Over the last two decades, healthcare costs have become a major topic of conservation and a major worry for governments,
businesses, healthcare providers and private citizens. Medicare and
Medicaid capture nearly one-quarter of the U.S. federal budget, while
according to Bloomberg, healthcare takes up more than 15% of consumer
spending. Healthcare costs have likewise loomed large for many corporate
pension plans and many companies have cut or stopped subsidizing health
insurance costs for workers.
So, what are the biggest items on the national healthcare bill? While
there are a lot of complicating factors in the math (as well as
double-counting), it's fairly clear that heart disease, obesity,
diabetes and cancer make some of the largest demands on the U.S.
healthcare budget.
Showing posts with label obesity. Show all posts
Showing posts with label obesity. Show all posts
Monday, June 18, 2012
Friday, October 29, 2010
Vivus Gets An Encouraging No
In a reversal of a recent trend, the FDA actually gave a glimmer of hope to a biotech company and its shareholders. Although almost everyone was counting on the FDA's rejection of Vivus's (Nasdaq:VVUS) obesity drug candidate Qnexa, the FDA left the window open wider than many people expected. With what amounts to an "encouraging rejection", there may yet again be reason to hope that at least one new obesity drug can make it to market in the foreseeable future.
More Analysis, Please
When the FDA rejects a drug, it sends companies what is called a "complete response letter" (or CRL) outlining the agency's objections and indicating the sort of deficiencies that the company must correct before the FDA will reconsider approval. In some cases, the FDA requires new full-scale clinical trials, while other times the agency simply wants the results of trials already underway or new kinds of data analysis. (For related reading, check out FDA To Obesity Drugs: Drop Dead.)
For the full piece, please click below:
http://stocks.investopedia.
More Analysis, Please
When the FDA rejects a drug, it sends companies what is called a "complete response letter" (or CRL) outlining the agency's objections and indicating the sort of deficiencies that the company must correct before the FDA will reconsider approval. In some cases, the FDA requires new full-scale clinical trials, while other times the agency simply wants the results of trials already underway or new kinds of data analysis. (For related reading, check out FDA To Obesity Drugs: Drop Dead.)
For the full piece, please click below:
http://stocks.investopedia.
Saturday, October 9, 2010
Will Amylin Succeed Where Other Obesity Drugs Fail?
With Vivus (Nasdaq: VVUS) and Arena (Nasdaq: ARNA) going down in flames during FDA panel meetings for their obesity drugs, and Orexigen (Nasdaq: OREX) widely expected to incur a similar fate, the near-term outlook for effective obesity drugs is poor.
Enter Amylin (Nasdaq: AMLN).
Amylin is best known for Byetta, the first-of-its-kind GLP-1 receptor agonist analog. Also known as exenatide, Byetta was derived from research on gila monster spit and has been a relatively successful drug for Amylin and its partner Lilly (NYSE: LLY). Now investor attention has moved on to the company's long-acting version of exenatide called Bydureon. Due to be approved by the FDA any day now, this should be a formidable competitor in a billion-dollar-plus market.
But that is not all that makes Amylin interesting. The company has a promising combination drug therapy for obesity that is currently not getting very much attention. In a 26-week Phase 2 study, a combination of pramlintide and metreleptin showed significant weight loss efficacy - patients in the highest dose group had an average weight loss of 11% (about 22 lbs). Better still, the effect endured in a subsequent 26-week follow-up, while placebo patients experience weight re-gain.
Takeda partnered with Amylin for obesity drugs back in 2009, and the companies are putting this combo therapy into a Phase 3 trial. What makes this even more encouraging is that side-effects were pretty moderate (some injection site reactions and nausea) and there was apparently none of the psychological or cardiovascular effects that so worry the FDA. On top of that, half of the active combination (pramlintide) has been on the market for years, marketed as Symlin by Amylin for Type 1 and Type 2 diabetes. It is not a very successful drug, but the safety profile is pretty well known now, and that should help the FDA's comfort level if the drug makes it that far.
