Eurand Announces National Title Sponsorship of New Cystic Fibrosis Foundation Fundraiser

BETHESDA, MD--(Marketwire - May 03, 2010) - Eurand N.V. (NASDAQ: EURX), a global specialty pharmaceutical company, has announced its national title sponsorship of the inaugural ZENPEP® CF Cycle for Life tour series, a new fundraising event of the Cystic Fibrosis Foundation. The announcement was made at the CF Foundation’s national headquarters, with Eurand donating $300,000 to support vital cystic fibrosis programs and research. Launching in the summer and fall of 2010, ZENPEP CF Cycle for Life is a series of one-day cycling tours to be held in 18 U.S. cities, where thousands of cyclists will come together to raise money to help find a cure for cystic fibrosis.

“Eurand is proud to serve as national sponsor of the inaugural ZENPEP CF Cycle for Life series,” said Ruth Thieroff-Ekerdt, M.D., Eurand’s Chief Medical Officer. “We’re pleased to support the Cystic Fibrosis Foundation in its efforts to advance life-saving medical research for CF and develop therapies that have the potential to add decades of life for those with this devastating disease.”

Eurand manufactures and markets ZENPEP® (pancrelipase) Delayed-Release Capsules, an FDA-approved pancreatic enzyme product (PEP) indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions. This condition affects approximately 90% of patients with CF.

“We are thrilled by Eurand Pharmaceuticals’ commitment to help support the Cystic Fibrosis Foundation’s mission and the CF Cycle for Life series,” said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation. “With Eurand’s support of this event, the CF Foundation looks forward to continuing the fight against cystic fibrosis, helping patients live longer, healthier lives.”

ZENPEP was approved by the FDA on August 27, 2009 and launched in November. For patients, families and caregivers affected by the FDA’s April 28, 2010 deadline, which the FDA indicated as a Stop Distribution date for unapproved PEPs, ZENPEP® is available in pharmacies nationwide. “We hope the ZENPEP CF Cycle for Life series also will raise awareness of the need for patients with EPI to use approved pancreatic enzyme therapies, which meet the FDA’s current safety, effectiveness and product-quality standards,” Thieroff-Ekerdt said.

The 2010 ZENPEP CF Cycle for Life series begins on June 26 in San Francisco, Calif. Other cities include Atlanta, Baton Rouge, La., Boston, Charleston, S.C., Denver, Dayton, Ohio, Grand Rapids, Mich., Hartford, Conn., Jacksonville, Fla., Portland, Ore., Malvern, Pa., Peoria, Ill., Phoenix, San Diego, Seattle, Tampa, Fla., and Tyler, Texas.

For more information about the Cystic Fibrosis Foundation and the ZENPEP CF Cycle for Life, visit: http://www.cff.org/aboutCFFoundation/NewsEvents/2010NewsArchive/CF-Foundation-Launches-ZENPEP-CF-Cycle-for-Life.cfm

About the Cystic Fibrosis Foundation

The Cystic Fibrosis Foundation is the world’s leader in the search for a cure for cystic fibrosis. The Foundation funds more CF research than any other organization and nearly every CF drug available today was made possible because of Foundation support. Based in Bethesda, Md., the Foundation also supports and accredits a national care center network that has been recognized by the National Institutes of Health as a model of care for a chronic disease. For more information visit www.cff.org.

About ZENPEP® (pancrelipase) Delayed-Release Capsules

ZENPEP is an FDA-approved, innovatively formulated pancreatic enzyme product for the treatment of exocrine pancreatic insufficiency. The product was developed in response to the 2004 FDA initial guidance on pancreatic enzyme products, which outlined the need to reduce the variability in enzyme levels, address stability issues associated with unapproved enzyme therapies and regulate them under NDAs. ZENPEP is a highly stable formulation of a porcine pancreatic extract that mimics the endogenous human pancreatic secretions necessary for proper human digestion.

Every dose of ZENPEP provides patients and physicians with the main pancreatic enzymes lipase, protease and amylase. This formulation with 100% labeled lipase content, without overage, allows health care professionals to fine tune treatment regimens to achieve dosing precision and provide patients with EPI enhanced symptom control for improved freedom from GI symptoms while also significantly increasing the protein and fat absorption a patient needs to thrive normally. Safety and efficacy of ZENPEP in EPI were demonstrated in two multicenter Phase III clinical trials in adult and pediatric patients as young as one year old. Good nutritional status is considered to be critically important to growth characteristics in children with cystic fibrosis.

Important Safety Information

ZENPEP has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks. As part of the REMS, a Medication Guide with important dosing and safety information about ZENPEP will be handed out with each new prescription and refill.

The REMS and Medication Guide address the risk associated with the use of ZENPEP, including fibrosing colonopathy, a rare, serious adverse reaction that has been reported following treatment with high-dose use of pancreatic enzyme replacement therapy in the treatment of cystic fibrosis patients usually over a prolonged time period. The total daily dose of ZENPEP should not exceed 10,000 lipase units/kg of body weight/day, and caution should be used with doses exceeding 2,500 lipase units/kg of body weight per meal. Also, there is a theoretical risk of transmission of viral disease, since ZENPEP, as other porcine-derived pancreatic enzymes, is sourced from pancreatic tissue from swine used for food consumption. No cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.

Care should be taken to ensure that ZENPEP is not chewed or retained in the mouth to avoid irritation of oral mucosa and/or loss of enzyme activity, and the capsules or beads should be swallowed immediately with adequate amounts of liquid. Caution should be exercised when using ZENPEP in patients with gout, renal impairment, or hyperuricemia; porcine-derived pancreatic enzyme products may increase blood uric acid levels. Caution should be exercised for patients with known allergies to proteins of porcine origin. In rare instances, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus have been reported with other pancreatic enzyme products with different formulations of the same active ingredient, pancrelipase, as that of ZENPEP.

In clinical trials assessing the short-term safety of ZENPEP, the incidence of adverse events (regardless of causality) was similar during double-blind ZENPEP treatment and placebo treatment. The most commonly reported adverse events occurring in at least two patients (≥6% of patients) included: abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion. The type and incidence of adverse events were similar in children and adults.

For complete information about safety, warnings and precautions for ZENPEP, please see full Prescribing Information and Medication Guide at www.zenpep.com.

About Eurand

Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies. Eurand has had six products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Its technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles and taste-masking orally disintegrating tablet (ODT) formulations. Eurand is a global company with facilities in the U.S. and Europe. For more information, visit Eurand’s website at www.eurand.com.


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