Labopharm/TCA's and Delivery Systems

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Anonymous

Guest
Hey Folks,

For the wild-eyed newbies of the board and the speculators who think that this is the best drug coming.....


The biggest drawback to selling trazadone, when we sold it, was the side effects. The delivery system is still providing the same old drug, systemically... The reason that the TCA’s bombed was the advent of the SSRI's, (Prozac) if you recall your antidepressant history-- for those that sold Cymbalta and the other Lilly portfolio products....



The psychs have no use for a new formulation of an old product unless there is a clear benefit… There really is none, according to the FDA and its final labeling of this product, check the pink sheet, ( &FDA.gov) for that fact. FDA approval, pending, is considered the equivalent "no new meaningful benefit to the patient,” it is of marginal use, and will be determined so by the PBMs and P and T committees of the world. There will be NO formulary support as the drug has no benefit over the old, unless it can be sold cheaper than the present day generics of this drug.. That is not likely. It will sink on recommendation of approval, if at all. Only special needs will be considered --- such a small margin as to be un-meaningful for gaining any type for sales threshold to support a sales force beyond telephone marketing and targeted magazine advertising.


There will be no sampling.

No one has ever heard of the drug company …. again, a complete waste of time to try and push the promotional effort beyond the high noise level of the larger firms… there will be marginal promotional marketing dollars to launch. NQ wound up paying for Lilly’s launch because Lilly was so broke, six years ago…. Again, would NQ front a “no name drug company” for an expensive launch? I don’t think so….

THE only redeeming benefit of trazadone was that it worked, as all TCA’s. They are still used, as backups, for failure to other drugs, by psychs only. Certainly the psychs all appreciate the use of drug cocktails, but the labeling for the product does not/will not have any new information on combinations that will warrant stronger "promotion"....

I would be surprised, if at launch, the drug ever clears a threshold of market impact of $1 million in sales for 2010. It would be amazing if it did.... then and only then as a last ditch for all products that didn't work in a resistant patient.

If sales forecasts are any more than that... they will be firing(trimming) the sales force (riffing) before the end of the year...

Your best bet, if this contract ever comes to "reality" and the product clears FDA approval is to ask the tough questions; otherwise you'll be back in the unemployment line, likely, by the end of the year, again.
 












Anonymous said:
Your best bet, if this contract ever comes to "reality" and the product clears FDA approval is to ask the tough questions; otherwise you'll be back in the unemployment line, likely, by the end of the year, again.
Click to expand...

Maybe so, but even six months on this contract means six months of experience calling on psychs. Great if you're trying to get that specialty rep experience everyone wants to see before giving you a second look for subsequent specialty positions, not so much if you're a career specialty rep looking for something long-term.
 






Anonymous said:
Hey Folks,

For the wild-eyed newbies of the board and the speculators who think that this is the best drug coming.....


The biggest drawback to selling trazadone, when we sold it, was the side effects. The delivery system is still providing the same old drug, systemically... The reason that the TCA’s bombed was the advent of the SSRI's, (Prozac) if you recall your antidepressant history-- for those that sold Cymbalta and the other Lilly portfolio products....



The psychs have no use for a new formulation of an old product unless there is a clear benefit… There really is none, according to the FDA and its final labeling of this product, check the pink sheet, ( &FDA.gov) for that fact. FDA approval, pending, is considered the equivalent "no new meaningful benefit to the patient,” it is of marginal use, and will be determined so by the PBMs and P and T committees of the world. There will be NO formulary support as the drug has no benefit over the old, unless it can be sold cheaper than the present day generics of this drug.. That is not likely. It will sink on recommendation of approval, if at all. Only special needs will be considered --- such a small margin as to be un-meaningful for gaining any type for sales threshold to support a sales force beyond telephone marketing and targeted magazine advertising.


There will be no sampling.

No one has ever heard of the drug company …. again, a complete waste of time to try and push the promotional effort beyond the high noise level of the larger firms… there will be marginal promotional marketing dollars to launch. NQ wound up paying for Lilly’s launch because Lilly was so broke, six years ago…. Again, would NQ front a “no name drug company” for an expensive launch? I don’t think so….

THE only redeeming benefit of trazadone was that it worked, as all TCA’s. They are still used, as backups, for failure to other drugs, by psychs only. Certainly the psychs all appreciate the use of drug cocktails, but the labeling for the product does not/will not have any new information on combinations that will warrant stronger "promotion"....

