CORK, Ireland, December 29, 2014 /PRNewswire/ --
-- Two Companies to also Collaborate on the Further Development of Complera®, Marketed as Eviplera® in the European Union --
Janssen R&D Ireland (Janssen) announced today an amendment to its existing agreement with Gilead Sciences, Inc. (Gilead), initially established in 2011, for the development of a once daily, darunavir-based, single-tablet regimen (STR) for the treatment of people living with HIV. This new STR contains a combination of darunavir (PREZISTA®), cobicistat (TYBOST®), emtricitabine and tenofovir alafenamide (TAF). A number of Phase 1 and 2 studies of the new STR have been completed. Under this amended agreement, Janssen will conduct all further clinical development of the regimen and, subject to regulatory approval, will be responsible for all manufacturing, registration, distribution and commercialization of the product worldwide.
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If successfully developed and approved by regulatory authorities, this treatment would represent the first protease inhibitor-based STR and thereby continue Janssen's commitment to providing its HIV products in more simplified dosing presentations.
"Janssen has vast experience in developing and making innovative HIV treatments available to patients and we have engaged in several successful collaborations with Gilead. We are proud to be extending our collaboration and leading the development of this darunavir-based single-tablet regimen," says Paul Stoffels, Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. "Our ultimate goal is to offer new treatment options for people living with HIV. If approved, this STR has the potential to provide additional choice in the form of another one pill, once a day, as a new and simplified regimen."
In addition to this collaboration, Janssen and Gilead have also expanded a separate agreement initiated in 2009 regarding the approved single-tablet regimen, COMPLERA®, marketed as EVIPLERA® in the European Union (EU) (rilpivirine, tenofovir disoproxil fumarate (TDF) and emtricitabine). This expanded agreement will allow for Gilead's investigational tenofovir alafenamide (TAF), a novel nucleotide reverse transcriptase inhibitor, to replace TDF within COMPLERA®/ EVIPLERA®. TAF has been shown in clinical trials to have a better renal and bone safety profile than TDF.[1] Gilead will be responsible for the development and commercialization in most countries, while Janssen will lead the commercialization in select markets.
Since the beginning of the HIV epidemic, almost 75 million people have been infected with the HIV virus.[2] It is estimated that 35 million people are currently living with HIV globally, with 2.5 million people becoming newly infected each year.[2],[3],[4]
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PREZISTA®
Indication
PREZISTA® (darunavir), coadministered with ritonavir (PREZISTA®/r), and with other antiretroviral agents (ARVs), is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from 2 controlled Phase 3 trials of 48 weeks duration in ARV treatment-naïve and treatment-experienced patients and 2 controlled Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.
In treatment-experienced adult patients, the following points should be considered when initiating therapy with PREZISTA®/r:
Important Safety Information
PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.
PREZISTA® is always taken with and at the same time as ritonavir (Norvir®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food.
PREZISTA® does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA®.
Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA® is right for you.
Important Safety Information
What is the most important information I should know about PREZISTA®?
Who should not take PREZISTA®?
This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
What should I tell my doctor before I take PREZISTA®?
What are the possible side effects of PREZISTA®?
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please refer to the ritonavir (Norvir®) Product Information (PI and PPI) for additional information on precautionary measures.
Please see full Product Information for more details:
http://www.prezista.com/sites/default/files/pdf/us_package_insert.pdf#zoom=100
About Janssen Pharmaceutical Companies of Johnson & Johnson
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, 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.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 including regarding product development. 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 known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen R&D Ireland and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product development, including obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; changes to regulations and domestic and foreign health care reforms; and general industry conditions, including trends toward health care cost containment. 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 the company's subsequent filings with the Securities and Exchange Commission. Copies of these 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 or Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.
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MEDIA CONTACT:
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