White-hot rivalry to curb gains from generic Seroquel
Cut-throat competition is seen limiting the opportunity on blockbuster anti-psychotic drug Seroquel, the patent on which expired on March 26 in the US.
The drug, innovated by UK-based AstraZeneca, is used to treat schizophrenia, depression and bipolar disorders. It had sales of $4.4-4.6 billion last year, accounting for over 15% of the company’s sales —- its No. 2 drug behind cholesterol treatment Crestor.
As many as 8-10 players are seen mounting bids to tap the huge generic opportunity on Seroquel following the patent expiry, according to analysts.
These include entries from US-based Mylan and Israel’s Teva, besides Indian firms Dr Reddy’s Laboratories, Sun Pharmaceuticals, Lupin and Aurobindo Pharma.
Mylan and Teva have, in fact, announced that they are starting commercial launch of quetiapine fumarate tablets.
Interestingly, there is no clarity yet on which generic maker holds the first-to-file, or FTF, status on Seroquel, a status which could have earned the player 180 days of exclusivity to market the generic version in the US.
Competition is therefore expected to be intense.
And this, in turn, could limit the sales opportunity for the players, said Bhavin Shah, analyst, Dolat Capital.
A Morgan Stanley report pegged the price erosion for Seroquel at a whopping 96-97% following the patent expiry and launch of generic products. This would earn the Indian players a market share of about 10-12% and sales of $15-17 million, it said.
An analyst at another brokerage estimated the opportunity at $40-50 million apiece for the companies.
วันศุกร์ที่ 13 เมษายน พ.ศ. 2555
Generic Seroquel Coming Soon
Generic Seroquel Coming Soon for Schizophrenia, Bipolar
By Psych Central News Editor
Reviewed by John M. Grohol, Psy.D. on April 12, 2012 The U.S. Food and Drug Administration (FDA) on Wednesday announced that it has approved generic versions of the atypical antipsychotic medication, Seroquel (quetiapine). Seroquel is commonly prescribed to treat symptoms of both schizophrenia and bipolar disorder.
Seroquel was initially approved to treat schizophrenia by the FDA in 1997. It received approval from the FDA to treat symptoms associated with bipolar disorder in 2004.
While quetiapine is not approved by the FDA for the treatment of behavioral problems in older adults with dementia, it is nonetheless commonly prescribed to older adults for a variety of concerns.
Quetiapine is one of many popular drugs recently approved by the FDA in a generic form. Generic drugs provide safe and effective alternatives to brand name drugs, usually at a lower cost.
Schizophrenia is a chronic, severe, and disabling mental disorder. The problem affects around one percent of Americans, according to the National Institute of Mental Health (NIMH). People with schizophrenia may hear voices other people don’t hear. They may believe other people are reading their minds, controlling their thoughts, or plotting to harm them.
Schizophrenia affects both men and women equally. It usually begins in the teen years or young adulthood but may begin later in life.
While treatment helps relieve many symptoms of both schizophrenia and bipolar disorder, most people who have these disorders cope with symptoms throughout their lives.
Seroquel helps decrease hallucinations, improves concentration, and prevents or decreases severe mood swings. The exact mechanisms of why Seroquel works are unknown.
In addition to treating schizophrenia, quetiapine is used alone or with other medications to treat or prevent episodes of mania or depression in patients with bipolar disorder. Quetiapine may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children.
The FDA expects that quetiapine tablets will be manufactured in several different strengths — likely in 25, 50, 100, 200, 300, and 400 mg tablets — and will be available to the public within the next 6 months.
The new announcement does not apply to sustained-release versions of the drug, which was approved in 2006 and will continue to remain available only as a brand name prescription.
Reviewed by John M. Grohol, Psy.D. on April 12, 2012 The U.S. Food and Drug Administration (FDA) on Wednesday announced that it has approved generic versions of the atypical antipsychotic medication, Seroquel (quetiapine). Seroquel is commonly prescribed to treat symptoms of both schizophrenia and bipolar disorder.
Seroquel was initially approved to treat schizophrenia by the FDA in 1997. It received approval from the FDA to treat symptoms associated with bipolar disorder in 2004.
While quetiapine is not approved by the FDA for the treatment of behavioral problems in older adults with dementia, it is nonetheless commonly prescribed to older adults for a variety of concerns.
Quetiapine is one of many popular drugs recently approved by the FDA in a generic form. Generic drugs provide safe and effective alternatives to brand name drugs, usually at a lower cost.
Schizophrenia is a chronic, severe, and disabling mental disorder. The problem affects around one percent of Americans, according to the National Institute of Mental Health (NIMH). People with schizophrenia may hear voices other people don’t hear. They may believe other people are reading their minds, controlling their thoughts, or plotting to harm them.
Schizophrenia affects both men and women equally. It usually begins in the teen years or young adulthood but may begin later in life.
While treatment helps relieve many symptoms of both schizophrenia and bipolar disorder, most people who have these disorders cope with symptoms throughout their lives.
Seroquel helps decrease hallucinations, improves concentration, and prevents or decreases severe mood swings. The exact mechanisms of why Seroquel works are unknown.
In addition to treating schizophrenia, quetiapine is used alone or with other medications to treat or prevent episodes of mania or depression in patients with bipolar disorder. Quetiapine may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children.
The FDA expects that quetiapine tablets will be manufactured in several different strengths — likely in 25, 50, 100, 200, 300, and 400 mg tablets — and will be available to the public within the next 6 months.
The new announcement does not apply to sustained-release versions of the drug, which was approved in 2006 and will continue to remain available only as a brand name prescription.
