> I am sorry, but this article is grossly incorrect and inaccurate. > > > Even if glumetza commands the entire "branded metformin" market, > it will be at 150 to 200 million in annual sales, and that would > mean that Fortamet, Glucophage, and Glucophage XR took 0% of the > branded market, and Glumetza took 100%. > > So you're billion dollar estimate is naiive, and uninformed. Furthermore, > Glucophage XR is actually chemically and functionally (almost) identical > to Glumetza. In fact, Depomed designed both pills. As you may (and > should) know, Glucophage XR is now largely generic and costs pennies > compared to Glumetza. > > Below is information regarding the similarities of Glumetza and Glucophage > XR (also posted on Yahoo Message Boards) > > Here is the package insert from Watson - a generic manufacturer of > Glucopahge XR. > > Read it, look at the "System Components & Performance", then > scroll down and read "The most common adverse reactions for Metformin > Extended release" > pi.watson.com/data_str...... > > > Glucophage XR & generic metformin extended-release > ----------------------... > > Adverse reactions: > Diarrhea - 9.6% > Nausea/Vomiting - 6.5% > > "Metformin hydrochloride extended-release tablets comprise a monolithic > hydrophilic polymer matrix system. Metformin hydrochloride is combined > with a drug release-controlling polymer to form the core of the matrix. > After administration fluid from the Gastro Intestinal tract (GI tract) > enters the tablet causing the polymers to hydrate and swell. Due > to hydration and swelling of the polymer, the size of the tablet > in the stomach increases. As a result, the dosage may remain in the > gastrointestinal tract for a prolonged period with slow release of > the drug." > > Here is the package insert for Glumetza > www.glumetzaxr.com/pro....... > > Glumetza > ----------------------... > Adverse Reactions: > Diarrhea - 12.5% > Nausea - 6.7% > > "GLUMETZA 500 and 1000 mg tablets both utilize polymer-based, oral > drug delivery systems, which allow delivery of metformin HCl to the > upper gastrointestinal (GI) tract."
Santarus, Depomed Poised to Gain from Anticipated Sales of Glumetza [View article]
I am sorry, but this article is grossly incorrect and inaccurate.
Even if glumetza commands the entire "branded metformin" market, it will be at 150 to 200 million in annual sales, and that would mean that Fortamet, Glucophage, and Glucophage XR took 0% of the branded market, and Glumetza took 100%.
So you're billion dollar estimate is naiive, and uninformed. Furthermore, Glucophage XR is actually chemically and functionally (almost) identical to Glumetza. In fact, Depomed designed both pills. As you may (and should) know, Glucophage XR is now largely generic and costs pennies compared to Glumetza.
Below is information regarding the similarities of Glumetza and Glucophage XR (also posted on Yahoo Message Boards)
Here is the package insert from Watson - a generic manufacturer of Glucopahge XR.
Read it, look at the "System Components & Performance", then scroll down and read "The most common adverse reactions for Metformin Extended release" pi.watson.com/data_str......
"Metformin hydrochloride extended-release tablets comprise a monolithic hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release-controlling polymer to form the core of the matrix. After administration fluid from the Gastro Intestinal tract (GI tract) enters the tablet causing the polymers to hydrate and swell. Due to hydration and swelling of the polymer, the size of the tablet in the stomach increases. As a result, the dosage may remain in the gastrointestinal tract for a prolonged period with slow release of the drug."
"GLUMETZA 500 and 1000 mg tablets both utilize polymer-based, oral drug delivery systems, which allow delivery of metformin HCl to the upper gastrointestinal (GI) tract."
Some conditions don't have testable biomarkers, thus subjective measurements have to be used. Thats just the way it is.
Depomed's first PHN study had a similar issue, where some patients were spontaneously resolving, and others were just responding well to placebo.
Some modifications in inclusion/exclusion criteria helped gear the study towards success. 2 years later, after another trial... they succeeded.
You dont have to "avoid compounds which don't measure with objective physical phenomena" you just have to design the trial for success, and hedge your stocks!
On Nov 08 09:40 PM Robert0713 wrote:
> It's not often, in fact never before, that I read some biopharma > post anywhere that mentions regression to the mean. I wonder how > many of SA readers know what it means, and what it means to study > design. Moreover, this is the umpteenth time that placebo effect > has scuttled a study. Reason enough to avoid compounds which don't > measure with objective physical phenomena.
Women's Health: After WHI, What's the Potential Market Size? [View article]
menerba looks promising, probably the best drug overally, but serada will be first to market and I the safety profile is well understood for gabapentin, so there is no surprises like with a new class.
I own both companies so I guess you know I've put my money where my mouth is.
Santarus: Business Fundamentals Improving [View article]
Jason Napodono: Your Depomed analysis is a re-explanation of my analysis, and looks eerily similar. Please cite my original article as a source or get your own ideas.
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Latest | Highest ratedSantarus, Depomed Poised to Gain from Anticipated Sales of Glumetza [View article]
pi.watson.com/data_str...
www.glumetzaxr.com/pro...
On Nov 20 01:56 PM ThreeBrothersHealth.com wrote:
> I am sorry, but this article is grossly incorrect and inaccurate.
