ImmuCell suspends Mast Out partnering effort, seeks FDA approval

Published on: Jul 18, 2013

ImmuCell Corp. announced July 18 that it has suspended its active pursuit of a partner for Mast Out, its nisin-based intramammary mastitis treatment product under development for dairy cows.

ImmuCell has presented this product opportunity to a variety of large and small animal health companies. According to an announcement, during the second quarter of 2013, ImmuCell received a $250,000 exclusive option payment from one prospective partner who decided not to execute a license after its final due diligence, which was conducted during the option period. This revenue will be recognized during the third quarter of 2013. Approximately $50,000 in related capitalized expenses will be written off during the third quarter of 2013.

ImmuCell was informed by the prospective partner that it "... could not cost effectively commercialize the product." During the protracted due diligence and negotiation process (which lasted more than 18 months), ImmuCell continued to move toward approval by the Food & Drug Administration's Center for Veterinary Medicine, gaining acceptance of the effectiveness and target animal safety technical sections. FDA acceptance of the chemistry, manufacturing and controls technical section represents the rate limiting step to final marketing approval, ImmuCell said.

"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," Michael F. Brigham, ImmuCell president and chief executive officer, said. "Having been unable to establish terms that 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 FDA approves the new animal drug application.