Navigation Links
InterMune Sells Danoprevir Rights to Roche for $175 Million

BRISBANE, Calif., Oct. 6 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that it has sold worldwide development and commercialization rights to danoprevir (also known as RG7227 or ITMN-191) to Hoffman-La Roche Inc. and F. Hoffman-La Roche Ltd. for $175 million in cash.  In connection with this transaction, the collaboration agreement that InterMune and Roche entered into in October 2006 has been terminated.  In addition, the companies are actively exploring ways to continue their ongoing work together on other HCV research programs.  InterMune noted that as a result of this transaction, the company will make no further investment in danoprevir and that, including net proceeds from the transaction, it currently expects to have a cash balance of approximately $290 million at the end of 2010.

Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "After conducting a careful review of our strategy and financial position, we have decided to divest our rights to danoprevir to Roche.  This transaction provides a very substantial non-dilutive cash infusion that allows us to continue to independently and aggressively pursue the registration and commercialization of pirfenidone in the US and EU, and eliminates our obligation to make significant ongoing investments related to the further development and commercialization of danoprevir.  We are now in a very strong financial position that provides us with the resources and flexibility to maximize the value of pirfenidone, our largest and nearest-term value creation opportunity."

Conference Call and Webcast Details

InterMune will host a conference call today at 4:30 p.m. EDT to discuss the transaction.  Interested investors and others may participate in the conference call by dialing 866-408-9480 (U.S.) or 706-643-9223 (international), conference ID# 16402032.  A replay of the webcast and teleconference will be available approximately three hours after the call.

To access the webcast, please log on to the company's website at at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.

The teleconference replay will be available for 10 business days following the call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291 (international), and entering the conference ID# 16402032.  The webcast will remain available on the company's website until the company's next earnings call.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology.  InterMune has an R&D portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections.  The pulmonology portfolio includes pirfenidone for which InterMune has completed a Phase 3 program in patients with IPF (CAPACITY).  A Marketing Authorization Application (MAA) for pirfenidone is under review by the European Medicines Agency (EMA).  The hepatology portfolio includes next-generation HCV protease inhibitor and NS5A research programs.  For additional information about InterMune and its R&D pipeline, please visit

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to projected cash balances and the likelihood of regulatory success for the use of pirfenidone for the treatment of IPF.  All 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.  Pirfenidone failed to achieve statistical significance on the primary endpoint in one of its two pivotal clinical trials and there can be no assurance that the regulatory authorities in either the United States or Europe will grant regulatory approval based upon these data, in combination with the other efficacy and safety results the company has submitted in support of its New Drug Application (NDA) and MAA filings. Furthermore, while the Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9 to 3 to recommend that the U.S. Food and Drug Administration (FDA) approve pirfenidone to reduce decline in lung function in patients with IPF, this result was not binding on the FDA and the FDA subsequently issued a Complete Response letter requesting an additional clinical trial to support the efficacy of pirfenidone in IPF. While we intend to continue to work diligently with the FDA to determine a regulatory path forward with respect to pirfenidone in the United States, we do not know whether the FDA will ultimately grant InterMune approval for the use of pirfenidone for the treatment of IPF, irrespective of whether InterMune conducts an additional clinical trial as requested by the FDA in the Complete Response letter.  

Other factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 15, 2010 (the "Form 10-K"), and other periodic reports filed with the SEC, including but not limited to the following: (i) the fact that physician prescriptions of Actimmune for the treatment of IPF, an indication for which Actimmune has not been approved by the FDA, have declined significantly following the March 2007 termination of the Phase 3 INSPIRE trial of Actimmune in IPF and the risk that InterMune's revenue will continue to decline as expected; (ii) risks related to significant regulatory, supply and competitive barriers to entry with respect to Actimmune; (iii) risks related to the uncertain, lengthy and expensive clinical development and regulatory process for the company's product candidates, including having no unexpected safety, toxicology, clinical or other issues; (iv) risks related to achieving positive clinical trial results for the company's product candidates; (v) risks related to timely patient enrollment and retention in clinical trials involving the company's product candidates; (vi) the results of the InterMune CAPACITY trials of pirfenidone differ in some respects from those of the Shionogi & Co., Ltd. Phase 3 trial of pirfenidone and there can be no assurance that the FDA or European regulatory authorities will approve the use of pirfenidone for the treatment of IPF; (vii) the results as reported by Shionogi concerning their Phase 3 trial of pirfenidone for the treatment of IPF may differ from those published or presented in a peer-reviewed forum; and (viii) risks related to the company's manufacturing strategy, which relies on third-party manufacturers and which exposes InterMune to additional risks where it may lose potential revenue.  The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at

SOURCE InterMune, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. InterMune to Present at 2010 Citi Health Care Conference
2. InterMune Receives FDA Complete Response Letter on Esbriet(TM) (Pirfenidone) New Drug Application
3. InterMune to Release First Quarter Financial Results on April 29
4. InterMune Announces Submission of MAA for Pirfenidone for the Treatment of Patients With IPF
5. InterMune Announces Proposed Public Offering of Common Stock
6. InterMune to Release Third Quarter Financial Results on November 5
7. InterMune Announces Collaboration With National Jewish Health on NIH-Supported Genetic Research in Idiopathic Pulmonary Fibrosis
8. InterMune to Present at Canaccord Adams Conference
9. InterMune Reports Second Quarter 2009 Financial Results and Business Highlights
10. InterMune to Release Second Quarter Financial Results on August 6
11. InterMune to Present at Goldman Sachs Healthcare Conference
Post Your Comments:
(Date:11/25/2015)... Nov. 25, 2015 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: ... business and prospects remain fundamentally strong and highlights ... doxorubicin) recently received DSMB recommendation to continue the ... review of the final interim efficacy and safety ... Endpoint in men with heavily pretreated castration- and ...
(Date:11/25/2015)... -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX ) today ... discussion at the Piper Jaffray 27th Annual Healthcare Conference ... is scheduled for Wednesday, December 2, at 8:00 a.m. ... will be available for 14 days after the event.  ... Corporate Communications and Business Development , BrewLife(858) 875-8629 ...
(Date:11/25/2015)... Francisco, CA (PRWEB) , ... November 25, 2015 ... ... microbial genomics company uBiome, were featured on AngelList early in their initial angel ... launching an AngelList syndicate for individuals looking to make early stage investments in ...
(Date:11/24/2015)... ... November 24, 2015 , ... The United States Golf ... the 2016 USGA Green Section Award. Presented annually since 1961, the USGA Green Section ... her work with turfgrass. , Clarke, of Iselin, N.J., is an extension ...
Breaking Biology Technology:
(Date:10/27/2015)... -- In the present market scenario, security is one ... verticals such as banking, healthcare, defense, electronic gadgets, and ... secure & simplified access control and growing rate of ... bank accounts, misuse of users, , and so on. ... and smartphones are expected to provide potential opportunities for ...
(Date:10/27/2015)... JOSE, Calif. , Oct. 27, 2015 Synaptics ... interface solutions, today announced that Google has adopted the ... of touch controller solutions to power its newest flagship ... 6P by Huawei. --> ... partners like Google to provide strategic collaboration in the ...
(Date:10/26/2015)... and LAS VEGAS , Oct. 26, ... , an innovator in modern authentication and a founding ... the launch of its latest version of the Nok ... organizations to use standards-based authentication that supports existing and ... Authentication Suite is ideal for organizations deploying customer-facing applications ...
Breaking Biology News(10 mins):