Mapi Pharma to launch generic Copaxone next year

Ehud Marom Photo: PR

Mapi Pharma has leased a Jerusalem plant, to manufacture delayed release Copaxone that can be taken twice a month.

Israeli drug development company Mapi Pharma, founded and managed by Ehud Marom, former head of Teva’s Copaxone development team, announced yesterday that it had rented the Jerusalem plant formerly owned by Omrix Biopharmaceuticals, which closed down most of its activity in Israel. Omrix invested $100,000 in the plant, which has 46,000 square meters. Several months ago, Australian company Aegros announced that it would rent the space, but the deal did not go through.

In the plant, Mapi Pharma will manufacture delayed release Copaxone that can be taken twice a month, instead of twice a week with the current version. A deal for this product has already been signed with Mylan, whose generic version of Copaxone is competing with Teva, the original developer of Copaxone. Mylan invested $20 million in Mapi Pharma, and will invest the same amount by purchasing merchandise in advance. Mapi Pharma will receive a share of Mylan’s proceeds from the product.

Mapi Pharma’s product is due to enter a Phase III trial in a month, a trial likely to be the last before marketing, after the success of its Phase II trial. Marom says that the Phase II trial results were better than for the original Copaxone. If everything goes according to plan, the launch will be in 2.5-3 years.

Purchase of the plant: Production in preparation for the launch

Why is Mapi Pharma buying a plant now? Marom says, “Today, in order to get FDA approval for a product, you have to show that you’re ready to launch it shortly after getting approval. So Mylan already needs a large quantity of the active ingredient now. We’re starting to manufacture the ingredient, and Mylan will buy it from us and give us the money in advance, and will financing the investment in the plan and in the production itself.”

The Israel Innovation Authority is providing 20% of the budget for the plant. In addition to the plant on Har Hotzvim, which is producing the finished drug, Mapi Pharma has a plant in Neot Hovav that is producing the active ingredient. $8 million has already been invested in the Neot Hovav plant, and $6 million more will be invested in it.

Mapi Pharma also plans to use the plant’s surplus production capacity to develop its own generic version of Copaxone in competition with Teva and Mylan, Mapi Pharma’s partner. “We’ll be in the market in a little more than a year,” Marom says.

“Globes”: Why do have to enter the competitive generic Copaxone market now, when you’re planning on launching a delayed release version in another few years?

Marom: “It’s usually worthwhile launching a generic drug if there are up to five competitors in the market, and Copaxone has three now. Each of them is getting $1 billion, and $20 million is enough for me right now. The last to enter is the one who determines the market conditions. Teva ignored us from start to finish. Mylan is a partner, but it’s all right for them to see that there’s another player in this market.”

Mapi Pharma has raised $130 million to date, with Mylan being the leading investor, together with aMoon and Chinese pharma company Zhejiang Jingxin. The company previously started an offering on Nasdaq, but did not get the company value it wanted.

Published by Globes, Israel business news – – on July 17, 2019

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