Tuesday, December 9, 2008

So, Merck Will Pair A Generic-Lipitor, With Zetia?


I am still scratching my head, here? Why? Why do that?

Forget, for just a moment, that Merck is going to spend $1.5 billion over the next four years, to build a business model (selling generic versions of biotech name-brands), where there is, as of this instant, no regulatory path (from FDA) -- as to how to approve such creatures. Why does it want a patent fight with Pfizer's Lipitor?

Perhaps Merck doesn't, actually. [Be sure of this, though: Pfizer will protect, litigate and attempt to extend its 800 pound gorilla of a patent on Lipitor -- beyond March of 2010 -- and Schering/Merck won't have launched until -- at best -- 2012.]

Perhaps, however, this is all simply a smoke-screen (think turn of the century opium-dens, here, in Southeast Asia!) -- to put a much-softer focus on the swan song for Vytorin. It may be "real", but only for the moment. Once Vytorin is cut-loose, this too will fade away.

On the bright side (I guess) -- if it is real, this will be a "Full-Employment Act" for New York, New Jersey and DC-area patent lawyers -- in the pharma space. . . . Wow.

4 comments:

Anonymous said...

This the comment to you at Cafepharma

http://www.cafepharma.com/boards/showthread.php?t=344729

condor,

i do not recall when wsj reported on the front page the pairing of zetia with lipitor. i know it was several years ago though.

bear with me. paraphrasing:
1. by the time lip went generic the dual inhibition would be THE standard.
2. then why would dr rx lip brand, or generic lip, when the pt. could get both barrels covered by the ins. co. with a low co pay?
3. remember this is pre disclosure that we have learned in the last 18 months besides enhance, sands etc....and even the insider trading by the emt.
4. that is why fred has fought so hard.....the real $ were not in the states but by pairing lip, the #1 statin, with zetia, at the time the #1 inhibitior, everyone taking this combo would be receiving a synergistic effect.
5. the front page of the wsj really laid out the plans. i am sure their library/staff could find it for you.
6. that is why the brand sinking is much more than just the zetia brand, it is the entire school of thought of dual inhibition going down the tubes with no real competition.
7. if the medical community had bought into the dual route and this became the gold standard of treatment now we're talking billions of profits. fred and his emt would be king midas.
8. also keep in mind that zetia is manufactured in singapore. they're not paying for retirement, unions, healthcare etc..................sad.

ellis taylor

Condor said...

DING!

I answered, over at cafepharma -- will get a post together -- but I may just run yours, above!

Anonymous said...

Facts Believed to be Associated With All Statin Medications:

Adverse events associated with the statin class of pharmaceuticals are thought to occur more often than they are reported- with high doses of statins prescribed to patients in particular. Since this class of drugs has existed for use for over 20 years, statins are considered safe and effective for enhancing the clearance of LDL noted to be elevated in the lipid profiles of patients..
Additionally, there is no reduction in cardiovascular morbidity or mortality, as well as an increase in a person’s lifespan, if one is on any particular statin medication for their lipid management. So caution should perhaps be considered if one chooses to prescribe such a drug for a patient if they are absent of dyslipidemia to a significant degree, or are under the belief that one statin medication provides a greater cardiovascular benefit over another. In other words, the health care provider should be assured that any statin therapy for their patients is considered reasonable and necessary if the LDL in their patients need to be reduced..
Abstract etiologies for those who prescribe statin drugs on occacsion , such as reducing CRP levels, or for Alzheimer’s treatment, or anything else not involved with LDL reduction is not appropriate prophylaxis at this point for any patient. All other benefits that appear to have favorable effects in such areas are speculative at this point, and require further research for disease states aside from dyslipidemia.
Several risk factors should determine if one is placed on statin therapy, and not just one particular reason. High LDL cholesterol is the apex of rationale for statin therapy, yet other risk factors of the patient should be examined and evaluated as well by their health care provider, perhaps- depending on the patient’s cardiovascular history to determine the appropriate dosage and strength of statin therapy for such patients as it relates to their present LDL level and the reduction that is needed.
Statins do decrease the risk of cardiovascular events significantly, it has been proven. This may be due to the fact that statins improve endothelial function as well as statins having the ability to stabilize coronary artery plaques, which prevents myocardial infarctions. Statins also decrease thrombus formation as well as modulate inflammatory responses. For those patients with dyslipidemia who are placed on a statin, the effects of that statin on reducing a patient’s LDL level can be measured after about five weeks of therapy on a particular statin drug. Liver Function blood tests are recommended for those patients on continued statin therapy, and most are chronically taking statins for the rest of their lives to manage their lipid profile in regards to maintaining the suitable LDL level for a particular patient.
In regards to other uses of statins besides just LDL reduction, there is evidence to suggest that statins have other benefits besides lowering LDL, such as reducing inflammation (CRP) with patients on statin therapy, those patients with dementia or Parkinson's disease may benefit from statin medication, as well as those patients who may have certain types of cancer or even cataracts. Yet again, these other roles for statin therapy have only been minimally explored. Because of the limited evidence regarding additional benefits of statins, the drug should again be prescribed for those with dyslipidemia only at this time involving elevated LDL levels as detected in the patient’s bloodstream.
It appears those statins that are produced specifically by fermentation, such as Zocor and Pravachol, have less incidences of myopathy than the other synthetic statins that exist presently. This may possibly due to the fact that fermented statins are believed to be much more hydrophyllic, which may optimize safety for a patient on a statin medication. Regardless, the lower the dose, the better, with any pharmaceutical prescribed to a patient. All pharmaceuticals have side effects, or they would not be pharmaceuticals. Statin drugs are not an exception.
Yet overall, the existing cholesterol lowering recommendations or guidelines should be re-evaluated, as they may be over-exaggerated upon tacit suggestions from the makers of statins to those who create these current lipid lowering guidelines. This is notable if one chooses to compare these cholesterol guidelines with others in the past. The cholesterol guidelines that exist now are considered by many health care providers and experts to be rather unreasonable, unnecessary, and possibly detrimental to a patient’s health, according to others. Yet statins are beneficial medications for those many people that exist with elevated LDL levels that can cause cardiovascular events to occur because of this abnormality.
Finally, a focus on children and their lifestyles should be amplified so their arteries do not become those of one who is middle-aged, and this may prevent them from being candidates for statin therapy now and in the future.
Dietary management should be the first consideration in regards to correcting lipid dysfunctions,

Dan Abshear

Anonymous said...

I really don't get why you think this is a bad idea. The Schering Merck pill comes out in 2012, two years after Lipitor goes off patent, right? So, why should you expect that Pfizer will litigate? They didn't do that with their last several generics.