I would be surprised, if at launch, the drug ever clears a threshold of market impact of $1 million in sales for 2010. It would be amazing if it did.... then and only then as a last ditch for all products that didn't work in a resistant patient.

If sales forecasts are any more than that... they will be firing(trimming) the sales force (riffing) before the end of the year...

Your best bet, if this contract ever comes to "reality" and the product clears FDA approval is to ask the tough questions; otherwise you'll be back in the unemployment line, likely, by the end of the year, again.
Click to expand...

Your 1 million mark is interesting, I am hearing 10-14 managers, 120-140 reps, 85 grand for managers, 70 + for reps, that is well over a million in salary alone. That many reps and managers means at least a 5 to 10 million in sales, or there wouldn't be a contract at all.
 






Anonymous said:
Your 1 million mark is interesting, I am hearing 10-14 managers, 120-140 reps, 85 grand for managers, 70 + for reps, that is well over a million in salary alone. That many reps and managers means at least a 5 to 10 million in sales, or there wouldn't be a contract at all.
Click to expand...

Mark my words.. plenty of duds they can sell by advertising w/o a sales force.
 






To the OP... Nicely written post. I respect your knowledge in this arena, as I too have been Psych Specialty and dealt with the CNS market for many years. I do have a couple of points/questions to raise.

First, I'm guessing there aren't many "wild-eyed newbies" paying much attention to this thread, as the requirements for the positions are a bit more stringent than a newbie in this market would have, in terms of experience. (Just a thought that struck me when I read your opener).

The position postings clearly call for 13 DM's, although there are only about 105 rep positions posted (it's been stuck at this number for a week or so), so my question to you is... assuming there is someone intelligent at the helm of this project, is it possible you're missing some information regarding the forecasting? I don't doubt your knowledge, I just can't imagine that Quintiles would set up a sales force of this size (not huge, but certainly not tiny) for a product that an "informed cafepharma contributor" could so easily deem "a bust".

With regard to Quintiles producing a launch for a company that no one has ever heard of... you need look no further than the Gastro contract. This is definitely a smaller contract (sales force of 49), and it's completely true that they have no (reasonably speaking) promo budget, but they are launching the first drug available in the US from "Eurand Pharmaceuticals", which I assure you, no one ever heard of. And yes, the market is different as well, but I keep coming back to my original question... Why would Quintiles bother with this Psych contract if they didn't feel it would be, at the very least, a reasonable business venture?

I haven't seen any info to date (or even a hint, for that matter) as to the intended length of this contract, but as sad as it is to say, I have to agree with the poster who stated (paraphrasing) that 6 months of pay is still 6 months of pay. These days, with long term contracts dismantling early, (6240,6175) it's hard to know how long you'll actually stay in the work force. Other than the Gastro/Eurand contract, which is supposed to be rolled over to Eurand after 1 year, I haven't seen another recent contract at Quintiles that has been signed for only 1 year. I certainly could be mistaken, but I'm hoping this will at least come out of the gate with a longer duration than just one year.

All in all, we are doing what we always do (former Quintiles reps) when new contracts hit the web site... we guess at who the partner is, the products, we speculate about those being "earmarked" for the positions, and we weigh in on whether the drug, or the contract parameters, should be considered good or bad. Until you get a call for an interview (or those returning from interviews share their info) we keep ourselves busy, informed and amuzed with this info.
 






Anonymous said:
To the OP... Nicely written post. I respect your knowledge in this arena, as I too have been Psych Specialty and dealt with the CNS market for many years. I do have a couple of points/questions to raise.

First, I'm guessing there aren't many "wild-eyed newbies" paying much attention to this thread, as the requirements for the positions are a bit more stringent than a newbie in this market would have, in terms of experience. (Just a thought that struck me when I read your opener).

The position postings clearly call for 13 DM's, although there are only about 105 rep positions posted (it's been stuck at this number for a week or so), so my question to you is... assuming there is someone intelligent at the helm of this project, is it possible you're missing some information regarding the forecasting? I don't doubt your knowledge, I just can't imagine that Quintiles would set up a sales force of this size (not huge, but certainly not tiny) for a product that an "informed cafepharma contributor" could so easily deem "a bust".

