dmab sales

again, my post was about Reclast and the Primary care market. I do not know enough about the oncology market to speak to it. If Prolia does well in the Oncology market, good for you but it won't affect me a bit. Also, I would agree that Amgen didn't have the primary care experience to launch the drug effectively but Amgen did have enough Reclast reps to know a little something about launching in the primary care market. And the answer to the poster above is yes, I am a little cocky about my job because I do it well and I work hard.
 






Also to the above, my area has a Prolia rep who came over from another Amgen BU and this person had never call on the PVPs before. It would have been different if they had the 3 or 4 Reclast reps that Novartis does but with 1 rep it is more than a challenge.
I feel for the Prolia reps but most of all I feel for the offices that are still waiting to be reimbursed. Just plays into the hands of the competition
 






Also to the above, my area has a Prolia rep who came over from another Amgen BU and this person had never call on the PVPs before. It would have been different if they had the 3 or 4 Reclast reps that Novartis does but with 1 rep it is more than a challenge.
I feel for the Prolia reps but most of all I feel for the offices that are still waiting to be reimbursed. Just plays into the hands of the competition

We're the expert in pmo we should be selling more.
 






Its interesting that the rebound issue is finally coming to light. I predict this will be the ultimate downfall of this drug in osteoporosis. Watch for excess fracture rate in the first six months after its stopped because of the explosive increase in bone turnover that occurs when the arrested osteoclast maturation is released from inhibition. It will take a while for this adverse event to surface, but with enough patients exposed it will eventually rear its head.

Troll, it's all about OS. Like the positive 147 study. Go Amgen
 












Its interesting that the rebound issue is finally coming to light. I predict this will be the ultimate downfall of this drug in osteoporosis. Watch for excess fracture rate in the first six months after its stopped because of the explosive increase in bone turnover that occurs when the arrested osteoclast maturation is released from inhibition. It will take a while for this adverse event to surface, but with enough patients exposed it will eventually rear its head.

Makes me want to run right out and shoot myself up with some Reclast just to see what will happen!!!
 












Its interesting that the rebound issue is finally coming to light. I predict this will be the ultimate downfall of this drug in osteoporosis. Watch for excess fracture rate in the first six months after its stopped because of the explosive increase in bone turnover that occurs when the arrested osteoclast maturation is released from inhibition. It will take a while for this adverse event to surface, but with enough patients exposed it will eventually rear its head.

You are wrong. There is no fracture wane.
 












If you are truly interested in why Prolia sales are somewhat low, from the perspective of an MD who specializes in osteoporosis -
I think it is a good drug for oncology (e.g., H of M, MBD, etc., and patients with tumors with a prediliction for bone, such as myeloma, prostate and breast cancer). However, currently, for osteoporosis, I'm reserving it for patients who are not appropriate candidates for Reclast, for the following reasons:
1. While the fracture efficacy data are terrific, they are no better than the data for Reclast, but there are several areas of potential concern:
a. 60 mg q 6 months appears to reduce the rate of bone turnover somewhat more than is optimal. Alendronate 10 mg/day or 70 mg/month, ibandronate 150 mg/month, and zoledronic acid 4-5 mg per year (or every 2 years) all reduce the rate of bone turnover by 50-70%, which reduces BT into the pre-menopausal normal range. Which is pretty comparable to the BT effect of full dose ERT. The effect of DMAB 60 mg q 6 months on BT is sgnificantly greater than these agents. While normalizing BT appears to result in improved bone strength, it is at least possible that reducing BT to a greater extent may not be optimal.
b. In this regard, as a bone expert, it is somewhat concerning that about 35% of the patients in the FREEDOM bone biopsy cohort did not demonstrate any TCN label. Not no double label - NO label at all. This finding, which is c/w NO ongoing bone turnover/bone formation, has not been seen in any of the histomorphometry programs with Fosamax, Actonel, Boniva or Reclast.
c. Both ONJ and atypical femur fractures appear to be due, at least in part, to over-suppression of bone turnover. The incidence of ONJ in the DMAB oncology program controlled by Zometa was comparable to the incidence with Zometa (numericaly greater, but NS difference). There are no data from extensive controlled trials (N about 60,000 p-y) that bisphosphonates at osteoporosis doses increase the risk of atypical fractures, although it is possible that they might increase in the risk in a small number of susceptible patients. However, and I speak as a KOL (and I suspect most of my colleagues would agree), if BPs do effect the risk of atypical fractures, I would expect Prolia to be at least as risky, because it reduces BT to a significantly greater extent than oral or IV bisphosphonates.
d. As mentioned by some of your more knowledgable sales rep colleagues, the rebound increase in osteoclastic bone resorption seen after stopping Prolia is of some concern. If patients who d/c Prolia are not placed on a BP, I would definitely predict the possibility of an increased fracture rate, especially in patients with more severe osteoporosis, due to enhanced trabecular perforation. The rebound increase in BT is actually quite impressive, as is the rapid loss of the BMD gains following discontinuation.

