The Big Red Biotech Blog

Big Pharma Betting Big on Research in China

Just the latest article detailing Big Pharma's move to invest more in research and development capability in China -- not only to cut costs but to acquire a foot hold in what is expected to become the world's largest pharma market in as little as 15 years -- fueled by such factors as 100's of billions in investment in infrastructure by the Chinese goverment, the rise of the middle class and an expected explosion in the numbers of diabetics (thank you Western diet).

Betting big on research in China | InPharm.

Companies that have made significant investments in R&D facilities in China include: Novartis ($1 B), AstraZeneca ($100 M), Novo Nordisk ($100 M), and GSK ($40 M).  These companies are far from alone in their commitments to China-based R&D - many others, including Genzyme, Sanofi, Johnson & Johnson, Merck-Serono and Boehringer-Ingelheim, have also established (or plan to establish) R&D bases in mainland China, often at the expense of their Western facilities. Many see the East as integral to any long-term business plan.

As Patrick Keohane, head of R&D, Asia Pacific and Japan at Astrazeneca, puts it: “Asia should now be at the centre of any significant company’s clinical development strategy.”

Don't look back Big Red is gaining on US.

 

 

Posted by Bruce Lehr Sep 15th 2011.

 

Is Reproducibility on New Drug Targets 50% or 20%?

This post from In the Pipeline talks about how venture capitalists with long careers investing in drug development have estimated in the past that only 50% of new drug target findings can be reproduced in an independent lab setting.  Now we have more data on that from Bayer Pharmaceuticals.

In the Bayer study that looked at its own in-house validation program aimed at showing which new targets in the literature could be confirmed -- and therefore developed into a potentially profitable drug -- uncovered that only 1/4 to 1/5 of all putative targets were reproducible in their labs. That's right, in looking at 67 projects (47 in cancer), the analysis showed only a 20% to 25% confirmation rate.

The conclusion is obvious.  You can't take the literature at face value.  You need to do the work to confirm which targets in the literature will actually be reproducible and it appears that rate will be well under 50%.  Keep that in mind when investing in new targets!

 

Posted by Bruce Lehr Sep 2nd 2011.

Roche Will Lead With Companion Diagnostics' Drugs

According to CEO Severin Schwan, Roche will continue to produce new drugs that have companion diagnostics.  He says he expects these products to become a much bigger percentage of the Roche pipeline -- more than 50% of the portfolio by next 10 years -- and account for higher percentages of revenue too.  Schwan says Roche has a good head start in this field as it has a strong diagnostics group that it began leveraging earlier than competitors.

"We believe that by having it integrated at a very, very early stage, we have a competitive edge," Schwan said.  He also said that everyone has to follow the science to be successful in pharma and that the revolution in molecular biology has provided new understanding that will enable Roche to keep coming up with innovative products. Schwan says cancer treatments, like Herceptin and newly approved Zelboraf, have benefited from these targeted drug approaches in defined populations and asthma patients may be next to realize these benefits with Roche's coming lebrikizumab. 

Schwan finishes by saying these more niche drugs can still be blockbusters (> $1 billion  in sales) as they deliver great benefits to the patients they treat.  Targeted drugs will also eliminate unneccessary testing and treatment of patients who won't be responsive which will save money and protect these patients from unnecessary side effects. He believes that healthcare policy makers will recognize this and be willing to pay a premium for drugs that deliver the goods in terms of real patient benefit.  See Fierce Biotech and Reuters. 

 

 

Posted by Bruce Lehr Sep 1st 2011.

 

"Benleasta" Leaves Door Open for Lupus Players

Analyst Yaron Werber says Human Genome Sciences new lupus drug Benlysta is being used right now but the door is open for better drugs to enter.  Benlysta is the first lupus drug in 50 years so specialists are prescribing it, but according to Yaron are not bowled over with its clinical benefits.  He says docs will be open to switch as soon as the next drug comes along with a better clinical profile.

Duh! That's true of most drugs.  It would be better to know more about what is specifically lacking in clinical performance with Benlysta.  In any event, Werber has downgraded sales estimates and the consequent HGS expected stock price.  Investors seem to be paying no attention though. See Fierce Biotech story.

Posted by Bruce Lehr Aug 30th 2011.

Roche CEO Whips Up Excitement for Company Pipeline

Roche Ceo, Severin Schwan is out beating the drum for Roche's next series of pipeline candidates that the company is counting on to drive revenue growth even as it is losing some drug sales to generic competition.

