Cimzia(R) (certolizumab pegol) Now Available for Self-Administration in Adult Patients With Moderate to Severe Crohn's Disease

UCB today announced that Cimzia(R) (certolizumab pegol), the only PEGylated anti-TNF (Tumor Necrosis Factor) approved in the U.S. for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have had an inadequate response to conventional therapy, is now available for self-administration in a prefilled syringe designed in partnership with OXO GOOD GRIPS(R) a company dedicated to providing innovative consumer products that make everyday life easier.

"We looked at a variety of unmet needs for Crohn's disease patients and found that many prefer a prefilled syringe when taking biologic medications," said David Robinson, vice president and general manager of UCB's Immunology Business Unit. "This newly designed, easy-to-use syringe, developed with a renowned consumer products company like OXO(R), will enable many patients to conveniently self-administer their therapy every four weeks."

The Cimzia(R) prefilled syringe, designed by UCB in partnership with OXO GOOD GRIPS(R) is available exclusively for use with Cimzia(R). The companies recognized the importance of designing a syringe and packaging components with the patient in mind to provide ease of use, comfort, control and confidence.

The new syringe provides a soft, non-slip grip on the flange which allows the patients to hold the syringe steady using various grip positions so it is easy and comfortable to use. The large and soft thumb pad on the plunger makes it easy to push for patients. The rounded finger loop allows for easy removal of the needle cover. The easy-to-read syringe barrel helps to ensure patients receive the entire dose as they can see the medicine inside and know when they have injected all of the medication. Additionally, the packaging utilizes Velcro(R) for easy opening and resealing.

In addition, the new Cimzia(R) prefilled syringe carries the Arthritis Foundation(R) Ease-of-Use Commendation. The Arthritis Foundation(R) created the program to encourage manufacturers to design user-friendly products and packaging. Manufacturers submit their products for testing by an independent lab experienced in the design and evaluation of products that are accessible to people with functional limitations due to the effects of arthritis.

Cimzia(R) was approved by the U.S. Food and Drug Administration on April 22, 2008 for reducing the signs and symptoms of moderate to severe Crohn's disease and maintaining clinical response in adult patients who have had an inadequate response to conventional therapy. The new prefilled syringe is now available to Crohn's patients taking Cimzia(R) for subcutaneous self-administration once every four weeks after initial doses once a physician has provided instruction for proper use.

The Crohn's approval was based on safety and efficacy data from clinical trials in more than 1,500 patients with Crohn's disease. Cimzia(R) was also recently approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis.

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FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall applies to the following lot number and product information:

-- Lot Number 813900
-- ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin

Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.

These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product.

The FDA urges patients and health care professionals to check their syringe packaging carefully for syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900.

Consumers and health care professionals who suspect they have the recalled product may also contact Covidien at 866-780-5436 or www.relion.com/recall for more information.

ReliOn Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle attached to the tip of the syringe.

During the packaging process for this lot, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin.

The manufacturer has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam's Clubs from Aug. 1, 2008, until Oct. 8, 2008.

Tyco Healthcare Group LP (Covidien) voluntarily recalled this lot of syringes on Oct. 9, 2008, asking that any units of the affected product be removed from inventory and placed in quarantine. Wal-Mart posted the recall announcement in Wal-Mart stores and Sam's Clubs, as well as on its Web site, and sent letters to more than 16,500 customers notifying them of the recall.

The manufacturer has received one adverse report related to a syringe from this product lot.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088

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