So I'm using Prolia in a couple of patients with pretty severe renal failure, and a couple of the rare patients who appear to be idiosyncratically sensitive to BPs (e.g., severe muscle & joint pains with oral BPs). But in the great majority of patients with moderately severe to severe osteoporosis, the 1st line is alendronate. If there are GI tolerability issues, or compliance issues, or evidence of poor absorption, I change to Reclast. Think about it from the perspective of the prescribing physician - with no efficacy advantage over Reclast, but with some additional safety concerns, and a smaller safety database (which will improve with time, of course), why would I go with Prolia right away?

This is not the fault of the sales reps, it's based on the controlled trial data. As more safety data rolls out, there's definitely the possibility that I may prescribe it for more patients. But no one should have predicted that this would be a blockbuster (for osteoporosis - I'm not talking about oncology here) right out of the blocks. Which I know doesn't help you with your sales targets, which are probably unrealistic in the current safety-focused environment.

endodoc
 






Great post above
Even if you are not a endodoc and are just a highly intelligent person you make
some very compelling points
DMAB will never be the drug if choice over Reclast unless for some reason Reclast leaves the market
Reclast will be generic in a year or two and then it will be impossible for Prolia
 






Great post above
Even if you are not a endodoc and are just a highly intelligent person you make
some very compelling points
DMAB will never be the drug if choice over Reclast unless for some reason Reclast leaves the market
Reclast will be generic in a year or two and then it will be impossible for Prolia

Great post because he/she agrees with you? Gimme a break. I can find other "endodocs" who take a completely different position than the one expressed by this individual. The issues he/she raises assume so many factors that we KNOW now to be true.

Patients DON'T comply with their alendrenate. We know that.
The effects of Prolia are reversable...we know that.
The "optimal" bone turnover reduction has been debated in the medical community for years.
Boniva fracture data, even in study populations, is inferior to Prolia

The reasons nursing homes are full or patients with hip fractures are docs who take this individual's position. Bouncing patients back and forth between bisphosponates is a joke. That is what this doctor is doing...and patients are paying the price.
 






If you are truly interested in why Prolia sales are somewhat low, from the perspective of an MD who specializes in osteoporosis -
I think it is a good drug for oncology (e.g., H of M, MBD, etc., and patients with tumors with a prediliction for bone, such as myeloma, prostate and breast cancer). However, currently, for osteoporosis, I'm reserving it for patients who are not appropriate candidates for Reclast, for the following reasons:
1. While the fracture efficacy data are terrific, they are no better than the data for Reclast, but there are several areas of potential concern:
a. 60 mg q 6 months appears to reduce the rate of bone turnover somewhat more than is optimal. Alendronate 10 mg/day or 70 mg/month, ibandronate 150 mg/month, and zoledronic acid 4-5 mg per year (or every 2 years) all reduce the rate of bone turnover by 50-70%, which reduces BT into the pre-menopausal normal range. Which is pretty comparable to the BT effect of full dose ERT. The effect of DMAB 60 mg q 6 months on BT is sgnificantly greater than these agents. While normalizing BT appears to result in improved bone strength, it is at least possible that reducing BT to a greater extent may not be optimal.
b. In this regard, as a bone expert, it is somewhat concerning that about 35% of the patients in the FREEDOM bone biopsy cohort did not demonstrate any TCN label. Not no double label - NO label at all. This finding, which is c/w NO ongoing bone turnover/bone formation, has not been seen in any of the histomorphometry programs with Fosamax, Actonel, Boniva or Reclast.
c. Both ONJ and atypical femur fractures appear to be due, at least in part, to over-suppression of bone turnover. The incidence of ONJ in the DMAB oncology program controlled by Zometa was comparable to the incidence with Zometa (numericaly greater, but NS difference). There are no data from extensive controlled trials (N about 60,000 p-y) that bisphosphonates at osteoporosis doses increase the risk of atypical fractures, although it is possible that they might increase in the risk in a small number of susceptible patients. However, and I speak as a KOL (and I suspect most of my colleagues would agree), if BPs do effect the risk of atypical fractures, I would expect Prolia to be at least as risky, because it reduces BT to a significantly greater extent than oral or IV bisphosphonates.
d. As mentioned by some of your more knowledgable sales rep colleagues, the rebound increase in osteoclastic bone resorption seen after stopping Prolia is of some concern. If patients who d/c Prolia are not placed on a BP, I would definitely predict the possibility of an increased fracture rate, especially in patients with more severe osteoporosis, due to enhanced trabecular perforation. The rebound increase in BT is actually quite impressive, as is the rapid loss of the BMD gains following discontinuation.

