The Promise of Relief

A steady pace of regulatory milestones is the mark of productive R&D efforts, critical to future growth and to meeting the needs of doctors, nurses and patients. Johnson & Johnson pharmaceutical operating companies launched multiple new products around the world during 2009, including four that address significant unmet medical needs:

SIMPONI™ (golimumab) was approved for the treatment of moderate to severe rheumatoid arthritis with the medicine methotrexate, active psoriatic arthritis alone or with methotrexate, and active ankylosing spondylitis by regulatory authorities in Canada, Europe and the United States. SIMPONI™ is administered subcutaneously (under the skin) once a month using a novel autoinjector or a prefilled syringe. The efficacy and safety of SIMPONI™ were shown in a Phase III development program with more than 2,000 patients.

STELARA™ (ustekinumab) is a first-in-class biologic treatment for moderate to severe plaque psoriasis that is administered subcutaneously once every 12 weeks following two starter doses. Psoriasis is a chronic immune-related disease that affects an estimated 125 million people worldwide and can present in various forms, ranging from mild to severe and disabling. With marketing approvals in 2009 in Europe, the United States, Brazil, Mexico, Australia and Singapore, STELARA™ is now approved in 44 countries.

The U.S. Food and Drug Administration (FDA) approved NUCYNTA® (tapentadol) Immediate Release Tablets, the first new molecule in analgesia in over 25 years for the relief of moderate to severe acute pain in patients age 18 or older. NUCYNTA® is a single molecule with a different approach to pain relief. In December, a New Drug Application was submitted to the FDA for tapentadol extended release (ER) tablets for the management of moderate to severe chronic pain.(1)

The FDA approved INVEGA® SUSTENNA™ (paliperidone palmitate), the first once-monthly atypical antipsychotic for the treatment of schizophrenia.

Our pipeline is robust. We expect to file several new compounds between now and 2013 and expand our core products with new indications. See the Pharmaceutical Pipeline chart at www.investor.jnj.com.

  • (1) NUCYNTA® is co-developed with Grünenthal GmbH.