CSL may have faced resistance from Shire when it launched hereditary angioedema drug Haegarda last year, but if you listen to the company's chief executive talk about the rollout, the decision to launch despite the legal trouble was worth it.
CEO Paul Perreault told FiercePharma at the J.P. Morgan Healthcare Conference that the Haegarda launch has gone "exceedingly well."
CSL rolled out Haegarda, which competes with Shire's Cinryze, in the U.S. last year despite a patent dispute with its rival. Haegarda is the first subcutaneous C1 esterase inhibitor designed to prevent angioedema attacks, and Shire sued, arguing that the CSL drug violates a patent on its own HAE candidate SHP616.
Shire's bid to block the Haegarda launch altogether fell short, and CSL introduced its new drug in July at about an 18% discount to Cinryze. Other drugs aimed at HAE patients are Shire's Firazyr and Kalbitor, and Pharming Group's Ruconest, all three of which treat attacks after they occur.
Shire has since amended its legal complaint, and a judge this month denied CSL's motion to dismiss the lawsuit.
Reacting to the Haegarda launch, Bernstein analyst Ronny Gal wrote in July that the discount was "critical" to steal share from Shire, as the new drug has “limited duration to penetrate the market” before Shire's once-every-two-weeks injection hits the market.
The Irish drugmaker, for its part, ran into trouble with its Cinryze manufacturer last year, and the ensuing shortage didn't help it defend the big-selling drug's market share. Speaking to analysts on the company's most recent conference call, Shire CEO Flemming Ornskov said his company "may have lost some HAE patients who have opted for other products" due to the manufacturing slipup.
"But given that some patients still had Cinryze inventory on hand, given patient loyalty to Shire, and the availability of Shire's Firazyr access program during this time period, we would expect that the majority of existing Cinryze patients will remain on product moving forward as our supply normalizes," he added. Firazyr is a subcutaneous injection patients can self-administer in the event of an HAE attack.
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Now, the drugmaker is requesting FDA permission to bring some Cinryze manufacturing in-house at a former Baxalta plant.
"Subject of course to FDA approval, we expect in-house production ramp-up as early as the first quarter of 2018," Ornskov said on the third-quarter call. "Until this second source is approved by the FDA and we of course have built up additional inventory, supply levels could be tight. "
Cinryze is an important contributor at Shire, bringing in $402 million in the first six months of 2017.