Ash Stevens to make API for Takeda's new oral blood cancer drug

24-Nov-2015 - Last updated on 24-Nov-2015 at 15:58 GMT

The US FDA has cleared Ash Stevens to make the API for Takeda's new multiple myeloma drug Ninlaro, which is the first oral proteasome inhibitor to be approved in the country.

The US contract manufacturing organisation (CMO) will produce the active pharmaceutical ingredient (API) - ixazomib - at its facility in Riverview, Michigan.

Ninlaro – which was developed by Takeda subsidiary Millennium Pharmaceuticals – was cleared as a treatment for multiple myeloma by the US regulator last Friday. It is the first oral proteasome inhibitor to be approved in the US.

Production volumes are not being disclosed, but Ash Stevens CEO Stephen Munk told us "We anticipate that in terms of API, it will be a low volume material like other proteasome inhibitors."

He predicted that the drug will be "a tremendous benefit for patients indicated in combination with leanlidomide and dexamethasone for the treatment of patients multiple myeloma who have received at least one prior therapy.

MM market

Ninlaro is intended as an alternative to Takeda's market-leading treatment Velcade (bortezomib), which is due to lose patent protection in the US in 2017.

Ash Stevens also makes the API for Velcade as Munk explained.

"We were the first FDA approved supplier of bortezomib, the API in Velcade and we continue to supply that API to Takeda today" he said, adding that "the initial approval was in May of 2003."

Ninlaro is the third multiple myeloma drug approved in the US this year, behind Novartis’s Farydak (panobinostat) and Johnson & Johnson’s Darzalex (daratumumab).