The Big Red Biotech Blog

FTC’s Leibowitz Says Rising Generic Drug Deals Hurt Consumers

As posted here last week, the FTC's Chairman Jon Leibowitz is up in arms over an increase in so-called pay for delay deals between innovator drug companies and generic competitors.

PharmaGossip: FTC’s Leibowitz Says Rising Generic Drug Deals Hurt Consumers - Bloomberg.

Leibowitz says the number of deals increased 63% (from 19 to 31) and involved 22 products with sales of more then $9.3 billion.  He said the deals " are outrageous and they harm consumers. Either the courts or Congress needs to stop them."  The FTC has long contended the deals are anticompetitive and violate antitrust law.  Leibowitz aslo says the deals add $3.5 billion to consumer's drug costs.

Lobbyists for the drug companies say the deals cut legal costs and avoid long court battles.  In some cases, the settlement may avoid years of patent litigation and bring a generic drug to marker sooner. The deals don't prevent competition beyond a patent's life says a spokesman for the Generic Pharmaceutical Association (GPA).

"The FTC is continuing to perpetuate the myth that pro-competitive, pro-consumer patent settlements are harmful to consumers,"  said David Belian, a GPA spokesman.

 

 

 

 

Posted by Bruce Lehr May 10th 2011.

FTC Complains Pay-To-Delay Deals ‘Skyrocketed’

The FTC won't give up in its battle to stop pay-for-delay deals despite set backs in court and legislative inaction. It still continues to bang the drum to get Congress to prohibit or curtail these deals.

FTC Complains Pay-To-Delay Deals ‘Skyrocketed’ // Pharmalot.

FTC Chairman, Jon Leibowitz released another report that indicates these deals rose by 63% in number in 2010 over 2009 -- at total of 31 deals in 2010. These involved 22 brand named drugs with annual US sales of about $9.3 billion. Leibowitz claims these type of "collusive" deals cost the US taxpayers $3.5 billion annually in higher prices.

The amount of savings differs rather dramatically from White House estimates of $540 million in 2012, rising to approximately $8.8 billion in 2021 should new legislation being proposed now go through. Of course, the Generic Pharmaceutical Association counters that these deals are not collusive and never have prevented competition beyond the original patent expiry of a drug.

Now we wait to see if anything will happen -- besides using calculators to tell us what we might save.

 

 

Posted by Bruce Lehr May 5th 2011.

 

 

CMS Rules for Provenge Reimbursement

The Centers for Medicare and Medicaid Services (CMS) have ruled that Dendreon's Provenge can be reimbursed for the treatment of prostate cancer. The approval came with no prohibition of "off-label" use despite its $93,000 cost per course of treatment.

Medicare Decides Provenge Can Be Reimbursed // Pharmalot.

The approval is good news for Dendreon and its shareholders.  It is also good news for patients who are being or will be prescribed Provenge.  The move by CMS was not expected as the decision mirrored the advisory panel recommendation of only 4 months ago. Provenge represents a novel therapy - is in fact the first therapeutic cancer vaccine -- so it is good to see it gain CMS acceptance at its high cost and its relatively modest (4 months) extension of patient survival. Hopefully, this will encourage the continued development of newer and better medications into the cancer therapeutic arena. See Xconomy report too.

 

Posted by Bruce Lehr March 30th 2011.

 

 

NIH hasn't Forgotten Neuroscience Drugs

Yesterday, I made a post concerning big pharma cutting back its investment in many areas of neuroscience due to the higher risk presented in this therapeutic area and the high costs associated with it.  It was also pointed out that much of the difficulty lies with there not being many good biomarkers and model systems to work in.

Today I see a post In the Pipeline that describes a development funding opportunity being presented by NIH in the neuroscience arena:

The NIH Blueprint for Neuroscience Research is establishing a ‘virtual pharma’ network of contract service providers and consultants and is soliciting applications for U01 cooperative agreement awards from investigators with small molecule compounds that could be developed into clinical candidates within this network. This program intends to develop drugs from medicinal chemistry optimization through Phase I clinical testing and facilitate industry partnerships for their subsequent development. By initiating development of up to 20 new small-molecule compounds over two years (seven projects were launched in 2011), we anticipate that approximately four compounds will enter Phase 1 clinical trials within this program.

