At least a slight delay...
FDA Questions on Merck's New Rebif Delay Approval
Feb. 6 (Bloomberg) -- Merck KGaA faces a delay in introducing a new formulation of Rebif, the world's second- biggest multiple sclerosis medicine, after U.S. regulators asked for more information.
``We've received questions from the FDA that require our response,'' said Benedicte Bogh, a spokeswoman at the company's Merck Serono unit in Geneva, in a telephone interview today. ``We continue to work very closely with the FDA to address these requests.''
Merck needs Rebif to beef up sales from branded pharmaceuticals, which are growing slower than at competitors, as the German company rebuilds the unit to focus on cancer, diabetes and central nervous diseases. Merck Serono plans to use the new formulation to increase its share of the $5 billion global market and surpass its larger rival, Biogen Idec Inc.'s Avonex for MS.
The company applied for approval of the treatment, which has fewer side effects than the current version, last April. The Food and Drug Administration, which usually gives its decision within 10 months, was due to rule on the application by Feb. 4. Bogh declined to comment on how long the regulator may take to complete its review.
The new version, which isn't made from human or animal-based materials although it is produced in mammalian cells, reduces reactions at the injection site and results in fewer antibodies forming compared with older versions of the medicine.
``The new formulation is intended to replace the current formulation,'' Bogh said. ``It will support our objective to reach global market leadership for Rebif.''
Elan Corp. and Biogen Idec's Tysabri is the latest treatment to enter the multiple sclerosis market as companies jostle to defend their share. Berlin-based Bayer Schering Pharma AG is widening the use of its Betaseron, the oldest multiple sclerosis therapy, to include patients with early stages of the disease to fend off the rising competition.
http://www.bloomberg.com/apps/news?pid= ... er=germany
FDA questions new Rebif formulation
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scoobyjude
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Guess I'll have to hang on till it's finally is available.
Viper,
As most people on this forum, you probably have a right to feel angry. However, it is not productive and in this case somewhat misguided. Inherently, what does Serono owe you or me?
I might get frustrated with government not doing enough, where the good of its citizens is raison de etre. But, a for profit organization?
A drug company is a company. And a company answers to its investors and their interests first. They do want to help people. A typical drug company is filled with believers in doing good. But never forget it is a company that would not exists if it was loosing money and whose duty in front of its investors is to make money and outperform the competition.
Unfortunately, if we didn't have that, we'd barely have anything; as these "greedy" institutions are the only ones interested in helping.
As most people on this forum, you probably have a right to feel angry. However, it is not productive and in this case somewhat misguided. Inherently, what does Serono owe you or me?
I might get frustrated with government not doing enough, where the good of its citizens is raison de etre. But, a for profit organization?
A drug company is a company. And a company answers to its investors and their interests first. They do want to help people. A typical drug company is filled with believers in doing good. But never forget it is a company that would not exists if it was loosing money and whose duty in front of its investors is to make money and outperform the competition.
Unfortunately, if we didn't have that, we'd barely have anything; as these "greedy" institutions are the only ones interested in helping.
Stavros,
I don't think you are being pessimistic. Not blaming others and believing in your own actions is what brings results in this world.
Drug companies are not evil because they don't research "LDN, Prokarin, dichloroacetate etc etc." It is not, nor was it ever, their battle to fight. One can blame our governments for cutting funding, leaving it all to economics, and not performing any research that is worthwhile outside of the big pharma.
Pure capitalism is not altruistic and gripping about a capitalistic entity's desire to make money is counterproductive. Actually, gripping about anything is countrproductive almost every time.
Look at it realistically. I.e., count the number of compounds/proceedures in research that are tracked on this site. Then, think how many of these are being pursued by these "greedy" organizations and how many are not. Then, think about how much money these "greedy" organizations are spending on all this research. Then go ahead and call them evil, condem them, call them money grabbing scum, hold demonstrations in front of their offices, and close them down. Feel better? Now, what are you left with?
All I am saying is spitting in the direction of these companies is not doing any good for anyone. (It is also a waste of perfectly good spit.)
I completely agree with you. If we want research on other things, it is up to us. No matter how small those actions are, they matter. E.g., vote for more research in every election, enroll in clinical trials that bring in new remedies (don't enroll in the one that compares to doses of rebiff), etc.
