Latest Drugwonks' Blog
Something that was ignored throughout the long ponderous, hollow debate over healthcare reform is clearly articulated by Jim Pinkerton:
"Healthcare is a great driver for the economy. It's the biggest employer, and medicine--not "health insurance"--is a product that people want to consume, sometimes desperately, ravenously. And not just Americans, but people around the world. So if that's not an economic engine, what is? Isn't that what we want?
But the argument has to be made. And alas, since, 98 percent of the discussion over healthcare has been over controlling costs--that is, shrinking the healthcare sector, perhaps provoking a recession in one of the few vibrant sectors of the economy--then it's little wonder that the country doesn't think of healthcare and medicine as an economic driver.
Serious Medicine Strategy has always been an economic strategy--now is the time to make that case."
seriousmedicinestrategy.blogspot.com/2010/01/democrats-slam-brakes-on-health-care.html
"Healthcare is a great driver for the economy. It's the biggest employer, and medicine--not "health insurance"--is a product that people want to consume, sometimes desperately, ravenously. And not just Americans, but people around the world. So if that's not an economic engine, what is? Isn't that what we want?
But the argument has to be made. And alas, since, 98 percent of the discussion over healthcare has been over controlling costs--that is, shrinking the healthcare sector, perhaps provoking a recession in one of the few vibrant sectors of the economy--then it's little wonder that the country doesn't think of healthcare and medicine as an economic driver.
Serious Medicine Strategy has always been an economic strategy--now is the time to make that case."
seriousmedicinestrategy.blogspot.com/2010/01/democrats-slam-brakes-on-health-care.html
The movie Extraordinary Measures chronicles the story and struggle of John and Aileen Crowley to find a treatment to save the lives of their two children, both of whom have Pompe Disease, an irreversible and rare disorder that prevents the body from breaking down glycogen (a form of sugar). Glycogen accumulates around the heart and skeletal muscles leaving children unable to walk or breathe on their own. I won't provide a movie review here since information about this new release is available everywhere, except to say that Extraordinary Measures is a family movie in two important ways.
First, it is a movie that parents and kids (13 and up in my opinion) can and should see together. It demonstrates the power of love and the determination parents have, even under the most dire circumstances, to provide children with hope and happiness each moment of their life. It shows that you can go up against and use the system to make a difference and that the "system" will invest in that risk and reward it. However the movie shows that making a miracle involves going against the grain, which is why meaningful change or advances take time. And the movie does the best job of explaining the interesection of capital, science, passion and faith the constitutes the process of biomedical innovation. A thoughtful, impactful movie about biotech and drug development? Extraordinary Measures is that and more because it ties the process of innovation to the ultimate purpose and people who benefit.
Second, the movie itself is the culmination of a process that has created a family of relatives, friends, supporters around the Crowleys. I was fortunate to have attended a post-movie reception that Geeta Anand, the gifted and gracious author of The Cure held in NYC yesterday. The group that gathered (including the Crowleys) -- including people involved in the movie, Geeta's literary agent (and mine) Joelle Delbourgo, former associates, etc. shared not only in the success of her book but in the spirit the book, the movie and the release of both have created: A sense that while anything may not be possible, nothing great happens without passionate intensity, friendship and cooperation and support of those you love. Such is the recurring source of hope.
Seeing the movie and reading The Cure will allow you to share in that experience. Few movies have been made to convey such a message. You read more about Extraodinary Measures and The Cure at the link below.
http://www.thecurebook.com/
First, it is a movie that parents and kids (13 and up in my opinion) can and should see together. It demonstrates the power of love and the determination parents have, even under the most dire circumstances, to provide children with hope and happiness each moment of their life. It shows that you can go up against and use the system to make a difference and that the "system" will invest in that risk and reward it. However the movie shows that making a miracle involves going against the grain, which is why meaningful change or advances take time. And the movie does the best job of explaining the interesection of capital, science, passion and faith the constitutes the process of biomedical innovation. A thoughtful, impactful movie about biotech and drug development? Extraordinary Measures is that and more because it ties the process of innovation to the ultimate purpose and people who benefit.
