Anonymous
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Anonymous
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Make a lot of $$? Are you seeing what they want to charge for this at Optimer? My pharmacists are already freaking out about this one. This is not going to be easy.
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Got the pricing on fidaxomicin from our GPO today.
You. Must. Be. Joking. We can use brand-name Vancocin capsules as first-line for that price!
You. Must. Be. Joking. We can use brand-name Vancocin capsules as first-line for that price!
Anonymous
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Anonymous
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Dificid is a dog. Way overpriced and Optimer didn't do their research on the market. Optimer Listened to the "consultants" who tell them all about market potential before talking to the sales people or customer. Everyone is using Vanc IV in a slurry in and out of the hospital. What are the sales of the tablet anyway? I bet the sales of Vancocin have been declining the last few years but the consultants wouldn't know the real market if it hit them in the face. Cha ching.
Anonymous
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Dificid is a dog. Way overpriced and Optimer didn't do their research on the market. Optimer Listened to the "consultants" who tell them all about market potential before talking to the sales people or customer. Everyone is using Vanc IV in a slurry in and out of the hospital. What are the sales of the tablet anyway? I bet the sales of Vancocin have been declining the last few years but the consultants wouldn't know the real market if it hit them in the face. Cha ching.
Neither would you. Vancocin has gone generic. And the oral version of Vanc., not the IV is what is used to treat C-diff. Bottom line, a 13% increase in refractory C-diff. is all this new drug has over oral Vanc. At the price, it will never be placed in a first line position over oral vanc., only will be tried for recurring C-diff. infections. The analysts never expected the drug to be a big money maker.
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Neither would you. Vancocin has gone generic. And the oral version of Vanc., not the IV is what is used to treat C-diff. Bottom line, a 13% increase in refractory C-diff. is all this new drug has over oral Vanc. At the price, it will never be placed in a first line position over oral vanc., only will be tried for recurring C-diff. infections. The analysts never expected the drug to be a big money maker.
Your wrong, most of the patients are started on Vanc IV slurry in the hospital are sent to the SNF, LTAC and even home infusion on the Vanc IV slurry not Vancocin tablet. Even though you, and I am sure the "consultant" companies, still think the tablet is being used. The only pts who get Vancocin are the pts with supplemental 3rd party insurance and only if they are screened out by the hospital as being able to go home (very few). The Vanc IV slurry is taken orally and cost less then $10 to the pharmacy - of course they charge at leat $50. Very little Vancocin (oral) was written becuase it cost too much around $45 a pill or $180 a day. Thus everyone uses the IV slurry and have been for years, even the small community hospitals.
Anonymous
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Anonymous
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Neither would you. Vancocin has gone generic. And the oral version of Vanc., not the IV is what is used to treat C-diff. Bottom line, a 13% increase in refractory C-diff. is all this new drug has over oral Vanc. At the price, it will never be placed in a first line position over oral vanc., only will be tried for recurring C-diff. infections. The analysts never expected the drug to be a big money maker.
$12 for a 5-gram vial of generic Vancomycin plus $7 in cherry syrup from our compounding supplier = cheaper for repeat courses of therapy than the garbage fidaxomicin that no PBM will cover at preferred.
Do you really believe ANY hospital, long term care facility or any PBM would ever choose anything else when you did NOT get the relapse labeling?
Looks like the Optimer people will not be getting that big buyout that Cubicin promised them if their drug would sell. Bye bye stock options hello unemployment line.
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Yes...get out Cubist people as soon as you get another offer. Does it not make you mad, that Optimer folks get paid about 50K higher base salaries than we do? Considering we have to work with now approximately 3-6 new Optimer counterparts which takes up much more time out of our days....and still do not make our bonus checks....why would anyone stay,......except can;t get another offer. You are better off taking a lower base with another company and then making their bonus which is reachable.$12 for a 5-gram vial of generic Vancomycin plus $7 in cherry syrup from our compounding supplier = cheaper for repeat courses of therapy than the garbage fidaxomicin that no PBM will cover at preferred.
