The Big Red Biotech Blog

Paragon Making the World Safer from Bioterrorism

The US Department of Defense awarded Paragon Bioservices a $15 M contract to develop a large scale mammalian cell culture process to produce vaccines to filoviruses. This virus class has long been considered by DoD to be a potential biological weapon and in this case is focusing on the Venezuelan equine encephalitis (VEE) virus and related viruses like Ebola and Marburg.

US DoD awards CMO Paragon Bioservices $15m vaccine deal.

The DoD expects the contract to be completed in 2020 and it is just another step in a long standing program by the agency to protect the US from potential filovirus events.

Posted by Bruce Lehr Jan 18th 2012.

China Wants to Boost Its Local Vaccine Industry

China has a goal of making itself the primary producer of vaccines that are used domestically.  To further that aim, the government is encouraging the development of production processes with proprietary IP rights. China is supporting the creation of new strains and technologies within this program.

China wants vaccine production innovation to boost local sector.

"It is clear from the plan that the Chinese government intends to create a favorable environment for the growth and development of China's domestic vaccine industry and to achieve self-reliance in the supply of vaccines", law firm Sidley Austin LLP released.

This is another example where the East is rapidly investing to make itself more market competitive.  It is also another example of where government policy is used in a strong way to drive economic development and technological advancement in a programmed direction.  The US policies need to support similar initiatives in the US biotechnology industry.

Posted by Bruce Lehr Jan 16th 2012.

PhRMA backs FDA plans for biosimilar fees

 Biosimilars are coming! Biosimilars are coming! in the USA and the FDA is planning to seek pharma industry input to design a set of users fees to defray costs and help expedite review of these new class of medicines.

PhRMA backs FDA plans for biosimilar fees discussion.

PhRMA says it is on board with this proposal and is eager to provide input at the hearings.  It is also in favor of a "science-based, separately funded regulatory program for biosimilars that is supported by appropriate dollars and user fees."

We're getting closer all the time.  Now if the FDA can just issue their guidelines.

Posted by Bruce Lehr Dec 12th 2011

Senators Unleash Lipitor-rent of Letters to Question Pfizer Plan

Three US Senators have written Pfizer over concerns that its unusual program with health plans and pharmacy benefits managers to block generic versions of its best-selling Lipitor cholesterol pill moves will increase costs for government health plans and others.   

Senators Probe Pfizer Plan To Block Generic Lipitor // Pharmalot.

Pfizer's move, aimed at retaining hundreds of millions of dollars in Lipitor sales over the next several months, has angered the Senators. “Consumers and taxpayers foot the bill when drug benefit companies and insurers manipulate the marketplace to prevent access to generic drugs for millions of Americans,” says Herb Kohl, a Wisconsin Democrat who heads the Special Senate Committee on the Aging - in his usual inflammatory rhetoric about such things.

In their letter to Pfizer Ceo Ian Read, the Senators reiterate concerns expressed by some pharmacies that the pharmacy benefits managers may pocket discounts offered by Pfizer, but Medicare and employers will pay the full freight.  The PBMs deny that this will occur.

A Pfizer spokesman adds: “The Senators’ letter is based upon an earlier article that contained incomplete and incorrect information about our Lipitor programs. We want the public to understand the facts. Our intent is to offer Lipitor to payers and patients at or below the cost of a generic during the 180-day period. As a result, patients receive Lipitor at co-pays comparable to generics.

As Pfizer says, "Trust us".  It's not like we've paid billions in fines for off label marketing, price fixing or other unethical marketing programs in the past is it?

 

 

Posted by Bruce Lehr Dec 1st 2011.

Info Clearinghouse May Clear Way in Fight Against Adulteration

Here's an interesting idea from the GAO.  They are advocating for the creation of an information clearinghouse to combat intentional product adulteration -- based on FDA comments that getting information from industry about potential instances of economic adulteration is crucial to addressing the problem. Up to now, companies have been reluctant to share this information. 

The clearinghouse would allow companies to share information anonymously on adulterated ingredients with FDA and other companies. It could help FDA disseminate information about adulterated products quickly and enable the agency and industry to respond to adulteration rapidly. The creation of a clearinghouse managed by a third party could further ensure that the information did not identify specific companies.

PharmTech Talk » Let’s Fight Adulteration with Information.

This strategy could help allay industry’s concerns about sharing information when an adulterated ingredient has not entered into commerce. Companies are afraid that they may be sued if they reported that a supplier intentionally adulterated a product and the accusation is later found to be baseless.