Second, the movie itself is the culmination of a process that has created a family of relatives, friends, supporters around the Crowleys. I was fortunate to have attended a post-movie reception that Geeta Anand, the gifted and gracious author of The Cure held in NYC yesterday. The group that gathered (including the Crowleys) -- including people involved in the movie, Geeta's literary agent (and mine) Joelle Delbourgo, former associates, etc. shared not only in the success of her book but in the spirit the book, the movie and the release of both have created: A sense that while anything may not be possible, nothing great happens without passionate intensity, friendship and cooperation and support of those you love. Such is the recurring source of hope.
Seeing the movie and reading The Cure will allow you to share in that experience. Few movies have been made to convey such a message. You read more about Extraodinary Measures and The Cure at the link below.
http://www.thecurebook.com/
Let the big government types defend comparative effectiveness generated decisions that exclude and undermine the health of minorities... We are supporting a different, more compassionate and equitable approach...
Prospective Health Consortium: Development and Assessment of Predictive Tools in Disease Prevention and Wellness Promotion
We are proud to support the launch of a consortium that would develop and evaluate a tool for health risk assessment and treatment selection based on predictive information relatively unique to that individual that can be used to reduce disease and promote wellness in medically underserved communities.
The idea of a consortium is based on discussions held in May at Brookings Institution at a meeting entitled “A Critical Path for Personalized Medicine”. That meeting -- chaired by Dr. Mark McClellan and Sir Michael Rawlins -- discussed ways to demonstrate how predictive or personalized medicine could be used to improve the quality of care and health outcomes. In particular, Ralph Snyderman MD, Chancellor Emeritus of Duke University Medical Center and CEO of Proventys, called for an evaluation of an tools bringing together the latest technologies to predict events and enable intervention before damage occurs. Combining personalized risk prediction and strategic health-care planning will facilitate what Snyderman calls ‘prospective health care’.
Maggie Mahar -- another liberal health care "expert" -- on why a bipartisan healthcare effort should not be pursued:
"Conservatives blame the sick for being sick, and they fault the poor for being poor. Health care reform must be compassionate, and it must be equitable."
Read more here.
"Conservatives blame the sick for being sick, and they fault the poor for being poor. Health care reform must be compassionate, and it must be equitable."
Read more here.
ITP? Not ASAP.
John Dalli, Commissioner-designate for Health and Consumer Policy (SANCO) has pledged new initiatives to break the deadlock on Commission proposals to liberalize controls on the provision of prescription drug information to patients. And we all know how fast Brussels operates.
As Pharma Times reports:
- In the new European Commission, the move of responsibility for the pharmaceutical industry from the Directorate General (DG) for Industry and Enterprise to DG Health and Consumer Safety (SANCO) has been welcomed by consumer and patient groups. One of the reasons holding back progress on the information directive has been concern that it was drafted by DG Enterprise and Industry - whose responsibilities include regulatory and industrial policy for the pharmaceutical industry – rather than DG Sanco, which is concerned with consumers and public health.
While countries including Denmark, Sweden and the UK support the Commission’s proposals, a number of others – including France, Germany and Spain - oppose any move to liberalize controls on the provision of prescription drug information, for reasons including the fact that the draft does not distinguish sufficiently between “information” and “advertising.” They also believe that the industry should have no role in the provision of information to patients and that the proposals would drive up health costs by increasing demand and because of the need to set up monitoring mechanisms.
John Dalli, Commissioner-designate for Health and Consumer Policy (SANCO) has pledged new initiatives to break the deadlock on Commission proposals to liberalize controls on the provision of prescription drug information to patients. And we all know how fast Brussels operates.
As Pharma Times reports:
- In the new European Commission, the move of responsibility for the pharmaceutical industry from the Directorate General (DG) for Industry and Enterprise to DG Health and Consumer Safety (SANCO) has been welcomed by consumer and patient groups. One of the reasons holding back progress on the information directive has been concern that it was drafted by DG Enterprise and Industry - whose responsibilities include regulatory and industrial policy for the pharmaceutical industry – rather than DG Sanco, which is concerned with consumers and public health.
