The Big Red Biotech Blog

FDA's Woodcock says Drug Approvals at 20-year high

The FDA's Janet Woodcock, Director CDER, testified before Congress that the number of new chemical and molecular entity approvals had reached a 20-year high to date in 2011. Twenty drugs have been approved in 2011 so far as compared to 21 drug for all of 2010.

Woodcock further pointed out that the low number of approvals was more a function of attrition in the pharma pipelines than due to regulatory rulings by the FDA.  A recently issued report states that drugs moving to phase III dropped by 55% in 2010, with comparable decreases of 50% and 47% for phase II and phase I respectively.  Thus, the number of drugs reaching a submission for approval is down and therefore the number of approvals would be expected to follow.  See Fierce Biotech.

 

 

Posted by Bruce Lehr July 8th 2011.

CMOs Look for Double-Digit Growth in 2011

According to a GEN article (July, Vol 31, No. 13, page 40), CMOs are guardedly optimistic that the segment has overcome the recent economic downturn and will be poised to grow in double-digits in the at least the near term.  Many have recently added capacity and are now turning their attention to create added flexibility for their clients, often using single-use disposable systems to accomplish the task.  CMOs are also enhancing their offers in the their service portfolio. 

Lonza, KBI BioPharma, Wacker Biotech, Boehringer Ingelheim, CMC Biologics, Cytovance and DSM are among those CMOs who have added recent capacity -- incorporating more use of disposables, raising their ability to meet regulatory requirements and increasing downstream capabilities. 

Despite the lack of availability of venture capital to their small and mid-size clients -- which has hurt business -- CMOs see more trends in the positive direction that give them optimism that they will see double-digit growth in 2011.  They say more companies are focused on advancing candidates in their pipelines rather than broadening them which should lead to more late stage projects in CMOs.  Also, Big Pharma is beginning to divest manufacturing capacity in favor of outsourcing it to CMOs as a strategy.  And, biosimilars and biobetters are coming on the scene to provide more projects and volume.  Finally, the biotech is going global which brings more customers in from Asia Pacific and other emerging markets.

There remain some concerns.  A few CMOs mentioned the possiblility of over-capacity in the industry once again as CMO capacity is also coming on in Asia and emerging markets leading to more competition.  That's certainly a trend that I'm seeing in my work -- primarily as a consequence of more biosimilar and biobetter companies emerging in those regions. So as many of the trends may be positive as compared to a the past few years, it still looks like a very competitive marketplace and companies will have to continue to differentiate their service offerings to maintain good margins and flow of business.

Posted by Bruce Lehr July 5th 2011.

Survey Says "Improve Downstream Processing"

BioPlan Associates just reported results of its 8th annual Survey of Biopharmaceutical Manufacturing Capacity and Production -- a summary of which appeared in July's GEN Vol. 31 No. 13, page 1. The number one issue cited by the 352 respondents as needing more attention was bottlenecks in downstream processing.

Due to the rapid increases in titer being achieved in upstream processes -- through improved expression systems, better cell lines, more optimized media/feeds, and more efficient bioreactors -- many are producing more product than the downstream processes were designed to handle. A total of 68.5% of respondents said that their facility was experiencing at least some bottleneck due to downstream issues -- with a historic survey high of 11.8% characterizing these as serious (up from 4.6% in 2008).  Respondents further indicated they were goign to spend more money to try to solve the issues with budgets for downstream work projected to increase by 6.4% in 2011. 

Technologies that were identified as important to downstream improvements included high-capacity resins, in-line buffer dilution systems, single use filters, and disposable UF systems.  Additionally, several platform level technological improvements were identified by companies as areas they were investigating, including:

• simulated moving bed chromatography
• improved resins that were cheaper, faster-flowing, more selective, and have higher bindng capacities
• novel separation methods like chromatography monoliths
• alternatives to protein A
• disposable protein A columns for mAb purification
• improved depth filters, ultrafiltration and membrane filters to replace columns
• more product-customized affinity purification media
• improved modeling of separation at the molecular and process level

The burden of improvement has clearly shifted downstream for the next phase of biopharmaceutical production optimization.  Downstream is now challenged to meet the improvements achieved upstream over the past 5-10 years to bring the system more into balance.

