Friday, December 13, 2013
PORTLAND — ImmuCell Corp. said it suspended its efforts to find a partner for Mast Out, its mastitis treatment product under development for dairy cows, after failing to reach an agreement to commercialize the product.
Shares of ImmuCell fell 14 percent, or 55 cents, to $3.35 in morning trading.
Mastitis is inflammation of breast tissue.
ImmuCell had reached out to a variety of large and small animal health companies. During the second quarter, ImmuCell had received a $250,000 exclusive option payment from one prospective partner who decided not to pursue a license after its final due diligence, ImmuCell said.
ImmuCell was informed by the prospective partner that it “… could not cost effectively commercialize the product.” It did not name the potential partner.
During the due diligence and negotiation process, ImmuCell continued to move toward approval by the Center for Veterinary Medicine and U.S. Food and Drug Administration.
“We are encouraged by the feedback from all prospective partners that our novel mastitis treatment can achieve FDA approval and have a significant, positive impact on the dairy industry,” said ImmuCell President and Chief Executive Michael Brigham. “Having been unable to establish terms which we consider to be fair and reasonable to both parties, we have decided to complete the final stages of the FDA approval process on our own in order to realize the optimal value for our stockholders.”
Commercial sales of Mast Out cannot begin until the company's New Animal Drug Application is approved by the FDA. Previously, the FDA confirmed that the regulatory requirements to demonstrate effectiveness and safety had been met, as well as granting Mast Out both “zero milk discard” and “zero meat withhold” claims.
This novel regulatory clearance creates a significant economic benefit to dairy producers by allowing them to sell milk while a cow is being treated. No other intramammary mastitis treatment can claim this “no-discard” status, ImmuCell said.