While countries including Denmark, Sweden and the UK support the Commission’s proposals, a number of others – including France, Germany and Spain - oppose any move to liberalize controls on the provision of prescription drug information, for reasons including the fact that the draft does not distinguish sufficiently between “information” and “advertising.” They also believe that the industry should have no role in the provision of information to patients and that the proposals would drive up health costs by increasing demand and because of the need to set up monitoring mechanisms.
Don’t think about Scott Brown as the 41st vote against healthcare reform. Consider him the 1st vote towards a new, more thoughtful approach. A more honest approach. An approach that doesn’t require Uncle Sam to become Uncle Sam, MD. An approach that doesn’t tax the middle class, gut Medicare and abolish Medicare Advantage. An approach that doesn’t put the power of government reimbursement decisions into the hands of a politically appointed panel without any oversight by elected officials. Perhaps even an approach that takes into consideration reform via a partnership between government and the private sector (a la Part D). And maybe even an approach that considers allowing Americans to buy insurance policies across state lines so that we can all benefit from a significant economy of scale and radically lower premiums. A study by University of Minnesota shows that Congress could boost by more than 12 million the number of people who have health insurance without spending taxpayer dollars. The change required is to allow people to buy health insurance across state lines, so they can shop for less expensive policies. For example, a typical health-insurance policy in heavily regulated New York costs more than three times as much as in less regulated Iowa ($388 a month versus $98 a month for the same coverage).
But – for starters – how about an approach that’s open and transparent.
But – for starters – how about an approach that’s open and transparent.
What exactly about the Scott Brown victory does Ezra (the mind of moment) Klein not get?
"There's nothing about Scott Brown's victory that needs to derail health-care reform in particular, or the rest of Obama's 2010 agenda in general. But if Democrats decide to cower and hide, they can end Obama's presidency on Brown's behalf.
That said, I really wonder what the Democratic Caucus thinks will happen if they let health-care reform slip away and walk into 2010 having wasted a year of the country's time amidst a terrible recession. It won't be pretty, I imagine. If health-care reform passes, the two sides can argue over whether it was a success. If it fails, there's no argument."
voices.washingtonpost.com/ezra-klein/
I have heard that petulant "it's all about me" tone before.. It's the gift that keeps on giving to those of us seeking sensible health care reform consistent with the need to sustain job creating biomedical innovation... I hope Klein and others keep pushing Dems to ignore the outrage of the voters... It will produce more Scott Browns.
"There's nothing about Scott Brown's victory that needs to derail health-care reform in particular, or the rest of Obama's 2010 agenda in general. But if Democrats decide to cower and hide, they can end Obama's presidency on Brown's behalf.
That said, I really wonder what the Democratic Caucus thinks will happen if they let health-care reform slip away and walk into 2010 having wasted a year of the country's time amidst a terrible recession. It won't be pretty, I imagine. If health-care reform passes, the two sides can argue over whether it was a success. If it fails, there's no argument."
voices.washingtonpost.com/ezra-klein/
I have heard that petulant "it's all about me" tone before.. It's the gift that keeps on giving to those of us seeking sensible health care reform consistent with the need to sustain job creating biomedical innovation... I hope Klein and others keep pushing Dems to ignore the outrage of the voters... It will produce more Scott Browns.
Michael McCaughan's blog in RPM First Take reveals that the operational definition of a follow on biologic is simply someone else's product that we want to copy...
therpmreport.com/Free/4e767e88-bc84-40e1-871a-4025e307e300.aspx
Saturday, January 16 2010
Teva’s Hedge on Complex Generics
By Michael McCaughan
Generic applications for Lovenox and Copaxone have become bellwethers for the emerging follow-on biologics pathway in the US. Teva is on both sides.
Who says you can’t have your cake and eat it too?