So I'm using Prolia in a couple of patients with pretty severe renal failure, and a couple of the rare patients who appear to be idiosyncratically sensitive to BPs (e.g., severe muscle & joint pains with oral BPs). But in the great majority of patients with moderately severe to severe osteoporosis, the 1st line is alendronate. If there are GI tolerability issues, or compliance issues, or evidence of poor absorption, I change to Reclast. Think about it from the perspective of the prescribing physician - with no efficacy advantage over Reclast, but with some additional safety concerns, and a smaller safety database (which will improve with time, of course), why would I go with Prolia right away?

This is not the fault of the sales reps, it's based on the controlled trial data. As more safety data rolls out, there's definitely the possibility that I may prescribe it for more patients. But no one should have predicted that this would be a blockbuster (for osteoporosis - I'm not talking about oncology here) right out of the blocks. Which I know doesn't help you with your sales targets, which are probably unrealistic in the current safety-focused environment.

endodoc

I am not too impressed with a MD taking his/her time to go into such detail, much of which has already been published. Were you paid by some company to post this?
 






Great post above
Even if you are not a endodoc and are just a highly intelligent person you make
some very compelling points
DMAB will never be the drug if choice over Reclast unless for some reason Reclast leaves the market
Reclast will be generic in a year or two and then it will be impossible for Prolia

Re your last line, I WONDER why Amgen didn't take this into consideration? Do we have another Enbrel in the making?
 






It's really interesting to me. So much of what is posted on message boards in general, and this one is no exception, is self-serving bulls**t. Yet when I take the time to try to and provide an educated response to the question as to why DMAB sales are not taking off as fast as some people would like, aspersions are cast. And to the poster who replied about Prolia having better fracture data than IV Boniva, you missed my point - I couldn't agree more (IV Boniva doesn't have any fracture data - which is why the only parenteral BP I use is Reclast).

Hey, take it or leave it. I am indeed a bone endocrinologist, and found this site during a google search on Reclast when I was preparing a CME talk on osteoporosis at a major medical center. Reading some of the posts by sales reps (some of whom may even be the reps I have been meeting with in my office for the past 20+ years) was pretty interesting, as it provided a look into the attitudes of the sales reps for their own company and management, which was an eye-opener for me. So I then checked out the links for the companies of other osteo drugs, such as Amgen, Merck, Lilly, Sanofi, Roche & GSK.

I agree, it's unusual for an MD KOL to take the time to post on a largely sales rep message board. However, I believe strongly in education, whether it's to my patients, residents and endo fellows, or drug reps. Your colleague posted a question about why DMAB sales were what they are, and I though (perhaps incorrectly) that s/he and perhaps other thoughtful sales reps might appreciate some input from a true expert, who actually prescribes drugs for osteoporosis.

