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Launch includes a delayed-release formulation, in-house and contract sales force, a REMS program and a patient-adherence program
Difficult diseases call for extra effort by biopharma companies to meet patient needs, but the situation for Zenpep (pancrelipase) is extraordinarily complex for its many moving parts. The product launch includes formulation to provide an enteric coating (based on Eurand’s Minitabs technology, one of several controlled-release technologies it offers), a risk-evaluation and mitigation strategy (REMS), and a patient-adherence program, called Z-Points. In addition, Eurand is selling the product into two markets: cystic fibrosis (and to this goal Eurand conducted clinical trials on children) and patients with pancreatic enzyme insufficiency. The CF market will be handled by an in-house sales force, calling on some 120 CF centers across the country, while other pancreatic conditions will be handled by a contract sales force from Innovex.
Zenpep, which was approved by FDA last August, is one of two drugs (the other is Creon [pancrelipase], from Solvay, approved last April) to have met FDA approval following the agency’s 2004 decision that pancreatic enzyme products (which have been on the market for decades) needed clinical trials. By formulating the drug as a coated bead, Eurand can deliver a measured dose to patients—a medical hurdle that was poorly handled by older forms of pancrelipase. The REMS requirement, which consists of a patient medication guide, arose because patients need to coordinate their eating habits closely with the drug regimen. And “because we wanted to treat the whole patient, and not just the pancreatic condition,” comments, Mike Walters, EVP at Eurand, “we’ve instituted the Z-Points compliance program, which allows patients to accumulate credits toward the purchase of a nebulizer for treating lung problems, or for purchasing foods formulated for CF patients.” Walters was president at CF Source, a company Eurand bought in 2007 in the run-up to commercializing Zenpep.
And that Innovex contract sales force? “Eurand has a small core sales force, and we decided it was better to contract non-CF sales rather than build out our organization,” says Walter. “With the contractions in pharma sales forces, it’s a unique time to pick up specialized expertise like gastrointestinal sales experience at this time.”
Although it’s early in the product rollout, Walters says that the company is “very pleased” with the response it has received so far. Eurand cites IMS Health data that the pancreatic insufficiency market was $1.13 billion worldwide in 2008.