When it comes to the follow-on biologics space, there are plenty of companies who are likely to try. As we’ve written before, the looming new pathway for abbreviated approval of biosimilars opens up opportunities for lots of companies—brand, generic and biotech—to consider whether to play as a true “follow-on” supplier, focus on improved “biobetters,” or do both.
But no one is in quite the same position as Teva. Not only is the company doing that analysis for the longer term biosimilar opportunity (you can read more about its latest thinking in “The Pink Sheet” DAILY here), but it is on both sides of the issue for two near-term decisions on complex molecules that are regulated as drugs.
Teva is one of three companies (along with Momenta and Amphastar) with pending applications to market a generic version of Sanofi Aventis’ enoxaparin (Lovenox). In that case, Teva wants FDA to agree that, while enoxaparin is a relatively complex molecule, it is not too complex to allow for a fully substitutable generic approval.
On the other hand, Teva’s largest and most important product is the branded multiple sclerosis therapy glatiramer (Copaxone). There are two would-be generics pending, Momenta’s and Mylan's.
In that case, Teva is arguing that Copaxone is far too complex a molecule to be copied closely enough to allow for substitutability—and is even suggesting that other manufacturers may have trouble even getting a non-interchangeable product approved without full clinical studies.
Teva, of course, is aware that this may sound like trying to have your cake and eat it too. But they don’t see a contradiction. Here is how Teva CEO Bill Marth put it during the Goldman Sachs CEO “unplugged” conference Jan. 6:
“When you think about Copaxone, many people try to equate it to Lovenox. It is
much, much different—vastly more complex—than Lovenox will ever be. We have not characterized it. We don't believe it can be fully characterized.
If one cannot fully characterize Copaxone, I'm not sure how you get it approved without a clinical study since the method of action is not well understood and exactly what the active sequence is. And, by the way, we think there are multiple methods of action, and potentially multiple reasons for that. We think that it is virtually impossible to prove your efficacy without a clinical study. So it really falls into more of that sweet spot of the biologics....
I think it is much different with Lovenox than it is with Copaxone because with Lovenox, the active sequence has been identified by us. It hs been identified by the
innovators. It has been identified of course by Momenta and Amphistar.
So it is defined. It is a sugar. When you look at those sugars and you look at the active sequence, then what you really have to do is understand what is the other stuff or junk that is within your protein or sugar, and there make sure that you don't have improper immunogenicity. They have asked us for immunogenicity testing. We have done that. And it seems to be acceptable so far.”
In other words, Teva thinks it can kept its Copaxone cake and take a huge slice of Sanofi-Aventis’ Lovenox cake too.
But there are other outcomes. From Teva’s perspective, an outright rejection of substitutable Lovenox wouldn’t be so bad, since it would underscore the company’s position that substitutable Copaxone is a pipe dream.
And while Teva would dearly love to tap into the $2 billion Lovenox market, at best it will only get a percentage of a big generic opportunity. With Copaxone, Teva hopes to maintain its own multi-billion dollar brand in something like perpetuity.
How important is that to the company? During its January 7 investor day, Teva’s bullish forecasts for growth for 2015 included what the company called a “conservative” forecast for Copaxone, with sales peaking at $3 billion and then eroding over time to $2 billion in 2015. But the erosion, in Teva’s view, will come only in the face of competition from other MS agents (including Teva’s own oral product)—not from any substitutable generic competition.
So call it a hedge: if generic Lovenox is rejected, Teva’s Copaxone franchise is more secure. If Copaxone can’t be protected, at least Teva will have some generic enoxaparin revenues to fill in the hole.
There’s really only one scenario where Teva loses. If one of the other applicants (Momenta being the most likely candidate) actually has superior technology, it could potentially get approval for generic Lovenox and generic Copaxone, while no one else can.
For Teva, that would be more like a pie in the face.
therpmreport.com/Free/4e767e88-bc84-40e1-871a-4025e307e300.aspx
Saturday, January 16 2010
Teva’s Hedge on Complex Generics
By Michael McCaughan
Generic applications for Lovenox and Copaxone have become bellwethers for the emerging follow-on biologics pathway in the US. Teva is on both sides.
