Gliatech Inc says that, following interim results of an externalinvestigation into a post-approval US trial of its biodegradeable surgical gel, Adcon-L, its president and chief executive officer, Thomas Oesterling, has retired. Furthermore, Michael Zupon, executive vice president of R&D, and Raymond Silkaitis, vice president of regulatory affairs, have handed in their resignations. The affair has caused shares in the company to hit rock-bottom this year, with a price of $6.84 on September 25, the day of the announcement. The year-low has been $6.13 compared to a year-high of $27.69.
The moves follow reports that data in the firm's dossier for Adcon-L had been altered, which led to the collapse of Gliatech's proposed merger with Guilford Pharmaceuticals, and is the second set of management changes to take place in the last few weeks (Marketletters September 4 and 11). The immediate retirement of Mr Oesterling may come as a surprise, as it had been announced that he would be replaced as chairman by Robert Pinkas but would remain as CEO and president. Mr Pinkas will now take on the two roles until a replacement can be found, says the firm. Clark Tedford has been promoted to vice president of R&D.
The board of Gliatech noted that "certain aspects of the company's post-approval US clinical study of Adcon-L were not conducted in accordance with good clinical practices," adding that it "does not believe that intentional misconduct occurred in connection with the submission of post-approval materials to the FDA." However, the board states, "there was insufficient supervisory oversight of the process."
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