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Tilda Dead before Launch, Patient Death

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Moderate Data and results it will be an uphill climb Bay and Dilip will have high expectations too there will be a mass exodus at Sun within the first 6 months of launch on this thing and the Blue U and Absorica have too many issues to make up the train wreck this thing will be you need PASI 90+ to compete. Not to mention the access group has no clue how to get profitable access for anything

reSURFACE 1 ran from Dec 10, 2012, to Oct 28, 2015. reSURFACE 2 ran from Feb 12, 2013, to Sept 28, 2015. In reSURFACE 1, 772 patients were randomly assigned, 308 to tildrakizumab 200 mg, 309 to tildrakizumab 100 mg, and 155 to placebo. At week 12, 192 patients (62%) in the 200 mg group and 197 patients (64%) in the 100 mg group achieved PASI 75, compared with 9 patients (6%) in the placebo group (p<0·0001 for comparisons of both tildrakizumab groups vs placebo). 182 patients (59%) in the 200 mg group and 179 patients (58%) in the 100 mg group achieved PGA responses, compared with 11 patients (7%) in the placebo group (p<0·0001 for comparisons of both tildrakizumab groups vs placebo). In reSURFACE 2, 1090 patients were randomly assigned, 314 to tildrakizumab 200 mg, 307 to tildrakizumab 100 mg, 156 to placebo, and 313 to etanercept. At week 12, 206 patients (66%) in the 200 mg group, and 188 patients (61%) in the 100 mg group achieved PASI 75, compared with 9 patients (6%) in the placebo group and 151 patients (48%) in the etanercept group (p<0·0001 for comparisons of both tildrakizumab groups vs placebo; p<0·0001 for 200 mg vs etanercept and p=0·0010 for 100 mg vs etanercept). 186 patients (59%) in the 200 mg group, and 168 patients (59%) [corrected] in the 100 mg group achieved a PGA response, compared with 7 patients (4%) in the placebo group and 149 patients (48%) in the etanercept group (p<0·0001 for comparisons of both tildrakizumab groups vs placebo; p=0·0031 for 200 mg vs etanercept and p=0·0663 for 100 mg vs etanercept). Serious adverse events were similar and low in all groups in both trials. One patient died in reSURFACE 2, in the tildrakizumab 100 mg group; the patient had alcoholic cardiomyopathy and steatohepatitis, and adjudication was unable to determine the cause of death
 




SPOT ON! Data is CRAP for this me too drug that may not even get approved! Enjoy those brief jobs bio reps!

QUOTE="anonymous, post: 6004481"]Moderate Data and results it will be an uphill climb Bay and Dilip will have high expectations too there will be a mass exodus at Sun within the first 6 months of launch on this thing and the Blue U and Absorica have too many issues to make up the train wreck this thing will be you need PASI 90+ to compete. Not to mention the access group has no clue how to get profitable access for anything

reSURFACE 1 ran from Dec 10, 2012, to Oct 28, 2015. reSURFACE 2 ran from Feb 12, 2013, to Sept 28, 2015. In reSURFACE 1, 772 patients were randomly assigned, 308 to tildrakizumab 200 mg, 309 to tildrakizumab 100 mg, and 155 to placebo. At week 12, 192 patients (62%) in the 200 mg group and 197 patients (64%) in the 100 mg group achieved PASI 75, compared with 9 patients (6%) in the placebo group (p<0·0001 for comparisons of both tildrakizumab groups vs placebo). 182 patients (59%) in the 200 mg group and 179 patients (58%) in the 100 mg group achieved PGA responses, compared with 11 patients (7%) in the placebo group (p<0·0001 for comparisons of both tildrakizumab groups vs placebo). In reSURFACE 2, 1090 patients were randomly assigned, 314 to tildrakizumab 200 mg, 307 to tildrakizumab 100 mg, 156 to placebo, and 313 to etanercept. At week 12, 206 patients (66%) in the 200 mg group, and 188 patients (61%) in the 100 mg group achieved PASI 75, compared with 9 patients (6%) in the placebo group and 151 patients (48%) in the etanercept group (p<0·0001 for comparisons of both tildrakizumab groups vs placebo; p<0·0001 for 200 mg vs etanercept and p=0·0010 for 100 mg vs etanercept). 186 patients (59%) in the 200 mg group, and 168 patients (59%) [corrected] in the 100 mg group achieved a PGA response, compared with 7 patients (4%) in the placebo group and 149 patients (48%) in the etanercept group (p<0·0001 for comparisons of both tildrakizumab groups vs placebo; p=0·0031 for 200 mg vs etanercept and p=0·0663 for 100 mg vs etanercept). Serious adverse events were similar and low in all groups in both trials. One patient died in reSURFACE 2, in the tildrakizumab 100 mg group; the patient had alcoholic cardiomyopathy and steatohepatitis, and adjudication was unable to determine the cause of death[/QUOTE]
 




There are a couple (2) good people working on Tildra. I mean really working, not this Customer Engagenent pre-sellling or clinical cling-on stuff.