 

 

 

Posted by Bruce Lehr July 5th 2011.

  

Too Much Innovation Spoils the Stew?

In the Pipeline this morning posts the results of a new study looking at the problem of R&D productivity in the pharma industry.  These author's argue that the industry's problems may stem from too much innovation and not from too little.  They note that drug failures have increased in all phases of the pipeline and especially in phase III as developers have tried to create new drugs for tough diseases like Alzheimer's, cancer and Parkinson's -- versus say HIV or cardiovascular disease where beter targets exist.

They note that pharma R&D programs have reacted to 3rd party payer and regulator signals that "me-too" drugs will be tougher to get approved (without clear benefits) and reimbursed.  This has led to development in new therapeutic categories, with new targets, with more uncertain outcomes.  This has also led to a higher failure rate.  The authors state the re-orientation (enrichment) of drug pipelines to these more novel areas accounts for the majority of increased attrition we are seeing with drug R&D programs.

So it is being too novel -- not being too "me-too" -- that is causing all our trouble. Interesting perspective.

 

 

Posted by Bruce Lehr July 5th 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.

Innovation as the Antidote to Biosimilar Market Erosion?

Here is an interesting report created by RBC Capital Markets, entitled Biosimilars - A Wall Street Perspective that discusses the evolution of biosimilars and offers an opinion as to how the market will evolve.  One of the more interesting aspects is a discussion of modifications that can be made to innovator biologics to fend off challenges from biosimilars - including such technologies:

• Pegylation - reduce injections
• Ultra potent antibodies and ligand traps - less injections, subQ dosing, safety
• Bispecific antibodies and antibody fragments - potency, dual activity
• Antibody/drug conjugates (ADCs) - potency
• Glycoengineering - potency
• Fc engineering - potency, half-life modifications, novel functions

I post frequently here about some of the ADCs advancing through the clinic - the two most advanced being brentuximab vedotin (Seattle Genetics) and T-DM1 (Genetech/Immunogen).  Both drugs are in late stages phase III and are expecting approval.  There are at least another 34 programs identified publicly -- 22 of which are in phase I or II. We can expect to see a continuing cavalcade when the first two are approved and shown to be successful.

Here's a copy of the report: Download Wall Street report on biosimilars

Posted by Bruce Lehr June 29th 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.  

 

Doing Deals With Biotechs Fails To Yield Results?

Here's some stats from a recent Thomson Reuters analysis of the pharma industry with respect to R&D spending and new drugs in the pipeline.  The study shows Big Pharma put the clamps on R&D spending while sharply reducing the number of new phase I and II trials and putting the brakes on phase III trials.

Doing Deals With Biotechs Fails To Yield Results? // Pharmalot.

The report shows that Big Pharma stopped 55 phase III trials in the past 3 years and that was 2x as many as had been terminated in the three previous years.  Additionally, phase I studies dropped by 47%, phase II studies by 53% and the number of new drugs entering phase III dropped by 55%. 

High failure rates, compounded by a big decrease in new NMEs, is a great concern to the industry. Only 21 NMEs were launched worldwide in 2010 and that followed only 26 the previous year.  This is the lowest number in a decade. It appears that the strategy of in-licensing more drugs for development is not yet paying off.  See Fierce Biotech.

Posted by Bruce Lehr June 27th 2011.

Vaccines: The New Blockbusters?

From the BioJobBlog this morning, a report from Frost & Sullivan outlines the state of the vaccine market on a global basis.  The report notes that vaccines, once a moribund market, have experienced a large turnaround and now represents growth opportunity over at least the next 10 years.

Vaccines: The New Blockbusters?.