With regard to Quintiles producing a launch for a company that no one has ever heard of... you need look no further than the Gastro contract. This is definitely a smaller contract (sales force of 49), and it's completely true that they have no (reasonably speaking) promo budget, but they are launching the first drug available in the US from "Eurand Pharmaceuticals", which I assure you, no one ever heard of. And yes, the market is different as well, but I keep coming back to my original question... Why would Quintiles bother with this Psych contract if they didn't feel it would be, at the very least, a reasonable business venture?

I haven't seen any info to date (or even a hint, for that matter) as to the intended length of this contract, but as sad as it is to say, I have to agree with the poster who stated (paraphrasing) that 6 months of pay is still 6 months of pay. These days, with long term contracts dismantling early, (6240,6175) it's hard to know how long you'll actually stay in the work force. Other than the Gastro/Eurand contract, which is supposed to be rolled over to Eurand after 1 year, I haven't seen another recent contract at Quintiles that has been signed for only 1 year. I certainly could be mistaken, but I'm hoping this will at least come out of the gate with a longer duration than just one year.

All in all, we are doing what we always do (former Quintiles reps) when new contracts hit the web site... we guess at who the partner is, the products, we speculate about those being "earmarked" for the positions, and we weigh in on whether the drug, or the contract parameters, should be considered good or bad. Until you get a call for an interview (or those returning from interviews share their info) we keep ourselves busy, informed and amuzed with this info.
Click to expand...

oops, I meant "amused"...
 












To post #6

Good post. I agree with the sentiment 6 months is better than a sharp stick in the eye. Sitting on my ass posting on CP pays really bad. As to your observation of small contracts, its possible we are witnessing ( I hate this phrase) a real paradigm shift in the business. Its been speculated that this was going to happen years ago and I think it finally has. That is the shift from share of voice to a pure specific target model. Some of you are going to say they have been doing this already, small companies, UCB, Watson, yes, big pharma no. The day of the pod, two or three reps with overlapping products, and a 400 rep contract force to support the pod, I don't see it happening any more, (or very rarely). I think the bulk of the cso business is going to be the small specialty type contracts like 6385. In the past when big pharma has contracted as it did last year and continuing into this year, it was usually a boon for the cso's as they(big pharma) would backfill with contract reps. I do not think it will happen this time. I have been doing this for fifteen years, and I hope I can get a few more in, ( the age thing is another topic that offers its own special challenge)but I'm not holding my breath waiting for Carl B. to come through. Good luck to all
 






Anonymous said:
To post #6

Good post. I agree with the sentiment 6 months is better than a sharp stick in the eye. Sitting on my ass posting on CP pays really bad. As to your observation of small contracts, its possible we are witnessing ( I hate this phrase) a real paradigm shift in the business. Its been speculated that this was going to happen years ago and I think it finally has. That is the shift from share of voice to a pure specific target model. Some of you are going to say they have been doing this already, small companies, UCB, Watson, yes, big pharma no. The day of the pod, two or three reps with overlapping products, and a 400 rep contract force to support the pod, I don't see it happening any more, (or very rarely). I think the bulk of the cso business is going to be the small specialty type contracts like 6385. In the past when big pharma has contracted as it did last year and continuing into this year, it was usually a boon for the cso's as they(big pharma) would backfill with contract reps. I do not think it will happen this time. I have been doing this for fifteen years, and I hope I can get a few more in, ( the age thing is another topic that offers its own special challenge)but I'm not holding my breath waiting for Carl B. to come through. Good luck to all
Click to expand...

I'm starting to find this whole "Oleptro" idea very interesting, which is not to say I understand it all that well, (I get the science, just not sure I understand the business/stock end of it completely) but it's amazing to me how you can find info to support opinions as varied as "this drug could revolutionize the antidepressant market", to "the challenges of a generic market place are far too great for this new formulation to find success". I suppose in the age of the internet, varying opinions and information are really nothing new.

One thing seems to be certain, though, labopharm expects VERY BIG THINGS from whomever they decide to partner with to get this drug off the ground, and it doesn't appear (to me anyway) that their decision has been made, certainly not publically, and until then... who knows what's going on behind closed doors. Quintiles is ramping up for something, obviously, but I wonder if the "idea" of it being Oleptro/Labopharm is similar to reading a monthly horoscope... you read it, and although horoscopes make very general statements, you swear it's specifically talking about YOU. Just wondering if the 6385 partner, and Labopharm, are positively one and the same. Sounds right, I'm just not sure.

