Touching More Patients
Global growth and market expansion of core brands proved successful pharmaceutical business drivers in 2009.
Several core brands in three franchise areas—Infectious Disease, Immunology and Neuroscience—achieved regulatory milestones, broadening the patient populations who can benefit. These include PREZISTA® (darunavir), INTELENCE® (etravirine) and REMICADE® (infliximab).
In early 2009, the European Commission approved once-daily dosing of 800 mg PREZISTA® (darunavir), a protease inhibitor, with low-dose ritonavir as part of combination therapy in treatment-naive adults (those who have not previously taken HIV medication). This approval broadens the previous indication of darunavir for treatment-experienced HIV-1 patients.
Following the U.S. Food and Drug Administration’s December 2008 approval of PREZISTA®, co-administered with ritonavir and other antiretroviral agents, for the treatment of HIV infection in pediatric patients age 6 and up, a lower-dose (75 mg) formulation of PREZISTA® for pediatric HIV patients was introduced in the U.S. in February 2009. Applications were also submitted in 35 other countries.
A non-nucleoside reverse transcriptase inhibitor (NNRTI), INTELENCE® (etravirine) is the first medication in the class to demonstrate antiviral activity against NNRTI-resistant virus. Nineteen additional countries approved the use of INTELENCE® in treatment-experienced patients, including Brazil, China, Croatia, Israel and Chile. INTELENCE® is now approved in 59 countries in Europe, the Middle East & Africa (EMEA), the Americas and Asia-Pacific.
An impressive example of the strategy to address unmet needs by investigating and seeking approval for additional indications—building a “pipeline in a product”—REMICADE® (infliximab) continues to meet the health care needs of patients with a number of inflammatory diseases involving the immune system. These include chronic, severe plaque psoriasis, moderate to severe rheumatoid arthritis, active psoriatic arthritis, moderate to severe Crohn’s disease in adults and children, moderate to severe ulcerative colitis and active ankylosing spondylitis.
REMICADE® is available in 91 countries and has achieved approvals for 15 indications.(2) Worldwide, REMICADE® has been used to treat more than 1 million patients. It is part of a growing immunology portfolio that includes other potentially versatile compounds.
Pursuing the Best Science
Breakthrough solutions can come from many sources. Several significant scientific collaborations and acquisitions evidence a pursuit of the best science to uncover these solutions and improve the odds of success for products and patients in areas of high unmet needs. These are a few examples related to R&D efforts in oncology and infectious diseases:
Johnson & Johnson and Tianjin Medical University Cancer Hospital in China established a partnership in February 2008. At the hospital, tumor specimens are collected from patients and catalogued, allowing scientists to identify biomarkers that could help personalize medicine and advance cancer treatment.
Johnson & Johnson acquired Cougar Biotechnology, Inc. in July 2009. Clinical trials are under way on a compound for the treatment of prostate cancer, a disease that accounts for 10 percent of cancer-related deaths in the United States.
In July 2009, Tibotec Pharmaceuticals entered into a license and collaboration agreement with Gilead Sciences, Inc. for the development and commercialization of a new once-daily, fixed-dose antiretroviral product.
In June 2009, Tibotec, Inc. announced a collaboration with the Global Alliance for TB Drug Development to accelerate the discovery and development of new drugs to fight tuberculosis. Among infectious diseases, TB is the second most common cause of adult deaths worldwide.
In May 2009, Tibotec-Virco Virology BVBA and Siemens Healthcare Diagnostics Inc. announced a licensing agreement that will allow Tibotec-Virco Virology BVBA to develop a new research technology platform to assist with the development of antivirals for the treatment of hepatitis C virus (HCV). More than 170 million people worldwide are infected with HCV, a virus that can lead to serious and fatal diseases of the liver.
- (2) Centocor Ortho Biotech, Inc. has marketing rights REMICADE® in the U.S., while Xian-Janssen Pharmaceutical, Ltd. markets the product in China and Janssen-Cilag in Hong Kong. Distribution agreements are in place with Merck & Co., Inc. and Mitsubishi Tanabe Pharma Corporation in other markets throughout the world.