Hepatitis Resource Center


BRISBANE, Calif. and SAN CARLOS, Calif., Oct. 8 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) and Inhale Therapeutic Systems, Inc. (Nasdaq: INHL) announced today an agreement for use of Inhale's technology to develop a PEGylated version of Infergen(R) (Interferon alfacon-1) (PEG-Infergen) for the treatment of chronic hepatitis C infections. PEGylation is a technology designed to prolong or improve the effectiveness of pharmaceutical products. InterMune currently markets Infergen, the non-PEGylated version of this product, for the treatment of patients with hepatitis C. 

"This agreement accelerates our ability to develop PEG-Infergen as a new treatment option for the millions of people in North America suffering from chronic hepatitis C infections," said Scott Harkonen, President and CEO of InterMune. "We believe PEG-Infergen will build on the success we are having with Infergen in this market. We expect this market will grow to $3 to $4 billion over the next five years. Based on positive data demonstrating Infergen's clinical advantage compared to other non-PEGylated alpha interferons, we believe PEG-Infergen could become a leading product in this market. We plan to initiate clinical trials with this compound in the first quarter of 2003." 

The agreement calls for Inhale to provide the PEGylation expertise and exclusive manufacturing for the reagent used in the PEGylation of Infergen. InterMune will conduct pre-clinical and clinical development of the product and commercialize it in North America. Inhale will receive milestones as the product progresses through the clinic and royalties on product sales. Other deal specifics and financial terms were not disclosed. 

"We are pleased to have obtained the technology from Inhale to develop PEG-Infergen, which has been shown in vitro to have improved biological potency compared to other PEGylated alpha interferons," said Peter Van Vlasselaer, Ph.D., Senior Vice President of Technical Operation at InterMune. "We look forward to a mutually rewarding partnership." 

"We, too, are pleased to be collaborating with InterMune to improve the performance and delivery of its Infergen product and to address a significant medical need for hepatitis C patients. This collaboration is another validation of the use of PEGylation as the industry standard method for enabling improved performance of macromolecules," said Ajit Gill, President and CEO of Inhale. "Further, it represents a continuation of the accelerated rate of collaborations for Inhale seen in the first half of 2002."   

About Hepatitis C 

Hepatitis is a liver disease caused by the hepatitis C virus that is found in the blood of people with this disease. According to the National Center for Infectious Diseases, there are an estimated 3.9 million (1.8%) Americans who have been infected with hepatitis C, of whom 2.7 million are chronically infected. The current standard of care is a combination of interferon alpha and ribavirin, which has been shown to eliminate the virus in up to 40% of those infected.  

About Infergen 

Infergen is a bio-engineered type I interferon alpha that is FDA-approved for the treatment of patients with chronic hepatitis C infections. Positive interim Phase IV clinical trial results first reported last year indicated that patients treated for chronic hepatitis C infections with Infergen in combination with ribavirin achieved a sustained virology response (SVR) of 56% compared with an SVR of 31% in patients treated with Interferon alfa-2b ribavirin (Rebetron(TM)).   

About PEGylation 

Inhale's proprietary advanced PEGylation technology was developed by its subsidiary, Shearwater Corporation. PEGylation is a technology for the chemical attachment of polyethylene glycol (PEG) polymer chains to a broad range of drug substances such as peptides and proteins including antibody fragments; small molecules, and other drugs. The effect of PEGylation is to increase drug circulation time in the bloodstream, improve drug solubility and stability, and reduce immunogenicity. The potential advantages of PEGylation are to decrease dosing frequency, improve drug efficacy and safety, improve stability, and simplify drug formulation.   

About InterMune 

InterMune is a commercially driven biopharmaceutical company focused on the marketing, development and applied research of life-saving therapies for pulmonary disease, infectious disease and cancer. For additional information about InterMune, please visit   

About Inhale 

Inhale Therapeutic Systems, Inc. provides a portfolio of leading performance-enabling drug delivery technologies and expertise to help pharmaceutical and biotechnology companies maximize the performance of their drug products. For additional information about Inhale, please visit   

Except for the historical information contained herein, this press release contains certain forward-looking statements by InterMune that involve risks and uncertainties, including without limitation the statements indicating that InterMune believes that PEG-Infergen will build on the success of Infergen, expects that the chronic hepatitis C infections market will grow to $3 to $4 billion over the next five years and expects that PEG-Infergen could become a leading product in the hepatitis C market. All InterMune's forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to those discussed under the heading "Risk Factors" and the risks and factors discussed in InterMune's 10-K report filed with the SEC on March 21, 2002, and other periodic reports (i.e., 10-Q and 8-K) filed with the SEC. The risks and other factors that follow, concerning the InterMune forward-looking statements in this press release, should be considered only in connection with the fully discussed risks and other factors discussed in detail in the 10-K report and InterMune's other periodic reports filed with the SEC. InterMune's forward-looking statement indicating that InterMune expects that the chronic hepatitis C infections market will grow to $3 to $4 billion over the next five years is subject to the risks and uncertainties associated with whether a cure is discovered for chronic hepatitis C infections; only a subset of patients respond to therapy; the actual dosage is different than currently anticipated; the treatment regimen is different than currently anticipated; InterMune cannot sell its drug at the price that is currently anticipated; or a competitor's drug is more effective or costs less than InterMune's. InterMune's forward-looking statements concerning PEG-Infergen building on the success of Infergen and becoming a lead product in the hepatitis C market is subject to the risks and uncertainties associated with the uncertain, lengthy and expensive clinical development and regulatory process; achieving positive Phase I, II and III clinical trial results; patient enrollment and retention in the clinical trials; budget constraints; third-party manufacturers; whether InterMune is able to obtain, maintain and enforce patents and other intellectual property; and significant regulatory, supply, intellectual property and competitive barriers to entry. 

This release contains forward-looking statements that reflect the current views of Inhale management as to future products, product development, and other future events and operations. These forward-looking statements involve uncertainties and other risks that are detailed in reports and other filings with the Securities and Exchange Commission, including Form 10-K and the most recent Form 10-Q. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review, manufacturing capabilities and marketing effectiveness.    


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