Digestive Care, Inc. Announces FDA Approval of Infant–Specific Dose of PERTZYE® (pancrelipase) Delayed-Release Capsules to Treat Exocrine Pancreatic Insufficiency (EPI) Due to Cystic Fibrosis
The new formulation will be offered in 4,000 lipase units capsule
BETHLEHEM, Pa., October 10, 2016 — Digestive Care, Inc. (DCI) and its marketing partner in the U.S. cystic fibrosis community, Chiesi USA, Inc., today announced U.S. Food and Drug Administration (FDA) approval for an infant-specific dose of PERTZYE® (pancrelipase) in a 4,000 USP lipase units capsule. The new capsule strength will enable guideline-recommended dosing and administration of PERTZYE for infants (up to 12 months) with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.
The recommended dose of PERTZYE in infants is 4,000 USP lipase units, one capsule, per 120 mL of formula or breast-feeding. The new dose strength approval means that PERTZYE will now be available in three dosing options, providing for improved dosing options from infancy through adulthood.
"Together with Chiesi USA, we are excited to offer an FDA approved therapy for enzyme delivery for the smallest CF patients," said Tibor Sipos, Ph.D., President and Chief Scientific Officer, Digestive Care, Inc. "Cystic fibrosis is a complex condition for anyone and the digestive challenges patients face are compounded in the infant stage due to dosing needs, infant size and the required mode of delivery, which also plays a role in the infant's ability to properly benefit from the medicine."
To support administration to infants, the 4,000 lipase units capsule features a reduced microsphere size ranging from 0.8 — 1.4 mm in diameter. This is in contrast to the 8,000 and 16,000 lipase units capsules, which contain microspheres in the range of 0.8 — 2.2 mm in diameter. The largest microspheres in the 4,000 lipase units capsule are approximately 35 percent smaller than the largest microspheres in the 8,000 and 16,000 lipase units capsules.
"Chiesi USA is committed to delivering therapeutic treatment options that meet the unique health needs of people with cystic fibrosis," said Alan Roberts, Senior Vice President of Scientific Affairs at Chiesi USA, Inc. "We continue to work to expand treatment options in order to fill unmet needs, and our partnership with Digestive Care, Inc. is one of the ways that we bring innovative solutions to CF patients."
In addition, Chiesi USA serves CF patients' unique health needs with the Chiesi CareDirect program, a comprehensive patient program that can provide patients with prescription access, financial assistance, 1-on-1 support, and much more. For more information, please visit www.pertzyecf.com/savings-support/chiesi-caredirect/.
ABOUT PERTZYE (pancrelipase) DELAYED-RELEASE CAPSULES
PERTZYE® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
IMPORTANT SAFETY INFORMATION ABOUT PERTZYE
Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PERTZYE exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day).
To avoid irritation of oral mucosa, do not chew PERTZYE or retain in the mouth. Hyperuricemia may develop. Consider monitoring uric acid levels in patients with hyperuricemia, gout, or renal impairment.
There is theoretical risk of viral transmission with all pancreatic enzyme products including PERTZYE.
Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.
The most common adverse reactions (≥10% of patients treated with PERTZYE) are diarrhea, dyspepsia, and cough.
PERTZYE® full Prescribing Information and Medication Guide are available at www.pertzyecf.com.
PERTZYE® (pancrelipase) is owned by Digestive Care, Inc. and is licensed to Chiesi USA for sales and marketing purposes in the United States.
About Digestive Care, Inc.
Digestive Care, Inc., headquartered in Bethlehem, PA, is a fully integrated pharmaceutical company, founded in 1990, dedicated to developing unique pharmaceutical products to alleviate complications and symptoms of gastrointestinal disorders. For more information, visit www.digestivecare.com.
Chiesi USA, Inc.
Chiesi USA, Inc., headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets. Key elements of the Company's strategy are to focus its commercial and development efforts in the hospital and adjacent specialty product sector within the U.S. pharmaceutical marketplace; continue to seek opportunities to acquire companies, marketed or registration-stage products and late-stage development products that fit within the Company's focus areas; and generate revenues by marketing approved generic products through the Company's wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. Chiesi USA, Inc. is a wholly-owned subsidiary of Chiesi Farmaceutici S.p.A. For more information, visit www.chiesiusa.com.