Healthcare Industry News: pirfenidone
News Release - November 2, 2006
InterMune Closes Collaboration Agreement With RocheBRISBANE, Calif., Nov. 2 (HSMN NewsFeed) -- InterMune, Inc. (Nasdaq: ITMN ) announced today that on October 30, 2006, it successfully closed its Exclusive License and Collaboration Agreement with Roche for the exclusive worldwide development and commercialization of InterMune's hepatitis C virus (HCV) protease inhibitor program. The parties received notice of early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976, on October 30, 2006.
Having closed the transaction, InterMune will receive an upfront payment of $60 million. Roche is now funding 67% of the global development costs associated with ITMN-191, InterMune's lead HCV protease inhibitor drug candidate. Assuming the successful development and commercialization of ITMN-191 in the U.S. and other countries, InterMune could receive up to $470 million in milestones, including a potential $35 million within the next 12 months.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes two Phase III programs evaluating possible therapeutic candidates for treatment of patients with IPF. The INSPIRE trial is evaluating ActimmuneŽ and the CAPACITY program is evaluating pirfenidone. The hepatology portfolio includes ITMN-191, the lead HCV protease inhibitor compound, a second-generation HCV protease inhibitor program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com .
This press release contains forward-looking statements. Any statements in this press release about InterMune's expectations, beliefs, plans, objectives, assumptions of future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as believe, could, will, expect, anticipate, potentially, estimate, intend, plan and would. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, amounts to be received, levels of activity, performance or achievements to differ materially from any results, level of activity, performance or achievements expressed or implied by any forward-looking statement. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from expectations and projections.
These forward-looking statements are subject to numerous risks and uncertainties. Some of the risks, assumptions, and uncertainties include but are not limited to, general industry conditions and competition; obtaining U.S. and other countries' regulatory approvals; health care changes in the U.S. and other countries; unexpected outcomes; product efficacy or safety concerns; product manufacturing issues; successful marketing of the product if developed; superior products being brought to market; loss of key employees; government reimbursement issues; economic conditions; technological advances and patents attained by competitors; manufacturing and supply disruptions; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents by competitors or allegations that the product infringes the patents of third parties; U.S. and other countries' health care reforms; governmental laws and regulations; product liability claims or litigation risks; governmental investigations; and trends toward health care cost containment. These risks and uncertainties also include the risks that clinical trials may not proceed as planned due to technical, scientific, or patient enrollment issues, or disagreements with regulatory authorities over trial design or other matters; that the scale and scope of future clinical and nonclinical studies may change and will be determined in significant part by data collected in ongoing and future trials; that further clinical studies may not reflect the results obtained in early clinical and nonclinical studies; that ongoing nonclinical studies, including toxicology studies, will yield currently unanticipated negative outcomes that could adversely affect planned clinical trials; that results from the clinical trials will be insufficient to support additional phase programs without additional trials and consequent delay in the timetable for potential approval; and that any potential product may not achieve sales sufficient to earn the royalties referenced above. The foregoing list sets forth many, but not all, of the factors that could impact upon the ability to achieve results described in any forward-looking statements. It is not possible to predict or identify all such factors and this list should be considered to be a complete statement of all potential risks and uncertainties. Neither company assumes any obligation to update any forward-looking statements as a result of new information or future events or developments. Actual results could differ materially from those anticipated in forward-looking statements. You should not place undue reliance on any forward-looking statement. Past performance is not indicative of future results.
A further list and description of these risks, uncertainties and other risk factors for InterMune can be found in the section entitled "Risk Factors" in its Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and other public periodic filings with the Securities and Exchange Commission. Copies of these Form 10-K filings, as well as subsequent and previous filings, including the most recent 10-Q filed with the SEC on August 8, 2006, are available online at www.sec.gov or at InterMune's web site at http://www.intermune.com .
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