Do you really believe ANY hospital, long term care facility or any PBM would ever choose anything else when you did NOT get the relapse labeling?
Looks like the Optimer people will not be getting that big buyout that Cubicin promised them if their drug would sell. Bye bye stock options hello unemployment line.
Anonymous
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Anonymous
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$12 for a 5-gram vial of generic Vancomycin plus $7 in cherry syrup from our compounding supplier = cheaper for repeat courses of therapy than the garbage fidaxomicin that no PBM will cover at preferred.
Do you really believe ANY hospital, long term care facility or any PBM would ever choose anything else when you did NOT get the relapse labeling?
Looks like the Optimer people will not be getting that big buyout that Cubicin promised them if their drug would sell. Bye bye stock options hello unemployment line.
Rumor is that par pharma will jump in and buy optimer soon. Par has a long standing relation with optimer and optimer's c diff compound is kicking ass so to say!
Anonymous
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Anonymous
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Your wrong, most of the patients are started on Vanc IV slurry in the hospital are sent to the SNF, LTAC and even home infusion on the Vanc IV slurry not Vancocin tablet. Even though you, and I am sure the "consultant" companies, still think the tablet is being used. The only pts who get Vancocin are the pts with supplemental 3rd party insurance and only if they are screened out by the hospital as being able to go home (very few). The Vanc IV slurry is taken orally and cost less then $10 to the pharmacy - of course they charge at leat $50. Very little Vancocin (oral) was written becuase it cost too much around $45 a pill or $180 a day. Thus everyone uses the IV slurry and have been for years, even the small community hospitals.
This does not happen at my hospitals. If a patient is getting it through an NG tube, then the tablet is crushed and mixed into the NG tube. Intravenous Vanc. is not given down an NG tube. The Intravenous form of Vanc. and the oral form of Vanc. are different, they work differently in the gut. And the 13% benefit on refractory c-diff. comes from one of the experts on c-diff. Bottom line, Vanc. will and should be used first line, then if the patient is refractory maybe they will try fidaxomicin. Besides the national expert uses another drug off-label for c-dff. that he studied besides Vancocin anyway.
Anonymous
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Anonymous
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This does not happen at my hospitals. If a patient is getting it through an NG tube, then the tablet is crushed and mixed into the NG tube. Intravenous Vanc. is not given down an NG tube. The Intravenous form of Vanc. and the oral form of Vanc. are different, they work differently in the gut. And the 13% benefit on refractory c-diff. comes from one of the experts on c-diff. Bottom line, Vanc. will and should be used first line, then if the patient is refractory maybe they will try fidaxomicin. Besides the national expert uses another drug off-label for c-dff. that he studied besides Vancocin anyway.
Push fida hard because it is superior to vanco. The patient benefits in all ways with the oral fidaxomicin. If it was your family member, now tell me what you would recommend
Anonymous
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Anonymous
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Push fida hard because it is superior to vanco. The patient benefits in all ways with the oral fidaxomicin. If it was your family member, now tell me what you would recommend
Our jobs depend on the success of fidaxomicin so lets justify that confidence
Anonymous
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Anonymous
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So do you have the two required clinical studies and FDA approved labeling saying that fidaxomicin is superior to vanco?
If not, maybe one of your colleagues would like to be the whistleblower to the FDA so they can collect 10% of the settlement.
The compounded vanco is used in the hospital because it is cheaper and in your own literature fidaxomicin was not proven to be superior in first line treatment results. The studies were not powered for equivalency and Optimer's claim for lower relapse was rejected.
If not, maybe one of your colleagues would like to be the whistleblower to the FDA so they can collect 10% of the settlement.
The compounded vanco is used in the hospital because it is cheaper and in your own literature fidaxomicin was not proven to be superior in first line treatment results. The studies were not powered for equivalency and Optimer's claim for lower relapse was rejected.