Now, this is an injected drug combo and that is going to limit the popularity to some extent. Still, I have to think that an effective weight loss aid is going to overcome needle-fear for a meaningful percentage of the target population.
Best of all, this could be the *only* new approved drug (if it gets approved, of course) on the market ... and that could be worth literally billions. So even if Amylin has to deal with competition in the GLP-1 space (and they do), they could have an arguably more lucrative drug on their hands if this combo works.
Oh, and for those who might be wondering ... yes, metreleptin is related to the work on the leptin hormone that Amgen (Nasdaq: AMGN) did years ago (remember the "fat mouse" and the "skinny mouse"?). As it turns out, leptin is not very helpful or effective as monotherapy, but it seems to have some pretty compelling synergies when given with some other compounds. If this works, Amgen will get a piece of the pie, though not a very large one.
I am not sure that I would buy Amylin just for this obesity drug candidate. Then again, it could very well be an important answer to the inevitable question of "ok, now what?" that will spring up once Bydureon is on the market. Of course, Lilly may just elect to take them out before then.
All in all, I think you can buy Amylin here and do pretty well. And who knows? Amylin wouldn't be the first example of a company to win a battle (in this case, a next-gen obesity drug) when most handicappers didn't even have them in the running.
Disclosure - I own shares of Amylin.
Enter Amylin (Nasdaq: AMLN).
Amylin is best known for Byetta, the first-of-its-kind GLP-1 receptor agonist analog. Also known as exenatide, Byetta was derived from research on gila monster spit and has been a relatively successful drug for Amylin and its partner Lilly (NYSE: LLY). Now investor attention has moved on to the company's long-acting version of exenatide called Bydureon. Due to be approved by the FDA any day now, this should be a formidable competitor in a billion-dollar-plus market.
But that is not all that makes Amylin interesting. The company has a promising combination drug therapy for obesity that is currently not getting very much attention. In a 26-week Phase 2 study, a combination of pramlintide and metreleptin showed significant weight loss efficacy - patients in the highest dose group had an average weight loss of 11% (about 22 lbs). Better still, the effect endured in a subsequent 26-week follow-up, while placebo patients experience weight re-gain.
Takeda partnered with Amylin for obesity drugs back in 2009, and the companies are putting this combo therapy into a Phase 3 trial. What makes this even more encouraging is that side-effects were pretty moderate (some injection site reactions and nausea) and there was apparently none of the psychological or cardiovascular effects that so worry the FDA. On top of that, half of the active combination (pramlintide) has been on the market for years, marketed as Symlin by Amylin for Type 1 and Type 2 diabetes. It is not a very successful drug, but the safety profile is pretty well known now, and that should help the FDA's comfort level if the drug makes it that far.
Now, this is an injected drug combo and that is going to limit the popularity to some extent. Still, I have to think that an effective weight loss aid is going to overcome needle-fear for a meaningful percentage of the target population.
Best of all, this could be the *only* new approved drug (if it gets approved, of course) on the market ... and that could be worth literally billions. So even if Amylin has to deal with competition in the GLP-1 space (and they do), they could have an arguably more lucrative drug on their hands if this combo works.
Oh, and for those who might be wondering ... yes, metreleptin is related to the work on the leptin hormone that Amgen (Nasdaq: AMGN) did years ago (remember the "fat mouse" and the "skinny mouse"?). As it turns out, leptin is not very helpful or effective as monotherapy, but it seems to have some pretty compelling synergies when given with some other compounds. If this works, Amgen will get a piece of the pie, though not a very large one.
I am not sure that I would buy Amylin just for this obesity drug candidate. Then again, it could very well be an important answer to the inevitable question of "ok, now what?" that will spring up once Bydureon is on the market. Of course, Lilly may just elect to take them out before then.
All in all, I think you can buy Amylin here and do pretty well. And who knows? Amylin wouldn't be the first example of a company to win a battle (in this case, a next-gen obesity drug) when most handicappers didn't even have them in the running.
