Nexavar : Sorafenib tosylate
Approval on: December 20, 2005
Manufacturer: Bayer & Onyx Pharmaceuticals
Indication: Advanced renal cell carcinoma (Cancer of the kidneys)
Benefit: Progression free survival of six months vs 3 mths on BSC.
(patients live for 6 months without the disease progressing any further compared to 3 months on placebo).
39% improvement in survival (39% people lived longer than the expected life of a kidney cancer patient)
Price: $4300 for one month
Side effects: 2.9% patients developed heart problems, compared to 0.4% in the placebo group.
How is it taken: Nexavar is dosed 400mg once a day.
Other tumors: Nexavar is being studied in Non-Small cell lung cancer
Sales potential: Nexavar is expected to garner sales of over $1.6 B according to Bayer news release.
Renal cancer is a deadly disease that affects 32000 patients each year in United States. Each year over 12000 patients die from renal disease. For more information, visit
For a blow by blow account of how Nexavar was developed, please Click Here
Wednesday, December 21, 2005
Sunday, August 21, 2005
Merck: Don't Write An Obituary Yet
Within minutes of the jury announcing a crushing $253 million verdict against Merck, the wallstreet reacted with a precipitous 8% decline in Merck's stock price. Today the stock price declined another 2% and is now hovering around $28.
Its an emotional reaction as any can be. Sure this was the first trial and the world was watching to see if Merck would win or loose. But loose one trial does not mean that that this is the end of the road.
Behind all of these Vioxx troubles, Merck is a solid blue chip company with an enviable track record of helping mankind through out its history. Just because Vioxx ended up in the dustbin does not mean that this company is no good. Its just the nature of the industry where companies have to assume huge risks in developing drugs, but the market place has no tolerance for risk.
While the pundits on the Wall Street would scoff at the idea of I would recommend that, now is the time to strengthen your positions in Merck. Merck will not be any cheaper than it is right now, and right now is an awsome opportunity to add to your portfolio at a bargain basement price.
And then, forget about it for the next five years. Merck will come back. And it will come back big. Then when you look back at the 5 year chart of stock price, you will be calling yourself a hero.
Its an emotional reaction as any can be. Sure this was the first trial and the world was watching to see if Merck would win or loose. But loose one trial does not mean that that this is the end of the road.
Behind all of these Vioxx troubles, Merck is a solid blue chip company with an enviable track record of helping mankind through out its history. Just because Vioxx ended up in the dustbin does not mean that this company is no good. Its just the nature of the industry where companies have to assume huge risks in developing drugs, but the market place has no tolerance for risk.
While the pundits on the Wall Street would scoff at the idea of I would recommend that, now is the time to strengthen your positions in Merck. Merck will not be any cheaper than it is right now, and right now is an awsome opportunity to add to your portfolio at a bargain basement price.
And then, forget about it for the next five years. Merck will come back. And it will come back big. Then when you look back at the 5 year chart of stock price, you will be calling yourself a hero.
Monday, May 09, 2005
Is Bristol Out of The Woods??
Good question. The fact that Bristol-Myers Squibb took a major hit in the last quarters earnings, to increase its reserve for legal costs by $110 million, would suggest that the execs are getting prepared for something or the other. Of course I am not the only one to think this way, others do to. There are several analysts quoted in Business Week who seem to believe that Bristol might be getting prepared to settle one of the cases brought against it in the accounting scandal that has clouded its nearterm prospects.
Another negative news, the US Attorney's office in Massachusetts has opened an investigation against marketing Abilify. Hmmmm.
On the positive side, the pipeline is being recognized a bit. A positive article in forbes about it confirms that the Bristol pipeline is better than that of peers in the industry. No wonder, WSJ recently cited BMS as a potential acquisition target for Merck, the injured giant that has its own pipeline woes.
Another negative news, the US Attorney's office in Massachusetts has opened an investigation against marketing Abilify. Hmmmm.
On the positive side, the pipeline is being recognized a bit. A positive article in forbes about it confirms that the Bristol pipeline is better than that of peers in the industry. No wonder, WSJ recently cited BMS as a potential acquisition target for Merck, the injured giant that has its own pipeline woes.
Saturday, May 07, 2005
Requip Approved For Restless Leg Syndrome
Glaxo SmithKline announced that its drug Requip (r) ropinirole HCL, has received FDA approval for Restless Drug Syndrome (RLS). Requip (r) is the first and only drug approved for moderate to severe RLS. Requip (r) is a dopamine agonist that stimulates the dopamine receptors in the brain. It is theorized that RLS is caused when the dopamine, which carries the signals between the nerves in the brain, starts functioning poorly. The dopamine receptor agonist is supposed to stimulate the dopamine receptors in the brain alleviating the sudden pain or overwhelmind desire to move caused in the legs of the patients suffering from RLS.
