At the World Congress of Neurology in London on June 22, Serono presented data from a head-to-head trial (the EVIDENCE trial) of its own product Rebif and Biogen's (Cambridge, MA) Avonex, both interferon β-1a products to treat relapsing-remitting multiple sclerosis (MS). Patients treated with Rebif showed significant improvements in the primary and secondary end points of the trial compared with Avonex patients—greater efficacy that Serono plans to use to break Avonex's orphan drug status and access the $1 billion US market. Biogen has mounted a vigorous attack on Serono to defend the coveted market, embroiling the companies in legal and scientific wranglings.
The first move in the ongoing legal battle was a preliminary injunction filed in Switzerland by Biogen charging that Serono had made “misleading claims of superior efficacy” relating to Rebif in a May 8 press release in which Serono disclosed preliminary data from the EVIDENCE trial. Filed on the morning of June 22, it left very little time for Serono to respond, according to Andrew Fellows, analyst at Pictet & Cie (Geneva, Switzerland). Serono went ahead with the presentation of the full trial results that, according to Nick Miles, director of media and public relations at Serono, back up the efficacy claims in the press release. This prompted Biogen to file a criminal complaint against Serono alleging infringement of the injunction. Serono then filed a criminal complaint against Biogen asserting that Biogen's action was both “maliciously motivated in order to prevent the legitimate dissemination of scientific data” and that Biogen's clear intent is to “damage Serono through harassment, defamation and manipulation of the media.” The civil case began on July 11.
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