Sanofi/REGN's Dupilumab Data Published

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Sanofi (SNY) and partner Regeneron Pharmaceuticals, Inc. (REGN) recently announced that positive data from a phase IIa study evaluating dupilumab (REGN668/SAR231893) for moderate-to-severe allergic asthma was published in the New England Journal of Medicine.

The study (n = 104) evaluated the efficacy and safety of dupilumab in patients suffering from moderate-to-severe persistent asthma whose disease was inadequately controlled by inhaled glucocorticosteroids (ICS) and long-acting beta agonist (:LABA) therapy. Additionally the asthma patients had elevated blood or sputum eosinophils.

As per study results, 87% reduction in the incidence of asthma exacerbations were observed in the dupilumab arm as compared to placebo. Moreover, dupilumab demonstrated statistically significant improvements in lung function and other asthma control parameters.

We note that Sanofi and Regeneron Pharma are also evaluating the candidate for treating patients suffering from moderate-to-severe atopic dermatitis (:AD) who did not receive sufficient benefit with existing topical treatments. In Mar 2013, the companies presented encouraging data from two phase Ib trials evaluating dupilumab for AD.

The randomized phase Ib trials (n = 67) assessed the safety of dupilumab at three different doses (75mg, 150mg, 300mg) for 8 weeks. The companies also evaluated dupilumab in other parameters including efficacy, pharmacokinetic and biomarker.

Sanofi carries a Zacks Rank #4 (Sell). We remain concerned about the generic erosion confronting most of Sanofi’s key drugs including Plavix, Avapro, Lovenox, Taxotere, Eloxatin and Xatral. The genericization of Avapro and Plavix is expected to negatively impact Sanofi’s business net income by around €800 million in the first half of 2013.

Currently, companies like Santarus, Inc. (SNTS) and Jazz Pharmaceuticals (JAZZ) look attractive. Both the stocks carry a  Zacks Rank #1 (Strong Buy).

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