Some salient facts that can be considered for this market:

• Pediatric vaccines lead adult vaccine sales and are the fastest growing segment
• Europe produces more than 90% of the total vaccine production
• The top 5 Big Pharma  manufacturers produce more than 80% of vaccine revenues and 40 manufacturers account for the other 20%
• North America accounts for more than 50% of the global vaccine spend
• Growing middle class in Latin America, Asia, and Africa will fuel market growth
• There are 80 new candidates in late stage clinical development and 40% of new vaccine candidates are for indications with NO exisiting vaccine on the market

As pediatric vaccines are the leading growers -- aimed at diseases like pneumococcal disease, rotavirus, measles, H. influenza b, pertusis and tetanus -- one can expect governments in emerging markets to continue to add exisiting and new vaccines to government-mandated vaccine programs (as promoted by orgs like WHO or the Gates Foundation).  Clearly, this is one of the most cost effective treatments in existence with almost incalculable benefits to patient well-being and to society.

Government investment, not-for-profit spending and industry alliances/partnerships, in addition to private R&D spending, are helping to drive the current resurgence of the global vaccine industry.

Posted by Bruce Lehr May 18th 2011.

The Global Outlook For Drug Spending

According to a new IMS Health report, global spending on pharmaceuticals will reach $1.1 trillion by 2015, which represents a 3-6% compound annual growth rate over the next 5 years.  This is lower than the 6.2 percent that was realized between 2005 and 2010.

And The Global Outlook For Drug Spending Is… // Pharmalot.

Slower growth will be fueled by less spending in the United States, patent expirations of big selling drugs, government price controls and price reductions, and increased generic competition.  Emerging markets are expected to double in size to between $285 B and $315 B up from $151 B in 2010. In fact emerging markets are expected to be larger than the combined market represented by Germany, France, Italy, Spain and the UK.   

Further, IMS says that brand name drugmakers sales will remain flat from 2010 to 2015 -- and branded market share will slide to 53% from its current 64% (and way down from 70% in 2005). This is due to the emergence of generics.  Generics will account for 80 cents of every dollar spent in the emerging markets and will grow by $47 B in these markets.  Drugs coming off patent will result in $98 B in savings to payers from 2010 to 2015, nearly double the total from 2005 to 2010. And by 2015, IMS predicts that biosimilars will actually have sales of $2 B or about 1% of the global market.

Posted by Bruce Lehr May 18th 2011.  

Big savings coming from emerging generic drugs, patent expirations

Here's the latest article from The Chicago Tribune over the weekend on all the drug patent expirations that are expected in the next 4 years and the expected financial impact as generics emerge to get their piece of the expiring pie.

Big savings coming from emerging generic drugs, patent expirations.

According to IMS Health data, more than $100 billion in annual brand-name drug sales will be at risk for generic competition from 2011 to 2015. That's about one-third of the annual spending on all prescription drugs in the U.S.

"You are going to see more and more people being pushed to generics," said Linda Bannister, health care analyst with Edward Jones in St. Louis. "For patients, I see a big dividend for the research the drug companies put in in the late 1980s and 1990s."

Analysts see future drug development moving toward biotechnology as scientists look for ways to treat diseases and conditions that include cancer, multiple sclerosis and Alzheimer's disease.  "A lot of people think drug development is cyclical," Bannister said. "There are a lot of innovative medicines on the horizon. Hopefully, there will be new products."

Posted by Bruce Lehr May 9th 2011.

 

How much did you shell out for Rx drugs?

From PharmaGossip, the market stats on the top selling drugs in the US in 2010.  More specifically, the top 10 drugs paid for by insurance companies in 2010 according to IMS Health data.

PharmaGossip: Hey, big spender. How much did you shell out for Rx drugs?.

As noted, most were heavily advertised brands for ailments like heartburn, high cholesterol and depression. Also as noted, there are generic products available that will do the job for many if not most patients. Drugs like Lipitor and Plavix will see their patent protection disappearing very soon.

Posted by Bruce Lehr April 21st 2011.

US Drug Spending - How Low Can You Go?

Reuters reports on IMS Health data that says US spending on drugs grew by only 2.3% in 2010 -- or the second lowest level in 55 years.  This confirms the fears, no doubt, of Big Pharma executives as they look at heightened generic competition, increasing patent expirations and slackening product development pipelines. 