This Biotech Buys a Generic Lifeline
This Biotech Buys a Generic Lifeline
Posted under: Investing
0 With its secondary hyperparathyroidism treatment, Sensipar, set to face generic competition in a few years, Amgen (NAS: AMGN) made the most obvious move to solve the problem. It bought a biotech developing a compound for the disease.
Amgen is paying $315 million for KAI Pharmaceuticals -- entirely, it seems, for KAI-4169, which has completed phase 2 development. KAI had a partnership with Bristol-Myers Squibb (NYS: BMY) to develop a heart drug, but that appears to have died in development.
Amgen wants to push KAI-4169 into phase 3 trials quickly, so it's lending KAI some money so the company can press on with trial planning before the deal closes. The fact that KAI needs a loan probably signals that it was a little desperate for a sale and that Amgen probably got a good deal.
There's no doubt the KAI acquisition is a good fit. There's the obvious experience in selling Sensipar, which brought in more than $800 million last year. But secondary hyperparathyroidism is a hormone imbalance that is often caused by kidney failure, so it fits well with Amgen's anemia drugs.
Follow-on compounds often struggle after the first-generation drug goes generic -- think Pfizer's (NYS: PFE) Pristiq and Johnson & Johnson's (NYS: JNJ) Invega competing against Effexor and Risperdal, respectively -- but KAI-4169 has one advantage because it'll be administered intravenously at the same time a patient is undergoing dialysis. Sensipar and Abbott Labs' (NYS: ABT) Zemplar, which is also approved for secondary hyperparathyroidism, are taken orally. Patients usually prefer popping pills to other methods, but not if you're already hooked up to a machine.
The true sales potential for KAI-4169 will ultimately depend on the phase 3 efficacy data, so it'll be a while before we know whether the KAI acquisition was a good buy. But for now, it looks like a good move to combat the inevitable loss of Sensipar.
Looking for a defensive play to hedge rising gas prices? Check out the Fool's free report, "3 Stocks for $100 Oil." Get yours free.
At the time this article was published Fool contributor Brian Orelli holds no position in any company mentioned. Check out his holdings and a short bio. The Motley Fool owns shares of Abbott Laboratories and Johnson & Johnson. Motley Fool newsletter services have recommended buying shares of Pfizer and Johnson & Johnson and creating a diagonal call position in Johnson & Johnson. The Motley Fool has a disclosure policy. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.
Posted under: Investing
0 With its secondary hyperparathyroidism treatment, Sensipar, set to face generic competition in a few years, Amgen (NAS: AMGN) made the most obvious move to solve the problem. It bought a biotech developing a compound for the disease.
Amgen is paying $315 million for KAI Pharmaceuticals -- entirely, it seems, for KAI-4169, which has completed phase 2 development. KAI had a partnership with Bristol-Myers Squibb (NYS: BMY) to develop a heart drug, but that appears to have died in development.
Amgen wants to push KAI-4169 into phase 3 trials quickly, so it's lending KAI some money so the company can press on with trial planning before the deal closes. The fact that KAI needs a loan probably signals that it was a little desperate for a sale and that Amgen probably got a good deal.
There's no doubt the KAI acquisition is a good fit. There's the obvious experience in selling Sensipar, which brought in more than $800 million last year. But secondary hyperparathyroidism is a hormone imbalance that is often caused by kidney failure, so it fits well with Amgen's anemia drugs.
Follow-on compounds often struggle after the first-generation drug goes generic -- think Pfizer's (NYS: PFE) Pristiq and Johnson & Johnson's (NYS: JNJ) Invega competing against Effexor and Risperdal, respectively -- but KAI-4169 has one advantage because it'll be administered intravenously at the same time a patient is undergoing dialysis. Sensipar and Abbott Labs' (NYS: ABT) Zemplar, which is also approved for secondary hyperparathyroidism, are taken orally. Patients usually prefer popping pills to other methods, but not if you're already hooked up to a machine.
The true sales potential for KAI-4169 will ultimately depend on the phase 3 efficacy data, so it'll be a while before we know whether the KAI acquisition was a good buy. But for now, it looks like a good move to combat the inevitable loss of Sensipar.
Looking for a defensive play to hedge rising gas prices? Check out the Fool's free report, "3 Stocks for $100 Oil." Get yours free.
At the time this article was published Fool contributor Brian Orelli holds no position in any company mentioned. Check out his holdings and a short bio. The Motley Fool owns shares of Abbott Laboratories and Johnson & Johnson. Motley Fool newsletter services have recommended buying shares of Pfizer and Johnson & Johnson and creating a diagonal call position in Johnson & Johnson. The Motley Fool has a disclosure policy. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.
Mylan Launches First Generic
Mylan Launches First Generic Version of Lescol® Capsules
PITTSBURGH, April 13, 2012 -- /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluvastatin Capsules USP, 20 mg and 40 mg, the first generic version of Novartis' Lescol® Capsules. This product is indicated for the treatment of both familial and nonfamilial hypercholesterolemia and mixed dyslipidemia. It is also indicated for the secondary prevention of cardiovascular disease.[1]
Pursuant to a settlement and license agreement with Novartis, Mylan was granted a license permitting launch prior to the expiration of the pediatric exclusivity associated with U.S. Patent No. 5,356,896, which expires on June 12, 2012.
Lescol Capsules had U.S. sales of approximately $27.9 million for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan has begun shipping its generic version of this product.
Currently, Mylan has 172 ANDAs pending FDA approval representing $100.2 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $25.7 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on allergy, respiratory and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.
[1] Fluvastatin should not be used in patients with hypersensitivity to any component of this medication, patients with liver disease, women who are pregnant or may become pregnant or mothers who are breast feeding.
SOURCE Mylan Inc.
