60 replies to this topic

[bluemoon]

I looked, but couldn't find this topic, so....

After rereading the New York Times July 2008 article, I wonder what led Glaxo to delay selling SRT501 since it seems like they were considering putting it out as a supplement this year, and so not need FDA approval.

Not that I care about their marketing stratedy, but if it is as good as the lead scientists think and apparently safe enough they thought they might put it out now, any idea why it might be 2012 or 2013? It seems like an ethical question since many could benefit including Morley Saffer who interviewed him at 78. Mike Wallace is no spring chicken at 91, either. Couldn't the government buy it off Glaxo as other possible pills are developed and get it to the public? I don't think it is a miracle drug, but it could really help many now.

[tunt01]

- drug isn't approved, thats how the system works.

- glaxo spent $800 M on the company and probably want to recoup their costs.

- mike wallace is a complete prick. i met him in the airport once, he walked past everyone in the security line and said, "i'm mike wallace, im cutting in front of everyone." guy got arrested for assaulting a police officer during a traffic ticket dispute about 3 months later. F him.

[2tender]

As soon as its made into a drug, less people will have access and there will be a much smaller market. It would have to be really tweaked to be much better than what is currently available. Just my thoughts.

[bluemoon]

- drug isn't approved, thats how the system works.

- glaxo spent $800 M on the company and probably want to recoup their costs.

- mike wallace is a complete prick. i met him in the airport once, he walked past everyone in the security line and said, "i'm mike wallace, im cutting in front of everyone." guy got arrested for assaulting a police officer during a traffic ticket dispute about 3 months later. F him.

I doubt Wallace is a nice guy, but he needs the pill.
Glaxo doesn't need to have it approved if marketed as a supplement, and someone said in the article that they could easily do that. I wonder if they assume it wouldnt sell well that way. And the government could buy either the first pill or the patent, so Glaxo would still make money.

What if back in 1992 HIV inhibitors were about to be released , but a company decided to wait until 1995? People would have gone apeshit. Those drugs wouldnt have been sold over the counter, but the idea is the same. many people will die that wouldn't have if Glaxo put this out as a supplement today. Not millions of people, but many.

[tunt01]

2tender:

I don't agree the market will be smaller, because I think the drug will take market share from existing medications. It will get approved from MELAS (orphan status) quickly and then get off label prescription by docs for patients who have diabetes or other metabolic problems. The markets for diabetes, statins, etc. are huge and this drug will take share and be very profitable.

Holmes:

Disagree. If you make it a supplement it will just get copied and sold for pennies on the dollar when it is worth more to them to have a patent protected version. It's good business sense, imo. If I was on the board or management team of GSK, there is no way on god's green earth I would agree to a supplement version over a patented protected drug.

And then after the patent runs out, I would make ANOTHER patented version called slow-release SRT501 with an improved delivery method and safety profile, blah blah, to extend the patent protection another 7+ years like all the drug companies do.

These people are in the business of making money. Some people die, it happens, that is life. I will die some day and so will you. The world is overpopulated in the first place. This is reality and economics in the real world.

Edited by prophets, 22 March 2009 - 12:56 PM.

[maxwatt]

The formula for SRT501 is publc knowledge; it was described in the methods section of one of Sinclair's papers. There are also patents covering this ad similar formulations, but they are very weak as patents go. I am surprised no one has made up a batch according to the method. I need a lab-grade magnetic stirrer, some micronized resveratrol.....

[tunt01]

The formula for SRT501 is publc knowledge; it was described in the methods section of one of Sinclair's papers. There are also patents covering this ad similar formulations, but they are very weak as patents go. I am surprised no one has made up a batch according to the method. I need a lab-grade magnetic stirrer, some micronized resveratrol.....

Go out and sell it and enjoy getting sued by GSK.

Part of GSK's due diligence process in buying Sirtris is analyzing their patent position. I have done the same during an investments analysis. I doubt the patent position is that weak that they wouldn't have grounds to protect their product.

You may say the patented drug is a minor improvement over what a supplement manufacturer can cook up, but I seriously doubt doctors will prescribe a supplement over an FDA approved drug with substantial research. The doctor would be risking malpractice and it's not worth it to them. They do whats safe and obvious, not experimental and on the fringe.

[unglued]

Reading between the lines from what I've read in press releases and interviews, I think Sirtris is going right for the New Chemical Entities that are 1000 times more potent and clearly patentable, and not spending more money testing their improved resveratrol. They had to go after low-handing fruit as a startup, but with the resources of Glaxo behind them, they can go right for the prize.