Because potential adulterants often are unknown or unidentified, it can be hard for FDA to detect them, as was the case in the recent heparin adulteration. Industry may be the best source of tests to detect adulteration because companies develop such tests to monitor the products they receive from their suppliers; however, industry officials indicated that they are often reluctant to share such information because it is proprietary. The clearinghouse might solve the fears surrounding sharing proprietary information -- which in turn could help the FDA do its job better and better protect the consumer.

It seems like an idea worth exploring.

Postd by Bruce Lehr Nov 29th 2011.

 

 

 

ViiV teams with Russian manufacturer

ViiV, GSK and Pfizer’s HIV joint venture, has partnered with Russia’s JSC Binnopharm to boost manufacturing capacity in the country.  The deal extends GSK and Binnopharm's manufacturing pact for GSK range of cervical cancer, pneumoncoccal and rotavirus vaccines.

ViiV teams with Russian manufacturer.

The deal is another example of the recent trend of Western pharma manufacturers partnering with Russian firms to manufacture products in Russia in accordance with the government's Pharma 20-20 plan.  The plan calls for increased investment in Russian manufacturing capability and creation of more highly skilled jobs to support the growth of a local Russian pharma industry to more international standards. The ViiV partners plan full manufacturing transfer of core antiretroviral products from overseas to the Russian Federation.

Independently, Pfizer has further bolstered its Russian manufacturing presence through a deal with Petrovax Pharm.  Petrovax will make Pfizer's pneumococcal vaccine.  One can expect more of these deals in alignment with Russian goverment priorities -- especially if one plans to grow sales in this pharmerging market.

Posted by Bruce Lehr Nov 3rd 2011.

EMA Still Not Supporting Biosimilar Interchangeability

Many health experts insist that biosimilars will not truly hit their upside potential until they achieve interchangeability status with the innovator product they are intended to mimic. The post below from the BioProcess Blog indicates that the EMA is still not supporting interchangeability as is contemplates its new guidelines for biosimilars.

EMA Still Not Supporting Biosimilar Interchangeability.

In the post, the EMA is lauded for updating its thinking and proposed guidelines on biosimilars from its 2005 regulations -- particularly its recognition of the importance of defining reliable PK/PD markers for biosimilarity in non-clnical studies, plus the possibility of using non-inferiority as an end-point for clinical trials. 

Non-inferiority should allos for faster, smaller and less expensive clnical trials, but will also likely make it harder to establish interchangeability. The current guidelines and proposed revisions do not address what it will take to establish interchangeability accordign to blog authors. The conclude that neither the EMA nor the FDA will likely establish a menaingful path to interchangeability in the forseeable future.  Thus, biosimilars will not achieve their peak market penetration and ultimate sales potential that could be predicted with interchangeability.

 

 

 

Posted by Bruce Lehr Oct 31st 2011.

Bayer Latest Company to Move on Russia

Bayer is the latest member of Big Pharma to move to Russia -- receiving $860 M in economic development aid to support domestic development and production of therapeutics.  Bayer will partner with the locally owned Yunona Holdings.

Russian officials have indicated unhappiness with the fact that the country has to import 80% of its therapeutics. And as a result they're giving preferential treatment to the companies that do more development and manufacturing work inside Russia.  The country also has been attracting a number of biotechs avid to tap into the lower-cost clinical studies that can be pulled off there. 

This is just the latest example of Big Pharma investing in emerging markets to spur top line growth in an effort to replace revenues lost through patent attrition.  In the case of Russia, government policy has been very forceful in demonstrating that you NEED to have a local presence if you want to play in their Market.

Posted by Bruce Lehr Oct 12th 2011.

India - No Cap on Foreign Drug Company Investment

India's policy makers had been contemplating putting a cap of 49% on foreign drug maker's ability to buy Indian drug companies, but decided not to go that route.  The policy discussion had been kicked off by the fact foreign companies had increased their share in India's drug market from 15% to more than 25% in the past three years.  It was feared that foreign drug makers would not have an interest in supplying affordable medicines to India's poorer citizens.

India Will Not Cap Foreign Investment In Pharma // Pharmalot.

However, a different compromise has been struck.  Foreign Investment instead of being capped will be closely scrutinized by India's Foreign Investment Promotion Board which will itself be overseen by the Competition Commission (anyway see any hints of previous British rule in this bureacracy?).  It seems terribly bureacratic to me, but all the key players seem happy from global multinationals like Pfizer to the domestic trade group Indian Pharmaceutical Alliance.

