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November 22, 2011
Regeneron Finally Makes It to the Market
Posted by Derek
I've been doing drug research since 1989 myself, which means that I'm fairly experienced. But Regeneron started in this business a year or two before I did, and they're just now getting their first major drug, Eylea (aflibercept) onto the market. To be fair, they did get approval for Araclyst (rilonacept) in 2008, but that one pays the electric bill and not much more - although that might be changing (see below).
As Andrew Pollack at the New York Times points out, the company has run through over two billion dollars over the years. I remember when they were working on nerve growth factors for ALS and other diseases, back in the early 1990s (I worked in the area briefly myself, to no good effect whatsoever). There are not a lot of nerve growth factor drugs on the market, although it seemed like a perfectly plausible mechanism for one back then.
That work shaded into another indication, ciliary neurotrophic factor for obesity. Regeneron spent a lot of time and money developing a modified form of that protein called Axokine, but in 2003 that project ran into the rocks. Some patients did lose weight on the drug (with daily injections), but too many of them developed antibodies to it, which raised the possibility of cross-reactivity with their own CNF, which would surely not have been a good thing. So much for Axokine.
But Eylea, a VEGF-based therapy for macular degeneration (entering the same space as Lucentis and Avastin), has now made it. And the company has another use for Arcalyst in preventative gout therapy coming along, and some interesting cholesterol work targeting PCSK9 in collaboration with Sanofi. So welcome, Regeneron, to the ranks of profitable biotech companies (well, pretty soon) who've developed their own products. It's taken a lot of time, a lot of patience - yours and your investors' - and a lot of cash. But you're still here, and how many other bioctech startups from the late 1980s can say that?
Comments (6)
+ TrackBacks (0) | Category: Cardiovascular Disease | Diabetes and Obesity | Drug Industry History | Regulatory Affairs | The Central Nervous System
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1. anchor on November 22, 2011 10:17 AM writes...
Derek: Well said and in addition there is ex-Merck CEO Dr. Roy Vagelos with them and that is a big deal. In these days of uncertainty, we need some one like him!
Permalink to Comment2. pete on November 22, 2011 12:55 PM writes...
Great testament to REGN's combo of good science and management's deal-making skills that the company survived through all the years w/o a marketed drug.
Permalink to Comment3. Aspirin on November 22, 2011 2:31 PM writes...
Roy Vagelos + THREE Nobel Laureates on the board. Not a bad deck.
Permalink to Comment4. Biotechtranslated on November 22, 2011 3:16 PM writes...
They are going to have a rough time considering the off-label use of Avastin.
Mike
Permalink to Comment5. Ben on November 22, 2011 3:51 PM writes...
They can aspire to be just like Merck.
www.businessinsider.com/merck-to-pay-nearly-1-billion-to-settle-vioxx-probe-2011-11
Permalink to CommentNote Merck only had to plead to a misdemeanor. You try marketing false drugs to patients out of your basement and you'll get 20 years. Ahhh, the joys of incorporation!
6. Anonymous on November 22, 2011 7:36 PM writes...
There appears to be a serious love /hate triangle/quadriangle?? going on here. Roche doesn't want Avastin to be used for this indication since it has Lucentis approved with Novartis. Avastin COULD be used at a fraction of the price. Now Regeneron has Eylea (aflibercept) which is a perhaps a "johnny come lately" but dosed less frequently than Lucentis. Regeneron also probably would do anything to avoid Avastin being approved for this indication!
So, what do we have ....hummmm a Stalemate or checkmate? The only solution is to have Roche acquire Regeneron and prove once and for all that Avastin CAN'T be used for MAD for whatever reason...if they can. Tall order! What a mess!
My friends, what you are witnessing is the results of the Genentech / Roche merger at its finest. Not including the layoff of TALENT, you are witnessing the blunder/incompetence of Roche given that Lucentis and Avastin were developed by Roche and genetech. Duhhh!! One has to laugh at this fiasco.
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