Funny you made the comment about age. I'm not using a walker by any means, but one thing I've really enjoyed about the several contracts I've been on with Quintiles is that I've met, and worked with, some amazingly experienced, knowledgable, business savvy reps here, and I can only hope that continues.

I do have one other question... not knowing "Carl B." at all, or specifically who he is, what do you mean when you say you're not holding your breath waiting for Carl B. to come through. Does this person have a role in the outcome of this contract??
 






to # 10

The oleptro concept is nothing new I have seen this many times, smaller firms taking generic compounds, loading them into a QD release tab, viola new and improved. Who has not sold a successful drug about to fall off patent and the R&D quickly developes XR or XL ( sold Cipro XR for Bayer, it was a battle) The only good approach was Sepracor taking old or troubled compounds and adjusting the molecule. I am by no means excited about selling somthing like oleptro, but any port in a storm . To answer the Carl B ? Carl was the national sales director on 6122 Lilly Diabetes. equally liked and hated by those of us who served.
 






Anonymous said:
to # 10

The oleptro concept is nothing new I have seen this many times, smaller firms taking generic compounds, loading them into a QD release tab, viola new and improved. Who has not sold a successful drug about to fall off patent and the R&D quickly developes XR or XL ( sold Cipro XR for Bayer, it was a battle) The only good approach was Sepracor taking old or troubled compounds and adjusting the molecule. I am by no means excited about selling somthing like oleptro, but any port in a storm . To answer the Carl B ? Carl was the national sales director on 6122 Lilly Diabetes. equally liked and hated by those of us who served.
Click to expand...

Right, I'm well aware of the way the industry takes the old and creates new. Been on several launches where this was the case. Just finding the info on this drug interesting because of the widely varied opinions on it's usefulness.
 












Anonymous said:
correction on the manager salaries - 90% of them make over six figure base, unless they only have a couple of years experience.
Click to expand...


OP here.... I have been tracking this thread and others on NQ/Lilly/BSM/Innovex bds.... I can't tell you that: I TOLD YOU SO.... but just be careful what CARL AKA Yoda tells you on these boards....

Everyone is still OUT of WORK!!!
 












Anonymous said:
Hey Folks,

For the wild-eyed newbies of the board and the speculators who think that this is the best drug coming.....


The biggest drawback to selling trazadone, when we sold it, was the side effects. The delivery system is still providing the same old drug, systemically... The reason that the TCA’s bombed was the advent of the SSRI's, (Prozac) if you recall your antidepressant history-- for those that sold Cymbalta and the other Lilly portfolio products....



The psychs have no use for a new formulation of an old product unless there is a clear benefit… There really is none, according to the FDA and its final labeling of this product, check the pink sheet, ( &FDA.gov) for that fact. FDA approval, pending, is considered the equivalent "no new meaningful benefit to the patient,” it is of marginal use, and will be determined so by the PBMs and P and T committees of the world. There will be NO formulary support as the drug has no benefit over the old, unless it can be sold cheaper than the present day generics of this drug.. That is not likely. It will sink on recommendation of approval, if at all. Only special needs will be considered --- such a small margin as to be un-meaningful for gaining any type for sales threshold to support a sales force beyond telephone marketing and targeted magazine advertising.


There will be no sampling.

No one has ever heard of the drug company …. again, a complete waste of time to try and push the promotional effort beyond the high noise level of the larger firms… there will be marginal promotional marketing dollars to launch. NQ wound up paying for Lilly’s launch because Lilly was so broke, six years ago…. Again, would NQ front a “no name drug company” for an expensive launch? I don’t think so….

THE only redeeming benefit of trazadone was that it worked, as all TCA’s. They are still used, as backups, for failure to other drugs, by psychs only. Certainly the psychs all appreciate the use of drug cocktails, but the labeling for the product does not/will not have any new information on combinations that will warrant stronger "promotion"....

I would be surprised, if at launch, the drug ever clears a threshold of market impact of $1 million in sales for 2010. It would be amazing if it did.... then and only then as a last ditch for all products that didn't work in a resistant patient.

If sales forecasts are any more than that... they will be firing(trimming) the sales force (riffing) before the end of the year...