Read more here: http://www.sacbee.com/2012/04/13/4411250/mylan-launches-first-generic-version.html#storylink=cpy
PITTSBURGH, April 13, 2012 -- /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluvastatin Capsules USP, 20 mg and 40 mg, the first generic version of Novartis' Lescol® Capsules. This product is indicated for the treatment of both familial and nonfamilial hypercholesterolemia and mixed dyslipidemia. It is also indicated for the secondary prevention of cardiovascular disease.[1]
Pursuant to a settlement and license agreement with Novartis, Mylan was granted a license permitting launch prior to the expiration of the pediatric exclusivity associated with U.S. Patent No. 5,356,896, which expires on June 12, 2012.
Lescol Capsules had U.S. sales of approximately $27.9 million for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan has begun shipping its generic version of this product.
Currently, Mylan has 172 ANDAs pending FDA approval representing $100.2 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $25.7 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on allergy, respiratory and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.
[1] Fluvastatin should not be used in patients with hypersensitivity to any component of this medication, patients with liver disease, women who are pregnant or may become pregnant or mothers who are breast feeding.
SOURCE Mylan Inc.
Read more here: http://www.sacbee.com/2012/04/13/4411250/mylan-launches-first-generic-version.html#storylink=cpy
Drug prices to see modest increase
Drug prices to see modest increase
April 09, 2012
Rene Letourneau, EditorFrom the April 2012 print issue
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Advancements in biosimilars should bring drug price relief in the near future.Generics and biosimilars to help moderate inflation
IRVING, TX - In its recently released Drug Price Forecast, supply contracting services company Novation projected an estimated weighted drug price inflation of 1.36 percent in the cost of pharmaceuticals from July 1, 2012, through June 30, 2013 in acute care hospital settings. The forecast is based on purchase history and data associated with Novation Pharmacy Program participant healthcare organizations.
“This is just a forecast of price … so we do not know what the actual price change will turn out to be,” said Steven Lucio, PharmD, director of pharmacy at Novation, adding that the three biggest factors that affect pricing are loss of patent for innovators, approval and adoption of new drugs and drug shortages.
The modest increase mirrors recent projections over the last two to three years and is substantially influenced by the continued introduction of numerous generic alternatives to commonly used branded pharmaceuticals.
With several blockbuster brand name drugs such as Lipitor, Zyprexa, Plavix and Enbrel losing patent exclusivity in 2011 and 2012, generic competition will play a major role in controlling overall drug expenditures through the middle of 2013.
A recent AARP Public Policy Institute price report on the 514 prescription drugs most commonly used by Medicare beneficiaries confirms the cost effectiveness of generics. In its “Rx Price Watch Report,” the institute found that while retail prices on brand name and specialty drug products increased by 8.3 and 8.9 percent in 2009, the cost of generics decreased by 7.8 percent.
“Older Americans take more prescription drugs than any other segment of the U.S. population, and many continue to struggle to afford their medications,” said Leigh Purvis, one of the report’s authors. “Considerably less expensive yet equally effective generic drugs are vitally important to consumers… (and) to federal programs like Medicare and Medicaid.”
According to Novation, another factor that could potentially impact drug prices in the near future are biosimilar products.
Biosimilars is a term used to describe officially-approved subsequent versions of innovator biopharmaceutical products produced by a different manufacturer after patent expiry. Biological products are therapies used to treat diseases and health conditions. They include a wide variety of products such as vaccines, blood and blood components, gene therapies, tissues and proteins.
Unlike most prescription drugs, which are made through chemical processes, biological products generally are made from human and/or animal materials.
The FDA released guidance information for biosimilars in mid-February and applications have yet to be submitted.
“However, we can estimate the anticipated impact based on the model seen in the European market where various biosimilars have been approved since 2006,” said Steven Lucio, PharmD, director of pharmacy at Novation. “In general, that market has seen a 20- to 30-percent decrease in price for biosimilar versions of innovator products.”
“(For example) it is expected that versions of Neupogen will be the first biosimilars marketed in the U.S., probably late 2013 or early 2014,” added Lucio. “The annual spend on Neupogen by the U.S. non-federal hospital market was approximately $373 million in 2011 (from IMS Health data). Therefore, a decrease in price of 20 percent would theoretically yield $75 million in savings.”
Lucio says it’s difficult to determine the exact financial effect of chronic drug shortages but notes that providers are commonly forced to purchase non-contract equivalents or therapeutic alternatives, all of which are generally more expensive.
“Labor costs associated with handling shortages and finding alternatives also increases costs,” added Lucio.
April 09, 2012
Rene Letourneau, EditorFrom the April 2012 print issue
Related Resources
Technology Standardization Toolkit: How to Gain Alignment and Maximize ROI
Case Study: Healing Budgeting Pains with Unified Planning at Cincinnati Children's Hospital
April 18th @ 3PM ET--Value Analysis - A Best Practice Approach to Elevated Performance
Overcoming Financial Challenges: Tips and Advice on How to Improve Healthcare Financial Performance
Floyd Memorial Case Study: Just Being Good was Never Good Enough
Advancements in biosimilars should bring drug price relief in the near future.Generics and biosimilars to help moderate inflation
IRVING, TX - In its recently released Drug Price Forecast, supply contracting services company Novation projected an estimated weighted drug price inflation of 1.36 percent in the cost of pharmaceuticals from July 1, 2012, through June 30, 2013 in acute care hospital settings. The forecast is based on purchase history and data associated with Novation Pharmacy Program participant healthcare organizations.
“This is just a forecast of price … so we do not know what the actual price change will turn out to be,” said Steven Lucio, PharmD, director of pharmacy at Novation, adding that the three biggest factors that affect pricing are loss of patent for innovators, approval and adoption of new drugs and drug shortages.
