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  #1  
Old 12-15-2012, 08:41 PM
Anonymous
 
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Default Uceris

Have the final hiring decisions been made? If not, anyone know when they expect to hear either way?
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  #2  
Old 12-16-2012, 10:14 AM
Anonymous
 
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Default Re: Uceris

They are still interviewing this week for some areas. Good luck to you.
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  #3  
Old 12-19-2012, 09:11 AM
Anonymous
 
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Default Re: Uceris

Quote:
Originally Posted by Anonymous View Post
They are still interviewing this week for some areas. Good luck to you.
Has anyone been told they are going to Kansas City for a final interview yet?
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  #4  
Old 01-02-2013, 03:00 PM
Anonymous
 
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Default Re: Uceris

How is this drug to sell?
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  #5  
Old 01-02-2013, 10:04 PM
Anonymous
 
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Default Re: Uceris

so far extremely difficult! sure hope they fix that whole fda approval thing...
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  #6  
Old 01-03-2013, 03:21 AM
Anonymous
 
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Arms Re: Uceris

Thought Uceris was expected to be approved January 16 - here anything different? My offer is contingent on the approval of this medication. Also, any comment on why Uceris is expected to sell? It looked like the data did not offer much benefit vs comparative established agents one of which is a generic. Non- systemic, yet the adverse events were stated as being similar in the clinical trials. Any constructive comments?
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  #7  
Old 01-03-2013, 03:23 AM
Anonymous
 
Posts: n/a
Arms Re: Uceris

Thought Uceris was expected to be approved January 16 - hear anything different? My offer is contingent on the approval of this medication. Also, any comment on why Uceris is expected to sell? It looked like the data did not offer much benefit vs comparative established agents one of which is a generic. Non- systemic, yet the adverse events were stated as being similar in the clinical trials. Any constructive comments?
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  #8  
Old 01-03-2013, 08:50 PM
Anonymous
 
Posts: n/a
Default Re: Uceris

There is no generic. The generic is for ibs not ibd


Quote:
Originally Posted by Anonymous View Post
Thought Uceris was expected to be approved January 16 - hear anything different? My offer is contingent on the approval of this medication. Also, any comment on why Uceris is expected to sell? It looked like the data did not offer much benefit vs comparative established agents one of which is a generic. Non- systemic, yet the adverse events were stated as being similar in the clinical trials. Any constructive comments?
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  #9  
Old 01-04-2013, 08:30 AM
Anonymous
 
Posts: n/a
Default Re: Uceris

The company seems very confident Uceris will be approved on the 16th, but sometimes it seems like the FDA just needs more time and a 3-month delay wouldn't be unheard of... Is there ANYTHING in the data that could hold it up? Usually I see lots of articles when drugs are on the cusp of approval... But with Uceris I'm not seeing anything!
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  #10  
Old 01-07-2013, 06:54 PM
Anonymous
 
Posts: n/a
Default Re: Uceris

Quote:
Originally Posted by Anonymous View Post
The company seems very confident Uceris will be approved on the 16th, but sometimes it seems like the FDA just needs more time and a 3-month delay wouldn't be unheard of... Is there ANYTHING in the data that could hold it up? Usually I see lots of articles when drugs are on the cusp of approval... But with Uceris I'm not seeing anything!
Yeah, what's the level of confidence here on approval of Uceris? Anyone??
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  #11  
Old 01-08-2013, 05:04 PM
Anonymous
 
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Default Re: Uceris

Read the press release. The FDA has approved and returned the labeling to Santarus right before Christmas. Now the official approval on the 16 th.
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  #12  
Old 01-09-2013, 02:43 PM
Anonymous
 
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Default Re: Uceris

Quote:
Originally Posted by Anonymous View Post
Read the press release. The FDA has approved and returned the labeling to Santarus right before Christmas. Now the official approval on the 16 th.
Yes, but the article I read on Dec. 20th stated that Santarus "cannot be certain the FDA will approve Uceris in a timely manner or at all, despite the receipt of the initial proposed labeling."

With that said, I feel pretty confident everything's going to go through. Yet you never know with the FDA and it doesn't hurt to be prepared to look again. Things certainly look good though and I'll be keeping my fingers crossed!
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  #13  
Old 01-10-2013, 12:54 PM
Anonymous
 
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Default Re: Uceris

Is Bill D going to make another KSB speech and hand out champaigne? Who remembers that? What a joke....... Please be careful of this company. If you are coming from an established company with experience, be careful. Yes, I am speaking from experience.
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  #14  
Old 01-10-2013, 07:03 PM
Anonymous
 
Posts: n/a
Default Re: Uceris

Quote:
Originally Posted by Anonymous View Post
Is Bill D going to make another KSB speech and hand out champaigne? Who remembers that? What a joke....... Please be careful of this company. If you are coming from an established company with experience, be careful. Yes, I am speaking from experience.
Ok, thanks for that valuable input fucker!
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  #15  
Old 01-11-2013, 03:05 PM
Anonymous
 
