24 replies to this topic

[rwoodin]

Here is a link to the SEC filing for the Sirtris IPO.

http://www.sec.gov/c...nclude&count=40

I thought it was interesting that they mentioned possible marketing of SRT501 as a supplement.

If we were to elect to commercialize SRT501 as a dietary supplement, we may not be able to successfully market one or more of our NCEs as a therapy for disease, if approved, and our results may be adversely affected.

Resveratrol is currently available for sale by other companies as dietary supplements. If we were to elect to market SRT501 as a dietary supplement, which we may do if we discontinue development of SRT501 as a therapeutic drug, we believe we could do so without the need to complete lengthy and costly clinical trials. If we were to obtain regulatory approval for one of our NCEs, we anticipate that we would price the NCE at a considerably higher level than SRT501 would be priced if we were selling SRT501 as a dietary supplement. While our NCEs are chemical entities distinct from SRT501 and resveratrol, patients suffering from diseases for which our NCEs may be approved for treatment may choose to use the lower priced SRT501

13


--------------------------------------------------------------------------------




dietary supplement, since it also activates SIRT1, rather than the higher priced approved NCE prescription product. As a result, if we choose to commercialize SRT501 as a dietary supplement, our ability to successfully commercialize NCE activators of SIRT1 may be adversely affected.

[proteomist]

Very interesting indeed. There's been some speculation that SRT501 is acetylated resveratrol which could be more bioavailable due to blocking sulfation/glucuronidation at the 4' hydroxyl.

But then there's this:

Our initial clinical candidate, SRT501, is a proprietary formulation of resveratrol that is designed to address these limitations of unformulated resveratrol. We formulate SRT501 by adding excipients to stabilize resveratrol in its active form. We have also increased levels of resveratrol that reaches the blood by optimizing particle size. Using SRT501 in mice, we are able to achieve an average of almost four times higher levels of resveratrol in the blood compared with administration of unformulated resveratrol after adjusting for differences in dosage levels. We believe that SRT501 creates the opportunity for a therapeutic version of resveratrol targeting diseases associated with aging such as Type 2 Diabetes.

Excipients and particle size? They make no mention of chemical alteration. SRT501 appears to simply be resveratrol. [:o] And they got three plus fold higher levels in the blood, but as compared to what? If we're just comparing formulations, was the control formulation handicapped in some way? Even if not, three-plus fold is not exactly monumental.

If this is correct their next gen drugs better be far superior, 'cause this thing is going to be a dog.

Edited by proteomist, 25 April 2007 - 07:58 AM.

[maxwatt]

...
Excipients and particle size? They make no mention of chemical alteration. SRT501 appears to simply be resveratrol.  [:o] And they got three plus fold higher levels in the blood, but as compared to what? If we're just comparing formulations, was the control formulation handicapped in some way? Even if not, three-plus fold is not exactly monumental.

If this is correct their next gen drugs better be far superior, 'cause this thing is going to be a dog.

...
if we were selling SRT501 as a dietary supplement. While our NCEs are chemical entities distinct from SRT501 and resveratrol, patients suffering from diseases for which our NCEs may be approved for treatment may choose to use the lower priced SRT501

This implies that their NCEs (New Chemical Entities) are not better than resveratrol in effect, and may differ only in the dosage necessary to obtain the desired effect. It may also be obfuscation to cover their tracks.

[rwoodin]

Something doesn't add up here. These guys are raising something like 80 million dollars or so. All for 'specially formulated' resveratrol? Couldn't resveratrol be 'specially formulated' for a lot less than that? And not have to be classified as a drug? Obviously, if they know that SRT501 works well, they could better serve public health by releasing this stuff as a supplement years ahead of releasing it as a drug. Obviously, what Sirtris mostly seems to be after is....making a whole lot of money for Sirtris. I thought these guys were a little more above that. Someone should try to 'specially formulate' resveratrol to have the same or better effects than theirs, but change the wording of the studies and manufacturing protocols so as not to infringe any patents, and then just start selling the stuff as a supplement. Gimme a break.

[proteomist]

This 'specially formulated' thing is ridiculous. Every drug company 'specially formulates' their drugs to maximize bioavailability. It's ubiquitous, common practice to put a lot of effort into working out optimal binders, particle size, excipients etc.

So this boils down to 'We're developing resveratrol as a drug.' Yep, we want to base our business on competing with a commonly available, low cost (as far as drugs go) natural product.

Watch for them to try to pull some crap with the FDA along the lines of what happened with Biostratum and pyridoxamine in order to try to protect their ill-conceived strategy. Alternatively, watch them fail to bring a product to market for five more years or so while they develop their NCEs.

Bah. I feel like the kid who just learned that Santa is a lie.

Edited by proteomist, 25 April 2007 - 06:28 PM.

[health_nutty]

So is anyone else guessing that SRT501 == resveratrol + quercetin?

I'm basing this on Sinclair's own regimine.