There you have it.  The NIH is trying to assemble the resources (in a virtual network) and provide the funding encouragment to develop new therapies for neuro diseases. And, they appear to be serious in seeking results:

Applicants must have available small-molecule compounds with strong evidence of disease-related activity and the potential for optimization through iterative medicinal chemistry. Applicants must also be able to conduct bioactivity and efficacy testing to assess compounds synthesized in the development process and provide all pre-clinical validation for the desired disease indication. . .This initiative is not intended to support development of new bioactivity assays, thus the applicant must have in hand well-characterized assays and models.

The goal is to develop at least one novel and effective drug for a nervous system disorder that is currently poorly treated and to catalyze industry interest in novel disease targets. Not everyone is loathe to pick up the challenge of developing new neuro drugs.

 

 

 

Posted by Bruce Lehr March 29th 2011.

Senators Ask FTC to Probe KV For Price Gouging

KV has stirred a hornet's nest among various patient, physician and thrid party payer constituencies with its pricing decision on the its new orphan drug Makena. Now its has the Senate and possibly the FTC to contend with.

Senators Ask FTC To Probe KV For Price Gouging // Pharmalot.

Readers will note that KV, upon FDA-approval of its version of the drug last week, chose to raise the price from about $20-$30 per dose received from most pharmacies to a new $1500 per dose price.  This has raised hackles amongst almost everyone execept perhaps KV investors.

Two senators - Minnesota Democrat Amy Klobuchar and Ohio Democrat Sherrod Brown - wrote FTC chair Jon Leibowitz that KV may be engaging in anti-competitive behavior. They maintain that a KV patient assistance program is insufficient because it does not cover “certain groups” of women.

Further, the Senaotrs said KV Pharmaceutical is taking advantage of FDA’s approval of Makena and orphan drug status leading to a monopolization of treatments to address preterm labors. The price increase will place a heavy burden on state Medicaid programs and may result in diminished access to appropriate health care for women and in increased preterm births.

"It’s critical that we make sure this company isn’t taking advantage of its orphan-drug determination to monopolize the market and engage in price gouging at the expense of pregnant women,” Klobuchar says.

This would appear to be an example of an unintended consequence of the orphan drug laws which primarily were meant to provide manufacturers incentives to bring new drugs to market for conditions with unmet need -- and for which the economic incentives to do so needed a boost.  What's happening here is that KV has identified a drug which has been around for more than 50 years -- but has never gone through an FDA approval process. 

KV recognized this and created an approved drug - which may in fact have some enhanced quality aspects.  However, KV has errored in my view in raising its price so egregiously - it appears greedy.  Maybe this is from need -- as it is trying to recover from a consent decree for distributing adulterated and unapproved drugs -- although that might be viewed as troubling in an of itself in terms of a pattern of corporate behavior.  Regardless, the pricing decision will likely encourage the congress in the time of budget crisis -- particularly around healthcare -- to review how it has structured orphan status for long known but unapproved drugs.  I would expect some type of redress but we'll see.

 
Posted by Bruce Lehr March 19th 2011.

FDA Official: Another Tainted Drug Is Inevitable

The statistics are there in black and white.  In 2001, there were roughly 1200 foreign manufacturing plants for pharmaceuticals.  In 2008, there were 3500.  That's an 185% increase.  The FDA increased its inspections by 23% but that only led to a 57% decrease in the foreign plant inspection rate.

FDA Official: Another Tainted Drug Is Inevitable // Pharmalot.

What to do about it?  The FDA is touting a 4 point plan.  The plan calls for the following:

• Partnering with foreign counterparts to creat a global coalition of regulators
• Building a global data information system
• Improve intelligence gathering and focus more on risk analytics
• Tap both public and private sources - like foreign regulators

Some of this process has begun for years now according to deputy FDA commissioner John Taylor,  but the efforts need to be stepped up. In meantime, he said "another pubic health crisis like Heparin seems inevitable." Not a cheery thought.

