Regeneron Chief Executive Leonard Schleifer hopes to file for approval by the end of 2004.
Regeneron tested its own drug in 47 Muckle-Wells patients, and it helped all of them.
Now the second NGF-1 antibody, from Regeneron and Sanofi-Aventis, has been put on ice, too.
Regeneron and Amgen, which is also developing a PCSK9 drugs, dismissed the possibility of a substantial delay.
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Regeneron's drug is given weekly and could be approved for Muckle-Wells and its milder cousin this year.
In 2003 Novartis had been collaborating with Regeneron Pharmaceuticals to test Regeneron's interleukin-1 blocker in rheumatoid arthritis.
Even if Regeneron's drug is identical to Avastin, it could drive down costs once it gets to market.
Then she heard Regeneron Pharmaceuticals was testing an experimental drug that might help.
When Schleifer, a 50-year-old neurologist, cofounded Regeneron with George Yancopoulos , a molecular immunologist, the main target was Lou Gehrig's disease.
The rarity of this stems from a long history of consolidation, but also confers on Regeneron a higher probability of clinical success.
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This includes the team of Regeneron Pharmaceuticals and Sanofi, Amgen, and Pfizer.
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In the recently ended third quarter, Eylea captured roughly one-third of the branded market share for wet AMD, according to Regeneron ceo Leonard Schleifer.
Regeneron has said it expects file with the U.S. Food and Drug Administration to market Arcalyst for gout in the middle of this year.
But the landscape changed a year ago when the FDA approved yet another drug for wet AMD, Eylea, which is sold by Regeneron Pharmaceuticals.
In the pharmaceutical space, Regeneron (NASDAQ:REGN), Onyx (NASDAQ:ONXX) and Celgene (NASDAQ:CELG) all had nice moves, and T3Live has listed them over the last few days.
But the reason companies including Regeneron, its partner Sanofi, Amgen, and Pfizer are so excited about PCSK9 is because it should be a safe target.
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The majority of analysts (53.8%) rate Regeneron Pharmaceuticals as a buy.
Tarrytown, NY-based Regeneron and its partner, Bayer, are betting there is.
Their returns this year range from the 57% of corporate information-data-services provider Teradata ( TDC), to 149% for drug designer and manufacturer Regeneron Pharmaceuticals ( REGN).
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Several drug companies, including Amgen and the team of Regeneron and Sanofi, are developing incredibly potent cholesterol shots that work by targeting a protein called PCSK9.
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Now comes a new glimmer of hope: a hunger-fighter called Axokine, from Regeneron Pharmaceuticals (nasdaq: REGN - news - people ) of Tarrytown, N.
In 2003 Novartis had been collaborating with Regeneron Pharmaceuticals (nasdaq: REGN - news - people ) to test Regeneron's interleukin-1 blocker in rheumatoid arthritis.
Yancopoulos, Regeneron's chief scientist, says he heard about the possibilities in treating Muckle-Wells and made an "impassioned plea" to Novartis to test Regeneron's drug for that malady.
Because the underlying biology is so clear, it is far more likely that the PCSK9 inhibitor Sanofi is developing with partner Regeneron will prove helpful to heart patients.
VEGF-Trap, from Regeneron and Sanofi-Aventis, is also much like Avastin.
Given how the remit of payers and regulators has developed in recent years, perhaps the most pertinent of these is the value story that Regeneron has successfully narrated for Eylea.
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The companies that experienced the reductions are: Gilead Sciences Inc. ( GILD), Biogen Idec Inc. ( BIIB), Pall Corp. ( PLL), Onyx Pharmaceuticals ( ONXX) and Regeneron Pharmaceuticals ( REGN).
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As analysts at Credit Suisse also note, there is a scarcity of pure play antibody companies, and Regeneron is now the largest biotech player focused almost exclusivity in this field.
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If this medicine doesn't pan out, the next competitor to Avastin is VEGF-Trap, a treatment that Sanofi is developing with Regeneron Pharmaceuticals (nasdaq: REGN - news - people ).
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