The modest increase mirrors recent projections over the last two to three years and is substantially influenced by the continued introduction of numerous generic alternatives to commonly used branded pharmaceuticals.
With several blockbuster brand name drugs such as Lipitor, Zyprexa, Plavix and Enbrel losing patent exclusivity in 2011 and 2012, generic competition will play a major role in controlling overall drug expenditures through the middle of 2013.
A recent AARP Public Policy Institute price report on the 514 prescription drugs most commonly used by Medicare beneficiaries confirms the cost effectiveness of generics. In its “Rx Price Watch Report,” the institute found that while retail prices on brand name and specialty drug products increased by 8.3 and 8.9 percent in 2009, the cost of generics decreased by 7.8 percent.
“Older Americans take more prescription drugs than any other segment of the U.S. population, and many continue to struggle to afford their medications,” said Leigh Purvis, one of the report’s authors. “Considerably less expensive yet equally effective generic drugs are vitally important to consumers… (and) to federal programs like Medicare and Medicaid.”
According to Novation, another factor that could potentially impact drug prices in the near future are biosimilar products.
Biosimilars is a term used to describe officially-approved subsequent versions of innovator biopharmaceutical products produced by a different manufacturer after patent expiry. Biological products are therapies used to treat diseases and health conditions. They include a wide variety of products such as vaccines, blood and blood components, gene therapies, tissues and proteins.
Unlike most prescription drugs, which are made through chemical processes, biological products generally are made from human and/or animal materials.
The FDA released guidance information for biosimilars in mid-February and applications have yet to be submitted.
“However, we can estimate the anticipated impact based on the model seen in the European market where various biosimilars have been approved since 2006,” said Steven Lucio, PharmD, director of pharmacy at Novation. “In general, that market has seen a 20- to 30-percent decrease in price for biosimilar versions of innovator products.”
“(For example) it is expected that versions of Neupogen will be the first biosimilars marketed in the U.S., probably late 2013 or early 2014,” added Lucio. “The annual spend on Neupogen by the U.S. non-federal hospital market was approximately $373 million in 2011 (from IMS Health data). Therefore, a decrease in price of 20 percent would theoretically yield $75 million in savings.”
Lucio says it’s difficult to determine the exact financial effect of chronic drug shortages but notes that providers are commonly forced to purchase non-contract equivalents or therapeutic alternatives, all of which are generally more expensive.
“Labor costs associated with handling shortages and finding alternatives also increases costs,” added Lucio.
Q&A with Momenta's Craig Wheeler
Q&A with Momenta's Craig Wheeler
by Ben Fidler
Published March 30, 2012 at 12:00 PM
The guidelines for the U.S. Food and Drug Administration's approval system for biosimilars -- generic biologic drugs -- are now in draft form, just in time for a wave of patent expirations for several of the world's blockbuster biologics, among them cash cows Enbrel, Remicade and Herceptin. The onset of a new multibillion-dollar market is near, and the arms race has begun.
Partnerships are springing up across the pharmaceuticals sector, most notably among large-cap powerhouses angling to get a part of what research firm IMS Health Inc. expects will be a market worth as much as $2.6 billion by 2015. (Biologic drugs represented a $138 billion market in 2010, according to IMS.)
Among the partnerships are Biogen Idec Inc. and Samsung Biologics as well as Amgen Inc. and Watson Pharmaceuticals Inc. Others, such as Merck & Co., Teva Pharmaceutical Industries Ltd. and Boehringer Ingelheim GmbH, are creating in-house divisions. Clearly, biosimilars will be a business geared toward companies with significant financial wherewithal.
Amid all that firepower is a middle-market entity out of Cambridge, Mass., Momenta Pharmaceuticals Inc. that produces generics and has two branded compounds in clinical development. Momenta's business is based on a technology developed at the Massachusetts Institute of Technology to analyze and understand complex biologic mixtures.
CEO Craig Wheeler -- the former president of the biotech division of Chiron Corp. before it was sold to Novartis AG in 2006 -- says Momenta initially intended to use the technology to do more efficient and rational drug design. But improvements to the technology paved the way for Momenta to create generic pharmaceuticals. including a copycat version of blood clot-prevention medicine Lovenox that was approved in July 2010 and has given it the revenue stream to fund the development of its pipeline.
Momenta's latest discovery may prove to be its most lucrative: the platform can be used to create biosimilars.
Now, Momenta has the chance to be at the forefront once Congress signs off on the FDA's guidelines. Momenta signed a collaboration agreement with Baxter International Inc. on Dec. 22 to develop and commercialize biosimilars. Under the deal, Baxter will decide which drugs to develop, and Momenta will get the backing to distribute them globally.
Wheeler earned degrees in chemical engineering from Cornell University and an M.B.A. from the Wharton School. Prior to Chiron, he spent 13 years in Boston Consulting Group's healthcare practice. In an interview with The Deal, Wheeler discusses the FDA's approval process for biosimilars, the battle for market share in generic biologics and why Momenta might be well positioned to profit.
The Deal magazine: How did Momenta Pharmaceuticals end up with the capability to produce biosimilars?
Craig Wheeler: It was about four years ago -- a year and a half after I came -- when our research group said that we could take these tools and make a generic biologic. We didn't have a lot of money then, because we didn't have an approved product.
So basically, I gave them a challenge, I said, "Prove it." I said, "I don't care if you bring me a product. I don't have the money to fund it right now. Take a cell line, take a gene, and show me you can make a generic version that is indistinguishable in every attribute from a brand. Pick your molecule."