 

 

 

Posted by Bruce Lehr March 15th 2011.

Will US get Left Behind in Making Biosimilar Rules?

The Biosimilar Blog makes the Biosimlar score:  Europe 14 US 4.

Europe has been out ahead of the US in creating guidelines and a regulatory pathway for biosimilars to reach its market.  They have guidelines in place to cover at least 36 separate marketed biopharmaceutical products and 14 products are already approved.

The US has only 4 approved "biosimilars" - being Omnitrope, Fortical, Hylenex and Glucagen.  None followed a true biosimilar regulatory pathway as there isn't one yet in the US.  The legislation has just passed and the FDA is still in the lengthy process of establishing the regulatory framework for biosimilars to be approved under the new legislation. It appears this will take a while. 

In the meantime, the only way generic recombinant proteins can get licensed is via the generic drug 505(b)(2) pathway.  And this only will be applicable if the drug in question was approved via CDER with an NDA - which normally is used only for small molecules.  Most biopharmaceuticals are approved under a BLA thorough CBER and therfore can't use 505(b)(2).

The authors worry that the US will dicker too long and be left out from being in the forefront of developing biosimilars regulations in the world stage.  Other geographies will lead the way and gain the upper hand in promulgating the regulations and gain experience working on them while the US is still drafting.

The authors plea for US constituencies to stop worrying about protecting innovators by blocking biosimilar competition and worry about creating a pathway whereby biosimilars can be approved --- like the rest of the world is doing.  They further note that there are many other ways to provide innovators with incentives to keep innovating (permanent R&D tax credit anyone?) but that blocking biosimilars shouldn't be one of them.  Let's get in the game.

Posted by Bruce Lehr March 12th 2011.

Feds Sign Contracts with Partners for Pandemic Vaccines

The Department of Health and Human Services, specifically BARDA, will be working with Novavax and VaxInnate to develop better vaccine preparedness for pandemics.  Contracts worth a total of $215 M were awarded to both companies.  Both contracts could increase in value to total as much as $375 M. 

The two companies will help the US goverment with next generation flu vaccines that can be produced faster in times of pandemic. Novavax will use its money to support trials of its VLP flu vaccine candidate with a new adjuvant.  Novavax is also developing a manufacturing facility plan to allow it to produce vaccine within 12 weeks and at least 50 million doses within six months.  VaxInnate will develop technology that combines influenza and bacteria proteins to stimulate strong immune response against the flu.  See Fierce Biotech story.

HHS hopes this partnership for pandemic and seasonal flu will prevent it from being caught with it fly down again when it comes time to deliver doses to the public.

 

A Flea and a Fly in a Flue

A flea and a fly in a flue
Were imprisoned, so what could they do?
Said the fly, "let us flee!"
"Let us fly!" said the flea.
So they flew through a flaw in the flue.
--Ogden Nash

 

Posted by Bruce Lehr March 2nd 2011.

 

Samsung and Quintiles to Join Forces on Biosimilars

Reuters and Fierce Biotech report that Samsung will invest $264 M in a joint venture with Quintiles in Incheon, South Korea to pursue biosimilars.  The venture will build a new plant for their CMO that they expect to be able to bring into production by 2013. 

Samsung executive vice president Kim Tae Han said his company hopes to generate $1.8 B in revenue from biopharmaceuticals by 2020. Samsung says it will pursue other biotech deals in 2011 and will eventually try to produce its own drugs after gaining experience through this joint CMO venture.  

Late last year, the South Korean government stated its intention to invest in the biosimilars industry.  They set the goal of achieving 22% market share of a market estimated to be $14.5 B in 2015. The government plans to provide financial and institutional support for the industry, e.g. manufacturing facilities to support biotech.  It will also name biosimilars as a "core green" industry.  Korea expects this effort to add $2 B extra to GDP, $1 B to its exports, to create 120,000 new jobs and to spawn 5 globally competitive biosimilar companies.

Looks like the biosimilars charge is coming. Samsung is getting on board.  The US government better get its funding for the US biotech industry in place sooner rather than later.

