STELARA® Awarded 2011 Prix Galien USA in Best Biotechnology Product Category

HORSHAM, Pa., Sept. 28, 2011 /PRNewswire/ -- Janssen Biotech, Inc. announced today that STELARA® (ustekinumab) has been awarded the prestigious 2011 Prix Galien USA Award in the category of Best Biotechnology Product.  The Prix Galien USA 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.  

Approved in the United States by the U.S. Food and Drug Administration (FDA) in September 2009 for the treatment of adults with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, STELARA is a human monoclonal antibody that selectively targets two cytokines, interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are believed to play a role in the development of psoriasis.  

"It is a tremendous honor to have STELARA recognized by the Prix Galien Committee as the Best Biotechnology Product," said Jay P. Siegel, M.D., Chief Biotechnology Officer and Head, Global Regulatory Affairs, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), one of the Janssen pharmaceutical companies.  "This achievement is representative of the drive, dedication and commitment of a global team of scientists spanning discovery, research, development and manufacturing."

"The unique mechanism of action of STELARA and the extensive psoriasis clinical program conducted underpin our continued commitment to innovation and developing additional treatment options in immunology," added Susan Dillon, Ph.D., Global Therapeutic Area Head, Immunology, J&JPRD.    

The Prix Galien Award recognizes the technical, scientific and clinical research skills necessary to develop innovative medicines and devices, and is considered the industry's highest accolade.  Prix Galien was first established in 1970 by French pharmacist Roland Mehl and was inaugurated in the United States in September 2007.  The Prix Galien USA award committee comprises eleven individuals including Nobel Laureates, founders of major biotech companies and editors of world-renowned biology journals.

"STELARA represents our company's commitment to patients by bringing innovative solutions to market for the treatment of immune-mediated diseases like psoriasis," said Robert Bazemore, President, Janssen Biotech, Inc.  "We are honored to be recognized for the significant contribution STELARA has made to the biopharmaceutical community, and importantly to patients in the U.S. who have benefited from this biologic medicine."

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.  For more information about STELARA, visit www.STELARAinfo.com.

Janssen Biotech, Inc. discovered STELARA and has exclusive marketing rights to the product in the United States.  Janssen companies have exclusive marketing rights in all countries outside of the United States.  

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.

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.

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

About Janssen Biotech, Inc.

Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology. Built upon a rich legacy of innovative firsts, Janssen Biotech has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Beyond its innovative medicines, Janssen Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and health care professionals have access to the latest treatment information, support services and quality care. For more information on Janssen Biotech, Inc. or its products, visit www.janssenbiotech.com.

Janssen Biotech is one of the Janssen pharmaceutical companies dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to people throughout the world.  Follow us on Twitter at www.twitter.com/JanssenUS.

SOURCE Janssen Biotech, Inc.



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