So they did. Our analytic tools were good, but we had to develop all the process tools to manipulate a cell-based process as opposed to a synthetic process. About 18 to 24 months ago, they came back to one of our portfolio steering committees and said they did it. At that point I said, "OK, we're going into this business." So we started investing in it, really in making the tools more robust so that we could really go after molecules.
Why did Momenta team up with Baxter?
We started talking about who we could partner with a couple of years ago, but two things really opened up the gates for us. One is showing we could actually use our technology to get a product approved with [generic] Lovenox, and the other was, there is a pathway that now allows us to take advantage of the technology. It was very hard to say we were going to use this to reduce clinical trials and get [interchangeability] when the FDA had no pathway for it.
So people can partner with us with a lot more assuredness because a pathway exists. And the FDA has accepted our approach technologically. So that kind of opened the door for a partnership.
How do you think the market for biosimilars will take shape?
This is a brand-new business, and it's probably the only multibillion-dollar healthcare business being created from ground zero in as many years as I can remember. The market's going to evolve. I think what you've seen in the last few months is, the battle lines are really being drawn. This is a market that requires deep pockets and science.
And so you're seeing Samsung and Biogen. Amgen and Watson. Us and Baxter. And then drug companies -- Pfizer, Merck, Novartis with [its generics arm] Sandoz coming in and then a couple of large generic players, Teva most notably -- that can cobble it together on their own because they have experience in making new drugs. So there's a large set of players. Korea has also made a big commitment to try to corner this market. They've put billions into it.
So it's going to be a market of big players. There's a lot of players who are on the periphery, but I really think it's going to start to settle into these big partnerships for big entities.
How has the FDA created its guidelines?
They basically put a public-meeting process in place where they would invite stakeholders in to advise and react to the FDA's thoughts in terms of how they would develop the [approval] pathway. So we, as a company, and also as members of [the Biotech Industry Organization], were present in those discussions. And those discussions are constrained by what the law says because there are lots of interpretations.
So there were lots of political positions going back and forth in those discussions. Should we ever have interchangeability [an FDA designation allowing a biosimilar to be substituted for its reference product without involving the prescribing physician]? Should we require people to do clinical trials?
In the end, I think the FDA came up with a very fair process, and it was signed on to by all sides. The process will allow companies, at their own discretion, to take advantage of different types of meetings.
The key meeting for us is what's called the "type 3" meeting, in which the FDA will accept your data package on physiochemical and biologic characterization as well as your process -- all the nonclinical things. And they will review it within 120 days, and then you'll have a meeting. And at that meeting they will give you guidance in terms of what kind of clinical trials are required and the potential for interchangeability.
How will Momenta try to get an edge over other developers in creating biosimilars and getting them approved?
We want to have discussions with [the FDA] with the goal of reducing the clinical-trial requirements as well as going directly towards an interchangeable generic. That's what we're hoping for.
Other companies can choose to go directly to clinical trials and do the full clinical trials, and whether they get interchangeability or not is going to be figured out down the road, after they get clinical experience.
[But] for us, we're trying to get interchangeability out of the blocks, and hopefully set the standard for the FDA and actually get those advantaged approvals [such as a proposed 180-day exclusivity window, or even de facto exclusivity for a branded biologic's first approved biosimilar]. If we can succeed with that, this is going to be a tough market for a lot of people who aren't interchangeable.
Assuming Congress ratifies the draft guidelines, how quickly could you bring biosimilars to the market?
It depends on how the FDA pathway evolves. If we go in and take advantage of this pathway and the type 3 meeting, and the FDA agrees with us that we don't have to do major Phase 3 trials, it could be relatively quick. If they're not quite ready to do that, and we have to do full trials, then it's going to take a little while because we're going to have to execute the full set of trials.
In terms of taking advantage of the pathway, I would hope once the pathway is fully up and running that would be a less-than-12-month process. But I don't expect it to be that way out of the blocks. This is brand new for the FDA; they're just staffing it up. It's going to be slower, so I'm kind of thinking it will be more in that 18- to 24-month range.
I hope it's much quicker, but I am also a realist. I have been burned many times before.
Read more: Q&A with Momenta's Craig Wheeler - The Deal Pipeline (SAMPLE CONTENT: NEED AN ID?) http://www.thedeal.com/magazine/ID/045648/dealmakers/movers-shakers-a-qa-with-momentas-craig-wheeler.php#ixzz1rvnBxAkE
by Ben Fidler
Published March 30, 2012 at 12:00 PM
The guidelines for the U.S. Food and Drug Administration's approval system for biosimilars -- generic biologic drugs -- are now in draft form, just in time for a wave of patent expirations for several of the world's blockbuster biologics, among them cash cows Enbrel, Remicade and Herceptin. The onset of a new multibillion-dollar market is near, and the arms race has begun.
Partnerships are springing up across the pharmaceuticals sector, most notably among large-cap powerhouses angling to get a part of what research firm IMS Health Inc. expects will be a market worth as much as $2.6 billion by 2015. (Biologic drugs represented a $138 billion market in 2010, according to IMS.)
Among the partnerships are Biogen Idec Inc. and Samsung Biologics as well as Amgen Inc. and Watson Pharmaceuticals Inc. Others, such as Merck & Co., Teva Pharmaceutical Industries Ltd. and Boehringer Ingelheim GmbH, are creating in-house divisions. Clearly, biosimilars will be a business geared toward companies with significant financial wherewithal.
Amid all that firepower is a middle-market entity out of Cambridge, Mass., Momenta Pharmaceuticals Inc. that produces generics and has two branded compounds in clinical development. Momenta's business is based on a technology developed at the Massachusetts Institute of Technology to analyze and understand complex biologic mixtures.