 

 

Posted by Bruce Lehr Feb 26th 2011.

Obama's Generics Plan Means -- "The End is Near"

It is clear to Big Pharma that Obama's biosimilars plan threatens the American Pharma's Way of Life, Liberty and Pursuit of Happiness. The new plan to stop "pay for delay" and cut exclusivity by 5 years will threaten innovation and jobs.

Obama's generics plan criticised | InPharm.

The plan is designed to cut the $1.1 trillion Federal deficit over the next 10 years.  Obviously the two provisions mentioned above are intended to make generics/biosimilars more available earlier and result in reduced governement expenditures of medications. The White House says it can save $12 B over the 10 years (by itself not much dent in the $1.1 trillion deficit I might add). 

PhRMA's President and chief executive, John Castellani said, "The proposed legislation could jeopardize American competitiveness since the US would then provide less data protectin for new, innovative biologics than is currently being bestowed in Europe [proposed 7 years in US vs. 10 years in Europe]". 

Time for PhRMA to bargain reasonably around the exclusivity provisions in exchange for policies to promote growth of private-sector R&D investment in US biotechnology and medical innovation.

 

 

Posted by Bruce Lehr Feb 18th 2011.  

Exclusivity out the Window? Time for More Horse Trading

Here's a post from In the Pipeline lamenting the President's new budget submission.  It seems the White House is now backing language that would limit exclusivity on biologics (biosimilars) to seven years instead of the previously agreed upon twelve.  Of course, if you look through posts on this blog and other sites - one can't really be sure what the data exclusivity agreement was the first time around.  At least three groups of Congressmen (and women) have sent letters to the FDA describing market or data (which is it?) exclusivity periods ranging from 4 to 12 years. So the budget submission should be no big shocker in my view.

Like most things in the realm of politics, they change.  It just opens a new season of bartering. Now, the industry can still lobby for the longer exclusivity periods but might also open up other territory like pricing or R&D credits/grants or patent protection revisions as chips to bargain with in exchange for concessions on exclusivity terms.  Or they can just engage in vigorous lobbying for the exclusivity terms they want and spend their money with the factions supporting their point of view -- i.e. engage in the usual Washington politics? 

What's really changed?   

 

 

 

Posted by Bruce Lehr Feb 17th 2011.

New Cures! Faster! Faster!

Here's one from the In the Pipeline blog, recounting the uproar in the academic research community over the NIH's plan to open a Translational Medicine center to help move discoveries quicker toward commercialization - based on the debatable assumption that Big Pharma is not acting on all the leads that are available to it in a timely manner.

On the pro side, the NIH program will be successful in helping to move more drugs to market. In fact, there was a recent study published in NEJM that supports the notion that academic centers have been very instrumental in helping to deliver about 20% of newly licensed drugs since the 1970's.  So maybe Francis Collins is right and a new translational medicine effort by NIH will bolster even these figures substantially.

On the con side, naysayers lament that medical research can't really be run according to a business timeline and that any effort to do so will result in wasted dollars/efforts that will seriously deplete the NIH coffers for years to come - and effectively produce a demonstrably negative impact on the science in the future.

In the Pipeline cites a Biocentury article that concludes that there is too much tendency among basic scientists to "sell their work" - which simplifies the process from basic discovery to practical cure. 

"There is a real danger of over-promising," states Keith Yamamoto, executive vice dean of the University of California San Francisco School of Medicine, "Scientists too often take an intellectual short cut.......they just say if you give me money we are about to cure the disease."

Well, let's hope that if the NIH does get the money for the translational medicine center that it will help promote some cures and bring some new therapies to market -- and that this will substantively augment the current Big Pharma R&D model.

But, I'm always reminded by my boss that "hope is not a strategy."

Posted by Bruce Lehr Feb 15th 2011.

Lilly CEO Promotes Regional Innovation Clusters

Lilly CEO John Lechleiter spoke on a familiar theme -- that of promoting regional innovation clusters to spur economic development -- at a recent Brookings conference.  The text of his speech has been made available on the PhRMA site.

