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Janssen Research & Development Release: STELARA™ Awarded 2012 International Prix Galien


10/5/2012 11:59:54 AM

SPRING HOUSE, Pa., Oct. 5, 2012 /PRNewswire/ -- Janssen Research & Development, LLC ("Janssen") announced today that STELARA® (ustekinumab) has been awarded the prestigious 2012 International Prix Galien Award at a ceremony in Lyon, France. The Prix Galien Award recognizes extraordinary efforts in biopharmaceutical and medical technology research and development by honoring biomedical advances impacting both individuals and public health in the past decade. The honor is acknowledgment of the technical, scientific and clinical research skills necessary to develop innovative medicines and devices.

"It is a tremendous honor for Janssen to be recognized with the International Prix Galien Award for STELARA," said Jay P. Siegel, M.D., Chief Biotechnology Officer and Head, Global Regulatory Affairs, Janssen Research & Development, LLC. "We remain focused on bringing innovative medicines, like STELARA, to patients and health care professionals around the world."

STELARA is a human monoclonal antibody currently approved in more than 60 countries, including Canada, Europe, the United States, Brazil, Mexico, Australia and Japan, for the treatment of moderate to severe plaque psoriasis.

"STELARA exemplifies the convergence of science, technology and medicine," added Susan Dillon, Ph.D., Global Therapeutic Area Head, Immunology, Janssen Research & Development, LLC. "We are proud of the difference that STELARA has and continues to make in the lives of patients battling moderate to severe plaque psoriasis, and are humbled to receive the International Prix Galien Award."

Considered the industry's highest accolade, the international Prix Galien Award is given every other year and selected from previous national contest Prix Galien winners. STELARA received the Prix Galien USA Best Biotechnology Product Award in 2011 and the Prix Galien Canada Innovative Product Award in 2010. Prix Galien was first established in 1970 by French pharmacist Roland Mehl, and the international award was inaugurated in 1990.

About Psoriasis
Psoriasis is a chronic, immune-mediated disease that results from the overproduction of skin cells, resulting in their accumulation on the surface of the skin, which causes red, scaly plaques that may bleed. It is estimated approximately 7.5 million Americans and nearly 3 percent of the world's population are living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.

About STELARA
STELARA, a human interleukin (IL)-12 and IL-23 antagonist, is approved for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in psoriasis.

Janssen Biotech, Inc. discovered STELARA and has exclusive marketing rights to the product in the United States. The Janssen pharmaceutical companies maintain exclusive worldwide marketing rights to STELARA, which is currently approved for the treatment of moderate to severe plaque psoriasis in 65 countries. For more information about STELARA, visit www.STELARAinfo.com.

Important Safety Information
STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:

Serious Infections
STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

  • Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®.
  • If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA®.

You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay.

Before starting STELARA®, tell your doctor if you think you have an infection or have symptoms of an infection such as:

  • fever, sweats, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in your phlegm
  • weight loss
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal
  • feel very tired
  • are being treated for an infection
  • get a lot of infections or have infections that keep coming back
  • have TB, or have been in close contact with someone who has TB

After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above).

STELARA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. It is not known if people who take STELARA® will get any of these infections because of the effects of STELARA® on these proteins.

Cancer
STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer.

Reversible posterior leukoencephalopathy syndrome (RPLS)
RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.

Serious Allergic Reactions
Serious allergic reactions can occur. Get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, trouble breathing, throat or chest tightness, or skin rash.

Before receiving STELARA®, tell your doctor if you:

  • have any of the conditions or symptoms listed above for serious infections, cancer, or RPLS
  • have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA® should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before taking STELARA® or one year after you stop taking STELARA®. Non-live vaccinations received while taking STELARA® may not fully protect you from disease.
  • are receiving or have received allergy shots, especially for serious allergic reactions
  • ever had an allergic reaction to STELARA®
  • receive phototherapy for your psoriasis
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if STELARA® will harm your unborn baby. You and your doctor should decide if you will take STELARA®.
  • are breast-feeding or plan to breast-feed. It is thought that STELARA® passes into your breast milk. You should not breast-feed while taking STELARA® without first talking to your doctor.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • other medicines that affect your immune system
  • certain medicines that can affect how your liver breaks down other medicines

Common side effects of STELARA® include: upper respiratory infections, headache, and tiredness

These are not all of the side effects with STELARA®. Tell your doctor about any side effect that bothers you or does not go away. Ask your doctor or pharmacist for more information.

Please read the Medication Guide for STELARA® and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The U.S. full prescribing information for STELARA® can be accessed at the following link: http://www.stelarainfo.com/pdf/PrescribingInformation.pdf

About Janssen Research & Development, LLC
At Janssen Research & Development, LLC, we are united and energized by one mission -- to discover and develop innovative medicines that ease patients' suffering, and solve the most important unmet medical needs of our time. As one of the Janssen Pharmaceutical Companies of Johnson & Johnson, our strategy is to identify the biggest unmet medical needs and match them with the best science, internal or external, to find solutions for patients worldwide. We leverage our world-class discovery and development expertise, and operational excellence, to bring innovative, effective treatments in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. For more information on Janssen R&D, visit http://www.janssenrnd.com/.

SOURCE Janssen Research & Development, LLC


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