As for the government buying the rights, which government do you mean? The U.S. government? The U.S. health care system doesn't work that way.

[maxwatt]

The formula for SRT501 is publc knowledge; it was described in the methods section of one of Sinclair's papers. There are also patents covering this ad similar formulations, but they are very weak as patents go. I am surprised no one has made up a batch according to the method. I need a lab-grade magnetic stirrer, some micronized resveratrol.....

Go out and sell it and enjoy getting sued by GSK.

Part of GSK's due diligence process in buying Sirtris is analyzing their patent position. I have done the same during an investments analysis. I doubt the patent position is that weak that they wouldn't have grounds to protect their product.

You may say the patented drug is a minor improvement over what a supplement manufacturer can cook up, but I seriously doubt doctors will prescribe a supplement over an FDA approved drug with substantial research. The doctor would be risking malpractice and it's not worth it to them. They do whats safe and obvious, not experimental and on the fringe.

Sinclair has been quoted as saying that Sirtris was not pursuing making SRT501 available as a supplement, because hen any one could sell it as a supplement. The implication seemed clear they had discussed this option as a way to provide cash-flow, but decided it would reduce the future value of their proprietary drugs, and the value of their company as a take-over target by a big pharmaceutical company. I believe the oft-quoted "10 x more potent" is an exaggeration. Graphs in the Nature paper on Sirtris proprietary Sirt activators did show at least a 10-fold increase for SRT1720 over Resveratrol for Sirt1, but the activation of the other Sirt genes shown was abut the same as for resveratrol. Sirt1 affects the cell nucleus, Sirt2 and 3 the mitochondria, the actions of the other four are being unravelled

I seriously doubt SRT501 will ever be marketed, when proprietary molecules will do the job. One thing about patents, they do not prevent individuals from following them for their own use, they only prevent marketing. I believe a non-profit co-op could provide members with a supplement, patent or no patent.

[tunt01]

max:

probably so, i dont know the specifics. either way the guy cashed out and probably only cares about the science at this point.

[maxwatt]

max:

probably so, i dont know the specifics. either way the guy cashed out and probably only cares about the science at this point.

Then why'd he endorse Shakley's dubious product? He didn't make enough to retire on the Sirtris sale? Not everything adds up.

[tunt01]

max:

probably so, i dont know the specifics. either way the guy cashed out and probably only cares about the science at this point.

Then why'd he endorse Shakley's dubious product? He didn't make enough to retire on the Sirtris sale? Not everything adds up.

those guys misused his name/research and he resigned immediately.

Edited by prophets, 23 March 2009 - 02:50 PM.

[kismet]

...I seriously doubt doctors will prescribe a supplement over an FDA approved drug with substantial research. The doctor would be risking malpractice and it's not worth it to them.

I really hope doctors are not that stupid these days or that it will change soon. You should read Dr. Davis' blog posts about how ridiculous it is to prescribe an FDA approved drug, even though the same is available as a high quality supplement. A doctor should at least tell patients about alternatives, otherwise he will be doing a great disservice to his patients or the country he lives in (in countries with universal health care). 

[tunt01]

...I seriously doubt doctors will prescribe a supplement over an FDA approved drug with substantial research. The doctor would be risking malpractice and it's not worth it to them.

I really hope doctors are not that stupid these days or that it will change soon. You should read Dr. Davis' blog posts about how ridiculous it is to prescribe an FDA approved drug, even though the same is available as a high quality supplement. A doctor should at least tell patients about alternatives, otherwise he will be doing a great disservice to his patients or the country he lives in (in countries with universal health care). 

i don't disagree, but america is a pretty high litigation society. something like 90% of all the corporate lawsuits on planet earth occur in US jurisdictions.

maybe obama will change that, idk. i'm personally skeptical that he will really improve overall health care, other than just cut the profit margins of major companies in the sector.

after having dealt with shitty doctors in the US, i personally demand copies of every test, every diagnosis and look up every drug/item prescribed to me.

[bluemoon]

Sinclair has been quoted as saying that Sirtris was not pursuing making SRT501 available as a supplement, because hen any one could sell it as a supplement. The implication seemed clear they had discussed this option as a way to provide cash-flow, but decided it would reduce the future value of their proprietary drugs, and the value of their company as a take-over target by a big pharmaceutical company. I believe the oft-quoted "10 x more potent" is an exaggeration.

