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 diabetes. Show all posts
Showing posts with label diabetes. Show all posts
Monday, June 18, 2012
Friday, December 3, 2010
Merck Makes A Smart Buy
Large pharmaceuticals buy small private companies all the time, often paying so little that they are not even obligated to report the transactions to shareholders. With Merck's (NYSE: MRK) deal to buy SmartCells, though, things are a little different on two levels. Not only is the purchase price large enough to get some attention, but the technology could be a real game-changer down the road.
The Deal
Rumors had been creeping around for a little while on this deal, but Merck made it official Thursday morning that it was acquiring SmartCells in an all-cash deal. Although the companies did not discuss the upfront payment, it is a comprehensive deal that includes potential milestones and follow-on payments that could all total in excess of $500 million. Given the size of the transaction and the timing of the payments, I am not sure that Merck will have to file an 8-K for this, so investors may be hard-pressed to find more details on the transaction. (For more, see The Wacky World Of Mergers And Acquisitions.)
Please click below for the full piece:
http://stocks.investopedia.
The Deal
Rumors had been creeping around for a little while on this deal, but Merck made it official Thursday morning that it was acquiring SmartCells in an all-cash deal. Although the companies did not discuss the upfront payment, it is a comprehensive deal that includes potential milestones and follow-on payments that could all total in excess of $500 million. Given the size of the transaction and the timing of the payments, I am not sure that Merck will have to file an 8-K for this, so investors may be hard-pressed to find more details on the transaction. (For more, see The Wacky World Of Mergers And Acquisitions.)
Please click below for the full piece:
http://stocks.investopedia.
Tuesday, November 9, 2010
Dark Days In Diabetes
Diabetes has long been one of the most "investable" diseases, with a host of pharmaceutical, biotech, and medical device plays on this serious (and increasingly common) condition. Recent weeks have not been kind to the sector, though, as a range of problems and challenges have sent investors to the sidelines.
FDA - Don't Call Us, We'll Call You
Several companies have seen their fortunes take a bad turn either in the clinic or from the Food and Drug Administration.
Roche (Nasdaq:RHHBY) has essentially been sent back to the drawing board on its weekly GLP-1 drug taspoglutide, and there is a good chance that the side-effect problems that halted a Phase 3 study will prove insurmountable. Another would-be long-acting GLP-1 drug (to be marketed by Eli Lilly (NYSE:LLY) was surprisingly rejected due to FDA worries about safety and a demand for a new study.
Biodel (Nasdaq:BIOD) recently saw its application for a new formulation of insulin rejected due to sample handling and patient drop-out problems, and the FDA's unwillingness to brook a post-hoc analysis of the data. Both Vivus (Nasdaq:VVUS) and Arena Pharmaceuticals (Nasdaq:ARNA) saw their obesity drugs rejected (obesity is a leading cause of Type 2 diabetes), though the FDA left a sliver of hope for both companies (particularly Vivus).
Please click the link for the full article:
http://stocks.investopedia.
FDA - Don't Call Us, We'll Call You
Several companies have seen their fortunes take a bad turn either in the clinic or from the Food and Drug Administration.
Roche (Nasdaq:RHHBY) has essentially been sent back to the drawing board on its weekly GLP-1 drug taspoglutide, and there is a good chance that the side-effect problems that halted a Phase 3 study will prove insurmountable. Another would-be long-acting GLP-1 drug (to be marketed by Eli Lilly (NYSE:LLY) was surprisingly rejected due to FDA worries about safety and a demand for a new study.
Biodel (Nasdaq:BIOD) recently saw its application for a new formulation of insulin rejected due to sample handling and patient drop-out problems, and the FDA's unwillingness to brook a post-hoc analysis of the data. Both Vivus (Nasdaq:VVUS) and Arena Pharmaceuticals (Nasdaq:ARNA) saw their obesity drugs rejected (obesity is a leading cause of Type 2 diabetes), though the FDA left a sliver of hope for both companies (particularly Vivus).
Please click the link for the full article:
http://stocks.investopedia.
Wednesday, July 14, 2010
Avandia Gets A Reprieve?
