Ischemic Stroke: Challenging Market, Huge Need

brainsTime is critical when a patient suffers from a stroke. Approximately 87 percent of strokes are caused by blood clots blocking blood flow to the brain, a condition known as ischemic stroke. The drug tPA can restore normal blood flow, but physicians only have a brief window of opportunity—just a few hours from the first symptom—to treat the patient. Furthermore, only 3 to 5 percent of patients are eligible for this treatment option. According to a recent USA Today article, only about a third of stroke sufferers reach the hospital in time for testing to determine their eligibility for tPA therapy.

In the United States, stroke affects approximately 800,000 people each year. It is the third leading cause of death as well as the leading cause of disability in the U.S. In many cases, the patient survives but suffers permanent disability or neurological damage. The American Stroke Association estimates that Americans will pay about $73.7 billion in 2010 for stroke-related medical costs and disability. The clinical need is clear: Patients who suffer an ischemic stroke but do not reach the hospital in time to qualify for tPA therapy desperately need a pharmacological alternative.

That alternative may come from Acorda Therapeutics, Inc. (Nasdaq: ACOR), a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and related nervous system disorders. Acorda is developing a treatment based on Glial Growth Factor 2 (GGF2), a protein that has been shown in preclinical models to protect the brain from the consequences of stroke. The Hawthorne, New York-based company announced Tuesday that data from two preclinical studies show that GGF2 promoted functional recovery following a permanent focal ischemic stroke. The drug demonstrated the ability to improve neurological and cardiac function up to seven days after stroke.

Data from both studies was recently published online in the journal Neuropharmacology and is scheduled to appear in a future print edition. Acorda submitted a New Drug Application to the U.S. Food and Drug Administration in March for GGF2 as a heart failure therapy. GGF2 is believed to promote the repair of tissue damage in the heart, improving the heart’s ability to contract. Acorda plans to conduct further preclinical stroke studies with GGF2 and eventually advance the compound to human clinical trials for stroke and heart failure.

Research firm GlobalData estimates that the global acute ischemic stroke market will grow from $2.9 billion in 2008 to $3.6 billion by 2015, a compound annual growth rate (CAGR) of 3.4 percent. The low CAGR is attributed to a weak pipeline landscape; the market has a history of clinical trial failures. However, the report also notes that the market is lucrative and has significant unmet clinical needs related to the limited window of opportunity for tPA treatment. If it successfully moves through clinical trials, GGF2 could provide a major market opportunity for Acorda. The pharmaceutical company could face competition from other players such as Athersys (Nasdaq: ATHX), which plans to begin clinical trials of a stem-cell treatment for ischemic stroke.

“Time lost is brain lost,” states the tagline of a stroke awareness ad campaign by the American Stroke Association (below). Until a new, effective treatment for ischemic stroke makes it to the global market, this catchphrase will unfortunately remain true.

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