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Fierce Biotech Article - Dupilumab could be as big as PCSK9

  1. Biowatch90

    277 Posts.

    Article Title: Regeneron says its allergy drug could be as big as PCSK9 blockers
    Author: Damian Garde
    Date: 11 February 2015

    Article begins...

    The antibody experts at Regeneron ($REGN) believe their in-development allergy treatment could be the next big thing at the Big Biotech, rolling toward the market with a potential blockbuster.

    The injection, dupilumab, targets two proteins, interleukin-4 and interleukin-13, that play a key role in the inflammatory process, and Regeneron believes it could treat a wide range of allergic ailments with a common root. Like the awaiting-approval cholesterol drug alirocumab, dupilumab is partnered with Sanofi ($SNY), and Regeneron says it could have similar commercial potential.

    It could be the next Praluent," Chief Scientific Officer George Yancopoulos said on an earnings call, name-checking alirocumab by its proposed trade name. Dupilumab is currently in Phase III for eczema, for which it received the FDA's coveted breakthrough therapy designation, and Regeneron is planning to begin a late-stage trial in asthma on the heels of reporting excellent mid-stage data in that disease. Next, the company wants to kick off a late-stage study targeting chronic sinusitis and complete a Phase II trial against eosinophilic esophagitis.

    "We are very excited by (dupilumab) because we see this incredible growth opportunity there, both within indications and among additional indications," Yancopoulos said. "We think that this could really be an important drug for very different assortments of allergic-related diseases."

    The bull case for dupilumab lies both in its panallergic treatment potential and in the fact that the standard of care for each of its targets consists of corticosteroids, which can lead to unpleasant side effects and immune disruption. Those factors have Regeneron thinking big with the antibody, hoping it can win approval and blossom into a blockbuster.

    But Yancopoulos is loath to focus too much on any single asset, pointing out that Regeneron has 15 antibody programs running concurrently. And the company is particularly excited about its early-stage pipeline, including a handful of projects in the burgeoning field of immuno-oncology. Regeneron just kicked off Phase I trials for REGN1979, a bispecific antibody that targets the cancer-tied CD20 and CD3 antigens, and REGN2810, which homes in on the en vogue PD-1. Those programs could usher the company into a fast-growing space, CEO Len Schleifer said.

    "If we can get that franchise going, there is some real opportunity for us to become real leaders in the field of immuno-oncology," Schleifer said on the call. "Because obviously you can use a plug-and-play strategy there, where the first one may be targeting CD20 but the others could target whatever target you might be interested in."

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