Tibotec Therapeutics Becomes Janssen Therapeutics, Part Of The Janssen Pharmaceutical Companies
Unified Janssen companies around the world continue commitment to patients and to addressing unmet medical needs
Titusville, NJ, June 22, 2011 – Tibotec Therapeutics, Division of Centocor Ortho Biotech Products, L.P. announced that it has changed its name to Janssen Therapeutics, Division of Janssen Products, LP. The change, effective immediately, is part of the global adoption of a common identity for all Janssen Pharmaceutical Companies to provide even greater collaboration, value and treatment innovation for individuals living with serious medical conditions, including HIV/AIDS and hepatitis C.
The Janssen name comes from Dr. Paul Janssen, who founded one of Johnson & Johnson’s earliest pharmaceutical companies more than 50 years ago, and who believed in driving for constant innovation to achieve progress and transformation. He exemplified the passionate pursuit of science for the benefit of all patients common to the many companies that subsequently became part of Johnson & Johnson’s pharmaceuticals group. Dr. Janssen discovered breakthrough treatments in multiple therapeutic areas.
Dr. Janssen (1926 – 2003) championed the HIV drug research that resulted in the discovery of rilpivirine, previously known as TMC278. Tibotec Pharmaceuticals continued the development of rilpivirine. In May 2011, rilpivirine, now marketed as EDURANTTM (rilpivirine) tablets, was approved in combination with other antiretroviral (ARV) medications for treatment of adults with HIV infection who are new to ARV therapy. EDURANT became the third HIV medication to be introduced in the United States by Tibotec.
“Our commitment to innovation and serving the needs of people living with HIV is one that Dr. Janssen shared,” said Vanessa Broadhurst, President, Janssen Therapeutics. “Our new name, Janssen Therapeutics, reflects our company’s history and our mission; it also points to our future. Uniting together under a common identity with the other Janssen Pharmaceutical Companies will allow us to operate more effectively, delivering even better solutions to patients and healthcare providers in the future.”
Since 2003, Janssen Therapeutics has been dedicated to delivering innovative virology therapeutics that help to address the serious unmet needs of people living with HIV. While its name and logo are changing, its brand names and organizational structure will remain the same, as will its commitment to patients, healthcare professionals and the HIV community.
For more information about Janssen Therapeutics, please visit www.JanssenTherapeutics.com.
EDURANT is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment‑naïve adult patients.
This indication is based on Week 48 safety and efficacy analyses from two randomized, double-blinded, active controlled, Phase 3 trials in treatment-naïve patients and Week 96 safety and efficacy analyses from a Phase 2b trial in treatment-naïve patients.
The following points should be considered when initiating therapy with EDURANT:
- More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared to subjects with HIV-1 RNA less than 100,000 copies/mL at the start of therapy.
- The observed virologic failure rate in EDURANT treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz.
- More subjects treated with EDURANT developed lamivudine/emtricitabine associated resistance compared to efavirenz.
EDURANT Important Safety Information
Please see full Prescribing Information for more details.
Warnings and Precautions
Use in Specific Populations
Please see full Prescribing Information for more details available at:
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About Janssen Therapeutics
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in HIV and other infectious diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Headquartered in Titusville, New Jersey, Janssen Therapeutics, Division of Janssen Products, LP, is one of the Janssen Pharmaceutical Companies. Please visit JanssenTherapeutics.com for more information.
Media Contact: Pamela Van Houten