7 replies to this topic

[malbecman]

UPDATE 1-Sirtris: FDA grants orphan status for red-wine compound
Wed Apr 2, 2008 9:50am EDT

April 2 (Reuters) - Sirtris Pharmaceuticals Inc (SIRT.O: Quote, Profile, Research) said the U.S. health regulators granted orphan drug status for resveratrol, a compound derived from red wine, to treat a fatal muscular disorder.
The biopharmaceutical company uses resveratrol to develop drugs to treat diseases related to aging. Resveratrol has been shown in several studies to prolong the life of mice and reduce the advance of age-related disease.
Sirtris' formulation of resveratrol, SRT501, is currently in an early-stage trial for MELAS syndrome and targets SIRT1, a gene tied to the aging process and improved mitochondrial function.
MELAS syndrome is a progressive muscular disorder caused by DNA mutations in mitochondria, the parts of cells which supply energy.
Early symptoms of MELAS syndrome include muscle weakness and fatigue. As the disease progresses, patients can suffer from seizures, dementia and impaired muscular function.
Orphan drug designation for resveratrol in MELAS syndrome would provide the company with seven years of marketing exclusivity upon approval for the indication.
Sirtris said it plans to seek orphan drug status, which is given to drugs that have the potential to treat rare diseases, for SRT501 in Europe.
Shares of Sirtris were down more than 5 percent at $13.15 in early morning trade on Nasdaq, after opening higher at $14.15. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Himani Sarkar)

[Hedgehog]

UPDATE 1-Sirtris: FDA grants orphan status for red-wine compound
Wed Apr 2, 2008 9:50am EDT

April 2 (Reuters) - Sirtris Pharmaceuticals Inc (SIRT.O: Quote, Profile, Research) said the U.S. health regulators granted orphan drug status for resveratrol, a compound derived from red wine, to treat a fatal muscular disorder.
The biopharmaceutical company uses resveratrol to develop drugs to treat diseases related to aging. Resveratrol has been shown in several studies to prolong the life of mice and reduce the advance of age-related disease.
Sirtris' formulation of resveratrol, SRT501, is currently in an early-stage trial for MELAS syndrome and targets SIRT1, a gene tied to the aging process and improved mitochondrial function.
MELAS syndrome is a progressive muscular disorder caused by DNA mutations in mitochondria, the parts of cells which supply energy.
Early symptoms of MELAS syndrome include muscle weakness and fatigue. As the disease progresses, patients can suffer from seizures, dementia and impaired muscular function.
Orphan drug designation for resveratrol in MELAS syndrome would provide the company with seven years of marketing exclusivity upon approval for the indication.
Sirtris said it plans to seek orphan drug status, which is given to drugs that have the potential to treat rare diseases, for SRT501 in Europe.
Shares of Sirtris were down more than 5 percent at $13.15 in early morning trade on Nasdaq, after opening higher at $14.15. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Himani Sarkar)

Why are they not using one of thier NCE's?

Edited by Hedgehog, 02 April 2008 - 06:09 PM.

[sUper GeNius]

UPDATE 1-Sirtris: FDA grants orphan status for red-wine compound
Wed Apr 2, 2008 9:50am EDT

April 2 (Reuters) - Sirtris Pharmaceuticals Inc (SIRT.O: Quote, Profile, Research) said the U.S. health regulators granted orphan drug status for resveratrol, a compound derived from red wine, to treat a fatal muscular disorder.
The biopharmaceutical company uses resveratrol to develop drugs to treat diseases related to aging. Resveratrol has been shown in several studies to prolong the life of mice and reduce the advance of age-related disease.
Sirtris' formulation of resveratrol, SRT501, is currently in an early-stage trial for MELAS syndrome and targets SIRT1, a gene tied to the aging process and improved mitochondrial function.
MELAS syndrome is a progressive muscular disorder caused by DNA mutations in mitochondria, the parts of cells which supply energy.
Early symptoms of MELAS syndrome include muscle weakness and fatigue. As the disease progresses, patients can suffer from seizures, dementia and impaired muscular function.
Orphan drug designation for resveratrol in MELAS syndrome would provide the company with seven years of marketing exclusivity upon approval for the indication.
Sirtris said it plans to seek orphan drug status, which is given to drugs that have the potential to treat rare diseases, for SRT501 in Europe.
Shares of Sirtris were down more than 5 percent at $13.15 in early morning trade on Nasdaq, after opening higher at $14.15. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Himani Sarkar)

Would this affect our ability to purchase resveratrol 99% from Anthony and other suppliers???

[Hedgehog]

UPDATE 1-Sirtris: FDA grants orphan status for red-wine compound
Wed Apr 2, 2008 9:50am EDT

April 2 (Reuters) - Sirtris Pharmaceuticals Inc (SIRT.O: Quote, Profile, Research) said the U.S. health regulators granted orphan drug status for resveratrol, a compound derived from red wine, to treat a fatal muscular disorder.
The biopharmaceutical company uses resveratrol to develop drugs to treat diseases related to aging. Resveratrol has been shown in several studies to prolong the life of mice and reduce the advance of age-related disease.
Sirtris' formulation of resveratrol, SRT501, is currently in an early-stage trial for MELAS syndrome and targets SIRT1, a gene tied to the aging process and improved mitochondrial function.
MELAS syndrome is a progressive muscular disorder caused by DNA mutations in mitochondria, the parts of cells which supply energy.
Early symptoms of MELAS syndrome include muscle weakness and fatigue. As the disease progresses, patients can suffer from seizures, dementia and impaired muscular function.
Orphan drug designation for resveratrol in MELAS syndrome would provide the company with seven years of marketing exclusivity upon approval for the indication.
Sirtris said it plans to seek orphan drug status, which is given to drugs that have the potential to treat rare diseases, for SRT501 in Europe.
Shares of Sirtris were down more than 5 percent at $13.15 in early morning trade on Nasdaq, after opening higher at $14.15. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Himani Sarkar)

Would this affect our ability to purchase resveratrol 99% from Anthony and other suppliers???

