New Sanofi drug lowers LDL three times more than Zetia!

[Anonymous]

Sanofi and Regeneron new drug (alirocumab), lowers LDL cholesterol three times more than Zetia - now that is impressive!

Meanwhile, back at the Merck ranch, we are busy working on our annual MyPMP, Competency Scores, and Career maps. Apparently we don't have time to fool around with silly notions like selling or bringing novel new drugs to market.......

 

[Anonymous]

Regeneron is Roy Vagelos' company.
Can't be stated enough. A science guy should be running Merck.
Like the OPs sentiment, let me go 5s my lab and work on my EDP and residual waste training.

What a joke this company has become.

 

[Anonymous]

At Merck, you are rewarded for labeling your drawers and making the lab look like the picture above your bench.
This place is a stifling and uninspiring place to work. No wonder nothing good has come out if the labs in years. We are led by a bunch of "yes sir" people with no original thought of there own.

 

[Anonymous]

Regeneron is Roy Vagelos' company.
Can't be stated enough. A science guy should be running Merck.
Like the OPs sentiment, let me go 5s my lab and work on my EDP and residual waste training.

What a joke this company has become.

Don't forget the Ladder Safety training, and my personal favorite: Driver's ed. And also office chair ergonomics. Does not matter that you did the exact same Ladder Safety training last year, and the year before that, and the year before that. It's not about caring for our safety, it is about Merck Legal covering their a$$ in a million different obscure scenarios. Legalities and process are king. Lather, rinse, repeat. After these trainings, the 5S inspections, and another training on not accepting bribes from foreign officials, you may have an hour to dabble in doing some science. Because as scientists, we frequently find ourselves in the dilemma: should we accept a year's supply of gummi bears from the Saudi King? Luckily, Merck training has prepared us for that. We've got all bases covered. Except the drug discovery part.

 

[Anonymous]

Sanofi and Regeneron new drug (alirocumab), lowers LDL cholesterol three times more than Zetia - now that is impressive!

Meanwhile, back at the Merck ranch, we are busy working on our annual MyPMP, Competency Scores, and Career maps. Apparently we don't have time to fool around with silly notions like selling or bringing novel new drugs to market.......

If you are foolish enough to believe in MK-0859 in the first place then realize that this therapeutic and mechanism are going to crush us in the market place.

 

[Anonymous]

Sanofi and Regeneron new drug (alirocumab), lowers LDL cholesterol three times more than Zetia - now that is impressive!

Meanwhile, back at the Merck ranch, we are busy working on our annual MyPMP, Competency Scores, and Career maps. Apparently we don't have time to fool around with silly notions like selling or bringing novel new drugs to market.......

Hurry up Ken but Sanofi! ASAP, construct some oddball reverse merger to try and screw their partners out of their share of co developed drugs so we can be sued again and lose!


HURRY HURRY HURRY!!!

COMET COMET COMET - LETS ALL COMET!!!!

 

[Anonymous]

If you are foolish enough to believe in MK-0859 in the first place then realize that this therapeutic and mechanism are going to crush us in the market place.

Medchem is a doomed art. Who needs small molecules when biologics can do the job and patients can inject themselves? Roger's plan to get more into biologics may be a little too late, but you can't blame the guy for trying.

 

[Anonymous]

Medchem is a doomed art. Who needs small molecules when biologics can do the job and patients can inject themselves? Roger's plan to get more into biologics may be a little too late, but you can't blame the guy for trying.

Extracellular proteins and mechanisms are exciting targets for biologics. Intracellular targets less so. Compounds, biologically active proteins/peptides, therapeutic mAbs and RNAi offer a variety of mechanisms for therapeutic intervention. To say which one is best before the molecular target has been defined is speculative folly. The costs of producing biologics, is by all accounts. more expensive than small molecules. Some patients may have the capacity to swallow a daily pill but may not be capable of self-injection. I am far from convinced that Medchem is a doomed art. I believe technological advancement offers other approaches that are challenging small molecule therapeutics dominance but will not completely displace them.

