MS treatment developer Mapi Pharma raises $ 10M

Mapi Pharma is close to beginning Phase III trials for once-a-month Copaxone.

Mapi Pharma, which is developing a version of multiple sclerosis drug Copaxone, has raised $10 million. Mapi’s version of the drug is administered once a month, compared with the delayed release version by Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA), which is administered several times a week. Shavit Capital Fund led the round, with participation from Mapi chairman and CEO Ehud Marom, who invested his own money.

Founded by Marom, who formerly worked on Teva’s Copaxone team, Mapi attempted a Nasdaq IPO twice in 2014, first seeking to raise $40 million at a company value of $200-230 million, and then submitting a more modest prospectus for raising $20 million as a company value of $120 million. Neither offering was successful, but the company said in the past that it was not giving up, and would again try to raise $10-30 million. The company’s announcement today did not say whether it would embark on an IPO, but the fact that the current round was led by Shavit Capital, whose business model is to invest in companies that are candidates for stock exchange offerings, makes such move likely.

Marom said, “The financing round is designed to enable the company to complete its Phase II trial (testing initial effectiveness and safety) of its product, for which we have already recruited 12 patients, with positive results so far for both safety and effectiveness, and to begin a Phase III trial. We have met with the FDA (US Food and Drug Administration), which authorized us to begin a Phase III trial in the first quarter of 2016, even if we have not completed the Phase II trials by then. The FDA also authorized us to submit the product for registration on the basis of a single Phase III trial on 920 patients, without any additional trials.”

If everything goes according to plan, Marom believes that the product will reach the market in 2019.

According to Marom, this development with the FDA and the initial results of the Phase II trial is only one of the areas in which the company made progress over the past year, making a Nasdaq IPO not worthwhile at a lower value. He believes that this progress will enable the company to hold a large offering later, whether on Nasdaq or through another instrument. He also cited the good performance of Teva’s Copaxone, the original drug, against competition from new products, as another positive factor. “I know Copaxone very well, and I believe that it is an excellent product. We only want to offer an upgrade of it,” he says. Mapi is currently producing the raw material – in effect generic Copaxone – for its product by itself. Once a Phase III trials begins, the possibility of cooperation with another company producing generic Copaxone, and even with Teva itself, will be considered.

Another development concerns the Company’s other products, which are administered through delayed release, and therefore in a monthly dosage. Since the company called off its IPO, joint drug development and marketing agreements have been signed with major pharmaceutical companies. Mapi is not disclosing with which companies the agreements have been signed, but Marom says that one of the products is a drug for Aids. “Thanks to these agreements, we are likely to see initial revenue already in 2017.” Know-how agreements has also been signed for Mapi’s method of administering certain products, and with several Chinese pharmaceutical companies for marketing exclusively in the Chinese market. “But these aren’t our main products. The flagship product is GA Depot – once-a-month Copaxone.”