So who am I to criticize?

 

 

 

 

Posted by Bruce Lehr Oct 11th 2011.

India May Cap Foreign Investment In Pharma

India has been worried about protecting its domestic pharma industry from MNC takeover for several years now -- especially as foreign buying companies have grown their market share to more than 15% in the last couple of years.

India May Cap Foreign Investment In Pharma // Pharmalot.

A high-level government think tank called the Planning Commission now has recommeded that India cap foreign investment in drug manufacturers to less than 49% rather than allow up to 100% investment as is theoretically possible now. Ostensibly this is to protect India's poor populace from being priced out of the market when the evil foreigners take over. This does not bode too well for foreign investment in India. Other members of the government argue that such protectionism is retrograde policy making -- and a few more forward looking Indian companies, like Biocon, say bring on the competition. 

Its chairman, Kiran Mazumdar-Shaw says, "Companies will do what makes business sense for them. This is a high-growth sector and you will devalue it if you start putting restrictions."

It's worth noting that India makes more than 20% of the world's generics now and its industry is expected to grow from $19 B in 2009 to $50 B by 2020.

 

 

 

Posted by Bruce Lehr Sep 27th 2011.

 

The Cost Of Treating Cancer Is ‘Unsustainable’

The crux of this one?  New cancer treatments cost too much, address too few patients and provide too little benefit (in terms of survival) to be sustainable in the future -- given the economic drag developing in the system.

The Cost Of Treating Cancer Is ‘Unsustainable’ // Pharmalot.

The Lancet Oncology says we need to wave a magic wand to create a radical shift in policy to stop tolerance of "unfairness in access to affordable cancer treatment" and to deliver "fair prices and real value from new technologies."

Oh! Is that all?

Posted by Bruce Lehr Sep 26th 2011.

 

 

 

Takeda and Baxter Cell Culture Based Flu Vaccine Advances

Takeda and Baxter formed a collaboration in August 2010 to commercialize cell culture based flu vaccines in Baxter's Vero cell system.  Today, Takeda announced it has received a $313 million grant from the Japanese government to build a new flu plant in Hikari that is slated to be operational in 2013.

Takeda gets 24bn yen Govt grant for cell culture vacc plant.

Takeda is looking to supply the flu vaccine to the Japanese public as soon as possible thereafter.  In the medium to long term, the Company says it continue to develop vaccines for unmet medical need with a high social demand. These will include combinaton vaccines, high value vaccines using new technology and supply to other Asian and emerging markets outside of Japan.

This is another example of the rebirth of the vaccine industry after decades of slow decline as more and more governments put emphasis back on creating new vaccines to prevent widespread disease.

Posted by Bruce Lehr Aug 23rd 2011.

China Ex-Pats Go Home to "Achieve Something" in Biotech

 
The Chinese government has made it well known by now that it wants to be a bigger player in biotech by announcing it will invest more than $300 billion in the next 5 years.  That kind of bait is drawing ex-Pats back to China from US biotechs to start up new biotechs or join other start ups. 

Says Xe Xin, a relocating researcher, "Though we were well paid at American companies, we wanted  to be more than just employees.  We are in our mid-30's and wanted to return home and make things happen."

We can expect this trend to continue as many well educated and well trained Chinese return to their homeland to exercise their entrepreneurial spirit in a land of heightened opportunity fueled by generous government investment and tax policies. 

The US government should take note and work with the groups like BIO to ensure we maintain policies and investment levels in US biotech to keep it at its current front-runner position in the World.  But don't look back as China may be gaining on us.  See Fierce Biotech.

 
Posted by Bruce Lehr Aug 19th 2011.

House Backs Biotech Tax Breaks

Fierce Biotech reports that key members of the House are pushing for tax benefits for the biotech and pharma industries.  The plan (if passed in the current form) would double the tax credit to 40% for the first $150 M in research spending.  Or, it wuld allow repatriation of up to $150 M in annual overseas profits at a tax rate of 5.25%, if it is then spent on R&D. 

Proponents hail it as a stimulus for R&D spending.  Opponents decry it as a tax give away to pay for R&D that would happen anyway.  Overall, I'd go for it.

Posted by Bruce Lehr Aug 5th 2011.

