Over the past year, Shire $SHPG has seen its shares buffeted repeatedly as Roche moved steadily ahead with its late-stage program for its closely-watched hemophilia A drug emicizumab (ACE910). Now it’s fighting back, taking Roche to court over the weekend, ahead of any regulatory decision for a series of what it claims are damaging and misleading comments about the drug’s relative safety and efficacy. But Roche immediately fired back Monday morning with more Phase III data, with no sign that Shire’s assault had influenced its latest update.
One day before Roche was slated to release new data at a scientific conference in Berlin, Shire announced on Sunday that it obtained a preliminary injunction from a court in Hamburg, Germany against Roche aimed at the way it’s positioned the data and shunted blame for thrombotic events – blood clotting – away from emicizumab and onto bypassing agents, including one from Shire.
While it’s common for drug makers to wrangle over intellectual property among rival therapies, IP has nothing to do with this legal counterattack. Shire is arguing that Roche has been making “inaccurate and misleading” statements about the serious adverse events tracked in its Phase III – events which have conspired to keep this would-be blockbuster under a cloud.
Shire claims that Roche has been misleadingly offering a look at “treated bleeds” — a secondary endpoint — instead of the “number of bleeds over time,” originally laid out as the primary endpoint in HAVEN 1. And by blaming thrombotic incidents on its bypassing agent, Shire adds, it’s been damaged.
Roche isn’t saying anything in direct response and declined to respond to my question of how the preliminary injunction could affect today’s presentation. In a statement to Endpoints News, the Basel company noted:
We are not commenting on press releases from other companies.
We stand behind the emicizumab data, our clinical trial protocol, investigators and the hemophilia community.
We are excited to be here at the International Society on Thrombosis and Haemostasis (ISTH) Congress to be a part of the scientific discussion around the emicizumab Phase III HAVEN 1 data. Our decisions and actions are always based on doing what is right for patients.
As promised, Roche rolled out HAVEN 1 data bright and early on Monday. Emicizumab, they say, not only reduced the rate of treated bleeds by 87%, hitting the primary endpoint, the drug also handily outscored bypassing agents like Shire’s. Their therapy slashed “on-demand BPAs across all bleed measurements, including zero treated bleeds (62.9 percent vs. 5.6 percent), zero treated spontaneous bleeds (68.6 percent vs. 11.1 percent), zero treated joint bleeds (85.7 percent vs. 50.0 percent), zero treated target joint bleeds (94.3 percent vs. 50.0 percent) and zero bleeds overall, which includes all treated and non-treated bleeds (37.1 percent vs. 5.6 percent).”
Roche, though, has also acknowledged that there were 2 cases of thromboembolic events and 3 instances of thrombotic microangiopathy, according to researchers engaged in the late-stage program. Back in February Roche rattled its most bullish followers on this drug with the report that a patient died from a rectal hemorrhage after being treated with emicizumab and a bypassing agent during a breakthrough bleeding episode. The incidents were attributed to the BPAs.
As a result of the adverse events, analysts backing Shire and Novo Nordisk – both of which have hemophilia franchises threatened by Roche’s drug – have been speculating about a possible direct tie to the Roche drug. While Roche would appear to have the inside track among patients who had developed inhibitors to standard drugs, it could face resistance to its use among others without inhibitors, restricting its use and limiting its commercial appeal.
Shire made it clear that it’s been rattling its legal sword behind the scenes, to no avail.
From Shire’s statement:
Based on Roche’s publicly available information to date (as of 7 July 2017), physicians, patients and caregivers may be misinformed about the appropriate management of breakthrough bleeds uncontrolled by emicizumab. In addition, through these actions, Shire believes Roche has unlawfully disparaged Shire’s proven bypassing agent, FEIBA (Anti-Inhibitor Coagulant Complex). Shire has issued multiple unheeded requests to Roche in an effort to resolve these concerns in an appropriate manner. As a result, Shire made the decision to seek court intervention.
There’s a lot at stake here for these companies. Roche badly needs to push through a slate of major new product approvals as biosimilar competition to its franchise drugs starts to carve into its revenue flow. Analysts have offered a variety of estimates on peak sales for emicizumab, including one of $1.5 billion by 2022, if Roche can establish this as a new standard of therapy for hemophilia.
Roche is slated to offer a new presentation on its drug on Monday at the 26th International Society on Thrombosis and Haemostasis (ISTH) Meeting in Berlin, Germany. The pharma giant did not immediately respond to a query from Endpoints News on Sunday.
Shire CEO Flemming Ornskov got into the hemophilia market in a big way with its acquisition of Baxalta. But it’s also been afflicted with wavering sales, which has hit the bottom line.
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