Emergency room patients who complain 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. An MRI scan is safer, but the images often aren’t sharp enough to make a proper diagnosis.
Enter Repligen Corp. The Waltham company is in the final stages of applying for Food and Drug Administration approval for synthetic human secretin (SecreFlo), a hormone-based drug 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.
Chief executive 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 said.
Repligen tried developing secretin more than five years ago to treat autism, but 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.
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 United States 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 said.
Repligen is still trying to make a mark as a drug developer, as well. But its recent efforts have been disappointing. In March, investors pounded Repligen’s stock down from nearly $5 a share to $3.50 on negative Phase 2 trial results of a drug it was developing to treat bipolar disorder. A positive pivotal trial of the company’s imaging product was released around the same time, but many investors were still disappointed, Herlihy acknowledges.
“If we had a safe and effective treatment for bipolar depression, that would be a blockbuster,’’ he said. Investors who were counting on that drug, he added, “exited the stock at that time.’’
Millipore was bought by Merck KGaA for $7 billion-plus in March 2010 and combined with EMD Chemicals, a Merck subsidiary in New Jersey. Recently, EMD Millipore named Robert Yates, a diagnostics veteran from Roche, as president. He succeeds Bernd Reckmann, the Merck executive who replaced Martin Madaus (another Roche veteran) as head of Millipore after the acquisition last year.
Amnis, spun out of the University of Washington in 1998, makes a device that provides detailed images of large numbers of cells, potentially enabling researchers to detect trace amounts of cancer in a blood sample or determine whether a drug will hit a particular protein target. Its customers include academic researchers and big drug makers. It had sales of $14 million in 2010.
Gregory T. Huang
■Adimab LLC, a Lebanon, N.H., provider of human antibody discovery technology, has formed discovery collaborations with Weston-based Biogen Idec Inc. and the Danish company Novo Nordisk.
Each pharmaceutical company will use Adimab technology to identify human antibodies against two targets. The specific targets and the dollar terms of the deals were not disclosed.
Both Novo Nordisk and Biogen Idec have the option to commercialize antibodies discovered from the Adimab partnership.
Adimab will receive upfront payments and preclinical milestones and could be eligible for clinical development milestones and sales royalties.
■The digital media and video-hosting firm Brightcove Inc. has filed papers with federal regulators indicating it hopes to raise $50 million in an initial public offering. Morgan Stanley and Stifel, Nicolaus & Co. will serve as joint book-running managers for the deal. Brightcove is based in Cambridge but plans a move to Boston.
This report was compiled by the editors of Xconomy, an online news website. Visit www.Xconomy.com/boston.