Your best bet, if this contract ever comes to "reality" and the product clears FDA approval is to ask the tough questions; otherwise you'll be back in the unemployment line, likely, by the end of the year, again.
Click to expand...

Not sure you're still reading the boards, but hoping you are! I have a couple of questions for you, as you stated you sold the "old" traz. Have you looked at the PI of Oleptro vs Trazadone (or Desyrel or any other formulation/generic)? Are there any substantial improvements in the side effect profile of Oleptro... improvements that physicians and patients would clearly benefit from? I was also wondering if Oleptro would be the only formulation with QID dosing. I'm very familiar with this market, but not this particular med, and though it doesn't "appear" that a contract is forthcoming, I'm still wondering about those couple of questions. Thanks for your help!
 






Anonymous said:
Not sure you're still reading the boards, but hoping you are! I have a couple of questions for you, as you stated you sold the "old" traz. Have you looked at the PI of Oleptro vs Trazadone (or Desyrel or any other formulation/generic)? Are there any substantial improvements in the side effect profile of Oleptro... improvements that physicians and patients would clearly benefit from? I was also wondering if Oleptro would be the only formulation with QID dosing. I'm very familiar with this market, but not this particular med, and though it doesn't "appear" that a contract is forthcoming, I'm still wondering about those couple of questions. Thanks for your help!
Click to expand...


The side effect profile of TCA's (about 30 of them -- with five or six that are commonly used) is well known.. Psychs know how to handle them... I f you still have any of your training materials, you'll remember that they have a small but significant portion of the market and used, in some formulary cases, as first line, along with generic SSRI's but a mainstay with the psychs who love the cocktail combos... Remember that in many studies that SSRI's are compared to TCA's because of their "gold standard" effectiveness... Difference was in the side effect profile, which with Prozac, was cleaner....

The major issue would be and will contiue to be who will pay for it... with a small company like this, arrayed against the payors -- PBM's and formulary committees, there's really not a chance of any significant market share penetration becuase of likely pricing pressure.

Additionally, the noise level, among the psychs, vs the other major pharmas - Pfizer, (Sinequan/Zoloft and others) Lilly, ( portfolio) BMS, (abilify), AZ (Seroquel)... own the psychs
 






Anonymous said:
The side effect profile of TCA's (about 30 of them -- with five or six that are commonly used) is well known.. Psychs know how to handle them... I f you still have any of your training materials, you'll remember that they have a small but significant portion of the market and used, in some formulary cases, as first line, along with generic SSRI's but a mainstay with the psychs who love the cocktail combos... Remember that in many studies that SSRI's are compared to TCA's because of their "gold standard" effectiveness... Difference was in the side effect profile, which with Prozac, was cleaner....

The major issue would be and will contiue to be who will pay for it... with a small company like this, arrayed against the payors -- PBM's and formulary committees, there's really not a chance of any significant market share penetration becuase of likely pricing pressure.

Additionally, the noise level, among the psychs, vs the other major pharmas - Pfizer, (Sinequan/Zoloft and others) Lilly, ( portfolio) BMS, (abilify), AZ (Seroquel)... own the psychs
Click to expand...

I appreciate your info, but I was really wondering about the 2 specific questions I asked. 1) how does Oleptro's side effect profile measure up to that which is currently available, and 2) are any of those currently out there dosed QD? I can do the research on my own, and most likely will out of curiosity, just thought you perhaps new this off the top of your head.

I will say, just from my background of training, I was always taught (and believed it to be reasonable), that while the SSRI's were reasonably efficacious, they were never comparable to the old TCA's as they excluded a very important element... the norepinephrin (sp - it's been a while) componant. Effexor XR (SNRI, as I'm sure you know) was far closer in it's chemical makeup and neurotransmitter effects. Anyway, thanks again for your reply.
 






An excerpt from today’s press release taken from the Labopharm site.

"Labopharm expects to launch OLEPTRO(TM) in the third quarter of 2010. The Company is focused on securing a marketing partnership that would allow Labopharm to participate in OLEPTRO(TM)'s marketing and sales effort. Labopharm's recently completed equity offering allows the Company to continue to prepare for the commercial launch of OLEPTRO(TM) in parallel with its partnering discussions."

http://www.labopharm.com/Default.aspx?id=83&reqId=1395336

How long can you hold your breath?
 












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