Apparently the expert panel commissioned by the FDA to evaluate GlaxoSmithKline's (NYSE: GSK) now-controversial diabetes drug Avandia has voted to recommend that the drug stay on the market. The vote, 20-12, is not binding and although the FDA usually does as its panels recommend, they do not always do so - particularly in cases of safety concerns.
As a brief background, Avandia (also known as rosiglitazone), is a gamma PPAR diabetes drug that makes cells more responsive to insulin. Although it is quite effective (reducing HbA1C by 0.5% or more, a nearly 10% improvement in this important diabetes diagnostic marker), some studies have indicated it carries a much higher risk of heart attack and death from cardiac problems than other gamma PPARs or other anti-diabetes drugs in general. The issue has grown with time, precipitating this FDA meeting.
Although Avandia may be allowed to stay on the market, its glory days are almost certainly over. Actos, a rival PPAR drug marketed by Takeda does not seem to have the same risks. Moreover, this whole class has been a sort of pharmaceutical Bermuda Triangle - AstraZeneca, Bristol Myers Squibb, and Daiichi Sankyo have all had serious issues with PPAR drugs they tried to develop, and relatively few compounds are in clinical studies now.
Moreover, there are plenty of other fish in the sea - including GLP-1 analogs (Amylin, Lilly, Roche, Novo Nordisk, and Glaxo) and DPP-4 inhibitors (Merck) on the market or in late development. Plus, very old drugs like metformin are still reasonably effective and have positive risk-benefit trade-offs.
I am a little surprised to see this result, but as I said, I do not think it will matter too much. Even if the FDA allows the drug to stay on the market, Glaxo is going to have a helluva time driving prescription growth. In the meantime, I have a vested interest here in hoping that Amylin's long-acting GLP-1 analog Bydureon steals the show.
Disclosure - I own shares of Amylin
Brief update: Of the 20 who voted NOT to remove Avandia, 10 want sells restricted and stronger warning labels, 7 want stronger labels but no new restrictions, and three recommended no changes. This breakdown makes me think that further restrictions (at a minimum) are a near-certainty and total withdrawal could still happen.
As a brief background, Avandia (also known as rosiglitazone), is a gamma PPAR diabetes drug that makes cells more responsive to insulin. Although it is quite effective (reducing HbA1C by 0.5% or more, a nearly 10% improvement in this important diabetes diagnostic marker), some studies have indicated it carries a much higher risk of heart attack and death from cardiac problems than other gamma PPARs or other anti-diabetes drugs in general. The issue has grown with time, precipitating this FDA meeting.
Although Avandia may be allowed to stay on the market, its glory days are almost certainly over. Actos, a rival PPAR drug marketed by Takeda does not seem to have the same risks. Moreover, this whole class has been a sort of pharmaceutical Bermuda Triangle - AstraZeneca, Bristol Myers Squibb, and Daiichi Sankyo have all had serious issues with PPAR drugs they tried to develop, and relatively few compounds are in clinical studies now.
Moreover, there are plenty of other fish in the sea - including GLP-1 analogs (Amylin, Lilly, Roche, Novo Nordisk, and Glaxo) and DPP-4 inhibitors (Merck) on the market or in late development. Plus, very old drugs like metformin are still reasonably effective and have positive risk-benefit trade-offs.
I am a little surprised to see this result, but as I said, I do not think it will matter too much. Even if the FDA allows the drug to stay on the market, Glaxo is going to have a helluva time driving prescription growth. In the meantime, I have a vested interest here in hoping that Amylin's long-acting GLP-1 analog Bydureon steals the show.
Disclosure - I own shares of Amylin
Brief update: Of the 20 who voted NOT to remove Avandia, 10 want sells restricted and stronger warning labels, 7 want stronger labels but no new restrictions, and three recommended no changes. This breakdown makes me think that further restrictions (at a minimum) are a near-certainty and total withdrawal could still happen.
Tuesday, June 22, 2010
A Little Good News From Lexicon
One of my least-successful investments, Lexicon Pharmaceuticals (Nasdaq: LXRX), re-reported some interesting news early today on one of its clinical programs.
Data from a Phase 2a study of LX4211 (a dual SGLT2 and SGLT1 inhibitor) in Type 2 diabetes showed a 1.15 reduction in HbA1c after just 28 days of use in the 150mg group, while the 300mg group showed 1.25 reduction. In this study, the placebo group showed a 0.49 improvement. Keep in mind, though, that this wasn't really "news" - the top line results from this study came out in January of this year.
