Biopharmaceuticals FDA

 News Release - April 13, 2010

FDA Approves New Drug Application for PANCREAZE(TM)

Pancreatic Enzyme Therapy Approved by FDA to Treat Exocrine Pancreatic Insufficiency

RARITAN, N.J., April 13 -- (Healthcare Sales & Marketing Network) -- Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) announced that the U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for PANCREAZE™ (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Exocrine pancreatic insufficiency is the inability to properly digest and absorb food due to a lack of enzymes made by the pancreas that are important in the digestion of fats, proteins, and sugars.

PANCREAZE is a combination of porcine-derived lipases, proteases, and amylases(1). Prior to FDA approval of PANCREAZE, PANCREASE MT has been available in the United States since the 1980's from McNeil Pediatrics, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. The FDA approval is a result of J&JPRD's response to the 2004 FDA requirement(2) that all pancreatic enzyme products be made available by prescription only and be approved through the new drug application process to standardize manufacturing procedures and enzyme activity in pancreatic enzyme products. New clinical trials evaluating efficacy and safety in infants, children and adults with cystic fibrosis were performed by J&JPRD to support the approval for PANCREAZE. In addition to complying with the requirements of the Federal Register notice, the product name was changed to conform to the FDA's current nomenclature guidance for new products.

"Certain medical conditions can decrease the amount of digestive enzymes that are normally produced by the pancreas. When the body does not have enough of these enzymes, it becomes more difficult to digest fats, proteins and sugars," said Bruce Trapnell, M.D., Francis R. Luther Professor of Medicine and Pediatrics, University of Cincinnati School of Medicine and principal investigator for one of the clinical trials on PANCREAZE. "I'm pleased the FDA has approved PANCREAZE, so that patients who are unable to produce enough pancreatic enzymes can now receive this prescription treatment."

About PANCREAZE

PANCREAZE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions. PANCREAZE may help your body use fats, proteins, and sugars from food.

PANCREAZE contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.

PANCREAZE is safe and effective in children when taken as prescribed by your doctor.

PANCREAZE capsules will be marketed by McNeil Pediatrics, a Division of Ortho-McNeil-Pharmaceuticals, Inc., and will be available in 4,200, 10,500, 16,800 and 21,000 doses by lipase units.

PANCREAZE will be available in pharmacies in the next few months.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about PANCREAZE?

• PANCREAZE may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you.

Call your doctor right away if you have any unusual or severe stomach area (abdominal) pain, bloating, trouble passing stool (having bowel movements), nausea, vomiting, or diarrhea.

Take PANCREAZE exactly as prescribed by your doctor. Do not take more or less PANCREAZE than directed by your doctor.

What are the possible side effects of PANCREAZE?

PANCREAZE may cause serious side effects, including:

• A rare bowel disorder called fibrosing colonopathy.
• Irritation of the inside of your mouth. This can happen if PANCREAZE is not swallowed completely.
• Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase in your blood uric acid levels
• Allergic reactions including trouble with breathing, skin rashes, or swollen lips.

Call your doctor right away if you have any of these symptoms.

The most common side effects include pain in your stomach (abdominal pain) and gas.

Other possible side effects: PANCREAZE and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.

These are not all the side effects of PANCREAZE. Talk to your doctor about any side effect that bothers you or does not go away.

You may report side effects FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to McNeil Pediatrics at 1-800-526-7736.

What should I tell my doctor before taking PANCREAZE?

Tell your doctor if you:

• are allergic to pork (pig) products.
• have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy).
• have gout, kidney disease, or high blood uric acid (hyperuricemia).
• have trouble swallowing capsules.
• have any other medical condition.
• are pregnant or plan to become pregnant.
• are breast-feeding or plan to breast-feed.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

The Product Information and Medication Guide for PANCREAZE is available at www.rxforsafety.com

About J&JPRD

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a member of the Johnson & Johnson family of companies, the world's most broadly-based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including Neuroscience, Infectious Disease, Immunology, Metabolic/Cardiovascular disease and Oncology, to address unmet medical needs worldwide. More information can be found at http://www.jnjpharmarnd.com.

About McNeil Pediatrics™

McNeil Pediatrics™, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is committed to meeting the needs of children, adolescents, adults and healthcare professionals through the development of therapies specifically formulated for children, adolescents and adults. McNeil Pediatrics™ is a leader in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and markets a leading medication prescribed in the United States for children, adolescents and adults with ADHD. The company is headquartered in Titusville, NJ. Visit www.McNeilPediatrics.net for more information.

(1) Lipase, protease, and amylase are digestive enzymes normally produced by the pancreas to break down fats, proteins, and sugars

(2) Department of Health and Human Services: Exocrine Pancreatic Insufficiency Drug Products; Draft Guidance for Submitting New Drug Applications; Notices:Federal Register / Vol. 69, No. 82 / Wednesday, April 28, 2004 / Notices

Source: Johnson & Johnson

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