BTW, the views I shared are those of a top osteoporosis expert, and not meant to represent the views of the great mass of prescribing physician's, most of whom don't actually know very much about osteoporosis (e.g., they think it's defined by T-score
< -2.5). The overwhelming majority of prescribers (like >95%) don't know the P3 data for any of the drugs they prescribe, and get most of their drug-specific info from the reps. For example, I just saw a patient who was switched from weekly Fosamax to monthly Actonel because "it is more effective". Right.....

I would expect that once Prolia has better reimbursement, lots of primary care docs and rheums/endos will be incentivized to prescribe Prolia instead of Reclast, as they can buy the drug and administer it in their office, making a profit on both the drug and the procedure twice per year, rather than referring the patient to an infusion center for Reclast once per year (making no profit). But as someone who read the Prolia FDA backgrounder as soon as it was available, and intimately knows the clinical & preclinical data from all the BPs, Forteo, Evista and Miacalcin, I prescribe based on actual data. Which is why I don't ever prescribe Miacalcin (lack of robust anti-fracture efficacy), and why I'm initially cautious about using Prolia (no efficacy concerns, but some safety concerns).

Those who prefer to assume that I'm a fraud are free to ignore the information I provided.

endodoc
 






It's really interesting to me. So much of what is posted on message boards in general, and this one is no exception, is self-serving bulls**t. Yet when I take the time to try to and provide an educated response to the question as to why DMAB sales are not taking off as fast as some people would like, aspersions are cast. And to the poster who replied about Prolia having better fracture data than IV Boniva, you missed my point - I couldn't agree more (IV Boniva doesn't have any fracture data - which is why the only parenteral BP I use is Reclast).

Hey, take it or leave it. I am indeed a bone endocrinologist, and found this site during a google search on Reclast when I was preparing a CME talk on osteoporosis at a major medical center. Reading some of the posts by sales reps (some of whom may even be the reps I have been meeting with in my office for the past 20+ years) was pretty interesting, as it provided a look into the attitudes of the sales reps for their own company and management, which was an eye-opener for me. So I then checked out the links for the companies of other osteo drugs, such as Amgen, Merck, Lilly, Sanofi, Roche & GSK.

I agree, it's unusual for an MD KOL to take the time to post on a largely sales rep message board. However, I believe strongly in education, whether it's to my patients, residents and endo fellows, or drug reps. Your colleague posted a question about why DMAB sales were what they are, and I though (perhaps incorrectly) that s/he and perhaps other thoughtful sales reps might appreciate some input from a true expert, who actually prescribes drugs for osteoporosis.

BTW, the views I shared are those of a top osteoporosis expert, and not meant to represent the views of the great mass of prescribing physician's, most of whom don't actually know very much about osteoporosis (e.g., they think it's defined by T-score
< -2.5). The overwhelming majority of prescribers (like >95%) don't know the P3 data for any of the drugs they prescribe, and get most of their drug-specific info from the reps. For example, I just saw a patient who was switched from weekly Fosamax to monthly Actonel because "it is more effective". Right.....

I would expect that once Prolia has better reimbursement, lots of primary care docs and rheums/endos will be incentivized to prescribe Prolia instead of Reclast, as they can buy the drug and administer it in their office, making a profit on both the drug and the procedure twice per year, rather than referring the patient to an infusion center for Reclast once per year (making no profit). But as someone who read the Prolia FDA backgrounder as soon as it was available, and intimately knows the clinical & preclinical data from all the BPs, Forteo, Evista and Miacalcin, I prescribe based on actual data. Which is why I don't ever prescribe Miacalcin (lack of robust anti-fracture efficacy), and why I'm initially cautious about using Prolia (no efficacy concerns, but some safety concerns).

Those who prefer to assume that I'm a fraud are free to ignore the information I provided.

endodoc

"FRAUD"? You said it, not me, but I do wonder if you have too much time on your hands. This site is more of a social commentary, rather than giving forth with your droning on about things that can be obtained from good old Amgen.

I still feel a tad hesitant about your curriculum vitae.

Maybe next time you can shorten up your dissertation, as my ink cartridge is being sucked dry.
 






