Israeli drug discovery company Mapi Pharma, which has developed a delayed release version of Copaxone, Teva Pharmaceutical Industries Ltd. drug for treatment of multiple sclerosis, has announced that it has received a NIS 9 million grant from the Israel Innovation Authority to construct a plant in Jerusalem to produce its drug, even though the product has yet to receive marketing approval. Investment in the plant will total NIS 46 million.
Mapi Pharma founder and CEO Ehud Marom told “Globes” that the company would soon begin production of the drug for a Phase III trial designed to be the final trial before marketing. He said that the production process was taking a year and required the construction of a complete plant.
Marom added that Mylan Pharmaceuticals, Mapi Pharma‘s commercial partner, would already begin paying for early orders for the product before it reaches the market as part of its preparation for production ahead of the trial.
Mapi Pharma will use the several million dollars it receives from Mylan’s orders to help pay for construction of the plant. Mylan, a generic drug company and Teva’s leading competitor, which already markets a generic version of Copaxone, bought the rights to market Mapi Pharma’s drug when it reaches the market. Mylan will fund the Phase III clinical trial for the treatment of aggressive multiple sclerosis, and Mapi Pharma will actually conduct it.
Marom was one of the developers of Copaxone for Teva. Mapi Pharma‘s delayed release version of the drug can be administered once every few weeks, instead of twice a week at present. The company has already built a factory to produce active ingredients for other drugs in the Neot Hovav industrial park in order to keep itself going while developing its leading product. The company has raised $130 million to date. The leading investor in Mapi Pharma is Mylan, with additional investments from the aMoon fund and Chinese pharma company Zhejiang Jingxin.
“Mylan chairman Robert Coury always thought that it was worthwhile building a plant in Israel,” Marom says. “They were also listed on the Tel Aviv Stock Exchange for a while when they wanted to acquire Perrigo. Maybe he wanted this in order to show that he was better than Teva in Teva’s backyard. In any case, I told him now, ‘Here’s your plant in Israel.'”
After turning its production facility into a factory, the company plans to hire 30 employees for the site.
Mapi Pharma is currently conducting a Phase II trial for progressive multiple sclerosis (in contrast to aggressive multiple sclerosis), a disease for which there is only one approved drug, Ocrevus (active ingredient Ocrelizumab), made by the Roche drug company. Marom emphasizes that Mylan obtained the rights to the product only for aggressive multiple sclerosis, while the right for progressive multiple sclerosis has not been promised to any company. Daily doses of Teva’s Copaxone were ineffective in the treatment of progressive multiple sclerosis, but relatively smaller earlier trials by Mapi Pharma showed that the active ingredient becomes effective in the company’s method of administering the drug. If the trials of the product in this form are successful, it will be another opportunity for Mapi Pharma.