The good news, if any, was that the US market remains the largest for drugs at $307.4 billion.  The subsidence of flu in 2010, more generics, and less spending on newer therapies were cited as reasons the growth rate dived from 5.1% in 2009 to the 2.3% in 2010. Though the 2010 rate was second lowest in the past 55 years, you only have to harken back to 2008 at 1.8% to find the lowest rate in that time span. OUCH!  And the impact of Lipitor's patent expiration this year hasn't even been felt yet.

Other factoids include:

• Patient visits to doc offices down 4.2%
• Patients starting treatments for chronic disorders fell by 3.4 million (unemployment and health insurance or lack thereof blamed)
• Medicare Part D and Medicaid prescriptions up to 30% of total (compared to only 22% in 2006)
• Spending on generics rose 21.7% and account for 78% of all retail prescriptions

 

Posted by Bruce Lehr April 19th 2011.

The Death Of The Blockbuster Drug: A Cheat Sheet

Here's more market data from PharmaGossip via Mathew Herper's blog that shows how the market for the top selling drugs has dramatically changed over the past two decades.  Now, only 1 of the top 15 most-prescribed medicines is still sold only in it's branded version.  New drug approvals peaked way back in the mid-90's and recent years are less than 50% of that peak performance.

PharmaGossip: The Death Of The Blockbuster Drug: A Cheat Sheet - Matthew Herper - The Medicine Show - Forbes.

All new, big-selling drugs now really tend to be biopharmaceutical products with high per patient treatment costs.  Nine drugs now cost more than $200,000 per patient on an annual basis.  Generics are here to stay. Broad-based blockbusters appear to be gone. New treatments will be targeted, more personalized, and more costly per patient -- but will presumably offer more specific patient benefits.

Posted by Bruce Lehr April 14th 2011.

 

A Decade In Drug Industry Layoffs

These sobering pharma industry employment statistics from the PharmaGossip blog using Mathew Herper's blog as the source.  It shows that almost 300,000 layoffs occurred industry-wide in the last decade.

PharmaGossip: A Decade In Drug Industry Layoffs - Matthew Herper - Forbes.

The brunt of the damage though has occurred in only the past 3 years with nearly 160,000 layoffs. Clearly, industry restructuring is ongoing. The sales and R&D groups seem to be the predominant groups hit with the cuts. Fortunately, a number of these folks have been redistributed to other companies in the industry but not everyone.  And, the final industry structure/model still has to evolve in my view with continued R&D down-sizing still being talked about as well as outsourcing to CROs and the like.

Posted by Bruce Lehr April 14th 2011.

Big Pharma M&A strategy has failed miserably

Burill and Co says Big Pharma blew it with its M&A activity over the past decade.  This published in a new report called Biotech 2011-Life Sciences: Looking Back to See Ahead.

The major finding in the report?  Big Pharma destroyed $1 trillion in value over the past decade. That trillion in lost  value is comprised of a decrease in market captilization of 17 of the industry's most active acquirers of $530 million plus an added $425 M spent on the acquisitions = nearly $1 trillion.

Article M&A strategy has failed miserably - Burrill.

To update and paraphrase Everett Dirkson, "A trillion here, a trillion there, and pretty soon you're talking about real money."

Looks like it is time to go back to the business model drawing board.  Companies are now looking to acquire smaller biotech's for their innovative pipelines but are being more careful not to assimilate them into their massive R&D structures (bureaucracies), or may be breaking their own massive R&D groups into more manageable (and agile) small units.

Burrill says, "If the industry is to return to the type of growth it once enjoyed, it must innovate its way out of its current predicament."

Posted by Bruce Lehr April 13th 2011.

 

How Many Patients Would Switch To Generics?

According to the Pharmalot blog, Express Scripts says the answer is?  82%!

Yes. 82% of patients switched to generics last year as their price fell by 10.2% as compared to an increase in price of brand-name drugs by 9.7%. 