Few points in response to this poster, and a question for Endodoc:

First, remember when George Morrow stated that Nursing Homes were full of patients with hip fractures....whatever the reason. Maybe why that is one of the reasons GM is now a Consultant. Nursing Homes are not full of patients like this to ever make a difference in DMab sales, and these places would NEVER pay for DMAB for a once every 6 month injection, and MD's would make no money since the injections would need to be given there. We don't even have reps that know anything about Nursing Homes and the reimbursement challenges, so how can we address this market anyway.

Second, for the Endodoc, I thought your post was terrific. Unfortunately, Amgen has become a very unhappy place to work for many. As an MD, I am sure you would not like being micromanaged to death, being tracked about where you are every half hour of the day (by some of the more insecure Managers), and so on, but that is our fate many days. The fact that the DMab marketing strategy was loaded with incorrect assertions and overblown sales targets by the Ivory Tower folks that live and work out of Thousand Oaks doesn't help and now they want to blame the sales force for their ineptitude for not having the uptake be quicker. Amgen has great science, but not great Business Minds. In this day and age, you need the latter every bit as much as the former.

Lastly, for the Endodoc, Cafepharma has become a sort of gathering place for the unhappy folks to feel safe to vent their frustrations. When a company is doing well, you will not see many posts on their Message Board. When you see alot of activity, you can be well assured that the great majority of posts/responses will be slanted towards the negative.

I, for one, thought your post was one of the most informative I have seen in a long time. However, just be aware that most Amgenites like myself are fed up being treated like children despite many, many reps in the field being more experienced than their Managers are, than our Home Office is, and are looking at alternatives to get away from Amgen, and in some cases outside this dying industry....


Toodle Ooh









Great post because he/she agrees with you? Gimme a break. I can find other "endodocs" who take a completely different position than the one expressed by this individual. The issues he/she raises assume so many factors that we KNOW now to be true.

Patients DON'T comply with their alendrenate. We know that.
The effects of Prolia are reversable...we know that.
The "optimal" bone turnover reduction has been debated in the medical community for years.
Boniva fracture data, even in study populations, is inferior to Prolia

The reasons nursing homes are full or patients with hip fractures are docs who take this individual's position. Bouncing patients back and forth between bisphosponates is a joke. That is what this doctor is doing...and patients are paying the price.
 






Thank you for your insight apologizing for some of the unintelligent posts of here.

QUOTE=Anonymous;3839129]If you are truly interested in why Prolia sales are somewhat low, from the perspective of an MD who specializes in osteoporosis -
I think it is a good drug for oncology (e.g., H of M, MBD, etc., and patients with tumors with a prediliction for bone, such as myeloma, prostate and breast cancer). However, currently, for osteoporosis, I'm reserving it for patients who are not appropriate candidates for Reclast, for the following reasons:
1. While the fracture efficacy data are terrific, they are no better than the data for Reclast, but there are several areas of potential concern:
a. 60 mg q 6 months appears to reduce the rate of bone turnover somewhat more than is optimal. Alendronate 10 mg/day or 70 mg/month, ibandronate 150 mg/month, and zoledronic acid 4-5 mg per year (or every 2 years) all reduce the rate of bone turnover by 50-70%, which reduces BT into the pre-menopausal normal range. Which is pretty comparable to the BT effect of full dose ERT. The effect of DMAB 60 mg q 6 months on BT is sgnificantly greater than these agents. While normalizing BT appears to result in improved bone strength, it is at least possible that reducing BT to a greater extent may not be optimal.
b. In this regard, as a bone expert, it is somewhat concerning that about 35% of the patients in the FREEDOM bone biopsy cohort did not demonstrate any TCN label. Not no double label - NO label at all. This finding, which is c/w NO ongoing bone turnover/bone formation, has not been seen in any of the histomorphometry programs with Fosamax, Actonel, Boniva or Reclast.
c. Both ONJ and atypical femur fractures appear to be due, at least in part, to over-suppression of bone turnover. The incidence of ONJ in the DMAB oncology program controlled by Zometa was comparable to the incidence with Zometa (numericaly greater, but NS difference). There are no data from extensive controlled trials (N about 60,000 p-y) that bisphosphonates at osteoporosis doses increase the risk of atypical fractures, although it is possible that they might increase in the risk in a small number of susceptible patients. However, and I speak as a KOL (and I suspect most of my colleagues would agree), if BPs do effect the risk of atypical fractures, I would expect Prolia to be at least as risky, because it reduces BT to a significantly greater extent than oral or IV bisphosphonates.
d. As mentioned by some of your more knowledgable sales rep colleagues, the rebound increase in osteoclastic bone resorption seen after stopping Prolia is of some concern. If patients who d/c Prolia are not placed on a BP, I would definitely predict the possibility of an increased fracture rate, especially in patients with more severe osteoporosis, due to enhanced trabecular perforation. The rebound increase in BT is actually quite impressive, as is the rapid loss of the BMD gains following discontinuation.

