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Shire seeks injunction against Roche over hemophilia A drug, Hemlibra


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Shire seeks injunction against Roche over hemophilia A drug, Hemlibra

Shire plc is seeking a preliminary injunction in the U.S. against two Roche Holding AG subsidiaries to limit sales of the Swiss drugmaker's recently approved hemophilia A biologic, Hemlibra.

Shire, which sells its own treatments for the bleeding disorder, claims that Hemlibra, also known as emicizumab or ACE910, infringes one of its patents.

The motion for injunction is a part of an ongoing lawsuit in the U.S. District Court for the District of Delaware. Shire's Baxalta unit had sued Japan's Chugai Pharmaceutical Co. Ltd., a majority-owned subsidiary of Roche, in Delaware regarding the patent. Chugai and Genentech, another Roche subsidiary, are named in Shire's motion.

The injunction aims to limit access to Hemlibra for inhibitor patients, the same group for which the medicine won U.S. Food and Drug Administration approval in November. These patients have developed antibodies called inhibitors that make certain hemophilia treatments less effective.

Hemlibra will continue to be accessible to patients until the court makes a decision on the injunction motion, which Shire expects in the middle of 2018. The company said it has proposed a carve-out provision to facilitate access for patients.

In July, Shire obtained a preliminary injunction against Roche in Germany to stop Roche from making further presentations containing "inaccurate and misleading characterization of the serious adverse events that occurred" during the Phase 3 trial of emicizumab. Shire alleged Roche "unlawfully disparaged" its bypassing agent Feiba when the company identified Feiba, among other bypassing agents, as a cause for the events observed in the study.

Shire has a hemophilia A treatment of its own, Adynovate , which was approved in patients under age 12 by the U.S. FDA in December 2016.