Disclosure - I own shares of Amylin.
Wednesday, September 15, 2010
Arena's Big day Looms Large
For investors who believe in the predictive power of Wall Street, things are not looking good for Arena Pharmaceuticals (Nasdaq: ARNA), the small biotech that is facing an FDA panel meeting for its potential obesity drug lorcaserin. Amidst downgrades and worries about FDA concerns regarding safety and efficacy, Arena shares were off more than a third midday Tuesday. This follows in the wake of the surprising recommendation against approval in July for Vivus' (Nasdaq:VVUS) drug Qnexa and widespread uncertainty regarding Orexigen's (Nasdaq:OREX) Contrave.
Is the Data Good Enough?
The biggest problem for Arena is the efficacy data. Although the one-year efficacy data on lorcaserin is okay, it is no blockbuster. More than 47% of patients who took lorcaserin in the BLOOM trial lost 5% or more of their baseline weight (versus about 20% in the placebo group), with an average loss of 5.8%. More than one in five people who took Lorcaserin saw better than 10% weight loss.
Please click below to continue to the full piece:
http://stocks.investopedia.com/stock-analysis/2010/Arenas-Big-Day-Looms-Large-ARNA-VVUS-OREX0915.aspx
Note: The editors at Investopedia made a small error here in the original version, capitalizing "lorcaserin", "valvulopathy", and "fenflueramine". That should all be changed and corrected soon.
Is the Data Good Enough?
The biggest problem for Arena is the efficacy data. Although the one-year efficacy data on lorcaserin is okay, it is no blockbuster. More than 47% of patients who took lorcaserin in the BLOOM trial lost 5% or more of their baseline weight (versus about 20% in the placebo group), with an average loss of 5.8%. More than one in five people who took Lorcaserin saw better than 10% weight loss.
Please click below to continue to the full piece:
http://stocks.investopedia.com/stock-analysis/2010/Arenas-Big-Day-Looms-Large-ARNA-VVUS-OREX0915.aspx
Note: The editors at Investopedia made a small error here in the original version, capitalizing "lorcaserin", "valvulopathy", and "fenflueramine". That should all be changed and corrected soon.
Thursday, July 15, 2010
FDA Panel Rejects Vivus Obesity Drug
Wow!
I am cynical and bitter enough that very little surprises me any more (hey, I lived in DC four years, worked on Capitol Hill for a year, and worked for investment firms through two bubble/busts!). But I have to say that I am very surprised to see Vivus get KO'd at the FDA.
In a 10-6 vote, the FDA's panel voted NOT to recommend Qnexa for approval. The panel was apparently bothered by the risks of depression, birth defects, and memory loss, particularly in relation to the weight loss benefits seen with the pill. Overall, it looks like a lack of safety data is what really bothered the panelists.
Now, the FDA could go against this recommendation and approve the pill anyway. In the wake of the panel decision, even representatives from the FDA expressed surprise and made comments that could be interpreted as suggesting the panel was too conservative and was not "strongly" opposed to Qnexa.
The FDA did ignore a negative panel vote on an obesity drug before; that years ago when a panel voted against a weight loss drug called Redux. The FDA approved the drug anyway, the drug was a major hit initially ... and then was withdrawn because of severe side-effects. All in all, it cost Wyeth (now part of Pfizer) billions in legal costs and class-action settlements.So, I have to think that the FDA is going to be *extremely* cautious about doing anything that could repeat that disaster.
What's more, I hate to say it, but drugs like Qnexa are not strictly necessary. You *can* lose weight without drugs. I speak from experience; I have been fat my entire life, but I have lost about 65 lbs in the last 9 months, and I have not been using any pharmaceuticals (just diet and exercise).
Vivus' news is clearly going to chill the sector. I would expect to see Arena and Orexigen both sell off tomorrow on the presumption that the FDA is just not receptive to less-than-perfect obesity drugs. I think Orexigen's drug Contrave is particularly at risk - the efficacy is not that great and the side-effect profile was worse than Qnexa.