Anonymous
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Our jobs depend on the success of fidaxomicin so lets justify that confidence
Bravo
Anonymous
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Anonymous
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Rumor is that par pharma will jump in and buy optimer soon. Par has a long standing relation with optimer and optimer's c diff compound is kicking ass so to say!
Cubist needs to act quickly!
Anonymous
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Anonymous
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Rumor is that par pharma will jump in and buy optimer soon. Par has a long standing relation with optimer and optimer's c diff compound is kicking ass so to say!
If par moves first, cubist will be forced to lay off staff
Anonymous
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Anonymous
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If par moves first, cubist will be forced to lay off staff
Why would Cubist need to lay off staff? Total of about 600 people and Dapto will sell close to 700 million this year?
Meanwhile Optimer hired how many sales people and expect how much in sales? Optimer overestimated the vancocin cdiff market big time. When are we going to see vancocin sales and rx data? Answer, never.
Someone is trying to create interest on this thread and it is pretty sad.
Anonymous
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Anonymous
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Why would Cubist need to lay off staff? Total of about 600 people and Dapto will sell close to 700 million this year?
Meanwhile Optimer hired how many sales people and expect how much in sales? Optimer overestimated the vancocin cdiff market big time. When are we going to see vancocin sales and rx data? Answer, never.
Someone is trying to create interest on this thread and it is pretty sad.
Why are you so sad?
WE need to push fidaxomicin as layoffs will ensue if we do not succeed. It is that simple as we have too many reps already. Optimer has a superior drug and our job is to prove them right. How easy can it be?
Anonymous
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(((((((((((OPTIMER'S HAS A SIGNIFICANTLY HIGHER CURE RATE))))))))
Clinical Infectious Diseases Publishes Subgroup Analysis Showing Optimer's DIFICID™ (fidaxomicin) Tablets Exhibited Higher Clinical Cure and Global Cure Rates Than Vancomycin in Patients with Clostridium difficile-Associated Diarrhea (CDAD) Receiving Concomitant Antibiotics
SAN DIEGO, Aug. 16, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that a subgroup analysis of patients receiving concomitant systemic antibiotics in two Phase 3 clinical trials exploring the use of DIFICID™ (fidaxomicin) tablets in the treatment of adult patients with Clostridium difficile-associated diarrhea (CDAD) was published online in the September 1 issue of Clinical Infectious Diseases (CID). The analysis found that in the presence of concomitant systemic antibiotic therapy, which is the use of antibiotics to treat concurrent infections, DIFICID achieved a significantly higher initial clinical cure rate, and higher rate of global cure, compared to oral vancomycin. In the article, approximately 28% of patients in the Phase 3 clinical trials required antibiotic treatment for concurrent infections, primarily lung and urinary tract, and these treatments had an adverse impact on the efficacy of both CDAD therapies.
(Logo: http://photos.prnewswire.com/prnh/20090413/LA97352LOGO)
Patients with CDAD who received DIFICID while taking concomitant antibiotics demonstrated a significantly higher clinical cure rate of CDAD than patients who received oral vancomycin and concomitant antibiotics (90.0% clinical cure rate vs. 79.4%, respectively; p=0.04).Regardless of concomitant antibiotic use, DIFICID was also statistically superior to oral vancomycin in global cure rate. Global cure is defined as clinical cure with no recurrence through the end of study visit 26 to 30 days after completion of CDAD treatment.
"To date, there has been little research demonstrating the impact of concomitant antibiotic use in patients being treated for CDAD," said Dr. Kathleen Mullane, Associate Professor of Medicine at The University of Chicago Department of Medicine and an author on the study. "Results from this subgroup analysis show that more than one in four patients with CDAD were also taking concomitant antibiotics for other infections and that concomitant antibiotic therapy can significantly compromise CDAD treatment. The results also suggest that DIFICID may help blunt the effect of concomitant antibiotics on response to CDAD treatment and that continued investigation of the impact of concomitant antibiotic use in this patient population is warranted."
