Belgian drugmaker UCB (Euronext Brussels: UCB) and private equity firms Avista Capital and Advent International have mutually agreed to terminate an agreement where UCB would have divested its specialty generics unit Kremers Urban Pharmaceuticals to the private equity firms for $1.5 billion (The Pharma Letter November 7).
This decision was taken primarily due to a conflict in the timing of the acquisition and the regulatory process for Kremers’ extended-release formulation of methyphenidate hydrochloride. UCB's chief financial officer Detlef Thielgen said: "While we are working on clarifying the situation around methylphenidate ER we will continue the divestiture process for Kremers Urban."
Kremers disclosed that the US Food and Drug Administration requested the company conducts an additional bioequivalence study based on recent draft guidance, in order to confirm that its product was indeed equivalent to Concerta, produced by Johnson & Johnson (NYSE: JNJ).
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