PORTLAND, Maine — After about 10 years of testing, publicly traded ImmuCell is moving ahead with expansion plans to produce the drug it developed for treating illness in milk cows, which it estimates costs the domestic dairy industry $2 billion annually.
“This is the first time we have a clear map to commercialization,” ImmuCell CEO Michael Brigham said in a telephone interview.
The Portland company earlier this month closed a public offering of 1.1 million shares to raise $5.3 million as part of that next phase, after spending about $12 million to develop and test its drug Mast Out, for treating the most common infection among milk cows, called mastitis.
ImmuCell plans to build the shell for its production facility this year on land behind its building at 56 Evergreen Drive.
That starts a long road to gaining additional approvals required by the Federal Drug Administration in order to get the drug to market, a process Brigham expects to be completed by 2018 or 2019.
The company’s drug aims to treat bacterial infection at the clinical stage, before it gets so severe that the cow’s milk has to be thrown away. A 2003 study by agricultural researchers at McGill University estimated there are about 20 to 40 subclinical cases of mastitis for every infection that gets to the clinical stage.
“The subclinical disease is largely ignored because you can sell that milk,” Brigham said of general dairy practice. “You’re not getting as much milk or the same quality of a milk, but you want it because you need revenue.”
That’s because treatment of the mammary gland infection with antibiotics typically requires taking the cow out of production. The active ingredient in ImmuCell’s drug, a proprietary strain of the food preservative Nisin, does not require taking the cow out of production, Brigham said.
“That can mean more treatment,” Brigham said, which would mean fewer cows dying or being killed for intractable cases of mastitis and less discarded milk.
The company has initial approvals from the FDA but will need additional review of its full-scale production before it starts selling the drug alongside its product First Defense, which bolsters the immune systems of newborn calves.
ImmuCell is up against giants in the industry such as Zoetis and Merck, but Brigham said the company has a competitive edge in seeking to change current treatment practice for mastitis.
That means the FDA would wait five years from ImmuCell’s final approval, expected around 2018 or 2019, before granting another company rights to market a similar Nisin-based treatment for mastitis.
The company reported quarterly earnings Wednesday, showing sales of First Defense rose 36 percent, to about $7 million, in calendar year 2015, which helped drive its net income of $1.2 million. That net income for 2015 beat out its loss of $167,000 one year before.
Brigham said the full commercial run of the company’s product will mean the addition of as many as six full-time positions, to be added as the expansion develops. The company, which trades on the NASDAQ exchange under the symbol ICCC, has 46 employees.