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InterMune Reports Fourth Quarter and Full Year 2008 Financial Results and Business Highlights

rporation. Based on InterMune's ownership of approximately 3 million Targanta shares, InterMune expects to receive approximately $6.0 million in the current quarter as a result of the transaction.

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:

    -- 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.

Operating Expenses

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. Of

SOURCE InterMune, Inc.
Copyright©2009 PR Newswire.
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Related biology technology :

1. InterMune to Release Fourth Quarter, Full Year 2008 Financial Results on February 26
2. InterMune Announces Issuance of U.S. Patent for ITMN-191
3. InterMune Announces Pricing of Public Offering of 3,500,000 Shares of Common Stock
4. InterMune Reports Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF
5. InterMune to Present at J.P. Morgan Healthcare Conference
6. InterMune to Present at Deutsche Bank Biotech Boston Confab
7. InterMune Reports Third Quarter 2008 Financial Results and Business Highlights
8. InterMune to Release Third Quarter 2008 Financial Results on November 6
9. InterMune Reports Japanese Regulatory Approval of Pirfenidone in IPF
10. InterMune to Present Four Abstracts on HCV Protease Inhibitor ITMN-191 at the AASLD Meeting
11. InterMune Earns Development Milestone in HCV Protease Inhibitor Collaboration With Roche
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