Regeneron's Rilonacept Granted European Marketing Authorization for Treatment of Cryopyrin-Associated Periodic Syndro... ( TARRYTOWN N.Y. Oct. 27 /- Regeneron P...)

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Regeneron's Rilonacept Granted European Marketing Authorization for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

Date:10/27/2009

TARRYTOWN, N.Y., Oct. 27 /PRNewswire-FirstCall/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced it has received marketing authorization in the European Union for rilonacept, an interleukin-1 blocker, for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged 12 years and older. Marketing authorization for rilonacept was granted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) under exceptional circumstances.

"Rilonacept, which is known as ARCALYST® in the United States, has been prescribed to treat the majority of patients documented to have been treated for CAPS symptoms to date in the U.S. ARCALYST is the only treatment for CAPS in the U.S. that has demonstrated a significant improvement in CAPS symptoms as reported by patients in a pivotal clinical program and is approved for self-administration at home," said Robert Terifay, Senior Vice President, Commercial at Regeneron. "Currently, rilonacept is available to patients in the European Union through their prescribers on a named-patient or individualized case review basis. We are evaluating our broader commercialization options for this very small, ultra-orphan patient population, which is dispersed across Europe."

CAPS include a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli. Rilonacept is a targeted inhibitor of interleukin-1 (IL-1), the key driver of inflammation in CAPS
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SOURCE Regeneron Pharmaceuticals, Inc.
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