Posts: n/a
Default Re: Uceris

Seemed valuable to me. Especially the steer clear message of be careful of this company. Past or even present employees have the inside scoop.
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  #16  
Old 01-11-2013, 03:40 PM
Anonymous
 
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Default Re: Uceris

Event Santarus needs Uceris approval to boost flagging pipeline
Source EP Vantage
Company Santarus, Cosmo Pharmaceuticals
Date December 24, 2012
The Californian biotech Santarus might want to postpone its New Year celebrations to January 16, when its ulcerative colitis drug Uceris will come up for US approval. With a thin pipeline, Santarus needs Uceris to add an important source of revenue.
Despite a three-month PDUFA extension from October owing to issues relating to good clinical practices, the company has proposed launching the drug in the first quarter of next year. However, generic competition is right around the corner and Santarus will have to play a convincing game to prove that Uceris is the one to prescribe.
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  #17  
Old 01-11-2013, 10:57 PM
Anonymous
 
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Arrow Re: Uceris

The problem with Uceris is that the data is not compelling enough to use first line vs. generics. It will be a second line medication. The company really does not gave much going on with it.
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  #18  
Old 01-11-2013, 11:43 PM
Anonymous
 
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Default Re: Uceris

WRONG! Spoken by one who didn't land the job. Better luck next time sour grapes.
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  #19  
Old 01-12-2013, 10:59 AM
Anonymous
 
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Default Re: Uceris

I see no sour grapes in that statement. What I see is truthful reality.

The percentage of patients achieving the primary endpoint of combined clinical and endoscopic remission at Week 8 in the Uceris 9mg group was significantly greater than that seen in the placebo group (17.9% vs. 7.4%, P=0.0143; odds ratio (OR): 2.71). The combined clinical and endoscopic remission rate for Uceris 6mg (13.2% vs. 7.4%, P=0.1393; OR: 1.9) and for the reference drug Asacol 2.4g (12.1% vs. 7.4%, P=0.22; OR: 1.71) were numerically greater than placebo, but the differences were not statistically significant.

Not a blockbuster by any means.
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  #20  
Old 01-13-2013, 09:58 AM
Anonymous
 
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Banghead Re: Uceris

Yes someone finally looked at the efficacy data. The adverse events were comparable also. "Dear doctor will you please use my me to medication that costs more and isn't established on any plans." "Well, no Johnny Boy Rep, i will use a generic first and then Asacol and then your Uceris." "Johnny, why on earth would you expect me to use Uceris first. Cant give me a single reason why." "Well doctor, it would really help out our stock that will soon be plummeting because Uceris is a bust and all we have is a bag of generic, that is why the company pays us so much less than the industry average
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  #21  
Old 01-14-2013, 10:27 AM
Anonymous
 
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Party Re: Uceris

So is there any upside to working for this company? My friend interviewed with this company and was really excited and then I did the research on the company and it looked really weak on paper. Their big diabetes medication had increased sales due to a lawsuit they won, Uceris is not going anywhere other than making up a little revenue from their other generic brands. Anyway she took the job. It looks like a paycheck for a short period of time
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  #22  
Old 01-14-2013, 10:56 AM
Anonymous
 
Posts: n/a
Default Re: Uceris

Stock is taking a dive today. Opened at 11.82, already down to 11.13 in fairly high trading.
Looks like a sale off is taking place today.
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  #23  
Old 01-14-2013, 11:58 AM
Anonymous
 
Posts: n/a
Default Re: Uceris

I thought it looked pretty likely that Uceris would be approved Wednesday and I'd be starting a new job on Friday. Now I'm not so sure... I just read an article that pretty much said it'll be like flipping a coin... And his bet is on receiving a Complete Response Letter (vs approval). If that happens, it will be very disappointing.
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  #24  
Old 01-14-2013, 04:12 PM
Anonymous
 
Posts: n/a
Default Re: Uceris

Dutch regulatory authority rejects Cortiment (Cosmo/Ferring) for Ulcerative Colitis - 11-Aug-2012
HIVCosmo Pharmaceuticals received a communication from the Dutch Regulatory Agency (MEB) declining the approval of Cortiment(budesonide with MMX technology), indi*ca*ted for the induction of remission in patients with active, mild to moderate Ulce*ra*tive Colitis. The reasons given for the decline were on the grounds of clinical relevance. Cosmo is awaiting the formal letter to get full disclosure of the reasons for this decision. Santarus has filed the drug as Uceris at the FDA. Ferring have ROW rights licensed from Cosmo except for the US and Japan.
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  #25  
Old 01-14-2013, 04:27 PM
Anonymous
 