 

[Anonymous]

Don't forget the Ladder Safety training, and my personal favorite: Driver's ed. And also office chair ergonomics. Does not matter that you did the exact same Ladder Safety training last year, and the year before that, and the year before that. It's not about caring for our safety, it is about Merck Legal covering their a$$ in a million different obscure scenarios. Legalities and process are king. Lather, rinse, repeat. After these trainings, the 5S inspections, and another training on not accepting bribes from foreign officials, you may have an hour to dabble in doing some science. Because as scientists, we frequently find ourselves in the dilemma: should we accept a year's supply of gummi bears from the Saudi King? Luckily, Merck training has prepared us for that. We've got all bases covered. Except the drug discovery part.

So classic Merck. But don't we look so good doing all this essentially look busy but meaningless activity. RIP Merck. RIP.

 

[Anonymous]

Extracellular proteins and mechanisms are exciting targets for biologics. Intracellular targets less so. Compounds, biologically active proteins/peptides, therapeutic mAbs and RNAi offer a variety of mechanisms for therapeutic intervention. To say which one is best before the molecular target has been defined is speculative folly. The costs of producing biologics, is by all accounts. more expensive than small molecules. Some patients may have the capacity to swallow a daily pill but may not be capable of self-injection. I am far from convinced that Medchem is a doomed art. I believe technological advancement offers other approaches that are challenging small molecule therapeutics dominance but will not completely displace them.

Don't hang your hat on "patients that may not be capable of self-injection" - there will be plenty of doctors more than willing to make this injection an ICD9 billable coded procedure available in the office for a nice fee and the ability to track patient compliance per Obamacare and the Accountable Care Act. We already know that just because a patient has the "capacity to swallow a daily pill" does not guarantee that the patient will be compliant and actually take their pill every day or continue to refill their bottle of pills on a reliable monthly basis. That is why pills are destined to become so yesterday as these injected biologic drugs continue to impress. You need to be more worried about the superiority demonstrated here: alirocumab vs. Zetia, 47.2% vs 15.6% with a p value less than 0.0001. Amazing and highly significant statistical confidence interval!

 

[Anonymous]

Don't hang your hat on "patients that may not be capable of self-injection" - there will be plenty of doctors more than willing to make this injection an ICD9 billable coded procedure available in the office for a nice fee and the ability to track patient compliance per Obamacare and the Accountable Care Act. We already know that just because a patient has the "capacity to swallow a daily pill" does not guarantee that the patient will be compliant and actually take their pill every day or continue to refill their bottle of pills on a reliable monthly basis. That is why pills are destined to become so yesterday as these injected biologic drugs continue to impress. You need to be more worried about the superiority demonstrated here: alirocumab vs. Zetia, 47.2% vs 15.6% with a p value less than 0.0001. Amazing and highly significant statistical confidence interval!