No...

But I still don't understand why they don't use a NCE? Maybe all their NCE's have bad side effects such maybe a estrogen effect?

[niner]

But I still don't understand why they don't use a NCE? Maybe all their NCE's have bad side effects such maybe a estrogen effect?

It might just be that resveratrol is way closer to approval, given that there are thousands of guinea pigs roaming the halls of imminst and DSM is talking about getting GRAS approval for it, not to mention that humans have been consuming it for millenia in foods. The NCEs, on the other hand, are weird new molecules that will have to go through the whole hardcore approval process, and they've hardly even been in people yet, if at all. If they could get a resveratrol product approved, there would probably be a lot of off-label use, and they could make a little money while they work on the NCEs.

[malbecman]

I imagine their strategy is to use a known natural compound that is consumed every day and get orphan drug approval for that first. It would be a lot easier to pass FDA and general public approval than some "nasty" synthetic NCE. (never mind that botulinim toxin, one of the most potent toxins on earth is completely "natural"). Also, I believe they have a lot more in vitro and in vivo data with SRT501 at this point.....

UPDATE 1-Sirtris: FDA grants orphan status for red-wine compound
Wed Apr 2, 2008 9:50am EDT

April 2 (Reuters) - Sirtris Pharmaceuticals Inc (SIRT.O: Quote, Profile, Research) said the U.S. health regulators granted orphan drug status for resveratrol, a compound derived from red wine, to treat a fatal muscular disorder.
The biopharmaceutical company uses resveratrol to develop drugs to treat diseases related to aging. Resveratrol has been shown in several studies to prolong the life of mice and reduce the advance of age-related disease.
Sirtris' formulation of resveratrol, SRT501, is currently in an early-stage trial for MELAS syndrome and targets SIRT1, a gene tied to the aging process and improved mitochondrial function.
MELAS syndrome is a progressive muscular disorder caused by DNA mutations in mitochondria, the parts of cells which supply energy.
Early symptoms of MELAS syndrome include muscle weakness and fatigue. As the disease progresses, patients can suffer from seizures, dementia and impaired muscular function.
Orphan drug designation for resveratrol in MELAS syndrome would provide the company with seven years of marketing exclusivity upon approval for the indication.
Sirtris said it plans to seek orphan drug status, which is given to drugs that have the potential to treat rare diseases, for SRT501 in Europe.
Shares of Sirtris were down more than 5 percent at $13.15 in early morning trade on Nasdaq, after opening higher at $14.15. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Himani Sarkar)

Would this affect our ability to purchase resveratrol 99% from Anthony and other suppliers???

No...

But I still don't understand why they don't use a NCE? Maybe all their NCE's have bad side effects such maybe a estrogen effect?

[Anthony_Loera]

Nope, no issues

[Hedgehog]

But I still don't understand why they don't use a NCE? Maybe all their NCE's have bad side effects such maybe a estrogen effect?

It might just be that resveratrol is way closer to approval, given that there are thousands of guinea pigs roaming the halls of imminst and DSM is talking about getting GRAS approval for it, not to mention that humans have been consuming it for millenia in foods. The NCEs, on the other hand, are weird new molecules that will have to go through the whole hardcore approval process, and they've hardly even been in people yet, if at all. If they could get a resveratrol product approved, there would probably be a lot of off-label use, and they could make a little money while they work on the NCEs.

yes I understand but what if i was another biotech company and had a patent for a NCE for SIRT1 activation. If I saw SRT501 going into the clinic again and I knew I had a better molecule then I would be happy that Sirtris is spending time and money on a supplement. Time is everything in Biotech. Sitting on your ass getting a supplement approved could prove to be a very bad idea IF other companies are developing NCE's for SIRT1.

imagine their strategy is to use a known natural compound that is consumed every day and get orphan drug approval for that first. It would be a lot easier to pass FDA and general public approval than some "nasty" synthetic NCE

Probably a lot easier to get approved. However, the FDA is the FDA and you still have to show and follow the same guidlines. But like what I stated above lets assume that their product works and but it took a lot of time and money get passed phase III (like all drugs). While I'm biotech compnay B. Biotech B had 4-6years to get a new NCE for SIRT1 into the clinic that probably activates SIRT1 much better than resveratrol. So 4-6 years down the line it could prove to be a mistake. In a few years I could submit a NDA for my SIRT NCE for MELAS / diabetes that would probably be much more efficacious and wouldn't have to be formulated with a monster amount of resveratrol or .... Plus I already know that it works because Sirtris already went through clinical trials w/ resveratrol

I'm just happy they keep using resveratrol. More data that it is safe for humans.

Edited by Hedgehog, 02 April 2008 - 11:15 PM.