BRISBANE, Calif., Aug. 6 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced results from operations for the second quarter and six months ended June 30, 2009. InterMune reported a net loss for the second quarter of 2009 of $36.7 million, or $0.81 per share, compared with a net loss of $29.6 million, or $0.76 per share, in the second quarter of 2008.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "The last several months have been exceptionally productive for InterMune and the coming months promise to be even more so. Regarding pirfenidone, we have made excellent progress on the preparation of our New Drug Application (NDA) for pirfenidone which we now expect to submit in the fourth quarter. It has taken more time than we anticipated to integrate the advice of a host of external expert advisors and to take every possible step to develop the strongest possible file that positions us for potential approval in the first review cycle. Our Marketing Authorization Application (MAA) is also progressing very well; we had a successful pre-submission meeting with the EMEA in July and we expect to submit the MAA for pirfenidone in the first quarter of 2010."
Mr. Welch continued, "Regarding ITMN-191 (R7227), we announced exciting news today on several important aspects of the program, specifically: the successful completion of six-month and nine-month chronic toxicology studies in rats and monkeys, respectively which clear the way for our Phase 2 and Phase 3 clinical programs; our expectation that our partner Roche will enroll the first patient in our Phase 2b study of ITMN-191 in combination with standard of care in August; our plans to start a Phase 1b MAD study of ITMN-191 in combination with low dose ritonavir in HCV patients in the thi
|SOURCE InterMune, Inc.|
Copyright©2009 PR Newswire.
All rights reserved