2009 Key Project Guidance
The company provided guidance on its key development projects, pirfenidone and ITMN-191.
The company plans to submit an NDA to the FDA and an MAA to the EMEA on pirfenidone in the summer of 2009 and around the end of 2009, respectively.
2009 ITMN-191 Clinical Development Plans and Timeline
InterMune provided an update on the development plan and key milestones for its protease inhibitor ITMN-191, being developed in collaboration with Roche as follows:
ITMN-191 MILESTONES AND KEY EVENTS EXPECTED DATE -- Scientific presentation of Phase 1b triple combination study Q2, 2009 (EASL) -- Top-line results of INFORM-1 STAT-C study at EASL Q2, 2009 * -- Phase 2b initiation by Roche ($20 million payment to InterMune) Summer 2009 -- Presentation of all cohorts of INFORM-1 at AASLD Q4, 2009 * -- Rapid Viral Response (RVR) data from Phase 2b (12-week regimen) Q4 '09 or Q1 '10 * Subject to acceptance of scientific abstract Guidance for 2009 Revenue and Expenses
Revenue for 2009, including Actimmune(R) and anticipated milestone payments from Roche, is expected to be in a range of approximately $40 to $50 million. Actimmune revenue represents approximately 50% of this revenue range.
R&D expense is anticipated to be in a range of approximately $90 to $100
million, net of development cost reimbursements under the Roche collaboration.
|SOURCE InterMune, Inc.|
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