Janssen HIV ART Price Reductions-Etravirine-UPDATES Access/TB Drug/Peds/Long-Acting Rilpivirine/PrEP
The Janssen Global Access & Partnerships Program (GAPP) team would like to share news and information about our ongoing efforts to ensure that HIV patients worldwide have sustainable and affordable access to our HIV medicines today.|
INTELENCE: Price Reduction
Special Effort Price of INTELENCE® (etravirine) Reduced by Half for Sub-Saharan Africa and Least Developed Countries.
The Janssen Global Access & Partnerships Program is committed to ensuring affordable and sustainable access to our HIV medicines. We are pleased to announce that effective 1 July 2012, the Special Effort access price of branded INTELENCE® (etravirine) in sub-Saharan Africa (SSA) and least developed countries (LDCs) will be reduced by 52 percent to US$1.20 (ex-factory) per patient for the 400mg daily dose.
This is the second price reduction for our branded HIV medicines in SSA and LDCs. In 2011, the daily Special Effort price of PREZISTA® (darunavir) was reduced by 26 percent in SSA and LDCs.
Our Special Effort prices in SSA and LDCs already represent significant reductions from those in the United States and Europe and we are committed to further increasing the affordability of our HIV medicines in SSA and LDCs as cost-savings in manufacturing allow.
New Global Access & Partnerships Materials
2012 Brochure and Supporting Information
Now Available Online
As part of our commitment to sharing information about our activities, progress, and policies, we are excited to announce the publication of our 2012 brochure! This new resource provides new details, graphics and data on the Program's key elements, including: our branded and generic licensing agreements, filing and registration status of our HIV medicines, special effort access pricing, and other global activities to ensure that quality and affordable medicines are available sustainably and used in the most appropriate way for people living with HIV/AIDS. To download a copy and access additional new materials, please visit:
New Drug Application: Multi-Drug Resistant Tuberculosis (MDR-TB)
New Drug Application Submitted to FDA for Bedaquiline (TMC207) for Treatment of MDR-TB.
On 29 June 2012, Janssen Research & Development, LLC (Janssen) submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) seeking accelerated approval for the use of bedaquiline (TMC207) in adults as part of combination therapy for pulmonary multi-drug resistant tuberculosis (MDR-TB). This is the first NDA to seek an indication specifically for MDR-TB.
The submission is supported by 24-week data from the Phase II clinical development program, which included a controlled randomized trial that evaluated the safety and efficacy of bedaquiline versus placebo in the treatment of patients with pulmonary MDR-TB in combination with a background regimen and an open-label safety study in 233 patients with MDR-TB, including several with pre-extensively drug-resistant TB (pre-XDR) and XDR-TB, in 11 countries (China, Estonia, Latvia, Peru, Philippines, Russia, South Africa, South Korea, Thailand, Turkey, and Ukraine).
TB is the second most common cause of adult deaths from infectious diseases worldwide. MDR-TB, which is characterized by resistance to at least two of the most powerful medicines in today's standard regimen for drug-susceptible TB, is a growing public health concern. In 2010, there was an estimated prevalence of 650,000 cases of MDR-TB globally.
The NDA filing is an important milestone in the development of bedaquiline and Janssen's commitment to discovering and developing novel medicines for unmet medical needs, such as tuberculosis, disproportionately affecting people in high burden countries.
U.S. Pediatric Approval
INTELENCE® (etravirine) Pediatric Formulation Approved by U.S. Food & Drug Administration (FDA)
In March 2012, we received our first regulatory approval for INTELENCE® (etravirine) 25mg scored and dispersible tablets for treatment-experienced children and adolescents aged six to 18 years of age by the U.S. Food & Drug Administration (FDA).
The indication was based on 24-week analyses of pharmacokinetics, safety, tolerability, and efficacy from PIANO (Pediatric trial with INTELENCE® as an Active NNRTI Option), an open-label trial in which treatment-experienced pediatric patients received INTELENCE® in combination with other antiretrovirals (ARVs).
The approval makes INTELENCE® the only non-nucleoside reverse transcriptase (NNRTI) indicated for use in both treatment-experienced children and adults with resistance to an NNRTI. The FDA approval is an important first step in making this medicine available for pediatric patients in resource-limited countries, as many countries require FDA and/ or European Medicines Agency (EMA) approval before a local regulatory dossier can be submitted.
Long-Acting HIV Medicines
Results of Rilpivirine Long-Acting Study Presented at CROI
Janssen recognizes that an injectable low-dose ARV may someday play a role in pre-exposure prophylaxis (PrEP). A recent study presented at the 19th Conference on Retroviruses and Opportunistic Infections (CROI), shared exciting data, which supports ongoing exploration of an investigational long-acting injectable formulation of rilpivirine (RPV-LA) as a potential PrEP agent.
Researchers from the St. Stephen's AIDS Trust and the University of Liverpool in the United Kingdom presented the results of an open-label stratified-dose study investigating pharmacokinetics in plasma and body tissue in a group of healthy volunteers with low behavioral risk for HIV. Female participants received a single intramuscular dose of RPV-LA at 300mg, 600mg, or 1200mg levels, while a small group of male subjects received an intramuscular dose of 600mg. Researchers measured RPV plasma levels and tissue concentrations on a regular schedule over the course of 84 days.
The results of the study indicate that all RPV-LA doses were well-tolerated, gave no serious adverse events and exhibited prolonged plasma and body tissue exposure, which supports further exploration of RPV-LA as a potential PrEP agent. The RPV-LA project is currently in the early stages of development and additional studies exploring the safety, pharmacokinetics and pharmacodynamics of RPV-LA after multiple injections will be needed to determine the next steps in the development of RPV-LA.
Regulatory Updates (as of 1 June 2012)
registration efforts are helping make Janssen HIV medicines available to patients in need in resource-limited countries. Recent regulatory filings include submissions for the EDURANT (rilpivirine) 25mg formulation for treatment-naïve adults with HIV infection in South Africa, Thailand, Vietnam, India and Indonesia; INTELENCE® (etravirine) 100mg formulation in Nigeria, and Vietnam; and the PREZISTA® (darunavir) 75mg & 150mg pediatric formulations for treatment-experienced patients in South Africa, Aruba, Honduras, Jamaica, El Salvador, Nicaragua and Guatemala. Additionally, the INTELENCE® 100mgformulation has received regulatory approval in Zambia.
For additional information about our products, please visit: www.janssentherapeutics.com/our-products
World Health Organization. "TB/ HIV Facts at a Glance." Accessed from www.who.int/tb/challenges/hiv/facts/en/index.html,
and World Health Organization. Tuberculosis Fact Sheet. Accessed from www.who.int/mediacentre/factsheets/fs104/en/index.html
Will P Stephens
Global Access and Partnerships