I hope they're looking after themselves, because no one else is.
 








The whole Tildra group is sad. They all went for the MONEY Sun is throwing at them not realizing how shitty Sun is and that Sun is OBLIVIOUS to their HORRIBLE reputation with Dermatologists...no one is going to get any traction with Tildra given the data and the excellent biologics already in place with great commercial coverage.
So, enjoy the short shit show, it will be over soon.
 




The sales team in particular is very sad ...

Don't worry too much, the pain will be over sooner than you already think.

WTF are you guys doing in the field anyway ? Disease state knowledge ? Yeah, there's something new. Fran and Seema, when they 'work', they're hosting dinners and talking product.

Sun is frickin' crazy - huge exposure for the Company.
 




The Tildra team are a bunch of money hungry "has beens", they've failed everywhere else and are desperate enough to join the Sun circus!

anonymous said:
The sales team in particular is very sad ...

Don't worry too much, the pain will be over sooner than you already think.

WTF are you guys doing in the field anyway ? Disease state knowledge ? Yeah, there's something new. Fran and Seema, when they 'work', they're hosting dinners and talking product.

Sun is frickin' crazy - huge exposure for the Company.
Click to expand...
 












anonymous said:
The Tildra team are a bunch of money hungry "has beens", they've failed everywhere else and are desperate enough to join the Sun circus!
Click to expand...


the-great-bombay-circus-at-jaipur.jpg
 








I had a reputable recruiter contact me last week about a position.
I've worked with some of the people that either left or who are still there and I enlightened the recruiter on the Sun culture.

I was actually surprised that the recruiter seemed to be genuine in their thanking me for the information. Whether they stay away, which they said they would, bc their reputation is more important than filling a single position, or whether that was just BS, this company has a horrible reputation among its employees and now among its customers.

Indeed, it's a stay-away.
 




Out at AAD, I had several people ask me 'what's going on at Sun' ? This was from both Derms and reps/marketing people.

I was surprised how much they all knew about who'd left, when, why and where they went. I'm on my way out, am being very selective and have done a lot of networking. There are good opportunities with good companies out there.
Speaking with my colleagues/competitors, who really are decent people, I felt embarrassed saying that I worked at Sun.

But it was definitely motivating to have those conversations.

#onmywayouttahere
 
















Lilly Taltz is already sending reps home due to poor sales. The dermatology biologic market is good, but not good enough to support the dozen or so companies all looking to generate $1 billion brands in a limited space. There are not enough severe psoriasis patients and liberal enough plans willing to foot the bill.

SUN is in for a rude awakening with Tildra. Keep selling pre-market. With no accountability everyone looks like a hero.
 




FDA WILL BE SHUTTNG DOWN SUN!

Bloomberg news 2/23/18

The Nine Observations
The U.S. FDA’s nine observations that Sun Pharma got in 2016 for the Halol facility:

  1. Field alert reports not submitted within three working days of getting information about bacteriological contamination and a significant chemical, physical or other change in a distributed drug.
  2. Drugs don’t bear an expiration date determined by appropriate stability data to assure they meet applicable standards of strength, quality and purity at time of use.
  3. Testing programmes not adequately designed to assess the stability of drugs.
  4. Test procedures, including any changes, are not adequately reviewed and approved by the quality control unit.
  5. The accuracy of test methods has not been established.
  6. No scientifically sound lab control mechanisms to ensure that components, containers, closures, in-process materials, or drugs conform to standards of strength, quality and purity.
  7. The responsibilities and procedures applicable to the quality control unit not fully followed.
  8. Changes to written procedures are not drafted, reviewed and approved by the appropriate organisational units.
  9. Appropriate controls not exercised to ensure that changes to documents related to drug manufacturing are instituted only by authorised personnel.
 




After failing in being able to comply with FDA quality standards, Dilip is forced to shutter Sun's largest manufacturing facility. Halol has been shut down for more than 2 years, and again failed FDA inspections.

Along with 3 product recalls in the US, and contamination issues in topical steroids which necessitated a self-imposed out of stock (before FDA required a product recall), SUN has demonstrated its absolute ignorance of and disregard for producing a safe product.

To anyone who is associated with Sun, you should be ashamed.
 








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