Requip has previously been approved for Parkinsons disease.
Requip has previously been approved for Parkinsons disease.
Friday, May 06, 2005
New CEO for Merck
Merck has a new CEO, and no, its not the Hollywood/TV celebrity Dick Clark, but another Dick Clark who rose through the ranks, and comes from the Manufacturing ranks. Challenges abound for the new CEO, not the least of which is, what is Merck's strategy to get out of this mess created by Vioxx, and the pipeline funk that looks like won't be delivering anything for the forseeable future. Forbes has a nice article on this that might interest you. Click here for the Forbes article
Friday, April 29, 2005
Byetta Approved But Amylin Swoons
Amylin received approval for its new diabetes drug yesterday, and the company was exstatic about it. But the market didn't respond with the same level of
exhuberence. Amylin shares were down today 6.6% due to the talk that the drug may have toxicities that might limit its use in broader population.
That may or may not be true. Byetta has demonstrated activity in patients who are not controlled by metformin or sulphonylureas. To these patients, Insulin is the only option available. While Insulin is a great drug, and one that has been used for years, the fact remains that Insulin causes other side effects such as weight gain, and increased CV risk. Byetta, from that perspective seems to be a better drug in that it doesn't cause the weight gain and could potentially be sparing to the insulin producing cells.
So it will be interesting to watch Amylin and Lilly, as the two companies go about teaching the market a thing or two about drug marketing.
exhuberence. Amylin shares were down today 6.6% due to the talk that the drug may have toxicities that might limit its use in broader population.
That may or may not be true. Byetta has demonstrated activity in patients who are not controlled by metformin or sulphonylureas. To these patients, Insulin is the only option available. While Insulin is a great drug, and one that has been used for years, the fact remains that Insulin causes other side effects such as weight gain, and increased CV risk. Byetta, from that perspective seems to be a better drug in that it doesn't cause the weight gain and could potentially be sparing to the insulin producing cells.
So it will be interesting to watch Amylin and Lilly, as the two companies go about teaching the market a thing or two about drug marketing.
Wednesday, March 30, 2005
A Think Week For Me!
Just yesterday I read an article about the Bill Gates "think week" in the "Wall Street Journal". If you don't know what I am talking about, here is the story. Apparently, Bill Gates, each year, twice a year, sets aside one week to do nothing but read up on interesting ideas, papers, concepts put together by Microsoft employees from around the world and think about them. Any one can contribute. Even a janitor in India can send in a paper, and if it makes past the "idea police", then Bill will read it. So Bill sets aside one week, secludes himself in a small cabin in the woods away from phone calls and family instrusions, to go over this pile of papers to think, and jot down his thoughts. If an idea is truly hot, the writer/creator can expect to hear from Bill. And if Bill approves of an idea, then you can expect to get the funds needed to move it forward.
Conceptually, this is such a great idea for a leader of any large organization that I am surprised I had never heard of this before. I have heard of the executives meeting, but haven't heard of a CEO secluding himself to just "think". But this makes even more of a sense for me as an individual. Yes, why can I not have a "think week" of my own?
Granted I don't run a multi billion dollar company, and don't have lackeys throwing their ideas at me. But I have plenty to think about. Here is a list of what I need time to think, and have never enough of...
1) I need to think about the direction in which my life is headed. My life has sort of gotten on an auto pilot. I am slowly moving in some direction - what direction I don't know. I need some time to think about it
2) I need to think about my finances...what the hell happened to the portfolio?
3) I need to start thinking about what I will do after I retire from my lousy job.
4) I need to think about my daughters education - private or public; Princeton or Rutgers!
5) And oh, I need to think about how I am going to build another room around our house that my wife's always complains is too small.
So, yes I DO have a lot to think about but no time to think!!
But here is the catch. If I blow a week on "think", then I will have thunked one week of my vacation time! Thats pretty precious vacation time when your family hardly gets to see you during the week.
So am I a bit jealous of Bill because of his "think week"? You betcha!
Just yesterday I read an article about the Bill Gates "think week" in the "Wall Street Journal". If you don't know what I am talking about, here is the story. Apparently, Bill Gates, each year, twice a year, sets aside one week to do nothing but read up on interesting ideas, papers, concepts put together by Microsoft employees from around the world and think about them. Any one can contribute. Even a janitor in India can send in a paper, and if it makes past the "idea police", then Bill will read it. So Bill sets aside one week, secludes himself in a small cabin in the woods away from phone calls and family instrusions, to go over this pile of papers to think, and jot down his thoughts. If an idea is truly hot, the writer/creator can expect to hear from Bill. And if Bill approves of an idea, then you can expect to get the funds needed to move it forward.