Who says you can’t have your cake and eat it too?
When it comes to the follow-on biologics space, there are plenty of companies who are likely to try. As we’ve written before, the looming new pathway for abbreviated approval of biosimilars opens up opportunities for lots of companies—brand, generic and biotech—to consider whether to play as a true “follow-on” supplier, focus on improved “biobetters,” or do both.
But no one is in quite the same position as Teva. Not only is the company doing that analysis for the longer term biosimilar opportunity (you can read more about its latest thinking in “The Pink Sheet” DAILY here), but it is on both sides of the issue for two near-term decisions on complex molecules that are regulated as drugs.
Teva is one of three companies (along with Momenta and Amphastar) with pending applications to market a generic version of Sanofi Aventis’ enoxaparin (Lovenox). In that case, Teva wants FDA to agree that, while enoxaparin is a relatively complex molecule, it is not too complex to allow for a fully substitutable generic approval.
On the other hand, Teva’s largest and most important product is the branded multiple sclerosis therapy glatiramer (Copaxone). There are two would-be generics pending, Momenta’s and Mylan's.
In that case, Teva is arguing that Copaxone is far too complex a molecule to be copied closely enough to allow for substitutability—and is even suggesting that other manufacturers may have trouble even getting a non-interchangeable product approved without full clinical studies.
Teva, of course, is aware that this may sound like trying to have your cake and eat it too. But they don’t see a contradiction. Here is how Teva CEO Bill Marth put it during the Goldman Sachs CEO “unplugged” conference Jan. 6:
“When you think about Copaxone, many people try to equate it to Lovenox. It is
much, much different—vastly more complex—than Lovenox will ever be. We have not characterized it. We don't believe it can be fully characterized.
If one cannot fully characterize Copaxone, I'm not sure how you get it approved without a clinical study since the method of action is not well understood and exactly what the active sequence is. And, by the way, we think there are multiple methods of action, and potentially multiple reasons for that. We think that it is virtually impossible to prove your efficacy without a clinical study. So it really falls into more of that sweet spot of the biologics....
I think it is much different with Lovenox than it is with Copaxone because with Lovenox, the active sequence has been identified by us. It hs been identified by the
innovators. It has been identified of course by Momenta and Amphistar.
So it is defined. It is a sugar. When you look at those sugars and you look at the active sequence, then what you really have to do is understand what is the other stuff or junk that is within your protein or sugar, and there make sure that you don't have improper immunogenicity. They have asked us for immunogenicity testing. We have done that. And it seems to be acceptable so far.”
In other words, Teva thinks it can kept its Copaxone cake and take a huge slice of Sanofi-Aventis’ Lovenox cake too.
But there are other outcomes. From Teva’s perspective, an outright rejection of substitutable Lovenox wouldn’t be so bad, since it would underscore the company’s position that substitutable Copaxone is a pipe dream.
And while Teva would dearly love to tap into the $2 billion Lovenox market, at best it will only get a percentage of a big generic opportunity. With Copaxone, Teva hopes to maintain its own multi-billion dollar brand in something like perpetuity.
How important is that to the company? During its January 7 investor day, Teva’s bullish forecasts for growth for 2015 included what the company called a “conservative” forecast for Copaxone, with sales peaking at $3 billion and then eroding over time to $2 billion in 2015. But the erosion, in Teva’s view, will come only in the face of competition from other MS agents (including Teva’s own oral product)—not from any substitutable generic competition.
So call it a hedge: if generic Lovenox is rejected, Teva’s Copaxone franchise is more secure. If Copaxone can’t be protected, at least Teva will have some generic enoxaparin revenues to fill in the hole.
There’s really only one scenario where Teva loses. If one of the other applicants (Momenta being the most likely candidate) actually has superior technology, it could potentially get approval for generic Lovenox and generic Copaxone, while no one else can.
For Teva, that would be more like a pie in the face.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