Effect of Concomitant Antibiotic Use on Clinical Outcomes
Among patients analyzed in the study, the use of concomitant antibiotics compromised response to CDAD therapy. For the combined DIFICID and vancomycin treatment groups, CDAD patients who received concomitant antibiotics had clinical cure rates of 84.4%, compared to cure rates of 92.6% among patients who did not (p<0.001), and experienced a median extended time to resolution of diarrhea of 97 hours compared to 54 hours in patients who did not receive additional antibiotics (p<0.001). Global cure was observed in 74.7% of patients who did not receive concomitant antibiotics compared to 65.8% of patients receiving concomitants antibiotics at any time during the study (p= 0.005). Use of concomitant antibiotics tended to increase the rate of recurrence but did not reach significance.
Effect of DIFICID vs. Vancomycin with Concomitant Antibiotics
In the absence of concomitant antibiotic use, DIFICID and vancomycin were similar in achievement of clinical cure by the end of treatment (92.3% vs. 92.8%; p= 0.80). However, when patients received one or more antibiotics concurrently with study drug, DIFICID was superior to vancomycin in achieving clinical cure (90.0% vs. 79.4% p = 0.04). When patients received no additional antibiotics at any time during the study, the global cure rate was 80.8% for DIFICID patients and 69.1% for vancomycin patients(p < 0.001). Global cure rates were substantially reduced in both treatment groups when patients received concomitant antibiotics at any time, but 72.7% of DIFICID patients achieved global cure compared to 59.4% for vancomycin (p = 0.02). Concomitant antibiotic use was associated with higher recurrence rates in both the DIFICID and oral vancomycin treatment groups. However, recurrence was consistently less frequent following DIFICID treatment whether patients received concomitant antibiotics or not. In patients receiving concomitant antibiotics at any time during treatment or follow-up, treatment with DIFICID was associated with a recurrence rate of 16.9% compared to 29.2% with oral vancomycin (p=0.048).
"Medical guidelines recommend discontinuation of concomitant antibiotics at the diagnosis of CDAD if possible. However, that may not always be practical because patients need the antibiotics for serious concurrent infections," said Dr. Sherwood Gorbach, Chief Scientific Officer at Optimer and an author on the study. "To the extent treatments for CDAD can help mitigate the adverse impact of concomitant antibiotics on response to treatment, they would offer a much needed treatment option for this patient population."
Clinical Infectious Diseases Publishes Subgroup Analysis Showing Optimer's DIFICID™ (fidaxomicin) Tablets Exhibited Higher Clinical Cure and Global Cure Rates Than Vancomycin in Patients with Clostridium difficile-Associated Diarrhea (CDAD) Receiving Concomitant Antibiotics
SAN DIEGO, Aug. 16, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that a subgroup analysis of patients receiving concomitant systemic antibiotics in two Phase 3 clinical trials exploring the use of DIFICID™ (fidaxomicin) tablets in the treatment of adult patients with Clostridium difficile-associated diarrhea (CDAD) was published online in the September 1 issue of Clinical Infectious Diseases (CID). The analysis found that in the presence of concomitant systemic antibiotic therapy, which is the use of antibiotics to treat concurrent infections, DIFICID achieved a significantly higher initial clinical cure rate, and higher rate of global cure, compared to oral vancomycin. In the article, approximately 28% of patients in the Phase 3 clinical trials required antibiotic treatment for concurrent infections, primarily lung and urinary tract, and these treatments had an adverse impact on the efficacy of both CDAD therapies.
(Logo: http://photos.prnewswire.com/prnh/20090413/LA97352LOGO)
Patients with CDAD who received DIFICID while taking concomitant antibiotics demonstrated a significantly higher clinical cure rate of CDAD than patients who received oral vancomycin and concomitant antibiotics (90.0% clinical cure rate vs. 79.4%, respectively; p=0.04).Regardless of concomitant antibiotic use, DIFICID was also statistically superior to oral vancomycin in global cure rate. Global cure is defined as clinical cure with no recurrence through the end of study visit 26 to 30 days after completion of CDAD treatment.
