The European Commission issued a statement of objections to Lundbeck on Wednesday regarding "pay for delay" deals with four drugmakers, saying that it is of the "preliminary view" that the agreements hindered the launch of generic versions of the company's antidepressant Celexa (citalopram). The Commission noted that these actions, if established, violate antitrust rules and "may have caused substantial consumer harm."
The statement of objections is also addressed to Merck KGaA, Generics UK, Arrow, Resolution Chemicals, Xellia Pharmaceuticals, Alpharma, A.L. Industrier and Ranbaxy, which the regulator said belonged to the generic groups that concluded the agreements. According to the Commission, the deals "foresaw substantial value transfers from Lundbeck to its four generic competitors, who subsequently abstained from entering the market with generic citalopram." The Commission added that these transfers included "direct payments from Lundbeck to the generic competitors and also occurred in other forms, such as the purchase of generic citalopram stock for destruction or guaranteed profits in a distribution agreement."
In response, Lundbeck said it "vigorously opposes any allegation of wrongdoing and does not believe its practice has violated European competition law." The drugmaker indicated that it will review the statement before submitting a reply, adding that "it is confident the allegations made by the Commission should be rejected as groundless." The Commission launched an antitrust inquiry into Lundbeck in January 2010.
Separately, Servier is also being investigated by the regulator over alleged "pay for delay" agreements related to generic versions of the company's cardiovascular drug Coversyl (perindopril). The Commission indicated Wednesday that it will "take further steps in the coming days," with EU antitrust commissioner Joaquin Almunia confirming the company will also be sent a statement of objections in the probe. The regulator alleges Servier and several drugmakers entered into agreements that may have delayed the entry of generic Coversyl into European markets. Lundbeck and Servier represent the EU's first case investigating "pay-for-delay" agreements, the Commission said.
Sources on Tuesday had divulged that Lundbeck and Servier would each be served with statements of objections as part of the ongoing investigations. According to the Commission, antitrust investigations are also ongoing against Teva and its Cephalon unit, Johnson & Johnson, and Novartis, as well as its Sandoz unit for possible violations, including practices involving generic companies.
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