CEO Craig Wheeler -- the former president of the biotech division of Chiron Corp. before it was sold to Novartis AG in 2006 -- says Momenta initially intended to use the technology to do more efficient and rational drug design. But improvements to the technology paved the way for Momenta to create generic pharmaceuticals. including a copycat version of blood clot-prevention medicine Lovenox that was approved in July 2010 and has given it the revenue stream to fund the development of its pipeline.
Momenta's latest discovery may prove to be its most lucrative: the platform can be used to create biosimilars.
Now, Momenta has the chance to be at the forefront once Congress signs off on the FDA's guidelines. Momenta signed a collaboration agreement with Baxter International Inc. on Dec. 22 to develop and commercialize biosimilars. Under the deal, Baxter will decide which drugs to develop, and Momenta will get the backing to distribute them globally.
Wheeler earned degrees in chemical engineering from Cornell University and an M.B.A. from the Wharton School. Prior to Chiron, he spent 13 years in Boston Consulting Group's healthcare practice. In an interview with The Deal, Wheeler discusses the FDA's approval process for biosimilars, the battle for market share in generic biologics and why Momenta might be well positioned to profit.
The Deal magazine: How did Momenta Pharmaceuticals end up with the capability to produce biosimilars?
Craig Wheeler: It was about four years ago -- a year and a half after I came -- when our research group said that we could take these tools and make a generic biologic. We didn't have a lot of money then, because we didn't have an approved product.
So basically, I gave them a challenge, I said, "Prove it." I said, "I don't care if you bring me a product. I don't have the money to fund it right now. Take a cell line, take a gene, and show me you can make a generic version that is indistinguishable in every attribute from a brand. Pick your molecule."
So they did. Our analytic tools were good, but we had to develop all the process tools to manipulate a cell-based process as opposed to a synthetic process. About 18 to 24 months ago, they came back to one of our portfolio steering committees and said they did it. At that point I said, "OK, we're going into this business." So we started investing in it, really in making the tools more robust so that we could really go after molecules.
Why did Momenta team up with Baxter?
We started talking about who we could partner with a couple of years ago, but two things really opened up the gates for us. One is showing we could actually use our technology to get a product approved with [generic] Lovenox, and the other was, there is a pathway that now allows us to take advantage of the technology. It was very hard to say we were going to use this to reduce clinical trials and get [interchangeability] when the FDA had no pathway for it.
So people can partner with us with a lot more assuredness because a pathway exists. And the FDA has accepted our approach technologically. So that kind of opened the door for a partnership.
How do you think the market for biosimilars will take shape?
This is a brand-new business, and it's probably the only multibillion-dollar healthcare business being created from ground zero in as many years as I can remember. The market's going to evolve. I think what you've seen in the last few months is, the battle lines are really being drawn. This is a market that requires deep pockets and science.
And so you're seeing Samsung and Biogen. Amgen and Watson. Us and Baxter. And then drug companies -- Pfizer, Merck, Novartis with [its generics arm] Sandoz coming in and then a couple of large generic players, Teva most notably -- that can cobble it together on their own because they have experience in making new drugs. So there's a large set of players. Korea has also made a big commitment to try to corner this market. They've put billions into it.
So it's going to be a market of big players. There's a lot of players who are on the periphery, but I really think it's going to start to settle into these big partnerships for big entities.
How has the FDA created its guidelines?
They basically put a public-meeting process in place where they would invite stakeholders in to advise and react to the FDA's thoughts in terms of how they would develop the [approval] pathway. So we, as a company, and also as members of [the Biotech Industry Organization], were present in those discussions. And those discussions are constrained by what the law says because there are lots of interpretations.
So there were lots of political positions going back and forth in those discussions. Should we ever have interchangeability [an FDA designation allowing a biosimilar to be substituted for its reference product without involving the prescribing physician]? Should we require people to do clinical trials?
In the end, I think the FDA came up with a very fair process, and it was signed on to by all sides. The process will allow companies, at their own discretion, to take advantage of different types of meetings.
The key meeting for us is what's called the "type 3" meeting, in which the FDA will accept your data package on physiochemical and biologic characterization as well as your process -- all the nonclinical things. And they will review it within 120 days, and then you'll have a meeting. And at that meeting they will give you guidance in terms of what kind of clinical trials are required and the potential for interchangeability.
How will Momenta try to get an edge over other developers in creating biosimilars and getting them approved?
We want to have discussions with [the FDA] with the goal of reducing the clinical-trial requirements as well as going directly towards an interchangeable generic. That's what we're hoping for.
Other companies can choose to go directly to clinical trials and do the full clinical trials, and whether they get interchangeability or not is going to be figured out down the road, after they get clinical experience.
[But] for us, we're trying to get interchangeability out of the blocks, and hopefully set the standard for the FDA and actually get those advantaged approvals [such as a proposed 180-day exclusivity window, or even de facto exclusivity for a branded biologic's first approved biosimilar]. If we can succeed with that, this is going to be a tough market for a lot of people who aren't interchangeable.
Assuming Congress ratifies the draft guidelines, how quickly could you bring biosimilars to the market?
It depends on how the FDA pathway evolves. If we go in and take advantage of this pathway and the type 3 meeting, and the FDA agrees with us that we don't have to do major Phase 3 trials, it could be relatively quick. If they're not quite ready to do that, and we have to do full trials, then it's going to take a little while because we're going to have to execute the full set of trials.
In terms of taking advantage of the pathway, I would hope once the pathway is fully up and running that would be a less-than-12-month process. But I don't expect it to be that way out of the blocks. This is brand new for the FDA; they're just staffing it up. It's going to be slower, so I'm kind of thinking it will be more in that 18- to 24-month range.