India "Floodgates" Poised on Compulsory Licenses

The third Indian generic drug maker in the past year has filed for a compulsory license to make a patented drug in India.  This time it is Natco that wants to make Bayer's cancer therapeutic Nexavar.  Natco had approached Bayer for a license in December and was turned down.

Compulsory Licenses are controversial.  They come into play in developing countries that argue the cost of many life-saving medications for diseases like AIDs and cancers are way too expensive for most patients in these countries (e.g. India, Thailand, Brazil, S. Africa).  The generic producer says they can offer the medicines at a fraction of the cost if they had the license.  Of course they can as they did not pay any of the discovery and development costs for these medicines. Innovator (brand name) drug producers are, needless to say, very mus opposed to compulsory licenses and say their imposition will remove financial incentives to find these innovative medicines.  

The Natco case will be closely watched.  If it is granted a compulsory license, then many Indian generic producers may also be encouraged to apply as well openign the floodgates potentially in India.  That won't do much for the marketing of innovative drugs in India in my view, nor will it be much help to multi-nationals who may be seeking to develop more business in countries like India to help cover revenue losses they may be experiencing in other parts of their portfolios due to patent expirations.  So much perhaps for developing markets serving as new growth engines. See Pharmalot.

 

 

 

Posted by Bruce Lehr Aug 4th 2011.

 

India Moves To Cap Foreign Investment In Pharma

After months of similar saber rattling, an India advisory panel recommended that a 49 percent cap on direct foreign investment in its domestic drug companies be adopted. The move comes from fears that foreign investors will dominate the Indian market and make policies for affordable drugs for the Indian populace difficult if not impossible to achieve.

India Moves To Cap Foreign Investment In Pharma // Pharmalot.

Foreign investment in Indian companies like Ranbaxy, Matrix Laboratories, Dabur Pharma, Shanta Biotech, Piramal Healthcare, Paras Pharmaceuticals and Orchid Chemicals has raised foreign ownership of Indian companies to 15 percent of the market.

Unsurprisingly, big pharma, as represented by the Organization of Pharmaceutical Producers in India, issued a statement calling the proposal "retrograde".  "It will have a chilling effect on FDI (foreign direct investment) in the country.  FDI should not stand for funds deserting India."

 
Posted by Bruce Lehr July 6th 2011.

BIO Says Americans Back Biotech

BIO released (see MNT) a new survey of 800 American voters, and perhaps not surprisingly, the voters supported a continued commitment to federal spending on biotech research.  A majority (53%) bellieved that support should extend to the Federal government tax policies or direct spending for the industry.

"These numbers are a testament to the life-saving scientifica research being conducted by the biotechnology industry.  Every day biotech researchers are working to cure deadly diseases, find cleaner alternative fuels, protect us against the threats of bioterrorism and feed a hungry world.  It is reassuring to know that our hard work lines up shoulder-to-shoulder with the priorities of the American people," said Jim Greenwood, CEO of BIO. 

You can read more by checking out the survey results on the BIO website.  Thus ends today's biotech commercial endorsement.

 

 

Posted by Bruce Lehr July 5th 2011.

The FDA, Avastin and Medicare

The FDA's expert panel says that Avastin is usually very effective against breast cancer and they can't endorse its use for that purpose.  Medicare says, not to worry, we'll pay for it. Huh? Isn't this the same Medicare that looked at whether or not it would reimburse for Provenge for nearly 1 year?  And that's for a drug that does meet its claims as far as I can tell.

I don't get it.  Presumably, Medicare was balking at Proveng's price tag ($93,000) and questioned cost-effectiveness before making its begrudging decision to provide coverage.  Now, we have an FDA panel of "experts" telling us that Avastin (and its $88,000 price tag) doesn't work too well for breast cancer patients and Medicare says we'll pay for its off-label use. It's spokesman says, "We often pay for off-label use of drugs, but not always."  So why this time for a drug that apparently doesn't work too often?

The Pharmalot blog suggests it is tradition.  That Medicare usually will cover indications for a drug - on or off-label - that are listed in compendia.  In this case, Avastin is listed as a breast cancer choice by the National Comprehensive Cancer Network (NCCN). Interestingly, 8 of the 33 members who consitute the NCCN breast cancer panel have ties to Avastin's creators Roche/Genentech.

So for now, it looks like Avastin whether recommended by the FDA's expert panel or not, will still be prescribed by physician's off-label when they feel it is appropriate and that Medicare will pick up the tab. Medicare does say that it will keep the situation under review as it evolves and "will consider its options".  See Pharmalot and In the Pipeline.

