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The Marshall Protocol Study Site > PROF. MARSHALL'S PERSPECTIVE > Prof. Marshall's Perspective > Sankyo's patent on Olmesartan Medoxomil runs until Oct 2016

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Prof Trevor Marshall
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Well, I am busy at the DNA-day conference in China, but I wanted to share with you some text from our FDA application for the NDP (new drug product) Pure Olmesartan:
"To the best of our knowledge and belief, the US patent on Pure Olmesartan, CAS: 144689‑24‑7, expired on April 25th, 2011.

The US patent on Olmesartan Medoxomil is listed in the FDA Orange Book as expiring on October 25th, 2016, with NPP exclusivity expiring on Aug 14, 2013"
There are also a number of ways Sankyo could seek to extend Olmesartan Medoxomil's patent and marketing exclusivities beyond even 2016.

Sometime in the future, after we get FDA approval for Pure Olmesartan, today will mark an important step in the evolution of the MP into mainstream medicine...

..Trevor..


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CONGRATULATIONS to Dr. Marshall and the entire ARF staff.

I hear strains of Beethoven's 9th symphony singing for all of us. Hallelujah,  HALLELUJAH, HALLELUJAH.

Sherry

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Congratulations to all involved. Well done and THANK YOU for all your hard work.

regards, k

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Congratulations to all involved!  :D

I look forward to the pure olmesartan study commencing soon!!

And I DID have an extra hot chocolate today .... spiked with some Irish Whiskey to celebrate this big date for the MP!!  :D

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Mmmm, I will have a wee celebration too, and raise my glass of sparkling mineral water (! all I have in the house atm) to Dr Marshall and the Team - and all of us!

The future is bright and in the meantime we have our NoIRs and OM!

Morag :cool:

Last edited on Wed Apr 27th, 2011 01:53 by Pipistrelle

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Excellent work, Dr Marshall and staff!

Congratulations and good luck with the study!

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Good news for MP. I have also joy.

Congratulations.:)
 


Exuce me, maybe this is not accurate place for one question, but:

I am not sure, whether olmesartan medoximil or pure olmesartan is better for MP treatment.
Noted, if good remember it, that olmesartan medoximil have got about one small windows more than pure olmesartan.

Gratefull for clear explain as for laic.
Daki
 

Last edited on Thu Apr 28th, 2011 05:25 by Daki

Lottis
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:D:D:D25th of April 2011:D:D:D


A day to remember! :cool:

cbay
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Does this mean no one can patent the PO again and it is wide open for ARF uses? I am rusty on patent laws...

Prof Trevor Marshall
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The main thing IMO is that manufacturers can freely manufacture the product. Patents now mainly cover its use (like my own patent applications for th1 disease). Up until now Sankyo's lawyers have 'persuaded' a number of manufacturers here in China not to make OM by threatening patent infringement.

In China, both patents (OM and PO) have now expired, as far as I can tell... Chinese intellectual property law is complex...
 

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How does this impact the start of the FDA pure olmesartan study ... if at all?  As you know I am anxious to get that going. 

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I would like to know what is the differant between Olmesartan Medoxomil and pure Olmesartan

cbay
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My simple understanding is the Medoxomil side chain that exists in OM (Benicar) is not there in pure Olmesartan.

Prof Trevor Marshall
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Sankyo put the medoxomil radical on Olmesartan in order to slow its absorption, so it could be dosed once a day. That is not what we need for the MP, we want it to go to work as quickly as possible. They also said that Pure Olmesartan was not absorbed as well as Olmesartan medoxomil, but that turned out to be because the flora in a Mouse gut converted most of the Olmesartan to Olmesartan Glucuronide. When we tested in Homo sapiens, that was not so much a problem, and the Pure Olmesartan is more effective at both immune activation, and palliation, when used as we do in the MP :)
 

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So is the advantage of pure olmesartan over olmesartan medoxomil just one of greater absorption and more consistent absorption, or is it more than that?  Could one simply increase their frequency and/or dosage of olmesartan medoxomil in order to achieve the same effect as switching to pure olmesartan?

Prof Trevor Marshall
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Oral Pure Olmesartan reaches its peak concentration at about one hour, and it therefore achieves a higher level peak than achievable with OM, as that absorbs more slowly. A high peak is the best way to bump ligands out of any receptors... It is also the best way to get palliation soon after you feel you need it, eg, when you have forgotten a dose...

