Mapi to establish $13m manufacturing plant for Copaxone generic

30-Jul-2019 - Last updated on 30-Jul-2019 at 07:22 GMT

(Image: Getty/gorodenkoff)

Mapi to turn a facility previously owned by J&J into a manufacturing plant for the production of GA Depot, a long-acting generic of Teva’s Copaxone.

Mapi Pharma announced the signing of a long-term lease agreement for the establishment of a sterile production plant in Har-Hotzvim Hi-Tech Park in Jerusalem.

The 50,000-square-foot plant will be used for the commercial manufacture of Mapi’s GA Depot (glatiramer acetate), which is currently being investigated for the treatment of relapsing remitting multiple sclerosis and primary progressive multiple sclerosis.

GA Depot is not an exact copy of Teva’s Copaxone but a long-acting injectable version that is administered once every four weeks, while Copaxone requires injections daily or every other day.

In April 2018, Mapi granted Mylan an exclusive license to commercialize GA Depot.

According to Mapi, the facility investment will add to the current Israeli Ministry of Health good manufacturing practice (GMP)-approved facility in the Neot Hovav industrial park in Beersheba, Israel, that the company operates to supply its ongoing Phase I and II clinical trials.

The building of the facility is partially funded by a grant of over $2.5m (€2.23m), received in March 2019, from the Israeli Ministry of Economy, as part of a wider investment in equipment of approximately $13m.

Mapi announced that the establishment of the facility will lead to the hiring of ‘tens’ of additional employees. The facility, which includes a cleanroom infrastructure, was previously part of Omrix Biopharmaceuticals, a Johnson & Johnson company.

Ehud Marom, CEO of Mapi, commented that the company has found “the right infrastructure and professionals at a convenient location” to prepare for the commercialization of GA Depot, which has “multi-billion dollar sales potential.”

Copaxone has been Teva’s main revenue-driving product, bringing in sales of $3.8bn globally in 2017. However, sales dropped significantly after the entry of Copaxone generics, such as Mapi’s product, with first quarter drug revenues in North America decreasing by 56% to $208 million in 2019, compared to the first quarter of the previous year.