>
>
> Even if glumetza commands the entire "branded metformin" market,
> it will be at 150 to 200 million in annual sales, and that would
> mean that Fortamet, Glucophage, and Glucophage XR took 0% of the
> branded market, and Glumetza took 100%.
>
> So you're billion dollar estimate is naiive, and uninformed. Furthermore,
> Glucophage XR is actually chemically and functionally (almost) identical
> to Glumetza. In fact, Depomed designed both pills. As you may (and
> should) know, Glucophage XR is now largely generic and costs pennies
> compared to Glumetza.
>
> Below is information regarding the similarities of Glumetza and Glucophage
> XR (also posted on Yahoo Message Boards)
>
> Here is the package insert from Watson - a generic manufacturer of
> Glucopahge XR.
>
> Read it, look at the "System Components & Performance", then
> scroll down and read "The most common adverse reactions for Metformin
> Extended release"
> pi.watson.com/data_str......
>
>
> Glucophage XR & generic metformin extended-release
> ----------------------...
>
> Adverse reactions:
> Diarrhea - 9.6%
> Nausea/Vomiting - 6.5%
>
> "Metformin hydrochloride extended-release tablets comprise a monolithic
> hydrophilic polymer matrix system. Metformin hydrochloride is combined
> with a drug release-controlling polymer to form the core of the matrix.
> After administration fluid from the Gastro Intestinal tract (GI tract)
> enters the tablet causing the polymers to hydrate and swell. Due
> to hydration and swelling of the polymer, the size of the tablet
> in the stomach increases. As a result, the dosage may remain in the
> gastrointestinal tract for a prolonged period with slow release of
> the drug."
>
> Here is the package insert for Glumetza
> www.glumetzaxr.com/pro.......
>
> Glumetza
> ----------------------...
> Adverse Reactions:
> Diarrhea - 12.5%
> Nausea - 6.7%
>
> "GLUMETZA 500 and 1000 mg tablets both utilize polymer-based, oral
> drug delivery systems, which allow delivery of metformin HCl to the
> upper gastrointestinal (GI) tract."
Santarus, Depomed Poised to Gain from Anticipated Sales of Glumetza [View article]
Even if glumetza commands the entire "branded metformin" market, it will be at 150 to 200 million in annual sales, and that would mean that Fortamet, Glucophage, and Glucophage XR took 0% of the branded market, and Glumetza took 100%.
So you're billion dollar estimate is naiive, and uninformed. Furthermore, Glucophage XR is actually chemically and functionally (almost) identical to Glumetza. In fact, Depomed designed both pills. As you may (and should) know, Glucophage XR is now largely generic and costs pennies compared to Glumetza.
Below is information regarding the similarities of Glumetza and Glucophage XR (also posted on Yahoo Message Boards)
Here is the package insert from Watson - a generic manufacturer of Glucopahge XR.
Read it, look at the "System Components & Performance", then scroll down and read "The most common adverse reactions for Metformin Extended release"
pi.watson.com/data_str......
Glucophage XR & generic metformin extended-release
----------------------...
Adverse reactions:
Diarrhea - 9.6%
Nausea/Vomiting - 6.5%
"Metformin hydrochloride extended-release tablets comprise a monolithic hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release-controlling polymer to form the core of the matrix. After administration fluid from the Gastro Intestinal tract (GI tract) enters the tablet causing the polymers to hydrate and swell. Due to hydration and swelling of the polymer, the size of the tablet in the stomach increases. As a result, the dosage may remain in the gastrointestinal tract for a prolonged period with slow release of the drug."
Here is the package insert for Glumetza
www.glumetzaxr.com/pro.......
Glumetza
----------------------...
Adverse Reactions:
Diarrhea - 12.5%
Nausea - 6.7%
"GLUMETZA 500 and 1000 mg tablets both utilize polymer-based, oral drug delivery systems, which allow delivery of metformin HCl to the upper gastrointestinal (GI) tract."
Serada Half Price Sale: DepoMed's Stock Price Poised to Climb [View article]
Depomed's first PHN study had a similar issue, where some patients were spontaneously resolving, and others were just responding well to placebo.
Some modifications in inclusion/exclusion criteria helped gear the study towards success. 2 years later, after another trial... they succeeded.
You dont have to "avoid compounds which don't measure with objective physical phenomena" you just have to design the trial for success, and hedge your stocks!
On Nov 08 09:40 PM Robert0713 wrote:
> It's not often, in fact never before, that I read some biopharma
> post anywhere that mentions regression to the mean. I wonder how
> many of SA readers know what it means, and what it means to study
> design. Moreover, this is the umpteenth time that placebo effect
> has scuttled a study. Reason enough to avoid compounds which don't
> measure with objective physical phenomena.
Women's Health: After WHI, What's the Potential Market Size? [View article]
threebrothershealth.com
Women's Health: After WHI, What's the Potential Market Size? [View article]
I own both companies so I guess you know I've put my money where my mouth is.
Tylenol Ban Will Hurt Several Drug Manufacturers' Bottom Lines [View article]
Santarus: Business Fundamentals Improving [View article]
Santarus: Business Fundamentals Improving [View article]
seekingalpha.com/artic...