There seems to be a limit on OM absorption, and it varies from person to person. An enzyme from Pseudomonas, or its homologue, is necessary for converting OM to O+M, and this may not be present in unlimited quantities in everybody's gut. the PO is just absorbed through the intestine wall intact (a little is degraded to Olmesartan Glucuronide with both OM and PO).
 
You cannot adjust the dosing and/or frequency of OM and achieve what PO can do...
 

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Do you know if that would mean you could take less PO than you would OM? And would the PO have less of some side effects like dizziness?

Sounds interesting.

Deb

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I am so keen to try the PO.

Yes, I will be patient.

Sherry

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Leroybrown,
PO is expected to work at 50% of OM dosage, or 20 mg PO instead of 40 mg OM. Dizziness is IP and not a side effect of olmesartan, who can say what IP a person will experience during treatment?

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That's great about the dosage reduction. The reason I mentioned dizziness was it seemed like olmecip produced less than OM, from what I read, certain people seemed to have an easier time with it.

Deb

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Deb,
That is a good point, I have read that OM fillers can be troublesome to some folks. I would not be surprised to see this addressed in the trial PO product.

Best,
Mike

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Can someone point me to the data that is currently available for human use of PO? Is it in a paper or a video? Thanks.

Good question, Russ. From DTM's answer, I now see more advantage than I was seeing before.

Prof Trevor Marshall
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The optimum PO dosage seems to be 25mg, initial administration will be by capsule. We are trying to figure out how to bulk-manufacture the capsules without fillers, and have no solution at this point. PO works fine without fillers, however.

The only paper available was written about a study describing Intra-Venous use of PO, as it is still believed by TPTB that PO is not absorbed properly from the gut.

"Pharmacokinetics of CS-866, a new angiotensin II receptor blocker, in healthy subjects"
http://www.ncbi.nlm.nih.gov/pubmed/11361048
 

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Dr Marshall, would intravenous treatment with PO be appropriate for some patients who can not swallow?  I know my swallowing is getting more compromised lately!! 

Prof Trevor Marshall
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Intra Venous delivery would work fine, but the FDA safety paperwork is pretty intense, I think. I will check up for you.
 

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I did not mean to imply that I cannot swallow pills now!  I can.. just have to be extra careful when I do.  But if I progress more it may become an issue for me down the line.  And it is certainly an issue for some more advanced ALS patients.  Though they can take soft food with a pill mixed in with it. 

Prof Trevor Marshall
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Ultimately we will need  to get approval for an IV drip so that unconscious or intubated members can still be maintained on olmesartan during an emergency. I am also working on ideas for an overnight patch (when one really needs a good solid 8hr sleep)
 

Last edited on Mon May 2nd, 2011 17:30 by Prof Trevor Marshall

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Wow a patch to slowly dispense the PO would be an ideal way to control the dosage for prolonged periods!!  What a great idea!!  Let's hope the FDA works speedily on this stuff.. their are a lot of sick people out there! 

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right on the sore spots i would need about two dozen patches.
about the size of those tiny round bandages. or an emoticon.:dude::dude::dude::dude::dude::dude::dude::dude::dude::dude::dude:

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Trevor,

I seem to remember from an earlier thread that a compounding pharmacy in Australia had offered to compound Olmesartan Medoxomil as a slow release capsule that could be taken once a day.   However you had suggested that it was not reliable enough.   Was this because the Medoximil complicated the release due to its effect of slowing the body’s absorption of the Olmesartan?   If so, then given pure Olmesartan’s better pharmokinetics and lower dosage, would it be possible to have a single slow release capsule compounded that could be taken once a day?

Time release technology for pharmaceuticals has been greatly improved.   Having slow release would ensure that serum levels and cellular perfusion of pure Olmesartan would be better maintained and result in improved compliance and efficacy of the protocol.

I’d be interested in your thoughts.

Teresa

 

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First, Yay! Yay! YAY!!!

Second, how nice that a drip and a patch might be coming our way.

And let's keep some pure (if time release is thought a good idea), as I've never met a time release medicine my body likes.