How Many Patients Would Switch To Generics? // Pharmalot.

What does this say about drug prices?  Patients and third-party payers prefer cheap drugs.  you can expect this trend to continue for any medications where a generic alternative is available.

But, you can also look at specialty drug sales -- which includes biologics for inflammatory diseases, MS and cancer -- where total spending increased by 19.6% last year.  This is indicates that there is a market for innovative medications (that work) and that payers will pick up the tab.

 
Posted by Bruce Lehr April 7th 2011.

mAb Development and FDA-Approval Facts

Deloitte Recap recently analyzed the 29 mAb approvals that have thus far passed the FDA. These drugs generated an aggregate $24 B in revenues in 2009.  In looking at the length of time the mAbs were in development, Deloitte found that their mean time to market was 7.6 years - but this time frame is getting longer.  For the period, 1994-2003, the mean time was 6.7 years and that has increased to 8.3 years for the time span 2004-2011. This could possibly be due to the increased complexity of diseases that developers are now trying to attack - most of this time is from additional time in the clinic.

Surprisingly, and unfortunately, Deloitte also discovered that the regulatory programs geared at speeding up a drug's time through the approval process - like fast track, accelerated approval, priority review or orphan status - did not seem to help mAbs arrive any faster.  In fact, fast track status was associated with a longer mean time in development. 

In looking at the data for mAbs, particularly as compare to small molecules, Deloitte also concluded that mAbs approval rates are higher (23 percent), and given some are blockbusters to boot, we're likely to see heavy investment in mAbs for the foreseeable future.  At present, 27 key companies followed by Deloitte have 130 mAbs in their pipelines aimed at 211 indications.

Posted by Bruce Lehr April 5th 2011.

 

Analysis of 2010 Biotech M&A's

Life Sci VC published excerpts of an analysis by HBM Partners of the 2010 Biotech M&A Survey. The post goes on to cite several observations from the survey/analysis:

• Acquisitions of VC-backed biotech companies were up in 2010 back to pre-crash 2007 levels.  The expectation is for M&A activity to accelerate in 2011
• ROI-capital multiples were good with several nice upfronts
• But...the average upfront payments were down to only 1.5-2x (3-4x for overall deal) which only represents 7-10% IRR.  This is not sustainable for most VC firms looking for 20+% IRR
• Small to mid-size PHARMA drove 60% of M&A activity - not big pharma or big biotech

In general, the environment seems to be improving but the greater unwillingness to pay large upfronts may ultimately result in a capital crunch - but this is unlikely to be the case in 2011.

Posted by Bruce Lehr March 27th 2011.

Big Pharma Numbers and Fun Facts

I saw a couple random posts today with some Big Pharma factoids that have some interesting implications I suppose.  The first via PharmaGossip from Business week related the enormity of Big Pharma profits that are being generated and invested abroad (outside US).  In many cases, the percentage of profits generated outside the US are much bigger than the percentage of sales so generated. 

PharmaGossip: U.S. multinationals have more than $1 trillion in profits stashed in overseas subsidiaries..

These companies do seem to be positioned to make whatever investments they need in terms of acquisitions of biotechs, product or technology acquisitions, or even R&D funding partnerships with biotech or academic research.  They never seem to be as poor as they sometimes let us believe -- patent cliff or no patent cliff.  There is ample raw material (i.e cash) to work with here.  It just needs to be applied appropriately it would seem. See Business Week here.

Then In the Pipeline reported on a post from Life Sci VC on the R&D spend in Big Pharma versus the rest of the industry.  It was basically examining the enormity of Big Pharma spend and looking at efficiency - plus also making some commentary on what Big Pharma's extravagance (and relative non-productivity is doing to the overall drug financing eco-system).

As pointed out in Derek's summary of the post, the top 20 Big Pharma companies spend ($96 billion) about 26 times more than the rest of the private biotech universe combined ($3.7 B).  Pfizer when compared to the universe of privately financed companies (460) reveals that it is equivalent to about 1000 biotechs -- or two and half times the number that exist!  Pfizer's proposed R&D cuts for itself over the next few years ($3-4 B) is equivalent to cutting all the funding to private biotechs! Egad - maybe there is some FAT to trim thereabouts.

