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Johnson & Johnson's (NYSE: JNJ) and partner AstraZeneca's (NYSE: AZN) rheumatoid arthritis hopes just got a totally unexpected new lease on life. The collaborators' novel RA treatment, which targets a different and promising pathway of treatment for the often crippling disease -- is awaiting FDA approval. But blockbuster hopes for the med, si??? were rapidly fading. That's because Regeneron (NASDAQ: REGN) and Sanofi (NYSE: SNY) similar new-age med was about to launch and steal the bulk of sales. Instead, on October 28, the FDA
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But Regeneron and its partner Sanofi (NYSE: SNY)
If sarilumab pans out, it will catalyze Regeneron much more than behemoth J&J, given the respective size of these companies and how much it takes to move J&J's needle. But both companies have partners in these for Regeneron and), andas well as how it might even might even cause a slight flutter in J&J's stock, along with its partner AstraZeneca (NYSE";AZN). as well as why analysts (mostly) are missing the boat on this battle.
The coming arthritis showdown
there hasn't been a lot of attention paid by analyst's to either Regeneron' or J&J's new RA drugs.Wall Street considers the rheumatoid arthritis market already saturated, so Peak expectations for Regeneron'ssarilumab, the new IL-6 drugs are $1 billion in annual sales, based on the RA market already being saturated with drugs such as Humira. While AbbVie's (NYSE: ABBV) Humira treats several conditions,, which is the world's best selling RA drug, raked in $15 billion http://www.winonadailynews.com/business/fda-approves-lower-cost-alternative-to-biotech-drug-humira/article_ee651b2f-9c03-57a6-939d-18a362bc0ea6.htmlin sales in 2015,Amgen's (NYSE: AMG) Enbrel and J&J's Remicade, as well as Humira.
What the Street is missing is that those drugs are all in the TNF (tumor necrosis factor) targeting group, while both J&J and Regeneron's drugs target the IL-6 pathway. That pathway could well be better approach to treating rheumatoid arthritis, based on clinical trial data. If that proves out, the RA market could be upended and today's blockbusters will see their share snatched by drugs with superior efficacy.
In addition, RA is a massive market--and highly lucrative for drugmakers. The disease affects 2 million Americans--and many current treatments don't cut the mustard, often leaving patients with crippling symptoms unchecked. Demand for RA drugs is also growing due to the global aging population and increasing female population (women suffer from RA more often than men). in RA,
Meanwhile, sarilumab has already shown superiority to market leader Humira in clinical trials. Specifically the SARIL-RA-MONARCH study released data on March 11, 2016, showing that RA patients taking sarilumab showed significantly more improvement 72% compared to http://www.pharmatimes.com/news/sanofis_biologic_beats_abbvies_humira_in_ra_trial_1020296over those taking Humira.
Regeneron's drug has shown superior efficacy
J&J and Glaxo are behind Regeneron and Sanofi in likely launch dates---but they are still hoping for best-in-class status. . That hope is based on these drugs having slightly different mechanisms. Sirukumab targets the IL-6 cytokine, while Regeneron's drug sar? ??? targets the IL-6 receptor http://www.epvantage.com/Universal/View.aspx?type=Story&id=603899&isEPVantage=yes.But that improvement in clinical efficacty has yet to show up.
In fact, data on sirukumab's trial against Humira https://clinicaltrials.gov/ct2/show/NCT02019472 is still pending. And even if that does show sirukumab does best Humira, that only puts it even with Regeneron's sarilumab. J&J's drug has a more seirous problem, as well. while the drug showed an impressive 83% http://www.epvantage.com/Universal/View.aspx?type=Story&id=603899&isEPVantage=yes patient response in RA signs and symptoms in a phase 2b study against a placebo, sirukumab fell well short of that in the more recent phase 3 study.
In that study, a similar response was only seen in 55% http://www.biospace.com/News/new-janssen-rd-phase-3-data-in-patients-with/422643/source=MoreNews of patients, a big drop from the previous trial, and also significantly less than the 72% patient in these trials, what was being measured is what percent of patients showed a certain set reduction in arthritis symptoms http://www.pharmatimes.com/news/sanofis_biologic_beats_abbvies_humira_in_ra_trial_1020296 response in signs and symptoms Regeneron's competing drug achieved in its trial against Humira.
The FDA is unpredictable, but the regulatory nod is probably based on sarilumab's stellar trial data. Assuming it happens, Regeneron will beat J&J to market with its med, conveying a strong commercial advantage.
So what's the verdict? the advantage right now goes to Regeneron's sarilumab. The biologic med has already outperformed also http://www.investors.com/news/technology/regeneronsanofi-drug-beats-humira-in-rheumatoid-arthritis-trial/the best-selling drug in the world, Humira, in a head-to-head trial.Among other things, J&J's sirukumab could cannibalize Remicade's sales in RA, which isn't a risk Regeneron faces since it has no other RA drugs. Plus, there's the
