Thursday, May 27, 2010

Intermune initiates major restructuring plan - will it effect future of HCV pipeline?

ITMN initiated a restructuring plan that will reduce 40% of its workforce by the end of June 2010 and is expected to generate approximately $12mn in cost savings annually. The workforce reduction follows the FDA's Complete Response Letter requesting data from an additional clinical trial before considering the regulatory approval of pirfenidone for the treatment of declining lung function in patients with idiopathic pulmonary fibrosis (IPF).


The FDA's complete response letter left ITMN in a difficult position both strategically and financially, with the company waiting for a 1H11 regulatory decision for pirfenidone in Europe while continuing to advance its HCV candidate, ITMN-191/RG7227, through ongoing Phase IIb trials. In order to further minimize costs, analysts believe ITMN could look to renegotiate the terms of its development and commercialization agreement with Roche, potentially moving from a cost/profit sharing arrangement to a straight royalty-based arrangement that would no longer require the one-third contribution of development costs.

InterMune currently has 146 employees.

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