June 22, 2011
Products & Operating Company

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 Indication
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

Drug Interactions

  • Coadministration of EDURANT™ with the following drugs is contraindicated because  significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance and cross-resistance: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, proton pump inhibitors such as esomeprazole, lansoprozole, omeprazole, pantoprozole, and rabeprozole, systemic dexamethasone, and products containing St. John’s wort (Hypericum perforatum). EDURANT should be used with caution when co administered with drugs that may reduce the exposure of rilpivirine
  • EDURANT™ should be used with caution when coadministered with a drug with a known risk of Torsade de Pointes
  • EDURANT™ should not be used in combination with NNRTIs
  • This is not a complete list of potential drug interactions.

Please see full Prescribing Information for more details.

Warnings and Precautions

  • Depressive Disorders: Severe depressive disorders, defined as depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, and suicidal ideation, have been reported with EDURANT™. Immediate medical evaluation is recommended for severe depressive symptoms
  • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed inpatients receiving antiretroviral (ARV) therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established
  • Immune Reconstitution Syndrome has been reported in patients treated with combination ARV therapy, including EDURANT™

Use in Specific Populations

  • Hepatic Impairment: EDURANT™ should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT™ have not been evaluated in these patients
  • Pregnancy Category B: EDURANT™ should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women
 

Adverse Reactions

  • The most common adverse drug reactions reported (incidence >2%) of at least moderate intensity (≥ Grade 2) in patients taking EDURANT™ through 48 weeks were depressive disorders (4%), insomnia (3%), headache (3%), and rash (3%)

Please see full Prescribing Information for more details available at:

http://www.tibotectherapeutics.com/sites/default/files/downloads/pdf/EDURANT-PI.pdf

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.

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Media Contact: Pamela Van Houten      
Office: 609-730-7902                                     
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