* Expects to launch Zenpep in Q4
* Intends to deploy own salesforce to market drug
* Shares up 34 pct in pre-market trade
(Adds details, stock movement)
Aug 28 - Specialty pharmaceutical company Eurand NV (EURX.O) said U.S. health regulators approved its pancreatic enzyme product, Zenpep, to treat the inability to digest food due to a lack of enzymes made by the pancreas.
The drug would come in four doses to meet the requirements of infants, toddlers, adolescents and adults.
Zenpep is the only approved treatment for exocrine pancreatic insufficiency (EPI), a relatively rare condition, the company said.
EPI is a common disorder for those suffering from cystic fibrosis and other conditions including pancreatic cancer and chronic pancreatitis.
Eurand, which plans to deploy its own salesforce to market the product, expects to launch Zenpep in the fourth quarter.
Zenpep, which was delayed by the U.S. Food and Drug Administration by three months to complete its review, has been approved with a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of the drug outweigh its risks.
According to IMS Health, the market for pancreatic enzyme products was about $1.13 billion worldwide in 2008, the company said.
Shares of the company were up 34 percent in pre-market trade from their Thursday's close of $13.45.
(Reporting by Anand Basu in Bangalore; Editing by Vinu Pilakkott)