Last week, Rule Breakers pick InterMune
Shares of InterMune have been very volatile since the beginning of July, falling more than 20% after an analyst opined that its hepatitis C drug could face a delay in development. Following the analyst's comments, InterMune updated investors that the first efficacy study of the drug, ITMN-191, would be starting a little later than expected, and that results of the trial would be out in the first quarter of 2008, rather than the previously-guided-for fourth-quarter announcement.
This slight delay is nothing to be worried about at the moment. InterMune noted that patients who took ITMN-191 with food had an unexpectedly higher concentration of the drug in their bloodstream, which was a primary contribution for the need to amend the phase 1b study. The drugmaker also cited other reasons for the delay, including its evaluation of results with competing protease inhibitor programs from Vertex Pharmaceuticals
In the second quarter, sales of Actimmune were $14 million, down 25% from the first quarter. Sales of the drug should continue their approach to zero through the rest of the year. InterMune plans on presenting more data from Actimmune's failed phase 3 idiopathic pulmonary fibrosis (IPF) study at a medical conference later in the year.
InterMune's other IPF drug candidate, pirfenidone, remains on track for the pivotal phase 3 studies to be completed by the end of 2008. Results of the trials are expected in the fourth quarter of 2008 or first quarter of 2009.
With the ITMN-191 study results delayed until 2008, there will likely be no new developments for InterMune's pipeline until next year. This doesn't mean that shares will trade flat for the rest of the year. Vertex will be generating more data for its protease inhibitor later in the year, and shares of InterMune will of course be subject to the unfailing biopharma volatility that always occurs.
A free 30-day Rule Breakers trial will let you see what other drug stocks join InterMune and Vertex on the recommendation list.