In his speech, Lechleiter touts the success of the Indiana innovation cluster - supported by a broad coalition of industry, academia, philanthropy and government - in drivng capital to the area to fund start ups thus spurring innovation and creating jobs. 

Lechleiter notes that as an innovative pharmacueitcal company - helping to create a viable innovation cluster in Indiana is in line with Lilly's mission to create a "fully integrated pharmaceutical network or FIPNet".  The FIPNet is essentially a value chain orchestrated by Lilly that assembles key pieces from partnerships, alliances and other relationships and transactions -- and not always outright ownership. Lechleiter points out Lilly deals with Covance and Evonik as successful examples.

Finally, he puts in a plug for the federal government to invest in these regional clusters and suggests it can lead the way through certain policy initiatives:

• Help establish an atmosphere where innovation can thrive and is valued -- where innovators can expect to be rewarded for taking risks
• Providing clear monetary supports - tax policies/make R&D tax credit permanent, solid IP protection, rigorous and transparent regulation - all incentives to investment
• Promotion of human talent and ideas - broad improvement to math & science instruction, encourage immigration of top scientific talent to the US

He concludes that fostering innovation clusters provides an engine for jobs and economic growth - and promotes a competitive advantage.  But, he also points out when innovation is promoted in health care arenas -- it also results in longer, healthier lives.

 

Posted by Bruce Lehr Feb 9th 2011.

 

Informex 2011: Tracking the Fortunes of Chemically Synthesized APIs

This article from the PharmaTech Talk blog comes to us from this year's Informex meeting in Charlotte, NC. It summarizes the pressures faced by US small molecule API manufacturers in a rapidly competitive and shifting environment.

PharmTech Talk » Informex 2011: Tracking the Fortunes of Chemically Synthesized APIs.

The gist?  Big Pharma is increasingly consolidating its vendor base.  It is looking to outsource more of its operations to gain flexibility. It is looking to both cut costs and to access emerging markets -- and can do so in one fell swoop by establishing more relationships with manufacturers in places like India and China.

Couple this with the issues Big Pharma is having with its dwindling pipeline, patent cliffs and recognition that large molecules, rather than small , are the more vigorous growth engines of the future -- you have a strong movement toward non-US API manufacturers.

Again, this is another reason, the US goverment needs to get behind our biotech industry to maintain its growth and prosperity so we can further develop a sustainable leadership position.  There are not that many industries where we still have clear leadership and it would be a monstrous mistake to let this one go too.

Posted by Bruce Lehr Feb 8th 2011.

Kohl Bill Proposes Ban to Pay for Delay Deals

Senator Kohl has introduced another bill that attempts to ban "pay-for-delay" deals between brand name pharma and its generic competitors.  The Senator notes that Waxman-Hatch has been very successful in the past in spurring generic drug competition.  He cited that 67% of all prescritpions filled are now for generics although these represent only 20% of the cost outlay.  He further claims because of this price disparity, deals between brand name producers and generic makers to delay competition are more profitable than competing in the market -- and therefore these deals will become more common if left unchecked.

Pay-for-delay in the Senator's view (and in the view of DOJ and FTC) are "contrary to free competition, the interests of consumers, and the principles underlying antitrust law."  The bill would allow the FTC to initiate an enforcement proceeding against any parties entering an agreement to settle a patent infringement claim in connection with a sale of a drug product. Such agreements will be deemed anticompetitive on their face and the parties involved will have the burden of showing that "procompetitive benefits of the agreement outweigh the anti-competitive effects of the agreement."

This is the thrid straight Congress in which Kohl has introduced such legislation.  Let's see if three times is a charm in terms of its passage. See the Patent Doc blog for more.

 

 

 

Posted by Bruce Lehr Feb 3rd 2011.

Vertex Urges CDC to Adopt Hep C Screening to Spur New Wave of Patients

Now that Vertex has convinced the FDA to give its Hepatitis C drug, telaprevir, expedited review, it is now working on convincing the CDC to help it get more patients. Xconomy reports that Vertex is lobbying the CDC to recommend that most people over 50 get blood tests for hepatitis C infection.