I've also thought the large potency claims were probably an exaggeration in terms of ultimate effectiveness. I thought Sinclair said that he helped with Shakley in order to have people benefit "right away." So how would that be different than the Longevinex I thought he was also helping on back in 2003/2004? He might have been misrepresented to an extent, but I don't think with respect to his public statements.

That seems somehow related to getting something "better" out to the public before the Glaxo pill is likely sold in a few years.

I realize that people die all the time anyway, but like I wrote, imagine if back in 1991 a company had an HIV treatment that would reduce risk of death 70% but that they wanted to wait until 1995 to market something similar but better. The AIDS community would have gone nuts. The government is pushing through a huge stimulus package, and if Obama wanted to buy the patent or SRT501, there would be a way to do it that would satisfy Glaxo. It would create a market distortion, but the argument would be that the benefit far outweights that cost - assumng it does.

[2tender]

The minute this becomes a drug, people will lose access to it. As a supplement it has a wider marketing value and a wider range of people can benefit from it. If a derivitive of it is made into a drug thats a different story and I think that could be at least a decade away. Just my thoughts.

[tunt01]

The minute this becomes a drug, people will lose access to it. As a supplement it has a wider marketing value and a wider range of people can benefit from it. If a derivitive of it is made into a drug thats a different story and I think that could be at least a decade away. Just my thoughts.

I doubt it's a decade away, unless something unforeseen or unplanned happens.

GSK doesn't step up and buy someone for $800 M today if they think the drug is out 10 years from now. They have to be targeting like a 2-3 year window at max. That's way too much money to bet on a 10 yr outlook.

[bluemoon]

I doubt it's a decade away, unless something unforeseen or unplanned happens.

GSK doesn't step up and buy someone for $800 M today if they think the drug is out 10 years from now. They have to be targeting like a 2-3 year window at max. That's way too much money to bet on a 10 yr outlook.

Sinclair has given different time projections over the years, which of course changed with new developments. In 2003, he mentioned on NPR that he thought he'd have a supplement in about 7 years, 2010. In a Time magaizne article around 2007, he thought by 2015. Then on 60 Minutes he said "conservatively, 5 years" or 2014. My guess is 2012.

[tunt01]

I doubt it's a decade away, unless something unforeseen or unplanned happens.

GSK doesn't step up and buy someone for $800 M today if they think the drug is out 10 years from now. They have to be targeting like a 2-3 year window at max. That's way too much money to bet on a 10 yr outlook.

Sinclair has given different time projections over the years, which of course changed with new developments. In 2003, he mentioned on NPR that he thought he'd have a supplement in about 7 years, 2010. In a Time magaizne article around 2007, he thought by 2015. Then on 60 Minutes he said "conservatively, 5 years" or 2014. My guess is 2012.

I have not seen the exact quotes, so I can't distinguish between which specific molecule you are referring to: supplement or patented drug (and specifically which one).

It seems to me like SRT501 is in Stage IIa, which is probably no more than 5 years, assuming all goes well.

It typically takes 8 years from beginning trials to final FDA approval to take a drug to market. These guys have Stage IIA (dosing level) complete and are now in Stage IIB (efficacy testing). Thats' like 3-4 years probably, particularly with their IND status on MELAS.

think people just have to be patient and let the science work itself out. a lot of people tend to read a handful of studies and in the era of 24 hr instant news and microwaves that instantly cook your meals, they immediately want the drug.

lot of time tho there are side effects in drugs that effect your metabolism/hormone/immune systems and they take years to uncover through extended use and thousands of patients. this isn't some vaccine against a virus or stupid bacteria that is being killed by an experimental penicillin derivative with only 1 time of usage. you are attempting to change people's metabolism on a sustained basis. that's pretty dramatic.

[John Schloendorn]

If you make it a supplement it will just get copied and sold for pennies

What is the mechanism that would prevent a supplement from being patent protected?

[tunt01]

If you make it a supplement it will just get copied and sold for pennies

What is the mechanism that would prevent a supplement from being patent protected?

a designer molecule that is an analogue of the natural substance. they will take an existing molecule in nature and add some carbon bond or w/e to it so that it has like 5x the half-life in the blood or 5x+ the effectiveness, then call it a proprietary molecule and patent it..

[niner]

If you make it a supplement it will just get copied and sold for pennies

What is the mechanism that would prevent a supplement from being patent protected?

a designer molecule that is an analogue of the natural substance. they will take an existing molecule in nature and add some carbon bond or w/e to it so that it has like 5x the half-life in the blood or 5x+ the effectiveness, then call it a proprietary molecule and patent it..