Posted by Bruce Lehr July 1st 2011.

 

 

Avastin Decision Signal for More Cost-effectiveness Measures by FDA?

Here's a couple interesting commentaries from Seeking Alpha and The Economist -- both having to do with issue of the high cost of drugs (particularly cancer treatments) and the future regulatory role in not only evaluating the science behind them but their cost-effectiveness too.

 Both pieces use the FDA's recent decision that Avastin does not usually work with breast cancer and a lightning rod for the discussion.  The Seeking Alpha piece predicts that the FDA will become more like its EMA counterpart and will not only make decisions on a drug's suitability on safety and efficacy grounds (as it does now) but will increasingly weigh its cost-effectiveness.  The argument is that it will become even harder to get FDA approval and that bodes poorly for the financial health ofthe pharma sector.

The Economist is less predictive in what may happen but notes that Americans spent $125 billion on cancer treatments in 2010 and are proejcted to spend $207 billion by 2020 (according to Medco). Thus, they predict that the FDA will have to engage in a serious discussion soon about "how much society should pay for the extension of life."  As do we all.

Posted by Bruce Lehr July 1st 2011.

 

Medicare will Reimburse for Provenge

More good news for Dendreon today as Medicare, after almost 1 year's consideration, announced it will reimburse healthcare providers who presecribe Provenge for the treatment of prostate cancer. The price for a single course of treatment is $93,000.

Medicare to cover prostate cancer drug - Boston.com.

The Centers for Medicare and Medicaid said Provenge is a "reasonable and necessary" medicine.  The agency will still accept comments for 90 days on the decision before making it final (finally!).  Medicare should issue a temporary reimbursement code today that will make claims easier to process -- within 30 days versus closer to 90 now.  See Xconomy.

This is all good news for Dendreon, its patients and investors as the company looks to make good on a forecast of $350 to $400 million in 2011.  All the more reason to be happy about its newest LA plant coming on line and its next plant in Atlanta expected in August.

 

 

Posted by Bruce Lehr July 1st 2011.

Biotech Emerging Markets: Perspectives from Brazil, India, Argentina, and South Africa

At BIO's Partnering for Global Healthcare Forum - panel representatives from the emerging markets of Brazil, India, Argentina and Sout Africa addressed trends in healthcare.

PharmTech Talk » Biotech and Emerging Markets: Perspectives from Brazil, India, Argentina, and South Africa.

They noted that goverment's in these regions all had a goal of getting more people into the healthcare system and providing "healthcare for all".  Targeted goverment investment is up in healthcare in areas like diangostics and biosimilars.

Aging populations and an evolving middle class are among demographic features driving some of this. Speakers from Argentia and South Amercia also talked about their countries as serving as potential regional gateways to other countries/markets in their regions. There is also an expectation that healthcare will shift from a focus of treating acute illness to one focused on chronic care and prevention - as ailments like diabetes, hypertension and cancer grow in developing nations.

Posted by Bruce Lehr June 29th 2011.  

 

China to Spend $308 Billion to become Biotech Player

China plans to flex some financial muscle by investing $308 billion in governement funds between now and 2015 to generate 1 MILLION new biotech jobs.  The ambitious program is part of the 12th Five-Year Plan (2011-2015).  In the healthcare arena, the broad goal is to add one extra year of life expectancy and a lower infant mortality rate.

The government plans to make biotechnology into an "economic pillar".  It will reserve 20 billion yuan for new drug development and control of disease in the process. Don't look back US, somebody may be gaining on us!  Better get the biotech investment bill moving here too. See Fierce Biotech.

Posted by Bruce Lehr June 28th 2011.

More Congressional Probes into Pricing of Newly Approved Old Drugs

Move over KV Pharmaceuticals, you are not alone!  Readers will recall that KV got itself in hot water with Congress, thrid-party payers, physician's groups, patients advocates, various foundations and the Mormon Tabernacle Choir and the Baja Marimba Band when it introduced an FDA approved version of progesterone, called Makena, for the treatment of some high-risk pregnancies. 

The problem was that it raised the price of the newly "approved drug" from about $20 to $1500 per dose.  The sound that arose from critics was liken to an orchestra of scorched cats. KV had to quickly back off on price but not before losing the support of long-time sponsor The March of Dimes and having the FDA refuse to enforce an prohibitions on use of "non-approved" versions of the drug made in hospital formularies.