I think you are mistaken, sir. I don't believe that I have "hung my hat" on "patients that may not be capable of self-injection". Did you skim through the rest of the post? I believe I was commenting on the viability of medchem. I believe I indicated in my view that this was simply indicated that it was a factor worth consideration as I did not start my post with this notion nor did I make any suggestion that it was the most important. As to your point, "You need to be more worried about the superiority demonstrated here: alirocumab vs. Zetia, 47.2% vs 15.6% with a p value less than 0.0001. Amazing and highly significant statistical confidence interval!" I think you have missed it again. Zetia is not even considered standard of care and is an add-on to statin treatment. Such a comparison is moot anyway. I believe Sanofi was simply dotting the tee's and crossing your eyes as they also tested this treatment against Fenofibrate to build their credentials. Since Alirocumab has already gut punched atorvastatin, a better comparison might be vytorin or crestor which doesn't appear to be in FDA trials yet. As I pointed out in an earlier post, and what Merck should concern itself with, is that fact that Alirocumab will be the undoing of Anacetrapib should it actually make it to market. Billed as an HDL-C raising medication is premature since mechanistically this drug raises HDL-C and lowers LDL-C. Since other interventional studies are rebuking the "HDL-C raising hypothesis" then the beneficial effects (which remains to be demonstrated) are likely due to LDL-C lowering. As it turns out Alirocumab does a much better job of lowering LDL-C than Anacetrapib does. I doubt that every patient will switch to Alirocumab simply because an efficacy argument can be made. Back to your point. I am willing to wager that there are plenty of individuals that will avoid an injectable for a variety of reasons. The question is whether there are enough to make a market and I think the answer is yes which just ANOTHER reason that Medchem is not going to become a lost art form. Seriously, who really gives a rats ass about the p values, as if there is something significant in that number. The accuracy and precision of LDL-C measurements are so refined that when there is such a large distinction (47.2% vs 15.6%) the p value is of such little concern as all studies with such differences always give this level of statistical significance. Is this some sort of marketing message?

 

[Anonymous]

Extracellular proteins and mechanisms are exciting targets for biologics. Intracellular targets less so. Compounds, biologically active proteins/peptides, therapeutic mAbs and RNAi offer a variety of mechanisms for therapeutic intervention. To say which one is best before the molecular target has been defined is speculative folly. The costs of producing biologics, is by all accounts. more expensive than small molecules. Some patients may have the capacity to swallow a daily pill but may not be capable of self-injection. I am far from convinced that Medchem is a doomed art. I believe technological advancement offers other approaches that are challenging small molecule therapeutics dominance but will not completely displace them.

I agree, medchem will not be completely displaced but certainly not needed at the current levels.

 

[Anonymous]

Extracellular proteins and mechanisms are exciting targets for biologics. Intracellular targets less so. Compounds, biologically active proteins/peptides, therapeutic mAbs and RNAi offer a variety of mechanisms for therapeutic intervention. To say which one is best before the molecular target has been defined is speculative folly. The costs of producing biologics, is by all accounts. more expensive than small molecules. Some patients may have the capacity to swallow a daily pill but may not be capable of self-injection. I am far from convinced that Medchem is a doomed art. I believe technological advancement offers other approaches that are challenging small molecule therapeutics dominance but will not completely displace them.

The cost of production is a minor concern with a drug. If a drug works, and works well, it will sell. The major cost is for clinical trials which would be the same for biologics or small molecules.

Selectivity for molecular targets is a major problem for small molecules, something a mABs has a better time avoiding.

 

[Anonymous]

Good thing Roy was forced to retire from CEO at 65. It's obvious he had nothing left in the tank & was too old to know how to lead a pharma company into the 21st century! Our board is the smartest!

 

[Anonymous]

Good thing Roy was forced to retire from CEO at 65. It's obvious he had nothing left in the tank & was too old to know how to lead a pharma company into the 21st century! Our board is the smartest!

He who laughs last, laughs best.

 

[Anonymous]

Don't hang your hat on "patients that may not be capable of self-injection" - there will be plenty of doctors more than willing to make this injection an ICD9 billable coded procedure available in the office for a nice fee and the ability to track patient compliance per Obamacare and the Accountable Care Act. We already know that just because a patient has the "capacity to swallow a daily pill" does not guarantee that the patient will be compliant and actually take their pill every day or continue to refill their bottle of pills on a reliable monthly basis. That is why pills are destined to become so yesterday as these injected biologic drugs continue to impress. You need to be more worried about the superiority demonstrated here: alirocumab vs. Zetia, 47.2% vs 15.6% with a p value less than 0.0001. Amazing and highly significant statistical confidence interval!

A PCSK9 antibody may end up making money in the lipid lowering space but because of its cost will never replace generic small molecule approaches . It will be used in patients who can't tolerate statins and are high risk

 

[Anonymous]

The cost of production is a minor concern with a drug. If a drug works, and works well, it will sell. The major cost is for clinical trials which would be the same for biologics or small molecules.

