With the biotechnology industry continuing to demonstrate outstanding returns, investors may want to take a close look at a promising biotechnology company that recently announced positive Phase 3 results. That company is InterMune (NASDAQ:ITMN).
InterMune is a biotechnology company focused on developing and commercializing innovative therapies in pulmonology and orphan fibrotic diseases. The company’s research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases.
The company’s flagship product is pirfenidone (marketed under the name Esbriet), used for the treatment of idiopathic pulmonary fibrosis (IPF.) IPF is a chronic and ultimately fatal disease characterized by a progressive decline in lung function. The term pulmonary fibrosis means scarring of lung tissue and is the cause of worsening dyspnea.
Pirfenidone is currently approved for use in the EU and Canada. Despite the fact that pirfenidone is not yet approved for use in the U.S., InterMune has done a remarkable job of growing its revenue over the years.
- 2011 — $5.4 million
- 2012 — $26.2 million
- 2013 — $70.3 million
Recent research indicates that the IPF market could surpass $1 billion across the US and EU by 2017. While Europe has dominated the market thus far, analysts expect the U.S. to capture significant market share in the years ahead. That is why InterMune is such an attractive story and why investors may be looking at significant returns in the future.
On February 25, shares of InterMune surged by more than 170 percent after the company announced positive Phase 3 ASCEND trial data. Although shares have fallen a little since the high, InterMune is still trading higher by approximately 130 percent.
The magnitude of the treatment effect of pirfenidone was measured by comparing the proportion of patients in the pirfenidone and placebo groups experiencing either a clinically meaningful change in FVC, or death. A 10 percent decline in FVC in an individual IPF patient is a strong sign of mortality. The ASCEND trial produced the following data points:
- Week 52 — There was a 47.9 percent reduction in the proportion of patients who experienced a meaningful change in FVC or death.
- Week 52 — There was a 132.5 percent increase in the proportion of patients whose FVC did not decrease between Baseline and Week 52.
Dr. Talmadge King, co-chair of the ASCEND protocol steering committee, said that, “The ASCEND data demonstrated that pirfenidone significantly reduced decline in lung function and significantly increased the proportion of patients who had no decline, which is an important advance in the field. The results for 6MWT distance, PFS, and mortality provide important supportive evidence of pirfenidone’s efficacy.”
In addition to the solid data points, pirfenidone also demonstrated an adequate safety profile. Investors can look forward to receiving additional data at the 2014 American Thoracic Society International Conference in May.
If InterMune can successfully navigate its way through the U.S. regulatory process and commercial launch phase, the company has the potential to eventually generate annual revenue of $1 billion.