[proteomist]

Or bioperine. [wis] No, they wouldn't do that....

Quercetin seems like an excellent guess. I've been taking it with every resveratrol dose for a while now, so I hope that's it. [lol]

So is anyone else guessing that SRT501 == resveratrol + quercetin? 

I'm basing this on Sinclair's own regimine.

[Karomesis]

Something doesn't add up here. These guys are raising something like 80 million dollars or so. All for 'specially formulated' resveratrol?

it's more than plausibe.

Biostratum raised 100mil for pyridoxamine. [:o]

oops, guess it sells on the internet for 15$ a bottle. [!]

edit...from what I hear there are some rogue chemists synthesising it as we speak. [thumb] [sfty]

[Anthony_Loera]

Well, if it's going to be 'specially formulated'... expect folks with similar formulations coming out the next day...

Sure, RevGenetics will probably be one of them. Now, if they raised that much cash, to build facilities and become not only manufacturers... but also 'farmers'...now we have something interesting happening that could pull pricing down for them... which will allow them to take over the market.


I would personally like to see that happen.

Anthony

[maxwatt]

So Sirtris is a pump-it dump-it stock scam?

[edward]

I doubt Sinclair would risk his entire professional career on a pump and dump scam. I think they are simply trying to figure out how best to market their products and what market to release what products in. It would seem that if they want to be a pharmaceutical company then they should not be producing supplements "right out of the gate" and their concern about hurting the integrity of their pharm. products by marketing a dietary supplement is valid. If they want to sell supplements then should consider reorganizing corporately and say have one division market supplements/neutraceuticals and another market pharmaceuticals, and try to keep the two as separate entities.

[stephen_b]

Could they generate positive cash flow selling SRT501 as a supplement (perhaps a somewhat expensive supplement) while waiting for full development of their NCEs?

The hype around the company would also serve to bring in supplement sales.

I would be happy to see STR501 available as a supplement. If it is not sold as a supplement, you can be sure that there will be lots of off-label use.

Stephen

[proteomist]

Well, their NCEs might be good drugs for all we know, and benefit from the attendant patent protection and thus make tons of money, but they are a very long, unsure way from bringing them to market. Sounds to me like they're hoping to tide things over with SRT501 until then, but I don't see this strategy as viable (based on current assumptions).

So Sirtris is a pump-it dump-it stock scam?

[sUper GeNius]

Or bioperine. [wis] No, they wouldn't do that....

Quercetin seems like an excellent guess.  I've been taking it with every resveratrol dose for a while now, so I hope that's it.  [lol]

So is anyone else guessing that SRT501 == resveratrol + quercetin? 

I'm basing this on Sinclair's own regimine.

Yep, and put it all in a Licap!

[sUper GeNius]

Or bioperine. [wis] No, they wouldn't do that....

Quercetin seems like an excellent guess.  I've been taking it with every resveratrol dose for a while now, so I hope that's it.  [lol]

So is anyone else guessing that SRT501 == resveratrol + quercetin? 

I'm basing this on Sinclair's own regimine.

Yep, and put it all in a Licap!

And have the t-res in a separate delayed-released "beadlets" to give the quercitin a head start saturate. Oops! That's what AOR does, right?

[Anthony_Loera]

Just some info on Licaps:

Licaps can hold a maximum of 262.5mg of powder, so if you make a formulation with different things, you may need to take this into account.

So...

for 50% Resveratrol powder the max it can hold is 125mg, no more.
for 90% Resveratrol powder the max it can hold is 225mg, no more.

We hoped they could produce a 350mg capsule at the very least, but unfortunately the machine is not tooled for this, and Pfizer could not help us.

Now, if you use micro-encapsulation (beadlets)... you have even less room in a capsule, so 350mg or 500mg are not possible either.

Having said that, we realized that the powder is stable for 2 years, and for those who require long term protection, we offer the "RevGenetics Shield" cheaply, which is a blanket of heavy inert gas that is used over powder and pushes oxygen up to float above the blanket and away from the supplements that need long term protection.

I still think this special formulation will be quite interesting. I still think the money will mostly be used to market the heck out of the product, and line up folks like morning talk shows, and other marketing folks.

I still believe that we are now getting on to a playing field where marketing, and price will be one of the only differences between some of the newer products.

Anthony

[tom a]

My guess from reading these excerpts from the SEC report is that Sitris is mainly presenting the risks it perceives it might have -- such risks are routinely outlined in all such reports, as regulations require.

Most likely, Sitris has not yet conclusively demonstrated that its new drugs/supplements are superior to already existing resveratrol products. Obviously, that doesn't entail that they are not, in fact, superior, but only that the evidence isn't decisive on the point. This would hardly be surprising, given the current relatively early nature of the research. It's not really known for sure just what currently available resveratrol supplements can achieve (is Longevinex, with its quercetin, better or worse than pure resveratrol, for example?). And I'm sure that the studies of the new drugs/supplements from Sitris are in a like early stage. The comparative advantages would be therefore pretty speculative at this point. Sitris would have to cover itself by acknowledging that further research may not validate some of the comparative advantages they at least expect to find for their new drugs/supplements.