"To date, there has been little research demonstrating the impact of concomitant antibiotic use in patients being treated for CDAD," said Dr. Kathleen Mullane, Associate Professor of Medicine at The University of Chicago Department of Medicine and an author on the study. "Results from this subgroup analysis show that more than one in four patients with CDAD were also taking concomitant antibiotics for other infections and that concomitant antibiotic therapy can significantly compromise CDAD treatment. The results also suggest that DIFICID may help blunt the effect of concomitant antibiotics on response to CDAD treatment and that continued investigation of the impact of concomitant antibiotic use in this patient population is warranted."
Effect of Concomitant Antibiotic Use on Clinical Outcomes
Among patients analyzed in the study, the use of concomitant antibiotics compromised response to CDAD therapy. For the combined DIFICID and vancomycin treatment groups, CDAD patients who received concomitant antibiotics had clinical cure rates of 84.4%, compared to cure rates of 92.6% among patients who did not (p<0.001), and experienced a median extended time to resolution of diarrhea of 97 hours compared to 54 hours in patients who did not receive additional antibiotics (p<0.001). Global cure was observed in 74.7% of patients who did not receive concomitant antibiotics compared to 65.8% of patients receiving concomitants antibiotics at any time during the study (p= 0.005). Use of concomitant antibiotics tended to increase the rate of recurrence but did not reach significance.
Effect of DIFICID vs. Vancomycin with Concomitant Antibiotics
In the absence of concomitant antibiotic use, DIFICID and vancomycin were similar in achievement of clinical cure by the end of treatment (92.3% vs. 92.8%; p= 0.80). However, when patients received one or more antibiotics concurrently with study drug, DIFICID was superior to vancomycin in achieving clinical cure (90.0% vs. 79.4% p = 0.04). When patients received no additional antibiotics at any time during the study, the global cure rate was 80.8% for DIFICID patients and 69.1% for vancomycin patients(p < 0.001). Global cure rates were substantially reduced in both treatment groups when patients received concomitant antibiotics at any time, but 72.7% of DIFICID patients achieved global cure compared to 59.4% for vancomycin (p = 0.02). Concomitant antibiotic use was associated with higher recurrence rates in both the DIFICID and oral vancomycin treatment groups. However, recurrence was consistently less frequent following DIFICID treatment whether patients received concomitant antibiotics or not. In patients receiving concomitant antibiotics at any time during treatment or follow-up, treatment with DIFICID was associated with a recurrence rate of 16.9% compared to 29.2% with oral vancomycin (p=0.048).
"Medical guidelines recommend discontinuation of concomitant antibiotics at the diagnosis of CDAD if possible. However, that may not always be practical because patients need the antibiotics for serious concurrent infections," said Dr. Sherwood Gorbach, Chief Scientific Officer at Optimer and an author on the study. "To the extent treatments for CDAD can help mitigate the adverse impact of concomitant antibiotics on response to treatment, they would offer a much needed treatment option for this patient population."
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To the FDA, a single subgroup analysis is not sufficient for a superiority claim in the approved product labeling. If it did not convince the FDA, it will not convince the conservative world of infectious diseases enough to make fidaxomicin first line for all CDAD infections.
ID docs always reserve newer drugs for infections that have not responded to therapeutic standard. In CDAD, that remains vancomycin or metronidazole.
And how many PBMs and GPOs have added fidaxomicin as a preferred agent? Are you on guidelines yet? If not--so sorry but the cheapo generic vanc and metronidazole will continue to be first line.
ID docs always reserve newer drugs for infections that have not responded to therapeutic standard. In CDAD, that remains vancomycin or metronidazole.
And how many PBMs and GPOs have added fidaxomicin as a preferred agent? Are you on guidelines yet? If not--so sorry but the cheapo generic vanc and metronidazole will continue to be first line.