If people have already been using a supplement, doesn't that represent prior art? If a company created a new formulation of the supplement, like SRT501, then that could be patented. This is sort of a fine point, but if a company makes an analog that's five times better, they don't just call it proprietary, it is proprietary. And it deserves some patent protection, since it took a lot of work to make it better. A new formulation is a lot less work than a new molecular entity, and IMHO ought to be accorded shorter exclusivity.

[maxwatt]

If you make it a supplement it will just get copied and sold for pennies

What is the mechanism that would prevent a supplement from being patent protected?

a designer molecule that is an analogue of the natural substance. they will take an existing molecule in nature and add some carbon bond or w/e to it so that it has like 5x the half-life in the blood or 5x+ the effectiveness, then call it a proprietary molecule and patent it..

If people have already been using a supplement, doesn't that represent prior art? If a company created a new formulation of the supplement, like SRT501, then that could be patented. This is sort of a fine point, but if a company makes an analog that's five times better, they don't just call it proprietary, it is proprietary. And it deserves some patent protection, since it took a lot of work to make it better. A new formulation is a lot less work than a new molecular entity, and IMHO ought to be accorded shorter exclusivity.

But its not. However formulation patents that use off-the-shelf methods like SRT501 uses are extremely weak. All it takes is money to invalidate it.

[tunt01]

personally, i am very willing to pay for a designer drug, gene therapy, a seriously bio-medically engineered product.

when a drug company is just taking a bunch of chemists and throwing molecules at a problem to see what sticks, then i am less inclined to want to pay. i can typically find the same molecules and nature, alter my diet, pop a few supplements or take a generic and get 90% of what they are doing.

and that's partly why they are under so much pressure these days.

[tunt01]

just as a passing thought.

i'm just getting up to speed on resveratrol, and Sirtris got paid a pretty penny ($720 M) by Glaxo. But the more i read some of this recent data about how resveratrol has minimal/zero effects on Standard Diets and only statistically significant results in High Fat diets or people with metabolic dysfunction, the more I think it makes sense that Sinclair & Co. decided to sell out Sirtris to GSK.

- if you honestly think you have the 'guaranteed' cure for longevity and a real miracle drug on your hands, then I don't see why you don't stay independent and keep going it alone. the pressure isn't on Sirtris to sell out. They had $100 M in cash in the bank. They can license their potential wonder drug overseas to partners with larger salesforces and wait for a bigger payday.

- if you feel the data is getting shaky, there are higher risks to what you think the addressable market (diabetics only vs. all of mankind), or maybe there are legitimate problems to trying to create a patent protected formulation of a plant product, then obviously you are more inclined to sell.

My point is that: It's interesting timing that Sirtris was sold in June 2008 and some of these studies coming out thereafter raise some caution flags about the ultimate potential of resveratrol. It's not always about money and maybe the intrinsic value of selling out Sirtris for ~$1.5 B in 2 years vs. $720 M today is of little difference to the entrepreneurs who built the company (how much money does a person really need). But the transaction could be telling in some ways...

Edited by prophets, 21 April 2009 - 12:46 PM.

[maxwatt]

just as a passing thought.

....

My point is that: It's interesting timing that Sirtris was sold in June 2008 and some of these studies coming out thereafter raise some caution flags about the ultimate potential of resveratrol. It's not always about money and maybe the intrinsic value of selling out Sirtris for ~$1.5 B in 2 years vs. $720 M today is of little difference to the entrepreneurs who built the company (how much money does a person really need). But the transaction could be telling in some ways...

The VC's who put up the money wanted a short-term profit. I think they say the current credit crunch coming, and bought gold with their profits and buried it in their back yards.

[tunt01]

The VC's who put up the money wanted a short-term profit. I think they say the current credit crunch coming, and bought gold with their profits and buried it in their back yards.

i actually helped run a $50 M VC fund at one point.

- most VCs are not that smart and have no clue about the bigger economic picture. they are fundamentally entrepreneurial and typically only see as far as their own company's prospects -- not understanding the broader issues of GDP, currencies. i've sat in board rooms where the CEO/CFO and board members mull a sell-out opportunity to Samsung or some prospective suitor. decisions come down to the actual company's economics and not the bigger picture.

- the VCs can always dump their stock (within the constraints of a lock-up agreement) and sell it into the hands of mutual funds, pension funds.