I'm up for the study!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

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How does this relate to the various Olmesartan compounds that one gets online from India?

Personally, I find that the Olmecip tablets work better than the brand name Benicar, and the one time I had to buy Olmezest - they were REALLY ineffective, such that I had to take two pills at once to sense an effect.

Looking at packaging for both, they are both labelled as 'Olmesartan Medoxomil'. So I suppose there is another ingredient that makes them different.

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I talked to my doctor about a PO study. He showed interest so keep me on the list. But, he was concerned about how involved he would need to be.

Prof Trevor Marshall
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Efrenz, olmesartan medoxomil is a very unstable compound. Additionally, there is some dispute about how to determine the structure - several bulk manufacturing variants seem to have a butyl moeity.

I would not be surprised if there were low quality generic floating around. We all know that Sankyo has enough trouble stopping their product smelling like butter (from batch to batch). No trouble has been reported with Olmecip, however, which is sold for pennies in India.
 

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We all know that Sankyo has enough trouble stopping their product smelling like butter (from batch to batch).
I inquired about the butter smell and what it was  - I was told by a reputable source that it is rancid - when I offered that this seemed simplistic and that the source hadn't actually checked any data i was told again that it was rancid - period.

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Dr Trevor Marshall wrote: I would not be surprised if there were low quality generic floating around. We all know that Sankyo has enough trouble stopping their product smelling like butter (from batch to batch). No trouble has been reported with Olmecip, however, which is sold for pennies in India.A friend of mine was in India recently, and I thought he might be able to get me some. So I did check the appearance, retail price etc of the Indian generics. I think it worked out something like $30/m for 40mg q6h. Unfortunately he wasn't able to get me any. :(

The online pharmacies seem to be making markups of 2-300% over the retail price. Considerably more over the wholesale price. If anyone has any connections in retail pharmacy in India, there's an opportunity to make a lot of money - while still saving us a lot of money...

Last edited on Fri May 20th, 2011 01:49 by pgeek

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Mark,
I tend to disagree with you about the butter smell indicating the Benicar is rancid. I just got my 540 pills 2 days ago and I know that the pharmacist opened all foil sealed bottles to count them into the container I get them in. I opened the bottle when I got home and they smelled like butter. They ALWAYS do.
I can't believe that all the Benicar I have received for 7 yrs now is rancid.
Don't mean to discount your theory, Mark.
HANG IN THERE, WE WILL MAKE IT!!!!BARNEY:D

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I think Barney's right about the butter smell; it seems to be a feature of Sankyo's manufacturing process, which leaves in some impurities.

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All of my Benicar smell the same every refill. I have been told it smells like cake batter. The Olmecip pills do not smell this way, but I feel the same affect taking them.

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Interestingly, the most recent Olmicip tabs that I opened smelled slightly buttery.  I've been taking them for 4.5 years (started with regular Benicar and could not tolerate the buttery aroma) and I've never had this happen before.

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Interestingly, before Olmesartan was approved for sale in Canada, we used to buy it from the U.S. and it smelled sort of buttery. The Olmetec tablets we buy now in Canada does not have this odor.

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All the Olmetec (Sankyo's European olmesartan brand) I've been taking for over two years now in Luxembourg smelt like butter with no exception. Has it all been rancid?

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Rico - all my olmetec smells like butter.

Deb

cbay
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Luxman,

I don't know about it being rancid. I have mixed Olmecip and Benicar (which all smelt buttery) and feel no difference between the two. We are talking about half a day taking Olmecip then switching. Or even taking one for a few days then the other. They both palliate and cause IP the same way for me.

Correcting my Olmesartan to say Benicar

Last edited on Fri May 27th, 2011 09:46 by cbay

Cynthia S
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Are you people telling us about the olmesartan, or how good your sense of smell is?  LOL, Cynthia

cbay
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That is funny to say :)

I have times where I can smell scents that others have no idea. Sometimes I wonder if I am imagining them.

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Funny Cynthia!..... I have about a years supply of Olmesartan (Olmecip in the blister packs) and was wondering how is the best way to store these meds so they don't go rancid. I think Dr. Marshall mentioned keeping Olmesartan in the refrigerator for long storage but I'm not sure if I am remembering that accurately. If anyone has successfully stored Olmesarten for long periods I would appreciate you sharing.

