>>NEW YORK, March 31 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today unveiled the company's new strategy, corporate realignment and pipeline initiatives to achieve its new vision of becoming a leader in the development and commercialization of innovative therapies in hepatology and pulmonology.
"InterMune has successfully charted a new course for the future and transformed itself into much more than an Actimmune IPF story," said Dan Welch, the company's Chief Executive Officer and President, at its investment community meeting held here today. "We have worked diligently to complete a strategic plan and implement operational changes that have positioned us for a promising future. There have also been a number of important developments in our focused, late-stage clinical pipeline aimed at large and underserved indications, especially in hepatology. We have strengthened our foundation to fortify and maintain our position as one of the few companies in the biotechnology industry with revenue-generating products to fuel a deep pipeline. This combination is unique and can drive sustained shareholder value."
During the meeting, Mr. Welch and his executive management team outlined and described the following strategic goals for InterMune:
Primary Goals:
1. Maximize the value of InterMune's hepatology franchise;
2. Maximize the value of InterMune's pulmonology franchise; and
3. Achieve financial self-sufficiency in 2006.
Supporting Goals:
4. Grow Infergen(R) (interferon alfacon-1) revenues by focusing on the
seriously underserved and growing patient population of hepatitis C
nonresponders;
5. Leverage the commercial capability of InterMune's sales and marketing
teams in the hepatology and pulmonary disease marketplaces;
6. Create near-term value from non-core assets that no longer fit within
InterMune's new strategic plan;
7. Establish value-creating strategic partnerships to leverage the value
of InterMune's core assets in hepatology and pulmonology; and
8. Leverage InterMune's research and development investments to create
value from ex-U.S. territories.
Enhanced Fiscal and Corporate Discipline
Critical to the company's strategic changes has been the implementation of procedures aimed at reducing overall expenses, enhancing efficiency, ensuring compliance with relevant regulations and improving fiscal discipline.
"InterMune continues to focus on our corporate goal of profitability in the fourth quarter of 2005 and financial self-sufficiency thereafter," added Welch. "By financial self-sufficiency, we mean we intend to fund our deep and late-stage development pipeline entirely from the cash flow generated from our revenues. We have already succeeded in significantly reducing overall research and development expenses while increasing our investment in our core hepatology and pulmonology programs. We have narrowed our therapeutic focus from four areas to two and realigned our organization around these areas. We will also pursue strategic partnerships that will help further decrease our rate of cash burn, increase development speed, mitigate risk and further maximize value for shareholders."
InterMune has several late-stage and differentiated development programs that show potential to address unmet medical needs in the hepatology and pulmonology specialty markets, which are large, growing, and significantly underserved.
One of the Strongest HCV Pipelines in the Industry
Infergen® (interferon alfacon-1), which is approved for the treatment of chronic HCV infection in patients 18 years of age or older with compensated liver disease, is currently the only FDA approved interferon with data in its label specifically for retreatment of nonresponder or relapsing patients. InterMune intends to make Infergen an important source of revenue growth and has significantly increased its commercial efforts on Infergen, focusing on the large and rapidly growing market of HCV nonresponders.
Over the last year, InterMune's hepatology portfolio has risen to prominence as a major development opportunity for the company. The company is currently conducting research to lead the development of new treatment paradigms for HCV and expand the options for patients suffering from chronic hepatitis C.
First line therapy of patients treated with pegylated interferons plus ribavirin is effective in approximately half of the patients treated, while the other half do not respond (nonresponders). There are approximately 150,000 nonresponders in the United States and the number is growing by an estimated 50,000 each year. Unfortunately, existing retreatment options deliver extremely poor response rates. InterMune's near-term clinical programs in hepatology are focused on expanding treatment options for this seriously underserved patient population.
Throughout 2003, promising data were presented demonstrating that Infergen, in combination with ribavirin, may have the potential to address the unmet medical need of the most treatment-resistant HCV nonresponders. Based on these data, InterMune is planning to initiate a Phase III clinical trial of this combination in this patient population in the first half of 2004. The company is also particularly excited by the prospects of combining its two marketed interferon products, Infergen and Actimmune® (interferon gamma-1b) for the treatment of hepatitis C nonresponders, for which there is strong scientific rationale. Pioneering in vitro experiments undertaken at InterMune demonstrated very strong synergistic effects for a range of doses of Infergen and Actimmune in combination. Further promising results were observed from an independent retrospective clinical analysis evaluating the use of Infergen plus Actimmune for the treatment of chronic hepatitis C nonresponders. This combination therapy represents a significant opportunity for InterMune, and the company plans on advancing this clinical program in the first half of 2004 with a Phase II study. The company is also now exploring the potential of combining Actimmune with marketed pegylated interferons to treat naive HCV patients in the first half of 2005. This approach, if proven successful, could potentially help the company penetrate the large patient population of untreated or naove patients.
Finally, InterMune is working on small molecule approaches to treating HCV that are rapidly progressing through preclinical development. The company and its partner, Array Biopharma, have identified and characterized several highly potent preclinical protease inhibitor candidates with improved bioavailability over competitive compounds.
Industry Leader in the Development of Innovative Therapies for IPF
In the area of pulmonology, InterMune is committed to developing therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a disease characterized by progressive scarring or fibrosis of the lungs, which ultimately results in death, and for which there is no approved therapy. InterMune is developing Actimmune and pirfenidone, which are the two most clinically advanced compounds for the treatment of this condition. The company's pivotal Phase III INSPIRE Trial, which is designed to evaluate the impact of Actimmune on survival time in IPF patients with mild to moderate disease, is actively enrolling patients at sites in North America and Europe. The trial was designed in collaboration with thought leaders and based on observations from its 330-patient randomized, double-blind, placebo controlled Phase III clinical trial, GIPF-001, as well as two other independently conducted randomized, controlled trials of Actimmune for the treatment of IPF.
The company is also very enthusiastic about the promise of pirfenidone, a molecule with broad in vitro biological activity and presented encouraging results of Phase II data of pirfenidone in IPF at the meeting. In much of 2004, InterMune obtained Orphan Drug Designation and expects to complete the pre-clinical and manufacturing activities as well as the clinical data analysis required to begin an IPF registration program in the first half of 2005.
Leveraging Core Expertise with Strategic Partnerships
A fundamental strength of InterMune is its commercial and development organizations and expertise. The company's sales organization and medical science liaisons are dedicated to supporting Infergen for HCV and supporting Actimmune in its marketed indications as well as educating the medical community on the awareness and early diagnosis of IPF. InterMune plans to more fully leverage this capability to achieve its commercial goals by establishing appropriate co-promotion agreements in hepatology and/or pulmonology, such as the one announced earlier this week with Baxter to co-promote Aralast® (alpha1-proteinase inhibitor (human)) to pulmonologists in the United States for the treatment of hereditary emphysema.
Creating Near-Term Value From Non-Core Assets
Consistent with its more focused strategy on hepatology and pulmonology, InterMune intends to capture near-term value from non-core assets, in particular by seeking another company to assume the future development investment in oritavancin, the company's novel hospital-based glycopeptide antibiotic agent and divesting its antifungal agent, Amphotec®. While oncology is no longer a core area, InterMune has decided to maintain control of Actimmune rights in oncology. The company's 800-patient Phase III clinical trial of Actimmune plus standard therapy in ovarian cancer will soon be fully enrolled, and InterMune will make a decision on the future of this program when the company conducts an interim analysis of progression-free survival anticipated to occur in mid-2005.<<
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Cheers, Tuck |
