs. This allows a once-daily dosing regimen of darunavir in children below the age of 12, adding to more convenience in this pediatric population. The second label extension is for the prescribing of cobicistat as an alternate booster for darunavir in adults aged 18 years or older in combination with other ARVs, providing another booster option for darunavir in people living with HIV.

About HIV  

Since the beginning of the HIV epidemic, almost 75 million people have been infected with the HIV virus.^[1] It is estimated that 35 million people are currently living with HIV globally, with 2.5 million people becoming newly infected each year.^[1],[2]

About PREZISTA^®(darunavir) 

Darunavir is a protease inhibitor used for the treatment of human immunodeficiency virus (HIV-1) infection and can be taken with either ritonavir (indicated for use in adults and pediatric patients from the age of 3) or cobicistat (indicated for use in adults only). Darunavir received initial approval in Europe in 2007 for use in HIV-1 infected highly pre-treated patients, with later approvals for treatment-naïve and less experienced adult patients, and then for use in pediatric patients. Darunavir/ritonavir is approved for use in pediatric patients aged 3-17.

About Tybost^[TM](cobicistat)

Tybost (cobicistat 150 mg tablets) is a cytochrome P450 3A (CYP3A) inhibitor. It boosts blood levels of atazanavir or darunavir by suppressing CYP3A, an enzyme that metabolizes these drugs in the body. Cobicistat acts only as a pharmacokinetic enhancer and has no antiviral activity. Cobicistat was developed by Gilead and is a pharmacokinetic enhancer or boosting agent used with the protease inhibitors darunavir and atazanavir for the treatment of HIV, and is also found in STRIBILD^® (elvitegravir / cobicistat / emtricitabine / tenofovir). Gilead is responsible for the manufacture, development and commercialization of cobicistat as a stand-alone product.

About Janssen  

At Janssen, we are dedicated to addressing some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.  Janssen-Cilag International NV is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

More information about Janssen can be found at http://www.janssen-emea.com.

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-Cilag International NV and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition, including 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; general industry conditions including 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 Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and our subsequent filings with the Securities and Exchange Commission.  Copies of these filings areavailable online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson.  Neither Janssen-Cilag International NV nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

1. World Health Organization. Global summary of the AIDS epidemic. Available at: http://www.who.int/gho/hiv/en/. Last accessed September 2014.
2. World Health Organization. Global summary of the AIDS epidemic. Available at: http://www.who.int/hiv/data/2012_epi_core_en.png . Last accessed September 2014.

PHGB/REZ/0914/0001
September 2014

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SOURCE Janssen-Cilag International NV

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