Thanks.....Terry 

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I have had olmesartan medoxomil tablets (Olmetec) in blister packs at -4 celsius (in our household freezer) for at least 8 months without noticing any evidence of deterioration, either in the form of an odour or of loss of effectiveness. I have also kept powdered olmesartan medoxomil in capsules in tightly sealed plastic jars at -4 celsius for about three years without evidence of deterioration.
 I have just tried one of them now, dispensed over 4 years ago by a compounding pharmacist in Melbourne. Again no smell or taste. I think the pharmacist got his supply from India and they worked well for me for the first 6 months on the MP. Then Olmetec was registered for supply on the PBS ( Pharmaceutical Benefits Scheme) and we could get it more cheaply and the tablets were easier to take. I had bought a big stock of the capsules at the end of 2006 and early in 2007. With a lot of them unused I switched back to them over the last half of 2009, early 2010 and they were fine. I have kept one jar as a souvenir or maybe for use if I need powdered olmesartan.

Last edited on Mon May 30th, 2011 05:17 by Jigsaw

Prof Trevor Marshall
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Jigsaw, FYI, we just did an HPLC test run on a year-old jar of Pure Olmesartan bulk powder from our manufacturer in China, and it was still approx 99.7% pure (by HPLC)(omitting the 0.5% water). The jars have been kept at room temperature (avg 22 C)

The bulk Olmesartan Medoxomil will be less stable, the compound is far more polar, but I suspect it should be fine at lower temperatures. I don't expect capsules to interact with either the PO or OM in any way which would degrade its shelf-life. That said, most pharmaceutical grade empty-capsules are only certified for a 2-year shelf life.

It is my understanding that the Indian suppliers repackage bulk OM product from  Chinese manufacturers. China is shipping tonnes of OM, and it has to be going somewhere (probably to Sankyo in Germany, too...).
 

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Mark,
I tend to disagree with you about the butter smell indicating the Benicar is rancid. I just got my 540 pills 2 days ago and I know that the pharmacist opened all foil sealed bottles to count them into the container I get them in. I opened the bottle when I got home and they smelled like butter. They ALWAYS do.
I can't believe that all the Benicar I have received for 7 yrs now is rancid.
Don't mean to discount your theory, Mark.
HANG IN THERE, WE WILL MAKE IT!!!!BARNEY:D

Not my theory Barney  - I asked a PhD in Biochem. about the buttery smell.

The question I asked was

Q - "Can you identify a chemical compound by it's buttery odor?"

A  - "It's rancid".

Q - "are you sure?" 

A - "Yes - It is rancid -  period "

 My generic blister-pack Olmetec has no buttery odor.

Last edited on Mon May 30th, 2011 05:45 by Markt9452

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Mark, no disrespect to the highly educated pharm guy, but the butter odor has been documented from the beginning as some kind of undeclared impurity in the Sankyo brand Benicar tablets. They smell that way from day one.

Smells just like buttered popcorn to me. Very odd.

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Seems to work fine with or without the buttery goodness... :)

jrfoutin
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This is indeed a great time in history, I hope we can get that PO going soon. Very, very good thing!

Best to all--Janet

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Another MP'er once told me that benicar's buttery smell seems to dissipate as you progress through MP. I guess the more you heal the less it smells like buttered popcorn. There may be something to it because I hardly notice the smell any more.....or maybe I have become accustomed it. :)

lionel forbes
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May I respectfully suggest that the smell is caused by the th1 disease process itself .I used to get a sewer smell every time I ate lunch,until I realised that it was due to the combination of rice biscuit and peanut butter. I now consider myself  "cured" after 5 1/2 years and for some time now that sewer smell has gone,  so p has the buttery smell of Olmesartan.regards,

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drying off after long shower i used to smell mildew on many a fresh towels  till i realised it was my own body.

the bleach in the water changed my body odor or scewed up my olfactory senses.:?
 and i cant stand fresh bread smell i got to toast it before it smells normal.

Last edited on Sun Jul 24th, 2011 12:32 by jlunn247

findinganswers
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My doctor gives me Benicar samples from time to time and although I have been on the MP for 4 years now, they still always still smell buttery to me, whereas my Olmecip tablets do not have this smell to them.



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