Arena does still have an outside shot here. The drug is not extremely effective, but it does help some. What's more, while it has side-effects, they do not seem to be too serious. My bigger fear, though, is that Arena gets caught up in guilt-by-association with Redux. Arena's drug lorcaserin is superficially similar to Redux and my fear is that the FDA panel looks at it and says "eh, why risk it?" and blacklists without realizing that Arena is different. Redux non-selectively stimulated 5-HT2b receptors; lorcaserin selectively stimulates 5-HT2c receptors. That is a major difference at the biochemistry level, and Arena's trials have shown none of the valvulopathy and pulmonary hypertension risks that doomed Redux, but will the panelists or the FDA care?
Vivus is not doomed yet. There is the chance that the FDA will overrule the panel. Vivus could also elect to try again when data from a 2-year study comes out later this quarter. Alternatively, the company may have to do a massive (10,000) additional Phase 3 study to fully allay these worries. Given the environment for financing right now (and the unusual deal that Arena had to strike with Eisai), I am not sure they can afford that.
All in all, a very surprising day.
I am cynical and bitter enough that very little surprises me any more (hey, I lived in DC four years, worked on Capitol Hill for a year, and worked for investment firms through two bubble/busts!). But I have to say that I am very surprised to see Vivus get KO'd at the FDA.
In a 10-6 vote, the FDA's panel voted NOT to recommend Qnexa for approval. The panel was apparently bothered by the risks of depression, birth defects, and memory loss, particularly in relation to the weight loss benefits seen with the pill. Overall, it looks like a lack of safety data is what really bothered the panelists.
Now, the FDA could go against this recommendation and approve the pill anyway. In the wake of the panel decision, even representatives from the FDA expressed surprise and made comments that could be interpreted as suggesting the panel was too conservative and was not "strongly" opposed to Qnexa.
The FDA did ignore a negative panel vote on an obesity drug before; that years ago when a panel voted against a weight loss drug called Redux. The FDA approved the drug anyway, the drug was a major hit initially ... and then was withdrawn because of severe side-effects. All in all, it cost Wyeth (now part of Pfizer) billions in legal costs and class-action settlements.So, I have to think that the FDA is going to be *extremely* cautious about doing anything that could repeat that disaster.
What's more, I hate to say it, but drugs like Qnexa are not strictly necessary. You *can* lose weight without drugs. I speak from experience; I have been fat my entire life, but I have lost about 65 lbs in the last 9 months, and I have not been using any pharmaceuticals (just diet and exercise).
Vivus' news is clearly going to chill the sector. I would expect to see Arena and Orexigen both sell off tomorrow on the presumption that the FDA is just not receptive to less-than-perfect obesity drugs. I think Orexigen's drug Contrave is particularly at risk - the efficacy is not that great and the side-effect profile was worse than Qnexa.
Arena does still have an outside shot here. The drug is not extremely effective, but it does help some. What's more, while it has side-effects, they do not seem to be too serious. My bigger fear, though, is that Arena gets caught up in guilt-by-association with Redux. Arena's drug lorcaserin is superficially similar to Redux and my fear is that the FDA panel looks at it and says "eh, why risk it?" and blacklists without realizing that Arena is different. Redux non-selectively stimulated 5-HT2b receptors; lorcaserin selectively stimulates 5-HT2c receptors. That is a major difference at the biochemistry level, and Arena's trials have shown none of the valvulopathy and pulmonary hypertension risks that doomed Redux, but will the panelists or the FDA care?
Vivus is not doomed yet. There is the chance that the FDA will overrule the panel. Vivus could also elect to try again when data from a 2-year study comes out later this quarter. Alternatively, the company may have to do a massive (10,000) additional Phase 3 study to fully allay these worries. Given the environment for financing right now (and the unusual deal that Arena had to strike with Eisai), I am not sure they can afford that.
All in all, a very surprising day.
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