Savient Pharmaceuticals SVNT (NASDAQ), the specialty pharmaceutical firm, announced the immediate resignation of its President and CEO Christopher Clement. Clement has been with the firm since 2002. The company has appointed senior vice president Paul Hamelin as president. According to the press release he will lead day-to-day operations of the company. Clement leaves the firm as it is in its last step to get FDA approval for Puricase. The drug, according to a June interview in the Wall Street Transcript with Stephan Patten, Portfolio Manager of Sector Asset Management,
… is a treatment for gout, a treatment that is looking like it will be far and above better than every other gout treatment that exists today.
The company had an additional press release today that announced a team of experts from the firm’s board of directors intended to assist in the FDA approval process and pre-launch of the drug if approved.
Board of Directors has formed a BLA Oversight Committee (”the Committee”)to oversee the regulatory and pre-launch activities for the company’s drug, pegloticase, effective immediately. The Committee will be comprised of independent Board members Lee S. Simon, M.D. and Alan L. Heller, who both have extensive experience with the Food & Drug Administration (FDA) process. Dr. Simon will chair the Committee. The Committee will work closely with Savient officers, Dr. Robert Lamm and Dr. Zeb Horowitz, who will continue to lead the Company’s discussions with the FDA.
The formation of the Committee followed Christopher Clement’s resignation as President, Chief Executive Officer and a director of the company, by mutual agreement between Mr. Clement and the Board.
The company really needs this approval. Pushing Clement out the door makes it appear Clement may have been an obstacle to the company’s efforts for approval and ultimate commercialization of Puricase. Investors should keep a close eye on Savient and the FDA approval process for their new drug.