Tguns - He is talking about Mongersen (GED-0301), which is Celgene's PhII Chron's Disease drug...the number he is pulling is coming from the abstract that was released by Celgene in tandem with their presentation at the UEG Conference in Vienna. Basically what that data says is Celgene has a Chron's drug that offers a high efficacy rate than its competitors, and is more convenient (competitors are injections while Mongersen is a pill). Its all good!
your post is important but very unclear....first are you talking about otezla?secondly are you comparing remission against the other drugs.....you were a bit cryptic....you could you dumb down this post and re do it as i want to understand it......also post your source.....i want to understand your post
The results announced shed light on the CELG paid a fortune for GED 0301. It essentially renders Crohns manageable and will change sufferer's lives. The old drugs involved IV's, were uncomfortable, and had side effects. This is a screamer for CELG and major pain point for J&J and Abbvie who's competing products sales will fall off a cliff.
I'm hoping for an early end to Phase III trials on compassionate grounds.
By AMY REEVES, INVESTOR'S BUSINESS DAILY
Posted 11:32 AM ET
Big biotech Celgene (NASDAQ:CELG) rolled out more data on its new drug for Crohn's disease Tuesday, sending Celgene shares up 3% in the stock market today.
On Monday, Celgene released the abstract on the phase two trial of GED-0301, also called Mongersen, which showed good results for patients after two weeks of taking the drug. On Tuesday, it presented the full data at the United European Gastroenterology Week in Vienna, revealing that four-week and 12-week data were also strong.
ISI Group analyst was especially interested in the four-week data, since that gave him a point of comparison with drugs already on the market. At the 160-milligram dose, the remission rate for this period was 72%; for 40 mg it was 70%, while at 10 mg it was 29%. The remission rate for the placebo group was 14%, meaning that unlike in the two-week data, even the lowest dose of Mongersen produced a noticeable improvement.
By comparison, Johnson & Johnson's (NYSE:JNJ) Remicade typically produced a remission rate of 48% after four weeks. Biogen Idec's (NASDAQ:BIIB) historic rate is 32%, while AbbVie's (NYSE:ABBV) Humira's is 28.5%.
RBC Capital Markets analyst Michael Yee pointed out that these other drugs typically do $4 billion to $5 billion for the Crohn's disease indication (and they all have other indications in the immunology space since the diseases have similar mechanisms). He also noted that Mongersen's success continued in the 12-week data, with the highest-dose group maintaining a remission rate of 67%. There were no significant safety issues to report.
ISI remission rates per the CONVENTIONAL definition were just reported - 72% remission at high dose 70% middle dose at 4 wks...these are what should be compared to biologics (Remicade 48%, Humira 28.5%, Cimizia 22%, Entyvio 14.5%)....
We now understand that remission rates per the CONVENTIONAL definition were just reported at the medical meeting.
At 4 weeks, the remission rates (defined as only a CDAI score below 150 at week 4) were:
72% high dose
70% middle dose
29% low dose
The numbers above (not the numbers in the abstract which we wrote about yesterday) should be used to compare to historical data for biologics.
The historical data is below:
(See investor village CELG board for slide doesn't print on yahoo -but it shows Remicade 48%, Humira 28.5%, Cimizia 22%, Entyvio 14.5% vs 72% GED-031 at high dose and 70% at medium dose. WOW WOW WOW
Also remember that the peak WW sales estimates of 2.4-3 billion is just for Crohn's and are fairly conservative for market share (slightly less than 50% of the total market). One thing that following biotechs has proven to me is that Doc's love prescribing a single pill over having to manage patient infusions/injections or complex monitoring of meds. And considering that Mongersen/GED-0301 had the same incident of adverse & serious effects as the PLACEBO. I think the sales numbers are conservative.
An expansion for ulcerative colitis treatment would add another 1.5 billion or so to sales. So I think this could be a 5 or 6 billion dollar sales drug in the future.
I think barring any huge event that would be bad for CELG, I think you can buy it and hold it until 2020 now. The earnings runway is now showing good positive growth out to that point.
Nice call. Big announcement today on GED-301 and CELG up $4+. I have a decent investment here and tend not to follow it that closely. I listen to the conference calls and whenever they present at forums. I expect that CELG will contiue to move higher over time. They have a great pipe line and are well managed. I like stocks where I can trust the management. No BS just results.
As an aside: I have known people with Crohns and I applaud these results from a non investing aspect.
I am pretty certain it was the 21 but you many not see data published until the next day. There has been a few early articles out today about it and it looks very good. Biggest problem for CELG was its earnings looked great out to about 2017 but there were no drugs to show continued growth beyond that. Now we have GED-301, AG-221, and AG-120 for the out years.