InterMune, Inc. Completes Divestiture of Actimmune(R) (interferon gamma-1b)
Published: Jun 20, 2012
BRISBANE, Calif., June 20, 2012 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced that on June 19, 2012, the company completed the previously announced sale of its rights to Actimmune® (interferon gamma-1b) to Vidara Therapeutics International Limited (Vidara). Vidara is part of an international specialty pharmaceutical group of companies with operations in Ireland and the United States.
Gross proceeds from the sale totaled $55.0 million. In addition, InterMune is eligible to receive a two-year royalty stream based on net sales of Actimmune, which is expected to contribute an aggregate amount of approximately $2-$4 million over the two-year period.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "We are pleased to complete the divestiture of Actimmune. The cash infusion from this transaction combined with $377.2 million of existing cash and cash equivalents at the end of Q1 2012, and our new estimates for lower operating expenses in 2012, will provide additional financial flexibility as we launch Esbriet® (pirfenidone) in Europe and work to make the medicine available to idiopathic pulmonary fibrosis patients in the United States and in other countries."
Guidance for 2012 Expenses
The company today updated its forward-looking financial guidance for operating expenses in 2012, initially provided on January 5, 2012:
- R&D expense: currently anticipated to be in a range of $90 to $105 million (previously $95 to $115 million). The updated R&D expense range reflects anticipated timing of completion of enrollment in the ASCEND Phase 3 study, which is currently expected around the end of 2012, as well as a delay of investments in certain non-Esbriet R&D activities.
- SG&A expense: currently anticipated to be in a range of $110 to $130 million (previously $120 to $145 million). The updated SG&A expense range reflects the company's current expectations for the timing of the completion of pricing and reimbursement discussions for Esbriet in Europe.
- Total Operating Expenses (R&D and SG&A): currently anticipated to be in a range of $200 to $235 million (previously $215 to $260 million).
Actimmune is a synthesized version of interferon gamma, a naturally occurring protein believed to stimulate the immune system. Actimmune is FDA approved for the treatment of two life-threatening, ultra-orphan, congenital diseases: chronic granulomatous disease and severe, malignant osteopetrosis. The most common side effects are flu-like symptoms, including headache, fatigue, fever, chills and rash. Physicians and patients can obtain additional prescribing information regarding Actimmune, including the product's safety profile, by visiting www.actimmune.com.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the company is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. Pirfenidone, the only medicine approved for IPF anywhere in the world, is approved for marketing by InterMune in the EU as Esbriet® and is currently in a Phase 3 clinical trial to support regulatory registration in the United States. InterMune's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
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 our expectations regarding the amount of royalties we may receive during the two-year period for sales of Actimmune, the uses of the capital from the divestiture of Actimmune for investing in the development and commercialization of Esbriet, our projections for anticipated operating expenses for 2012, and our expectation regarding the timing of full enrollment in the ASCEND study.
Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from any results expressed or implied by such forward-looking statements. 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 February 29, 2012 (the "Form 10-K") and quarterly report on Form 10-Q for the three months ended March 31, 2012 filed with the SEC on May 10, 2012 (the "Form 10-Q"), and other periodic reports filed with the SEC, including but not limited to the following: (i) risks related to the regulatory process for the company's product candidates, including the possibility that the results of the new 52-week Phase 3 clinical trial (ASCEND) having an FVC endpoint may not be satisfactory to the FDA for InterMune to receive regulatory approval for pirfenidone in the United States; (ii) risks related to unexpected regulatory actions or delays or government regulation generally; (iii) risks related to our ability to successfully launch and commercialize Esbriet in the EU, including successfully establishing a commercial operation in the EU and receiving favorable governmental pricing and reimbursement approvals in each EU country; and (iv) InterMune's ability to obtain or maintain patent or other proprietary intellectual property protections. 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. 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 Form 10-Q and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at www.intermune.com.
Actimmune® and Esbriet® are registered trademarks of InterMune, Inc.
SOURCE InterMune, Inc.