Vertex Urges CDC to Recommend Hep C Screening, To Nudge Second Tsunami of Patients.

Vertex is working with other companies in the Viral Hepatitis Action Coalition to fund a $3.6 M research study to assess whether this type of screening program would be cost effective.  There are currently 600,000 patients in the US who are expected to seek treatment for hepatitis C from either Vertex's telaprevir or Merck's similar drug (also receiving expedited review).  However, the screening program envisioned could generate an additional 1 M patients for both companies - out of an estimated 3 to 3.9 M persons in the US with chronic hepatitis C infections.

With such an untapped patient market, and a better therapy to boot, analysts are predicting that Vertex's telaprevir could be a more than $2 B blockbuster at annual peak sales. To make sure it gets there, Vertex is spending money on a public awareness campaign for hepatitis C and also is working hard to get the CDC's support for screening. 

 

Posted by Bruce Lehr Feb 2nd 2011.

 

Derek is Dubious of NIH Translational Med Success

The In the Pipeline blog this morning has a post entitled, "The NIH's New Drug Discovery Center: Heading into the Swamp?"  That would seem to capture his thougts well on the chances of the Center making a transformational difference in drug discovery area. I think his concluding blog post paragraph sums it up well:

...So, reluctantly, I'll make a prediction: if years of effort and billions of dollars thrown after genetic target-based drug discovery hasn't worked out, when done by people strongly motivated to make money off their work, then an NIH center focused on the same stuff will, in all likelihood, add very little more. It's not like they won't stay busy. That sort of work can soak up all the time and money that you can throw at it. And it will.

This seems to represent a majority pharma industry consensus and may also be shared by some significant percentage of the NIH as a whole.  Time will tell if Collins is visionary or father of an academic funding boondoggle.

Posted by Bruce Lehr Feb 1st 2011.

BIO Supports Obama's Call for Biotech Innovation too!

As covered in the Patent Doc blog, like PhRMA, BIO issued a statement whole-heartedly supporting the President following his State of the Union address calling for support of innovation in biotechnology.  BIO emphasized that no American industry is in better position to be a World leader.

BIO called out several areas in which US biotechnology is poised and ready to support the President's agenda of building innovation with some help from Washington.

• Therapeutic Discovery Project (TDP). BIO urges that the TDP be extended to fund more R&D in small to mid-size biotechs to support development of more therapies across a range of diseases like cancer, Parkinson's and MS.
• Alternative Energy Sources.  The biotechnology industry provides the key technology to make advanced biofuels work to make more GREEN jobs in the US and to develop secure and sustainable energy sources.
• Regulations for Agriculture Biotechnology Products. Please review barriers to growth so solutions can be provided to help feed and clothe the world, support energy security, and reduce agricultural environmental impact. Safety and reviews of these products needs to be swifter to sustain growth.  

America is the World leader in biotech and will continue to be so with sustained investment -- and with support of the right goverment policies that encourage investment in biotech.

 

 

Posted by Bruce Lehr Jan 28th 2011.



More on Data or Market Exclusivity

The Patent Doc blog provides another clear discussion explaining the debate on data versus market exclusivity resulting from the Patient Protection and Affordable Care Act and its provisions for follow on biologics.

What do we know for sure?  The PPACA says the FDA cannot accept an application for a follow-on biologic until 4 years after the reference drug.  The follow-on biologic cannot be approved until 12 years after the reference drug.   That apparently is clear.

What's not clear is the term "exclusivity" in the bill.  Innovator drug manufacturers and their Senator or Representative allies say that the bill clearly means that the innovator's data is to be held exclusive for 12 years after the reference product.  That means a follow-onproducer could not use the data before that time and therefore would not reach market until much later than 12 years after the reference product.

The follow-on manufacturers, payers and their Senator or Representative allies say the bill allows the data to be cited after four years and that the remaining 8 years gives the reference product market exclusivity.  Thus a follow on application could well be ready for approval when the 12 year market exclusivity period had expired for the reference product.  This will result in lower prices for patients and the Federal goverment.