Selectivity for molecular targets is a major problem for small molecules, something a mABs has a better time avoiding.

Completely wrong, cost of goods is a critical component of drug development. Go back to business school dimwit!

 

[Anonymous]

Don't hang your hat on "patients that may not be capable of self-injection" - there will be plenty of doctors more than willing to make this injection an ICD9 billable coded procedure available in the office for a nice fee and the ability to track patient compliance per Obamacare and the Accountable Care Act. We already know that just because a patient has the "capacity to swallow a daily pill" does not guarantee that the patient will be compliant and actually take their pill every day or continue to refill their bottle of pills on a reliable monthly basis. That is why pills are destined to become so yesterday as these injected biologic drugs continue to impress. You need to be more worried about the superiority demonstrated here: alirocumab vs. Zetia, 47.2% vs 15.6% with a p value less than 0.0001. Amazing and highly significant statistical confidence interval!

Just because a patient can have a doctor perform the injection and bill for his services does not guarantee that the patient will be compliant and actually continue to show up for their appointment and make their co-pay on a reliable monthly basis.

 

[Anonymous]

Regeneron is Roy Vagelos' company.
Can't be stated enough. A science guy should be running Merck.
Like the OPs sentiment, let me go 5s my lab and work on my EDP and residual waste training.

What a joke this company has become.

If this drug lowers LDL 3x better than ZETIA, then even Crestor has competition.
However, you hit the target that Merck lost its way after Vagelos left.

It drifted along for a while on the Vagelos legacy, but the unqualified and self-centered
management that followed him have driven this once great company close to ruin.

 

[Anonymous]

I think you are mistaken, sir. I don't believe that I have "hung my hat" on "patients that may not be capable of self-injection". Did you skim through the rest of the post? I believe I was commenting on the viability of medchem. I believe I indicated in my view that this was simply indicated that it was a factor worth consideration as I did not start my post with this notion nor did I make any suggestion that it was the most important. As to your point, "You need to be more worried about the superiority demonstrated here: alirocumab vs. Zetia, 47.2% vs 15.6% with a p value less than 0.0001. Amazing and highly significant statistical confidence interval!" I think you have missed it again. Zetia is not even considered standard of care and is an add-on to statin treatment. Such a comparison is moot anyway. I believe Sanofi was simply dotting the tee's and crossing your eyes as they also tested this treatment against Fenofibrate to build their credentials. Since Alirocumab has already gut punched atorvastatin, a better comparison might be vytorin or crestor which doesn't appear to be in FDA trials yet. As I pointed out in an earlier post, and what Merck should concern itself with, is that fact that Alirocumab will be the undoing of Anacetrapib should it actually make it to market. Billed as an HDL-C raising medication is premature since mechanistically this drug raises HDL-C and lowers LDL-C. Since other interventional studies are rebuking the "HDL-C raising hypothesis" then the beneficial effects (which remains to be demonstrated) are likely due to LDL-C lowering. As it turns out Alirocumab does a much better job of lowering LDL-C than Anacetrapib does. I doubt that every patient will switch to Alirocumab simply because an efficacy argument can be made. Back to your point. I am willing to wager that there are plenty of individuals that will avoid an injectable for a variety of reasons. The question is whether there are enough to make a market and I think the answer is yes which just ANOTHER reason that Medchem is not going to become a lost art form. Seriously, who really gives a rats ass about the p values, as if there is something significant in that number. The accuracy and precision of LDL-C measurements are so refined that when there is such a large distinction (47.2% vs 15.6%) the p value is of such little concern as all studies with such differences always give this level of statistical significance. Is this some sort of marketing message?

Phase III trials showed a 47% reduction in LDL-C. There was a high rate of adverse events with 69% experiencing side effects (most common problem was infection). Sounds like the next candidate for 1-800-bad-drug!