- the VC profits get distributed back to their investors, not reinvested into gold or any other asset class. they have to give profits back to their original fund investors.

anyone who sold a business in June 2008 looks like a genius, but these decisions are typically all related to the fundamental perspective of the individual company's outlook (products, earnings, etc.). You have to sit there and say to yourself... if you have the fountain of youth in a pill.. why are you selling your company? It's either cuz you DON'T have the fountain of youth, your patent/product position is shakey, or this is enough money and you have more altruistic goals about getting your product into the hands of all people and not making money.

[nowayout]

just as a passing thought.

i'm just getting up to speed on resveratrol, and Sirtris got paid a pretty penny ($720 M) by Glaxo. But the more i read some of this recent data about how resveratrol has minimal/zero effects on Standard Diets and only statistically significant results in High Fat diets or people with metabolic dysfunction, the more I think it makes sense that Sinclair & Co. decided to sell out Sirtris to GSK.

- if you honestly think you have the 'guaranteed' cure for longevity and a real miracle drug on your hands, then I don't see why you don't stay independent and keep going it alone. the pressure isn't on Sirtris to sell out. They had $100 M in cash in the bank. They can license their potential wonder drug overseas to partners with larger salesforces and wait for a bigger payday.

- if you feel the data is getting shaky, there are higher risks to what you think the addressable market (diabetics only vs. all of mankind), or maybe there are legitimate problems to trying to create a patent protected formulation of a plant product, then obviously you are more inclined to sell.

My point is that: It's interesting timing that Sirtris was sold in June 2008 and some of these studies coming out thereafter raise some caution flags about the ultimate potential of resveratrol. It's not always about money and maybe the intrinsic value of selling out Sirtris for ~$1.5 B in 2 years vs. $720 M today is of little difference to the entrepreneurs who built the company (how much money does a person really need). But the transaction could be telling in some ways...

I think it is also possible that they may have unpublished information on incidence of possible side effects that made them decide that the drug would indeed be unapprovable for the general population.

Edited by andre, 21 April 2009 - 01:47 PM.

[Ringostarr]

just as a passing thought.

i'm just getting up to speed on resveratrol, and Sirtris got paid a pretty penny ($720 M) by Glaxo. But the more i read some of this recent data about how resveratrol has minimal/zero effects on Standard Diets and only statistically significant results in High Fat diets or people with metabolic dysfunction, the more I think it makes sense that Sinclair & Co. decided to sell out Sirtris to GSK.

- if you honestly think you have the 'guaranteed' cure for longevity and a real miracle drug on your hands, then I don't see why you don't stay independent and keep going it alone. the pressure isn't on Sirtris to sell out. They had $100 M in cash in the bank. They can license their potential wonder drug overseas to partners with larger salesforces and wait for a bigger payday.

- if you feel the data is getting shaky, there are higher risks to what you think the addressable market (diabetics only vs. all of mankind), or maybe there are legitimate problems to trying to create a patent protected formulation of a plant product, then obviously you are more inclined to sell.

My point is that: It's interesting timing that Sirtris was sold in June 2008 and some of these studies coming out thereafter raise some caution flags about the ultimate potential of resveratrol. It's not always about money and maybe the intrinsic value of selling out Sirtris for ~$1.5 B in 2 years vs. $720 M today is of little difference to the entrepreneurs who built the company (how much money does a person really need). But the transaction could be telling in some ways...

Or maybe Sirtris saw that resveratrol (by itself or mixed with other substances) was nearly as effective as the synthetic molecules (NCE's) and knowing that you can't patent resveratrol decided to get out. Let's face it, Glaxo is basing it huge purchase price on the NCE's as resveratrol is not patentable and resveratrol delivery and technology is increasing rapidly. In other words, maybe the NCE's are not needed?

[tunt01]

Or maybe Sirtris saw that resveratrol (by itself or mixed with other substances) was nearly as effective as the synthetic molecules (NCE's) and knowing that you can't patent resveratrol decided to get out. Let's face it, Glaxo is basing it huge purchase price on the NCE's as resveratrol is not patentable and resveratrol delivery and technology is increasing rapidly. In other words, maybe the NCE's are not needed?

i tried to include this point of view by commenting that they had a patent/product problem. i think it is a relevant issue especially given Sinclair's comments in his Nature journal article on xenohormetics whereby he notes that 1/3rd of the top 10 selling drugs are based on plants and are not really patentable NCEs.