Entyvio- vedolizumab

Any news on launch date?

 

Word is that FDA is wanting additional data prior to approval. Looks like we are going to have to do some additional studies to keep them happy & if they pan out then will get approval in next couple of years, if not then will not get approved.

 

Maybe you shouldn't be promoting the drug before approval then.

Pretty sure thats a violation of federal law

 

Also keep in mind this is heresay. It was beneficial for both parties to extend the PDUFA. Analyzing the general consensus from the oversight committee is a decent metric for evaluation. It would be a massive loss for Takeda if they could not get approval this June with all the upcoming competition.

 

Someone better roll out another fan for all the sh*t that's going to start flying

 

OK boys and girls here are the numbers and facts about crohn’s:
Size of market Pts. Now 1.2 MM
2022 Pts 1.5 MM WOW (really)
Estimated sales by 2015 Humira and Remicade $ 3.3 billion
3 drugs expected to be approved 2014/2015 Millenium, Jansen and GSK
And you guys think you’re going to get $1.0 Billion in sales, please what are they making you smoke

U B GONE SOON

 

Any idea if it's going to be in IV or SubQ formulation?

 

Studies are with IV...right?

 

Yep, nothing done in SubQ (that I could find).

 

Would say benchmark is belatacept of BMS - vedolizumab is an IV infusion - no bolus no s.c. - in comparison to e.g. Humira - self injectable by sophisticated device by patient - great compliance advantage for vedolizumab!

 

Haha Its not gonna play out like that

 

How's it gonna play out?

 

Name a successful drug launch from Takeda since Lilly launched Actos? Track record speaks for itself, why is going to be different this time?

 

worldwide sales of belatacept 2011 3 million US$, 2012 11 million US$, 2013 26 million US$...very good science, but same safety issue (PML) discussed also for Veodolizumab see www.nulojix.com

 

Based on revenue for this drug, it actually does sound like a Takeda product. UC market size is 2.1 Billion, getting a 25M product for Takeda would be a grand slam in the market!

 

It will be the gi version of colcrys

 

Are you kidding - vedolizumab is a real biologics - taken by infusion over 30-60 minutes - peak sales at least 1 billion!!!

 

Sure

 

3-4 years to exploit vedolizumab - rectal and little bit later oral highly innovative products are coming from Sweden and Italy (these countries are in Europe). Main advantage is excellent safety!!!

InDex (Kappaproct) and Guiliani (GED-0301) are the originators.

 

You mean Krystexxa