[rwoodin]

Sure, RevGenetics will probably be one of them. Now, if they raised that much cash, to build facilities and become not only manufacturers... but also 'farmers'...now we have something interesting happening that could pull pricing down for them... which will allow them to take over the market.


I would personally like to see that happen.

Anthony why would you want to see Sirtris take over the market (for resveratrol) ?

[Anthony_Loera]

rwoodin,

I would simply like the price of Resveratrol to fall for the consumers. I think wholesale pricing is still high enough to deter most of the population over 25 to take advantage of it.

If Sirtis can lower pricing for everyone and do double duty to provide resveratrol to people who can not afford it at the present time, while taking over the market...

Then I will be a happy reseller of Sirtis products, and new products we have been considering for a while now. But somehow I don't think Sirtis has this in their plans at the moment.

At this time we will continue to grow RevGenetics and provided Resveratrol, and Resveratrol related products. We happen to have great pricing for capsules, and hopefully we can get better pricing as Resveratrol comes down.

I suppose you want to know why we think Sirtis taking over the market is good for RevGenetics? It's not Sirtis, if a large supplement maker can take over the market and bring down pricing, that is what I would like to see. There are simply lots of great new resveratrol products that RevGenetics has ideas for... other than capsules, but cannot make available because of the high price of Resveratrol at this time.

Anthony

[maestro949]

I doubt Sinclair would risk his entire professional career on a pump and dump scam.

Agreed. Looking over the board and management team I would think these guys are seriously looking to get some drugs through trials and the FDA approval process. I don't think they'll be heartbroken if a major pharmeceutical comes along and buys them while these molecules are traversing the trial process though but it hardly looks like a scam operation.

It would seem that if they want to be a pharmaceutical company then they should not be producing supplements "right out of the gate" and their concern about hurting the integrity of their pharm. products by marketing a dietary supplement is valid.

Is there any evidence that they are interested in the supplement market or is this just speculation?

[maxwatt]

I doubt Sinclair would risk his entire professional career on a pump and dump scam.

Agreed. Looking over the board and management team I would think these guys are seriously looking to get some drugs through trials and the FDA approval process. I don't think they'll be heartbroken if a major pharmeceutical comes along and buys them while these molecules are traversing the trial process though but it hardly looks like a scam operation.

It would seem that if they want to be a pharmaceutical company then they should not be producing supplements "right out of the gate" and their concern about hurting the integrity of their pharm. products by marketing a dietary supplement is valid.

Is there any evidence that they are interested in the supplement market or is this just speculation?

I was being facetious when I opined that Sirtris might be a pump and dump operation.
The language of the IPO implied they might be considering marketing the SRT501 formulation as a supplement; perhaps it ws to assure investors of a potential rapid cash flow? Or to warn them whey they might not go that route?

[PWAIN]

I think the supplement idea was a worst case scenario. If they cannot get the FDA approval, they can still market it as a supplement to try an recoup some money.

[proteomist]

I think that's right. I believe they are required by SEC regulations to disclose all reasonably possible negative scenarios, and are simply doing so. I still think however that they will have a hard time competing their SRT501 formulation against lower priced resveratrol purveyors unless they successfully endeavor to control the market for that material.

[sUper GeNius]

Very interesting indeed. There's been some speculation that SRT501 is acetylated resveratrol which could be more bioavailable due to blocking sulfation/glucuronidation at the 4' hydroxyl.

But then there's this:



Excipients and particle size? They make no mention of chemical alteration. SRT501 appears to simply be resveratrol.  [:o] And they got three plus fold higher levels in the blood, but as compared to what? If we're just comparing formulations, was the control formulation handicapped in some way? Even if not, three-plus fold is not exactly monumental.

If this is correct their next gen drugs better be far superior, 'cause this thing is going to be a dog.

It is definitely resveratrol. They state that further down, mentioning that it as a risk factor from the investment point of view, as they mention that the "active ingredient, resveratrol", cannot receive "composition of matter patent protection," but perhaps only "method of use and formulation patent protection."

I find that somewhat exciting, as I believe it provides some evidence that they have some data already that t-res can be effective in humans. I imagine they probably did some initial informal testing on themselves, perhaps a small group of individuals, which provided the initial impetus to go further and begin raising money, the IPO, and the "official" phase 1 trials.

[mirian]

Check this out:

http://www.economist...FTOKEN=51104714

which says:

"Resveratrol, however, is only a starting point. Sirtris Pharmaceuticals, a firm based in Cambridge, Massachusetts, of which Dr Sinclair is a co-founder, has identified a number of synthetic molecules whose effect on yeast is many times more potent than resveratrol's."

Dr. Sinclair may come out with a pill with the synthetic molecule that activates Sir2/SIRT1 many times over what trans resveratrol does!