Nevertheless, those numbers compare to a 1.5 improvement seen in a recently-announced 26-week study of Amylin's (Nasdaq: AMLN) Byetta, and the 1.2 reduction seen in Merck's (NYSE: MRK) Januvia in that same study.
In the big picture, then, these results would be competitive with most of the state-of-the-art diabetes medications. Better still, LX4211 is administered as a once-daily oral medication and so far SGLT1/2 inhibition has not shown any serious side-effects.
As I am an owner of these shares, I have a certain amount of built-in optimism, but I'm under no illusions that the path to approval will be quick or easy. Lexicon is looking at a minimum of five years before this drug could be approvable and will need even more money to make that happen (dilutive financings have already raised the sharecount here to over 330 million shares). And that, of course, assumes that the drug continues to show a competitive degree of efficacy and no serious side-effects.
All in all, it's a good reminder of why I'm holding out hope on this one, but it's definitely not a widows-and-orphans situation.
Disclosure: I own shares in Lexicon and Amylin.
Data from a Phase 2a study of LX4211 (a dual SGLT2 and SGLT1 inhibitor) in Type 2 diabetes showed a 1.15 reduction in HbA1c after just 28 days of use in the 150mg group, while the 300mg group showed 1.25 reduction. In this study, the placebo group showed a 0.49 improvement. Keep in mind, though, that this wasn't really "news" - the top line results from this study came out in January of this year.
Nevertheless, those numbers compare to a 1.5 improvement seen in a recently-announced 26-week study of Amylin's (Nasdaq: AMLN) Byetta, and the 1.2 reduction seen in Merck's (NYSE: MRK) Januvia in that same study.
In the big picture, then, these results would be competitive with most of the state-of-the-art diabetes medications. Better still, LX4211 is administered as a once-daily oral medication and so far SGLT1/2 inhibition has not shown any serious side-effects.
As I am an owner of these shares, I have a certain amount of built-in optimism, but I'm under no illusions that the path to approval will be quick or easy. Lexicon is looking at a minimum of five years before this drug could be approvable and will need even more money to make that happen (dilutive financings have already raised the sharecount here to over 330 million shares). And that, of course, assumes that the drug continues to show a competitive degree of efficacy and no serious side-effects.
All in all, it's a good reminder of why I'm holding out hope on this one, but it's definitely not a widows-and-orphans situation.
Disclosure: I own shares in Lexicon and Amylin.
Thursday, December 11, 2008
Finally a little good news for Amylin
Amylin (AMLN) hasn't had the best run of late.
There have been safety concerns about the drug Byetta (largely overblown), competition concerns from rival drugs (not-so-overblown), and worries about the timing, efficacy, and competitive profile of the long-acting version of Byetta. Making matters worse, Amylin management hasn't exactly conducted themselves in the most up-front and transparent matter, burying notice of a potentially significant delay in the LAR drug in an 8-K.
I don't like companies that put out press releases to trumpet success, but try to bury setbacks in SEC filings that they hope no one will read.
In any case, word today from Lilly/Amylin/Alkermes suggests that the can use a current ongoing study in place of a separate bioequivalence study. That's good news, as this company clearly needs to get the LAR drug on the market as quickly as possible...
(full disclosure - I'm long Amylin, though some days I wonder why...)
There have been safety concerns about the drug Byetta (largely overblown), competition concerns from rival drugs (not-so-overblown), and worries about the timing, efficacy, and competitive profile of the long-acting version of Byetta. Making matters worse, Amylin management hasn't exactly conducted themselves in the most up-front and transparent matter, burying notice of a potentially significant delay in the LAR drug in an 8-K.
I don't like companies that put out press releases to trumpet success, but try to bury setbacks in SEC filings that they hope no one will read.
In any case, word today from Lilly/Amylin/Alkermes suggests that the can use a current ongoing study in place of a separate bioequivalence study. That's good news, as this company clearly needs to get the LAR drug on the market as quickly as possible...
(full disclosure - I'm long Amylin, though some days I wonder why...)
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