The Patent Doc blog points out that if the intent is to get follow-on biologics on the market as quickly as possible then the latter argument makes most sense as to the policy.  However, if the latter path is pursued then the innovator may find it much more difficult to earn a return on their investment in creating the reference product -- which is a big problem.

History shows that generic producers in the non-biologic space don't produce innovative products typically in the absence of an innovator.  If no innovator - then no new drug. In the non-biologic space, innovators were given longer patent life under Hatch-Waxman to compensate for generics entry.  There is no such provision in PPACA.  A couple economic studies in the biologic and non-biologic space have concluded that a longer period of exclusivity for the innovator actually does lead to more drugs being produced and introduced to market - and results in patient benefits in terms of things like life-expectancy gains.

The Post conlcudes that there may be a need for a compromise and a modification of the exclusivity language in the law to accomodate both sides of the argument.  In the meantime, in the absence of clarification it is up to the FDA to sort out the policy -- thus the politicking now.

 

 

 

Posted by Bruce Lehr Jan 27th 2011.

 

Big Pharma Putin in Some Russian Manufacturing

Russian PM Vladimir Putin has spoken.  Foreign drug manufacturers who want to operate in Russia will need to manufacture there and to transfer technology to the local economy or face restrictions to the market. Putin's Russia plans to raise the domestic pharmas share of the Russian drug market to more than 30%.

Big Pharma has heard the message and is responding. Teva will expand its Russian manufacturing operations in the country. It has pledged to invest $100 M to bolster its goal of tripling its sales in Russia by 2015. 

GSK will also pour cash into the emerging Russian market. It struck a deal earlier this year to invest in Russia's Binnopharm to produce cervical cancer, rotavirus and pneumococcal vaccines for the domestic market.

The drug makers Novo Nordisk, Sanofi-Aventis, AstraZeneca, Novartis, Pfizer and Nycomed also plan to place manufacturing in the Russian market through building or partnerships. See in-PharmaTechnologist

 

 

 

Posted by Bruce Lehr Jan 26th 2011.

Does Exclusivity = 4 yrs? or = 8 yrs? or = 12 yrs? Market or Data or both?

As discussed in several entries in this blog, the data exclusivity provision in the follow-on biologics pathway are being much discussed by branded and generic manufacturers, public and private payers - and the Senate has gotten into both sides of the act.

The "branded side" interprets the healthcare bill as endowing them with 12 yrs of data exclusivity for their branded products and also the possibility of extending this another 12 years by significantly altering a product's safety or efficacy profile.  Thus, the branded biologics manufacturer would be protected from having a generics producer using any of their data package for at least 12 years -- and thus new generic products would take even longer than that to reach the market.

The "generics and payers side" interprets the legislation as affording the branded manufacturer 4 years of data exclusivity and an additional 8 years of market exclusivity.  The generic manufacturer could thus start their application well in advance of the 12 yr market exclusivity window and be ready to launch when the 12 year mark expired.

Needless to say there is a lot of money involved here for both sides, and the lines are being drawn to stake out the lobbying position one way or another with the Congress to influence the FDA decision on what final regulations will be adopted for biosimilars. We can expect to see more jostling and wrangling for the foreseeable future. See Patent Doc blog, Fierce Biotech and WSJ for more.

When it comes to writing legislation, Senators might try to mean what they say and say what they mean.

Posted by Bruce Lehr Jan 26th 2011.

PhRMA Backs Obama Pledge to Invest in Biomedical Research

PhRMA issued a statement today that supports President Obama's intent to invest in biomedical research delivered in last night's State of the Union address.  In part the PhRMA statement read:

"...The President recognized this crucial point tonight, as he stressed the need for investments in biomedical research.  The good news is that this important research is already taking place -- with more than $65 billion invested in R&D by the biopharmaceutical industry in 2009 alone. There is no doubt that innovation is a critical building block for growing the US economy. For this reason, it is important that the Administration and Congress view the biopharmaceutical research sector....as a national health and economic asset."

PhRMA went on to pledge its support in working with the Administration and members of Congress on solutions that would spur the US economy.

