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InterMune Reports Third Quarter 2009 Financial Results and Business Highlights
Date:11/5/2009

r than $22.7 million in the first nine months of 2008, primarily reflecting costs related to preparation for the potential commercialization of pirfenidone, which is subject to regulatory approvals. Expenses in the first nine months of 2009 included a milestone payment of $13.5 million for pirfenidone made to Marnac/KDL in accordance with the pirfenidone purchase agreement and InterMune's decision to submit NDA and MAA filings for pirfenidone.

On January 1, 2009, the company adopted guidance in the Debt Topic of the Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC"), formerly FASB Staff Position APB 14-1, "Accounting for Convertible Debt Instruments That May Be Settled In Cash Upon Conversion (Including Partial Cash Settlement)," and recorded additional interest expense for the third quarter of 2009 of $1.0 million and $3.7 million for the first nine months of 2009. This guidance requires retrospective application upon adoption; therefore, net losses attributable to InterMune for the third quarter and first nine months of 2008 have been adjusted from those which were previously reported to reflect additional interest expense of $1.5 million and $6.0 million, respectively.

Clinical Development Highlights - Third Quarter and Recent Events

Pirfenidone:

  • On November 4, InterMune announced that it had submitted an electronic NDA with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with IPF. Pirfenidone has been granted both "Fast Track" and Orphan Drug designations by the FDA.
  • An oral presentation focused on the safety profile of pirfenidone was presented at the European Respiratory Society (ERS) Annual Congress in Vienna, Austria on September 14. Safety data from four clinical studies -- CAPACITY 1, CAPACITY 2, RECAP and a long-term open-label study -- showed that treatment with pirfenidone was
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SOURCE InterMune, Inc.
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Related medicine technology :

1. InterMune Announces Approval of Clinical Trial Authorization for Phase 1b Trial of ITMN-191
2. InterMune Announces Start of Phase 1b Trial of ITMN-191
3. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
4. InterMune Provides Additional Information on ITMN-191 (R7227) MAD Study Results
5. InterMune Announces Progress on Pirfenidone in IPF
6. InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA
7. InterMune Announces Start of 14-Day Triple Combination Study of ITMN-191 in Patients With Chronic Hepatitis C
8. Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C
9. InterMune to Report Top-Line Results of Triple Combination Study of ITMN-191 in January 2009
10. InterMune to Conduct Conference Call and Webcast to Discuss Results of Triple Combination Study of ITMN-191
11. InterMune to Announce Results of Phase 3 CAPACITY Program of Pirfenidone in IPF Tomorrow, February 3
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