PharmTech Talk » Congress Probes Pricing of URL Pharma’s Gout Medication.

Now, URL Pharma and Avanir Pharmaceuticals may be moving into the same dangerous territory. URL Pharma has introduced its version of the old drug, colchicine, under the brand name Colcrys for the treatment of gout. In doing so, it raise dthe price from pennies per dose to about $5.  Maybe that doesn't seem quite as egregious as the KV case due to lower nominal amounts but it still drew Congress' attention.  Sen. Kohl and Sen. Waxman have written a letter to URL's CEO to 'splain himself on pricing. Uh-oh, this was the similar move KV experienced before all hell broke loose. URL has vigorously defended its pricing as competitive with other gout medications.

Similarly, Avanir markets a drug called Nuedexia, a combination of the legacy drugs quinidine and dextromethorphane, for the treatment of a rare condition called pseudobulbar affect (involuntary emotional outbursts).  It pricing raised the ante from about $20 for the old drugs to about $600 for the new. Again, their CEO recieved his Congressional letter in the mail asking about the pricing rationale for the product.

Clearly, all three of these companies took drugs they did not invent (or in some cases even manufacture), but added quality controls and clinical trials to the process to enhance the safety profile. The question is -- what is legit in terms of the mark up for these quality enhancements to compensate them for their investment?  Clearly they should be able to earn that back, but not by exhorbitant pricing - particularly given the drugs in question had decades of use prior to their "improvement" by FDA licensing.  A balance needs to be struck between profit motive and patient gouging.  It looks like companies and Congress will need to zero in on where that balance lies.

 

Posted by Bruce Lehr May 26th 2011.

Human Genome Project Made Us Money

A few weeks ago, Battelle Memorial Institute issued a report estimating the economic impact of mapping the human genome.  The conclusion?  The US Government earned a handsome return on its $3.8 billion investment between 1988 and 2010.  See Patent Doc blog.

The major findings in the report were as follows:

1. The project generated a total economic output of $796 billion between 1998 and 2010, generating 310,000 jobs, and $244 billion in personal income (or $63,700 per job-year).
2. The Feds invested $3.8 billion from 1990 to 2003 ($5.6 billion in 2010 dollars) and realized an ROI of 141 to 1.  Wow!
3. The benefits of the project are still in their early stages and "the best is yet to come".
4. The project "is arguably the single most influential investment to have been made in modern science and a foundation for progress in the biological sciences moving forward."

In calculating these returns, the work of private entitities like Celera Genomics were included in the analysis by Battelle.  The project has been called "one of the best uses of of taxpayer dollars the US government has ever made."

What do we do for an encore?  More government support for R&D in the pharma and biotech industry - tax credits anyone -- to support more translation of the genome findings into therapies?  Imagine that! a government investment in technolgy that paid off big.

Posted by Bruce Lehr May 24th 2011.

Patent Doc Counterpoint to FTC Report on Pay-for-Delay

The FTC says pay for delay deals are rapidly on the rise -- up from 19 to 31from 2009 to 2010 -- and costing consumers big bucks -- $3.5 billion annually -- in inflated drug prices. It calls for the courts or the Congress to step in and block these deals. 

The Patent Doc blog points out that pay-for-delay is an outgrowth of the Waxman-Hatch Act - where first ANDA filers can earn up to 180-day exclusivity for a successful application.  However, if unsuccessful, the ANDA filer needs to wait until after patent expiration before reaching the market.  Under many pay-for-delay deals (or patent settlements), the generic challenger does wait to get to market but does so in exchange for reaching the market prior to the patent expiration date or earlier than would be the case under an unsuccessful ANDA challenge -- this is particularly true of ANDA filers who are not the first filer.

Patent Doc also says to look at the FTC's own data under a different light.  The number of potential pay-for delay deals (deals that involved compensation for the generic producer and an agreement to not to market for a longer term than provided under a successful ANDA) did increase but so did the number of settlements.  As a percentage of the total though, the frequency of pay for delay deals is trending down since 2006.  It's the same story for potential pay for delay deals among first filers too since 2007.  See data here.

ANDA settlements are trending downward in their liklihood to result in an agreement that provides monetary compensation to generic drugmakers in exchange for delayed market entry. It would seem there is a recognition of the wastefulness associated with ANDA litigation among innovators and generic producers alike.

Look at both sides arguments and make up your own mind.

Posted by Bruce Lehr May 10th 2011.