Conceptually, this is such a great idea for a leader of any large organization that I am surprised I had never heard of this before. I have heard of the executives meeting, but haven't heard of a CEO secluding himself to just "think". But this makes even more of a sense for me as an individual. Yes, why can I not have a "think week" of my own?
Granted I don't run a multi billion dollar company, and don't have lackeys throwing their ideas at me. But I have plenty to think about. Here is a list of what I need time to think, and have never enough of...
1) I need to think about the direction in which my life is headed. My life has sort of gotten on an auto pilot. I am slowly moving in some direction - what direction I don't know. I need some time to think about it
2) I need to think about my finances...what the hell happened to the portfolio?
3) I need to start thinking about what I will do after I retire from my lousy job.
4) I need to think about my daughters education - private or public; Princeton or Rutgers!
5) And oh, I need to think about how I am going to build another room around our house that my wife's always complains is too small.
So, yes I DO have a lot to think about but no time to think!!
But here is the catch. If I blow a week on "think", then I will have thunked one week of my vacation time! Thats pretty precious vacation time when your family hardly gets to see you during the week.
So am I a bit jealous of Bill because of his "think week"? You betcha!
Sunday, March 20, 2005
Bristol Myers Does The Right Thing!
Bristol-Myers Squibb company had a good week, with its Hepatitis B drug, Baraclude being given a thumbs up by the FDA advisory committee in United States. Granted, Hepatitis B is not a huge market in United States, and the monetary rewards for the company are rather limited, but this drug could be very important for the Asian countires. In fact, Baraclude is likely to have a positive impact to more people than many of the big Pharma products, simply because of the severity of Hepatitis B problem around the world.
To quote WHO,
"Hepatitis B is one of the major diseases of mankind and is a serious global public health problem. It is preventable with safe and effective vaccines that have been available since 1982. Of the 2 billion people who have been infected with the hepatitis B virus (HBV), more than 350 million have chronic (lifelong) infections."
Yes, you read it right, there are over 2 billion people infected with this disease!! About 5% or 60 million Indians suffer from chronic Hepatitis B infection. The rate is not much different in China. And Baraclude is designed to help just these chronically ill patients. Being approved in United States, even when profits here are going to be miniscule, is an important statement. It tells the world that drug is safe and indeed good enough to withstand the scrutiny of the FDA. This will make it easier to get approvals in other countries, many of which rely on "certificate of free sale" for their own approvals.
So, in this day and age, when it seems to be more fashionable to develop lifestyle drugs that bring in tons of profits, Bristol-Myers Squibb seems to have done the right thing. This drug is never going to be a block buster - and yet they have developed it. And because they have developed it, many patients who would never have had a chance otherwise, will now be able to benefit from the miracle of modern technology, not just in the developed nations but around the world.
Bristol-Myers Squibb company had a good week, with its Hepatitis B drug, Baraclude being given a thumbs up by the FDA advisory committee in United States. Granted, Hepatitis B is not a huge market in United States, and the monetary rewards for the company are rather limited, but this drug could be very important for the Asian countires. In fact, Baraclude is likely to have a positive impact to more people than many of the big Pharma products, simply because of the severity of Hepatitis B problem around the world.
To quote WHO,
"Hepatitis B is one of the major diseases of mankind and is a serious global public health problem. It is preventable with safe and effective vaccines that have been available since 1982. Of the 2 billion people who have been infected with the hepatitis B virus (HBV), more than 350 million have chronic (lifelong) infections."
Yes, you read it right, there are over 2 billion people infected with this disease!! About 5% or 60 million Indians suffer from chronic Hepatitis B infection. The rate is not much different in China. And Baraclude is designed to help just these chronically ill patients. Being approved in United States, even when profits here are going to be miniscule, is an important statement. It tells the world that drug is safe and indeed good enough to withstand the scrutiny of the FDA. This will make it easier to get approvals in other countries, many of which rely on "certificate of free sale" for their own approvals.
So, in this day and age, when it seems to be more fashionable to develop lifestyle drugs that bring in tons of profits, Bristol-Myers Squibb seems to have done the right thing. This drug is never going to be a block buster - and yet they have developed it. And because they have developed it, many patients who would never have had a chance otherwise, will now be able to benefit from the miracle of modern technology, not just in the developed nations but around the world.
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