So I'm using Prolia in a couple of patients with pretty severe renal failure, and a couple of the rare patients who appear to be idiosyncratically sensitive to BPs (e.g., severe muscle & joint pains with oral BPs). But in the great majority of patients with moderately severe to severe osteoporosis, the 1st line is alendronate. If there are GI tolerability issues, or compliance issues, or evidence of poor absorption, I change to Reclast. Think about it from the perspective of the prescribing physician - with no efficacy advantage over Reclast, but with some additional safety concerns, and a smaller safety database (which will improve with time, of course), why would I go with Prolia right away?

This is not the fault of the sales reps, it's based on the controlled trial data. As more safety data rolls out, there's definitely the possibility that I may prescribe it for more patients. But no one should have predicted that this would be a blockbuster (for osteoporosis - I'm not talking about oncology here) right out of the blocks. Which I know doesn't help you with your sales targets, which are probably unrealistic in the current safety-focused environment.

endodoc[/QUOTE]
 






Few points in response to this poster, and a question for Endodoc:

First, remember when George Morrow stated that Nursing Homes were full of patients with hip fractures....whatever the reason. Maybe why that is one of the reasons GM is now a Consultant. Nursing Homes are not full of patients like this to ever make a difference in DMab sales, and these places would NEVER pay for DMAB for a once every 6 month injection, and MD's would make no money since the injections would need to be given there. We don't even have reps that know anything about Nursing Homes and the reimbursement challenges, so how can we address this market anyway.

Second, for the Endodoc, I thought your post was terrific. Unfortunately, Amgen has become a very unhappy place to work for many. As an MD, I am sure you would not like being micromanaged to death, being tracked about where you are every half hour of the day (by some of the more insecure Managers), and so on, but that is our fate many days. The fact that the DMab marketing strategy was loaded with incorrect assertions and overblown sales targets by the Ivory Tower folks that live and work out of Thousand Oaks doesn't help and now they want to blame the sales force for their ineptitude for not having the uptake be quicker. Amgen has great science, but not great Business Minds. In this day and age, you need the latter every bit as much as the former.

Lastly, for the Endodoc, Cafepharma has become a sort of gathering place for the unhappy folks to feel safe to vent their frustrations. When a company is doing well, you will not see many posts on their Message Board. When you see alot of activity, you can be well assured that the great majority of posts/responses will be slanted towards the negative.

I, for one, thought your post was one of the most informative I have seen in a long time. However, just be aware that most Amgenites like myself are fed up being treated like children despite many, many reps in the field being more experienced than their Managers are, than our Home Office is, and are looking at alternatives to get away from Amgen, and in some cases outside this dying industry....


Toodle Ooh

Maybe the incorrect assertions and overblown sales targets you refer to were an effort to prepare for an acquisition that never happened. DNA & Wyeth were purchased but apparently AMGN did not represent a good value, now we are just drifting aimlessly like a submarine with a broken rudder!
 






Maybe the incorrect assertions and overblown sales targets you refer to were an effort to prepare for an acquisition that never happened. DNA & Wyeth were purchased but apparently AMGN did not represent a good value, now we are just drifting aimlessly like a submarine with a broken rudder!


You are right. Tear apart the 10Qs and you uncover that the company's declining sales appear to be better than they are. Magic of it is, cutting overhead and raising prices makes most people feel they are doing fine. If they were doing a good job, the share price wouldn't be so low.

Nothing is going to happen until we clean house but that may prove difficult as the house is run by the top executive and his posse Sort of like hiring the fox to guard the henhouse. Yes, it's broken rudder.