Sadly, if one calculates the annual utilities and facility costs (avg 3%) for the top 20 Big Pharma's R&D organizations, get this now, it exceeds ALL the funding for venture-backed biotechs combined. 

There is efficient use of capital right?  Whatever happened to economies of scale? If venture backed funding only amounts to 4% seen in the whole system, why is venture backed production and innovation greater than 4%? The numbers certainly indicate that smaller R&D groups are being more efficient in the current circumstances (and probably have been for some time).

It looks like it is the RIGHT thing to do for Big Pharma (Top 20) to invest more in private and small-cap biotechs to get some more productivity out of the system. MIght be a better thing to do than buy back stock or pay a bigger dividend.  Maybe even result in some products to meet the "unmet needs".

 

Posted by Bruce Lehr March 25th 2011. 
 

10 Popular Drugs Set to Lose Their Patents

This one from The Street via PharmaGossip is self-explanatory. 

PharmaGossip: 10 Popular Drugs Set to Lose Their Patents - TheStreet.

Can anyone say "Patent Cliff"?

 

Posted by Bruce Lehr March 3rd 2011.

Cool chart - Top 200 Pharma Products in 2009

This is a COOL chart straight out of Pharmagossip. It details the top 200 selling drugs in 2009, provides revenues, company producing/selling, molecular structure and indication/target.

PharmaGossip: Cool chart.

The chart was produced by the Njardarson Group (Cornell University).

Enjoy!

Posted by Bruce Lehr Feb 18th 2011.

How Many New Drugs Did FDA Approve Last Year?

This post from Pharmalot shows that the number of FDA drug approvals was down again last year - with only 18 new molecular entitites and 3 biologics for a total of 21. Totals for 2009 and 2008 were 26 and 24 respectively.

How Many New Drugs Did FDA Approve Last Year? // Pharmalot.

But....and this is an important BUT......new applications are also down.  In 2010, the FDA received 23 applications as compared to 37 in 2009, 34 in 2008 and 35 in 2007.  The 23 filed in 2010 was the lowest number filed in past 15 years.  For those of you who can do the math, 21 approvals from 23 applications is 91.3%!  So much for FDA being solely responsibile for holding up approvals.

If you don't submit applications, you can't get your drug approved seems to be the message. 

 

 

Posted by Bruce Lehr Feb 18th 2011.

Who Discovers Innovative Meds? The Public Sector

A new NEJM study casts doubt on the dogma that academic researchers contribute by discovering underlying mechanisms and pathways for diseases but don't contribute much to applying the research for creation of commercial drugs.  According to the study, the public sector contributed heavily to the development of more than 20 percent of new drugs between 1990 and 2007.

Who Discovers Innovative Meds? The Public Sector // Pharmalot.

Public sector was defined as universites, research hospitals, nonprofit research institutes, and federal labs.  Using patent database informaton, the study authors determined that the public sector produced 21.2 percent of all new drugs receiving priority review -- a marker signaling the innovativeness of these products. Innovative drugs from the public sector were disproportionately overrepresented in the totals.

Wow!  Put another way, 46.2 percent of NDAs from the public sector received priority reviews, as compared with 20 percent of applications from the private sector - a 2.3 fold difference in rate.  The study authors also noted that the public sector concentrated more efforts on different disease areas than the private sector - particularly in the areas of hematology, oncology and infectious disease (not the heartbreak of psoriasis, restless leg syndrome or female sexual dysfunction). 

The public sector helped finance the development of some of the world's biggest blockbusters including Remicade for rheumatoid arthritis and the pain drug Lyrica (see Fierce Biotech). Seventy-five public sector sites discovered or co-discovered at least one product, with the NIH taking first place with 22 products.  Who'd thunk?  Maybe Francis Collins Translational Insitute has legs afterall.

 

 

 

Posted by Bruce Lehr Feb 10th 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.