Posts: n/a
Default Re: Uceris

Dutch regulatory authority rejects Cortiment (Cosmo/Ferring) for Ulcerative Colitis - 11-Aug-2012
HIVCosmo Pharmaceuticals received a communication from the Dutch Regulatory Agency (MEB) declining the approval of Cortiment(budesonide with MMX technology), indi*ca*ted for the induction of remission in patients with active, mild to moderate Ulce*ra*tive Colitis. The reasons given for the decline were on the grounds of clinical relevance. Cosmo is awaiting the formal letter to get full disclosure of the reasons for this decision. Santarus has filed the drug as Uceris at the FDA. Ferring have ROW rights licensed from Cosmo except for the US and Japan.
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  #26  
Old 01-14-2013, 05:03 PM
Anonymous
 
Posts: n/a
Talking Re: Uceris

Take the job and make the best of it. Their medications are really pathetic. No added value. Guess ill just flatter them with my beauty and talk about the Niners. This company is a stepping stone and the pharmaceutical industry is kicking up. Hey, Santaris people where are the posts on how hour company is going to survive. Stock opions worth shit they offer u guys. Let me guess the moran biy will comment that they passed me over for the job. Guess what i took a better job with a brighter future and it pays twenty grand more a year on bAse salary.
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  #27  
Old 01-14-2013, 05:43 PM
Anonymous
 
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Default Re: Uceris

Very nervous about the health of this company. How much longer can you sell against a free generic?? Docs only RX because they like the rep. Will Uceris be enough???
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  #28  
Old 01-14-2013, 07:18 PM
Anonymous
 
Posts: n/a
Default Re: Uceris

Quote:
Originally Posted by Anonymous View Post
Very nervous about the health of this company. How much longer can you sell against a free generic?? Docs only RX because they like the rep. Will Uceris be enough???
"Will Uceris be enough?"... Uceris may not even get approved!
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  #29  
Old 01-14-2013, 07:22 PM
Anonymous
 
Posts: n/a
Default Re: Uceris

Quote:
Originally Posted by Anonymous View Post
"Will Uceris be enough?"... Uceris may not even get approved!
Actually it IS approved!!!!! News just posted!
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  #30  
Old 01-14-2013, 11:59 PM
Anonymous
 
Posts: n/a
Default Re: Uceris

From the Santarus statement of Approval
About Ulcerative Colitis
Ulcerative colitis is a form of chronic inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon, which can interfere with the normal function of the colon. The disease typically starts to manifest in patients as young adults. Ulcerative colitis is an intermittent disease with periods of exacerbated symptoms, or flares, and periods that are relatively symptom-free. Although the symptoms of ulcerative colitis may resolve without treatment, the disease usually requires medication to go into remission. According to the Crohn's and Colitis Foundation of America, as many as 700,000 people in the U.S. suffer from ulcerative colitis.

So exactly what percentage of these 700,000 people does Santarus hope to get doctors to write a prescription for?
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  #31  
Old 01-15-2013, 11:33 AM
Anonymous
 
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Arms Re: Uceris

YESS! Approved! pretty happy
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  #32  
Old 01-17-2013, 05:46 PM
Anonymous
 
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Default Re: Uceris

Quote:
Originally Posted by Anonymous View Post
YESS! Approved! pretty happy
Takeda will kick your ass when their new UC drug is approved
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  #33  
Old 01-18-2013, 11:03 AM
Anonymous
 
Posts: n/a
Default Re: Uceris

I see your point.
http://www.docguide.com/maintenance-...n-rates?tsid=5
Vedolizumab 35-37% remission after 8 weeks vs Uceris 15-18%
Huge difference. Makes you wonder why the FDA made the decision it did.
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  #34  
Old 01-18-2013, 07:09 PM
Anonymous
 
Posts: n/a
Default Re: Uceris

Both ulcerative colitis medication, but will be used at different times in the treatment paradigm. There will be plenty of room for Uceris To generate good revenue
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  #35  
Old 01-18-2013, 10:42 PM
Anonymous
 
Posts: n/a
Default Re: Uceris

Quote:
Originally Posted by Anonymous View Post
Both ulcerative colitis medication, but will be used at different times in the treatment paradigm. There will be plenty of room for Uceris To generate good revenue
EXACTLY!
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  #36  
Old 01-18-2013, 11:03 PM
Anonymous
 
Posts: n/a
Default Re: Uceris

Quote:
Originally Posted by Anonymous View Post
I see your point.
http://www.docguide.com/maintenance-...n-rates?tsid=5
Vedolizumab 35-37% remission after 8 weeks vs Uceris 15-18%
Huge difference. Makes you wonder why the FDA made the decision it did.
Its IV! Every 4 or 8 weeks for a year. Now think about that silly!
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