Recognizing Regeneron Pharmaceuticals, Inc.
By Nadine Wong -- With the FDA approval of Arcalyst (IL-1 Trap) as a treatment for Cryopyrin-Associated Periodic Syndromes (CAPS), Regeneron (NASDAQ: REGN) launched the biological on March 25, 2008. Arcalyst will be priced at $250,000 per patient or $5,000 per vial per week. Therapy will be life-long with weekly injections. While Arcalyst for CAPS is a small indication with modest sales of $10 million expected in 2008, Arcalyst will allow Regeneron to build a commercial infrastructure for future products. Regeneron is looking to expand the label for Arcalyst, which is also being evaluated in a Phase II trial for gout flares. Back in February 2008, Regeneron initiated a double-blind, placebo controlled Phase II study of IL-Trap for the prevention of gout flares induced by the initiation of allopurinol (uric acid-lowering drug therapy used to control the disease). Data from the Phase II study is expected in the second half of 2008. The study will enroll 80 patients and the primary endpoint will be the number of flares during the 16 week period after the initiation of allopurinol therapy. So far, treatment with IL-1 Trap demonstrated a statistically significant reduction in patient pain scores in a single-blind, placebo run-in-controlled study of 10 patients with chronic active gout.
The FDA‘s acceptance of Arcalyst sets a precedence for the utility of Regeneron’s Trap technology, hopefully paving the way for future BLAs utilizing their novel Trap program, such as VEGF Trap oncology and VEGF Trap wet acute macular degeneration (AMD).
The VEGF Trap Eye program is expected to continue with the initiation of a second Phase III trial in the EU and the rest of the world in the second half of 2008. VEGF Wet AMD can potentially compete successfully with Genentech‘s Lucentis with higher dosing and bimonthly frequency.
With Regeneron expertise in antibody therapy, its focus on large markets of cancer and AMD therapeutics, and a solid cash position, we maintain our target price of $29.
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