Eurand says Zenpap important to Q1 growth that recent FDA move provides the drug with significant potential for further expansion in cystic fibrosis (CF) market
For the three months ended March 31 the drug delivery technology specialist reported operating income of €1.4m ($1.73m), up from just $60,000 in the comparable quarter in 2009.
Revenue for the period also increased, climbing 7 per cent from Q1 last year to $31.1m thanks in part to improved contributions from partnered drug products it manufactures including Amrix, Ultrase and Lamictal ODT.
However, the majority of the growth came from the delayed-release pancreatic insufficiency (EPI) drug Zenpep, which generated revenue of “approximately $2m” according to CFO Mario Crovetto.
The importance of this contribution was echoed by CEO Gearoid Faherty who said that: “We are delighted to report another solid quarter and we are particularly pleased by the recent growth in Zenpep sales.”
Much of the Zenpep growth can be attributed to the recent US Food and Drug Administration (FDA) clampdown on pancreatic enzyme derived products (PEP) that had been on the market despite not being approved by the agency.
This move, undertaken late last month, meant that Zenpep is one of three PEP products approved by the FDA for the treatment of cystic-fibrosis (CF) related EPI.
This according to Faherty means that Zenpep, along with other products in Eurand’s pancrelipase range, will be an important revenue driver for the rest of 2010.
“We believe that the FDA's recent enforcement of its April 28th, 2010 deadline and the decision by CMS to cease Medicaid rebates for certain unapproved PEPs create a substantial market opportunity for Zenpep.
“These actions have created a competitive landscape that we believe presents a unique window of opportunity for Zenpep as one of just two currently FDA-approved PEPs on the market to gain market share."
Recent data from IMS Health suggests that the global PEP market is worth some $1.5bn a year.