ImmuCell going it alone on mastitis product approval

ImmuCell going it alone on mastitis product approval

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, and instead will seek final product approval on its own.

ImmuCell said it presented this product opportunity to a variety of large and small animal health companies and, during the second quarter of 2013, received a $250,000 exclusive option payment from one prospective partner.

ImmuCell reported that the prospective partner decided not to execute a license after its final due diligence, which was conducted during the option period.

During the protracted due diligence and negotiation process (which lasted more than 18 months), ImmuCell continued to work toward approval for Mast Out by the Food & Drug Administration's Center for Veterinary Medicine, gaining acceptance for the product's 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 (NADA).

ImmuCell explained that FDA previously confirmed that the regulatory requirements to demonstrate effectiveness and safety had been met, as well as taking the unprecedented step of granting Mast Out zero milk discard and zero meat withholding claims.

ImmuCell said its plan is to refocus its efforts on obtaining NADA approval of Mast Out.

Volume:85 Issue:30

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