Takeda says its new oral multiple myeloma drug Ninlaro is on course to become its biggest-ever cancer product.
Takeda Chief Executive Christophe Weber told investors that Ninlaro is already rolling out faster than expected in the U.S. and--just a few months after launch--one in five new patients who are receiving second-line treatment for the disease are being prescribed the drug. That is the highest market share for any new multiple myeloma therapy, he said.
Added to that, the EU's Committee for Medicinal Products for Human Use (CHMP) reversed an earlier decision to reject Ninlaro on appeal, setting up a possible launch early in 2017. The drug has also been approved in Canada, Israel and Venezuela and filed in Japan.
Ninlaro is the first orally active proteasome inhibitor to reach the market and is making headway against injectables such as Takeda's own market-leading Velcade (bortezomib) and Amgen's currently underperforming Kyprolis (carfilzomib).
Sales reached ¥13 billion (around $125 million) in the first six months of this fiscal year, and the product is already accounting for one-third of the growth in the U.S. business, despite what Weber said is a "very limited" label claim. As it stands, Ninlaro is approved only for use in combination with lenalidomide and dexamethasone in patients who have received at least one prior therapy.
"I would like to stress our belief in Ninlaro's potential, that it will be a much bigger product than … Velcade is today," said Takeda's CEO, adding he believes firmly that Ninlaro is on track to become a "$3 billion-plus product" and "one of the backbones of multiple myeloma treatment in the future."
Ninlaro also has a sizable lead over other oral proteasome inhibitors, which have yet to hit the market. Its closest rivals--Amgen/Onyx's oprozomib and Nereus Pharma's marizomib--are still in midstage clinical testing. Takeda's plans to move the drug into first-line treatment are also well-advanced, with Phase III trials ongoing.
Takeda needs Ninlaro to grow quickly and step into the revenue void that will be created when Velcade loses U.S. patent protection next year. Sales of Takeda's flagship drug slipped 6.5% in the first half of the fiscal year, coming in at ¥71 billion ($675 million), thanks to stiff competition from other new multiple myeloma drugs, notably Johnson & Johnson's Darzalex (daratumumab).
Overall, the Japanese group reported first-half revenues down 6% to ¥851 billion, although cost-cutting helped operating profit rise 47% to ¥162 million.
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