Pipeline updates are highly awaited events in the pharmaceutical/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Earlier this week, Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY) announced that dupilumab has met all primary and secondary endpoints in a randomized, double-blind, placebo-controlled phase IIa proof-of-concept study. The study evaluated dupilumab in patients (50% underwent prior surgery) suffering from moderate-to-severe chronic sinusitis with nasal polyps (CSwNP) who did not respond to intranasal corticosteroids. 58% of the patients also suffered from asthma.
The primary endpoint of the study was measured by the improvement in the size of nasal polyps. Dupilumab showed a statistically significant improvement in the size of nasal polyps. Moreover, dupilumab significantly improved objective measures of sinusitis by CT scan, nasal air flow, and patient-reported symptoms including sense of smell, congestion, postnasal drip, runny nose and sleep disturbance.
According to Regeneron and Sanofi, almost 75% of CSwNP patients experience a decreased sense of smell. It is estimated that 3% − 5% of the patients in the U.S. and Europe suffer from CSwNP with many patients unresponsive to intranasal corticosteroids (the only available therapy). Additionally, in the U.S., approximately 200,000 CSwNP patients undergo sinus surgery to improve breathing, nasal drainage and remove inflamed mucosal tissue. Nearly 30% of CSwNP patients are also detected with asthma.
In view of the continuous increase in the number of patients affected by various forms of allergy there is an urgent need for the development and commercialization of therapies that would be effective in multiple types of allergic conditions.
Meanwhile, Regeneron and Sanofi are studying dupilumab for two other indications − moderate-to-severe atopic dermatitis and asthma patients with elevated eosinophils. A phase III study for atopic dermatitis is expected to commence in 2014−2015 timeframe.
We expect investor focus to remain on pipeline updates from the companies.
Investors interested in the health care sector may consider stocks like Gilead Sciences Inc. (GILD) and Medivation, Inc. (MDVN).
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