Product
Zenpep
Approval Date
August 28, 2009
Release Date
Fourth quarter of 2009
Company
Eurand
Class
Pancreatic enzyme product (PEP)
Indication
Delayed-release capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions. Zenpep is the only FDA-approved pancreatic enzyme product (PEP) that has been evaluated in clinical studies in adults and children—including children from one to 12 years old—and will offer four dosage strengths to meet the varied needs of infants, toddlers, adolescents and adults with EPI.
Active Ingredient
Pancrelipase
Agency Roster
Lab 9—primary agency
T&D Partners—conventions
Marketing Strategy/Execution
Zenpep was developed specifically to meet the FDA’s guidelines on PEPs. Historically, PEPs have not been regulated and approved by the FDA. In 2004, due to inconsistent quality that affected the safety and efficacy of PEPs, the FDA determined it was necessary to better control these products. All manufacturers of EPI drug products were required to file NDAs and receive marketing approvals by April 2010.
The US commercial launch of Zenpep is planned for the fourth quarter of 2009. Eurand will market Zenpep for the approved indication through its own sales force to the different physician groups that treat EPI within each of the target CF and non-CF patient populations.
Physician Outlook
Eurand’s Zenpep is the first FDA approved pancreatic enzyme product (PEP). Historically, PEPs were not FDA regulated, leading to inconsistent quality, safety and efficacy. Zenpep is indicated for use in both adults and children (ages one to 12) with cystic fibrosis and other conditions that compromise pancreatic function. Zenpep will afford physicians constancy in managing patients’ Exocrine Pancreatic Insufficiency (EPI), which is critical to maintaining proper nutrition.
—Mary McBride, Associate Vice President, Research, GfK Healthcare
Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: ALTU 135
Manufacturer: Cystic Fibrosis Foundation Therapeutics/ Alnara Pharmaceuticals
Indication: Pancreatic disorders
Active ingredient: Liprotamase
Phase: III
Source: Wolters Kluwer Pharma Solutions
Recent MM&M Coverage
The Top 75: Lab9
Pharmacology
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Clinical Trials
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adverse Reactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adults
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Children
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Contraindications
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Precautions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Interactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