I hope it's much quicker, but I am also a realist. I have been burned many times before.
Read more: Q&A with Momenta's Craig Wheeler - The Deal Pipeline (SAMPLE CONTENT: NEED AN ID?) http://www.thedeal.com/magazine/ID/045648/dealmakers/movers-shakers-a-qa-with-momentas-craig-wheeler.php#ixzz1rvnBxAkE
Abbott drug tops sales
Abbott drug tops sales as Lipitor, Plavix era ends
LONDON, April 11 (Reuters) - Abbott Laboratories' $9-billion arthritis drug Humira is set to take the crown as the world's top-selling medicine this year, highlighting the dominance of costly biotechnology products as revenues from old-style pills decline.
Neither of last year's biggest sellers - Pfizer's cholesterol fighter Lipitor or blood thinner Plavix from Sanofi and Bristol-Myers Squibb - will even make it into the top 10 in 2012, according to consensus forecasts compiled by Thomson Reuters Pharma.
The dramatic shift in the sales landscape, triggered by a record wave of patent expiries, will be centre-stage during the forthcoming quarterly results season as investors weigh up how leading pharmaceutical companies are adapting.
"They've all seen this coming but their ability to manoeuvre is limited," said Simon Friend, global pharmaceutical leader at PricewaterhouseCoopers.
"It's a tale of two worlds ... there is certainly a rush to streamline costs and step up looking for new products."
Roche, the first Big Pharma to report sales figures on April 12, is relatively well-placed in the new era, given its leading position in biotech and cancer drugs, which it hopes to consolidate by buying gene sequencing firm Illumina.
Roche has three anti-cancer drugs in the global top 10 with Rituxan, Avastin and Herceptin. Others are less fortunate.
Pfizer is already feeling the loss of Lipitor, after the U.S. patent ran out in November, while for Sanofi and Bristol the first three months of 2012 were the last full quarter of U.S. Plavix sales before cheap generics hit.
Bottom of the pack is AstraZeneca, trading on just 7 times this year's expected earnings. It has already warned that earnings will fall by more than 10 percent in 2012 as its antipsychotic Seroquel and other drugs face generic competition.
ON A ROLL
Abbott's Humira, by contrast, is on a roll.
Analysts expect the U.S. firm to report first-quarter revenue from the injectable medicine up 11 percent from a year ago and worldwide sales, including those booked by Japan's Eisai , are forecast to reach $9.3 billion this year.
Although best known as a treatment for rheumatoid arthritis, Humira is also used for a range of other inflammatory diseases. On Wednesday, it was approved in Europe for a seventh indication against ulcerative colitis.
The medicine is expected to retain its market-leading position through 2016, by which time it will rack up sales of $11.75 billion - still short of the $13 billion achieved by Lipitor at its peak.
Two other biologic rheumatoid arthritis drugs - Johnson & Johnson and Merck & Co's Remicade and Amgen and Pfizer's Enbrel - are set to take second and third place behind Humira this year, but they are growing more slowly.
Humira will be the key asset when Abbott spins off its pharma business from the wider diversified healthcare company later this year. Competition, however, is looming.
A U.S. advisory panel will meet on May 9 to consider whether to approve a novel arthritis pill from Pfizer called tofacitnib, challenging so-called anti-TNF drugs like Humira.
Mark Schoenebaum, an analyst at ISI Group, expects a vote for approval but believes tofacitnib may be restricted to patients for whom anti-TNFs do not work, given the outstanding questions about its safety record in clinical trials.
With a growing emphasis on drugs to treat conditions like cancer and inflammatory conditions, which are typically prescribed by specialists for relatively limited numbers of patients, some analysts doubt if any single drug will ever match Lipitor's sales peak.
The one area where sales above $13 billion a year seem plausible is Alzheimer's disease - but expectations for an effective treatment remain low, despite ongoing late-stage clinical trials with experimental products from Eli Lilly and Pfizer and J&J.
LONDON, April 11 (Reuters) - Abbott Laboratories' $9-billion arthritis drug Humira is set to take the crown as the world's top-selling medicine this year, highlighting the dominance of costly biotechnology products as revenues from old-style pills decline.
Neither of last year's biggest sellers - Pfizer's cholesterol fighter Lipitor or blood thinner Plavix from Sanofi and Bristol-Myers Squibb - will even make it into the top 10 in 2012, according to consensus forecasts compiled by Thomson Reuters Pharma.
The dramatic shift in the sales landscape, triggered by a record wave of patent expiries, will be centre-stage during the forthcoming quarterly results season as investors weigh up how leading pharmaceutical companies are adapting.
"They've all seen this coming but their ability to manoeuvre is limited," said Simon Friend, global pharmaceutical leader at PricewaterhouseCoopers.
"It's a tale of two worlds ... there is certainly a rush to streamline costs and step up looking for new products."
Roche, the first Big Pharma to report sales figures on April 12, is relatively well-placed in the new era, given its leading position in biotech and cancer drugs, which it hopes to consolidate by buying gene sequencing firm Illumina.
Roche has three anti-cancer drugs in the global top 10 with Rituxan, Avastin and Herceptin. Others are less fortunate.
Pfizer is already feeling the loss of Lipitor, after the U.S. patent ran out in November, while for Sanofi and Bristol the first three months of 2012 were the last full quarter of U.S. Plavix sales before cheap generics hit.
Bottom of the pack is AstraZeneca, trading on just 7 times this year's expected earnings. It has already warned that earnings will fall by more than 10 percent in 2012 as its antipsychotic Seroquel and other drugs face generic competition.
ON A ROLL
Abbott's Humira, by contrast, is on a roll.
