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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