 

Posted by Bruce Lehr Jan 26th 2011.

Senators Reintroduce Pay-To-Delay Legislation

As reported in the Pharmalot blog, Senators Herb Kohl and Chuck Grassley have introduced legislation that would limit pay for delay deals.  The move comes after Congress failed to pass a bill last month, and several payer groups, ppharmacy and retail chains, the FTC and the CBO have called for more limits.  The FTC calls the deals anticompetitive and the CBO says the US government could save $2.7 B over 10 years with limits.

Senators Reintroduce Pay-To-Delay Legislation // Pharmalot.

Kohl and Grassley say it is wrong to continue to allow brand-name companies to pay generic providers to keep their products off the market thus costing consumers millions. They argue that in the past 4 years, 63 of 194 patent settlement deals had pay for delay provisions for the generic rival in the deal.  In 2009, there were 19 such deals so the trend is seen to be on the rise.

Posted by Bruce Lehr Jan 26th 2011.

More Discussion of Longer Data Exclusivity and Innovation Incentive

On Jan 12th I had a post via the Pharmalot blog that discussed a new academic study that concluded an extension of data exclusivity for 12 years for small molecule drugs would translate into more innovation over a 50 year time span (2060).  A 55yr-old at that time would experience a life-extension of 1.7 months on average -- perhaps in part resulting from the incremental 228 drug approvals that could be expected to result from extended exclusivity and more reinvestment.

Now the Patent Doc blog publishes more of this study conducted by Health Affairs to let you examine it in more detail.  The rub is that a 55 year old today would need to spend more money out of pocket for drugs (i.e. higher prices with more exclusivity) and would not see any life-span extension for him- or herself.  The benefits of such a policy shift would accrue to the future generations. Of course, this is all predicated on certain assumptions.  Assumptions that may not hold up - like no unforeseen changes in 'laws, regulations, science and medicine" or changes in drug manufacturer behaviour (like generics chasing their own independent clinical trial data).  These limits in interpretation are at least recognized.

It's an interesting study to read.  One might consider whether the benefits are great enough to consider a policy change.  One might also consider whether a generation today really is willing to pay for a future generation's benefits - benefits that will never be realized by the generation paying for it.  This type of altruism perhaps at one time was explicit and now may not be even implicit. 

Posted by Bruce Lehr Jan 21st 2011.

 

Will the Vise Tighten on Pay-for-Delay Agreements?

This PharmaTech Talk post recaps the recent events with pay-for-delay deals. The FTC and DOJ are both on record as opposing these arrangments as anti-competitive.  Several pharmacies and wholesalers have legally challenged their validity in an antitrust suit, and now 31 AG's from around the US have filed an amicus brief asking the Supreme Court to review these arrangments - specifically in a case involving Bayer and the generic producers Barr Pharmaceuticals and Watson Pharmaceuticals.

PharmTech Talk » Will the Vise Tighten on Pay-for-Delay Agreements?.

Interestingly, the EU has also cracked down on what they term "patent settlements".  The European Commission is reviewing patent settlements from Big Pharma companies in 2009 - indicating that patent settlements are a concern because they may delay the market entry of cheaper generics.

According to the EU, its monitoring is beginning to pay off. It declared that only 10% f patent ssettlements in the period July 2008 to Dec 2009 were problematic as compared to 22% for the period Jan 2000 to June 2008.  See Reuters.

The Pharmalot blog adds some further interest to this topic. It notes that in relation to a pending pay-for-delay suit -- involving Cephalon and the generic drugmakers - Ranbaxy Labs, Mylan Labs and Teva Pharamceuticals over copycat versions of Provigil -- 3 dozen other drug makers are suing to prevent the FTC from disclosing the contents of their pay-for-delay deals in response to a Cephalon petition to force FTC disclosure.  Cephalon want the documents to challenge FTC conclusions that pay-for-delay deals are bad for consumers.  The other drugmakers apparently fear this disclosure despite what Cephalon may think.

We may get to see the Man Behind the Curtain in these pay for delay deals.

 

Posted by Bruce Lehr Jan 20th 2011.