Analysts expect the U.S. firm to report first-quarter revenue from the injectable medicine up 11 percent from a year ago and worldwide sales, including those booked by Japan's Eisai , are forecast to reach $9.3 billion this year.
Although best known as a treatment for rheumatoid arthritis, Humira is also used for a range of other inflammatory diseases. On Wednesday, it was approved in Europe for a seventh indication against ulcerative colitis.
The medicine is expected to retain its market-leading position through 2016, by which time it will rack up sales of $11.75 billion - still short of the $13 billion achieved by Lipitor at its peak.
Two other biologic rheumatoid arthritis drugs - Johnson & Johnson and Merck & Co's Remicade and Amgen and Pfizer's Enbrel - are set to take second and third place behind Humira this year, but they are growing more slowly.
Humira will be the key asset when Abbott spins off its pharma business from the wider diversified healthcare company later this year. Competition, however, is looming.
A U.S. advisory panel will meet on May 9 to consider whether to approve a novel arthritis pill from Pfizer called tofacitnib, challenging so-called anti-TNF drugs like Humira.
Mark Schoenebaum, an analyst at ISI Group, expects a vote for approval but believes tofacitnib may be restricted to patients for whom anti-TNFs do not work, given the outstanding questions about its safety record in clinical trials.
With a growing emphasis on drugs to treat conditions like cancer and inflammatory conditions, which are typically prescribed by specialists for relatively limited numbers of patients, some analysts doubt if any single drug will ever match Lipitor's sales peak.
The one area where sales above $13 billion a year seem plausible is Alzheimer's disease - but expectations for an effective treatment remain low, despite ongoing late-stage clinical trials with experimental products from Eli Lilly and Pfizer and J&J.
Horizon Pharma's Rayos
Horizon Pharma's Rayos - A No-brainer Or Speculation?
(RTTNews.com) - Rheumatoid arthritis, which is a chronic inflammatory disease, is estimated to affect about 1.8 million Americans. A number of effective treatments have been approved by the FDA for treating rheumatoid arthritis and drugs like Orencia, Remicade, Enbrel, Humira and Actemra are just to name a few.
At the altar, awaiting the FDA decision is a new drug for rheumatoid arthritis - Rayos, a delayed-release formulation of low-dose prednisone, developed by Horizon Pharma Inc. (HZNP). This drug is approved for rheumatoid arthritis in 16 European countries under the brand name Lodotra and is marketed in Europe by the company's distribution partner, Mundipharma International Corp. Ltd.
For readers who are new to Horizon Pharma, here's a brief overview of its business and the upcoming events to watch out for...
Horizon Pharma is involved in developing medicines to treat arthritis, pain and inflammatory diseases. The company has two marketed drugs - Duexis, approved by the FDA last year for signs and symptoms of osteoarthritis and rheumatoid arthritis, and Lodotra approved in Europe in 2009 for rheumatoid arthritis.
Horizon Pharma has sought approval for Duexis in United Kingdom and a modified Marketing Authorization Application to this effect was submitted in February of this year. The company anticipates a decision on the updated application in the second half of 2012.
Late last month, Horizon Pharma filed a patent infringement lawsuit in the United States District Court for the District of Delaware seeking to block Par Pharmaceutical Inc. from marketing a generic version of Duexis. The patent on Duexis expires July 18, 2026, according to the FDA's Orange Book.
Lodotra, the company's lead product, is marketed in Europe for the treatment of moderate to severe, active rheumatoid arthritis in adults when accompanied by morning stiffness. This drug, known as Rayos in the U.S., is under FDA review.
Lodotra/Rayos was developed utilizing SkyePharma's proprietary GeoClock and GeoMatrix technologies, for which Horizon Pharma holds an exclusive worldwide license for the delivery of corticosteroids.
Horizon Pharma submitted the New Drug Application for Rayos last September based on results from a pivotal, 12-week, double-blind, placebo-controlled phase III trial involving 350 rheumatoid arthritis patients. The NDA for Rayos was accepted by the FDA last November with a decision date set for July 26, 2012.
Lodotra/Rayos is also being investigated as a potential treatment for polymyalgia rheumatica, or PMR, an inflammatory disorder involving aching and stiffness in patients over the age of 50 typically affecting the shoulders and arms, in a phase II study. Beginning in the second half of 2012, a separate clinical trial for Lodotra/Rayos for the potential treatment for PMR, mostly a phase III study, is expected to be conducted by Horizon Pharma's distribution partner Mundipharma.
The company also has a couple of preclinical drug candidates in its pipeline namely, TRUNOC for pain-related diseases and HZN-602 for mild to moderate pain and arthritis. However, Horizon Pharma currently has no plans to further develop these products on its own.
A quick look at the company's balance sheet...
Since inception in June 2005, the company has incurred significant operating losses, and as of December 31, 2011, had an accumulated deficit of $220.3 million. The company recognizes revenue from up-front license fees, milestone receipts and product deliveries.
Net loss for the year ended December 31, 2011, was $113.3 million or $12.56 per share compared to a net loss of $27.1 million or $21.16 per share in the prior year, hurt largely by a $69.6 million intangible impairment charge recorded during the fourth quarter of 2011. The annual revenue in 2011 increased to $6.9 million from $2.37 million in 2010.
The company ended the year 2011 with $18.0 million in cash. Subsequent to the end of the year, in February and March 2012, the company completed debt and equity offerings raising combined net proceeds of $81.7 million. As a result, Horizon Pharma had $82.5 million in cash on hand as of March 16, 2012.
Horizon Pharma went public in July 2011, offering its shares at $9 each. The stock has thus far hit a low of $3.05 and a high of $9.34. HZNP lost over 7.5% on Tuesday to close the day's trading at $3.55.
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