Do what one can to promote novel research.
I don't think you are being pessimistic. Not blaming others and believing in your own actions is what brings results in this world.
Drug companies are not evil because they don't research "LDN, Prokarin, dichloroacetate etc etc." It is not, nor was it ever, their battle to fight. One can blame our governments for cutting funding, leaving it all to economics, and not performing any research that is worthwhile outside of the big pharma.
Pure capitalism is not altruistic and gripping about a capitalistic entity's desire to make money is counterproductive. Actually, gripping about anything is countrproductive almost every time.
Look at it realistically. I.e., count the number of compounds/proceedures in research that are tracked on this site. Then, think how many of these are being pursued by these "greedy" organizations and how many are not. Then, think about how much money these "greedy" organizations are spending on all this research. Then go ahead and call them evil, condem them, call them money grabbing scum, hold demonstrations in front of their offices, and close them down. Feel better? Now, what are you left with?
All I am saying is spitting in the direction of these companies is not doing any good for anyone. (It is also a waste of perfectly good spit.)
I completely agree with you. If we want research on other things, it is up to us. No matter how small those actions are, they matter. E.g., vote for more research in every election, enroll in clinical trials that bring in new remedies (don't enroll in the one that compares to doses of rebiff), etc.
Do what one can to promote novel research.
Gkalman,
I appreciate what you are saying, and while I may have been a bit dramatic, I certainly don't feel like the jist of my message was misguided. I don't care if the drug companies make profit, I care that they manipulate data, or present data out of context in order to get people to buy their drugs so they can provide profits to share holders. Rebif really isn't that effective, or at least not for the vast majority. You could be on a placebo and get the same effect, statistically.
The new formulation is just 'More of the same'. However, when they spend millions of dollars on marketing this new formulation, it will probably go something like this: "New Rebif Formulation will help delay onset of MS by an additional X%, and in the SH*T (haha) study it was shown to reduce Enhancing Lesions by 85 - 90%"
Of course thats not actual, but again, more of the same. I hope that soon Gov't takes an intrest in medical research, instead of leaving up to companies. Companies have a conflict of interest.
Also, look how careless these companies are being in developing new drugs/compounds. They have no idea what the hell causes MS, and yet they still continue churning out compounds that will reduce lesions. Very few are pursuing neuroprotection, which is very hard to quanitfy. They are desperate to develop something that will cover up lesions that is also safe for human consumption so they can market it, and sell it. Next time you see a new compound/drug in the first stages of clinical trial ask your self this question: "How did they come up with this drug?, What is the novel action of this drug supposed to accomplish? What was the discovery of this drug based on?"
To me, this will make it a little more clear what the drug companies are trying to accomplish.
Brock
P.S. Do you own stock in a Pharma Co.?
I appreciate what you are saying, and while I may have been a bit dramatic, I certainly don't feel like the jist of my message was misguided. I don't care if the drug companies make profit, I care that they manipulate data, or present data out of context in order to get people to buy their drugs so they can provide profits to share holders. Rebif really isn't that effective, or at least not for the vast majority. You could be on a placebo and get the same effect, statistically.
The new formulation is just 'More of the same'. However, when they spend millions of dollars on marketing this new formulation, it will probably go something like this: "New Rebif Formulation will help delay onset of MS by an additional X%, and in the SH*T (haha) study it was shown to reduce Enhancing Lesions by 85 - 90%"
Of course thats not actual, but again, more of the same. I hope that soon Gov't takes an intrest in medical research, instead of leaving up to companies. Companies have a conflict of interest.
Also, look how careless these companies are being in developing new drugs/compounds. They have no idea what the hell causes MS, and yet they still continue churning out compounds that will reduce lesions. Very few are pursuing neuroprotection, which is very hard to quanitfy. They are desperate to develop something that will cover up lesions that is also safe for human consumption so they can market it, and sell it. Next time you see a new compound/drug in the first stages of clinical trial ask your self this question: "How did they come up with this drug?, What is the novel action of this drug supposed to accomplish? What was the discovery of this drug based on?"
To me, this will make it a little more clear what the drug companies are trying to accomplish.
Brock
P.S. Do you own stock in a Pharma Co.?
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