Repligen Seeks Approval for Imaging Product While Pursuing Rare-Disease Drugs and Manufacturing Platform

9/1/11Follow @arleneweintraub

Patients who arrive in the emergency room complaining of abdominal pain often have to undergo a type of endoscopy—an invasive and sometimes dangerous test— so doctors can determine if the problem is in the pancreas. Taking an MRI scan is a safer alternative, but the resulting images often aren’t sharp enough to make a proper diagnosis.

Enter Repligen (NASDAQ: RGEN). The Waltham, MA-based company is in the final stages of applying for FDA approval for synthetic human secretin (SecreFlo), a hormone-based drug that’s designed to enhance MRI images of the pancreas. The FDA has granted the product fast-track status, meaning it has vowed to hand Repligen its verdict within six months of receiving the application. Even though Repligen is pursuing other opportunities, CEO Walter Herlihy is counting on the imaging product to boost Repligen’s profile as a commercial player. “The hormone is very specific for the pancreas, and that opens up the potential for exciting applications,” Herlihy says.

Repligen initially tried developing secretin more than five years ago to treat autism, but clinical trial results were disappointing. So scientists there started looking into a different capability that they knew the hormone possessed: It stimulated the ducts in the pancreas to fill with water, which made them appear bright enough in MRI images for physicians to make a diagnosis and come up with a treatment plan for abdominal problems.

The company is applying for FDA approval in pancreatitis, an inflammatory condition, which it estimates is at least a $100 million-a-year opportunity in the U.S. and Europe. Repligen is also examining the hormone’s utility in other pancreatic diseases. The market opportunity could double if the product is approved for the diagnosis of pancreatic cancer, Herlihy says. Proper imaging “is a critical point in the treatment of this cancer,” he says. “If a surgeon can get the tumor out early, it greatly increases the chance of the patient having a good outcome.” Repligen has recently initiated a trial in pancreatic cancer, with the goal of eventually applying to the FDA for a label expansion.

For the fiscal year ending in March, Repligen broke even on sales of $27 million—more than half of which came from Opus, a technology platform the company acquired last year when it purchased BioFlash Partners, a Marlborough, MA-based company. Manufacturers of biotech drugs use Opus to simplify … Next Page »

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