Schwan says analysts and other commentators are being premature in saying that all the low hanging fruit has been picked (and eaten).  He says, "I believe there are enormous opportunities in this industry as we are only now beginning to understand how diseases are working."  Schwan stays true to his mantra that continued investment in R&D will pay off for Roche's future pipeline.

Next out of the shoot are several drugs that Roche management and the investment community are counting on as the next Roche blockbusters and revenue drivers.  These include:

• Metmab for the treatment of lung cancer
• Lebrikizumab for the treatment of asthma
• Pertuzumab for the treatment of breast cancer (to be filed in the US and EU in 2011)
• Dalcetrapib (a CETP inhibitor) to boost "good cholesterol"

Roche also has its recently approved melanoma drug, Zelboraf to drive sales.  Dalcetrapib is being picked by some analysts as the next mega-blockbuster with peak annual sales estimates ranging up to as high as $6.8 billion.  However, others view it as a potential cautionary tale as Merck is also targeting this indication with its drug, anacetrapib.  Pfizer's entrant into this category, torcetrapib, has already gone down in flames and may not bode well for the other similar drugs.

Nevertheless, Roche has a big bet on its next pipeline candidates and odds appear to be in its favor that some will prove their worth as big revenue drivers.  See the WSJ, Fierce Biotech 1, and Fierce Biotech 2. 

 

Posted by Bruce Lehr Aug 22nd 2011.

eHarmony for Drugs at Stanford?

According to piece in Fierce Biotech today, researchers at Stanford University have come up with a new way to try to match drugs coming off patent with new diseases and indications.  They likened their matching algorithms to online dating services, i.e. matching a drug's mode of action with disease symptoms it would be likely to affect.

Preliminary studies identified two old drugs that had positive attributes in animals, including an ulcer drug that might have effects against lung cancer.  These type of studies would fit into the NIH's new translational medicine intiative to get new drugs to market faster.

Drug-discovery investigators generally responded warmly to the research.  Certainly, finding a new use for an old drug has the potential to save money and get to market much quicker - especially if the Feds will support the program's funding.  It could be the perfect date.

Posted by Bruce Lehr Aug 18th 2011.

 

 

Pfizer Does Another Academic Development Deal With UCSD

Pfizer has done it again.  The biggest of Big Pharma has signed another development deal with a US University as it attempts to build a discovery model that takes advantage of academia. The news marks Pfizer's expansion of its West Coast Center for Therapeutic Innovation, following announcements for Boston, New York and San Francisco. This latest deal will provide the University of California at San Diego $50 M in funding over the next 5 years.

Pfizer established its Centers for Therapeutic Innovation (CTI) as part of a drive for more open, collaborative, and entrepreneurial-minded research, with the goal of dramatically slashing years from the time spent in drug development.  Pfizer's goal is to cut down the academic development stage to a fraction of the eight-year average. The partnership is intended to build on the expertise in translational medicine that UC San Diego boosted last year, when its Clinical and Translational Research Institute received a five-year, $37.2 million award from the National Center for Research Resources, part of the NIH.

The partnership will open some of Pfizer's antibody libraries to UC San Diego scientists to help support the pre-clinical and clinical development of sponsored programs. Pfizer grants intellectual property rights to its partners, who also are granted milestone payments and royalties based on how well drug candidates advance in the pipeline.  See Xconomy and Fierce Biotech.

These early-stage academic programs are a central feature of Pfizer's new approach to drug development as the pharma giant chops billions of dollars out of its R&D budget. With major R&D centers slated to be shuttered or scaled back, Pfizer is trying to establish an open ecosystem for R&D, where collaboration is a centerpiece of drug development work.

 

 

Posted by Bruce Lehr Aug 8th 2011.

Pharma Mega-Mergers Bad News for R&D Productivity

Former Pfizer R&D Chief John LaMattina says pharma mega-mergers may have made some sense in terms of short-term business rationale but were/are devastating to the R&D function.  He points to several factors that have negatively impacted industry R&D productivity:

• Merged companies slash R&D spending and close entire R&D sites (to help pay for merger)
• The number of companies has been reduced from 42 to only 11 (from 1988 to 2011) resulting in less diversity in the pipeline
• Many companies used to pursue the same targets which increased chances of someone being successful - pipelines are now less broad
• He says there is a correlation between the number of companies and the number of new drugs
• Unlike the past, mergers now result in R&D cuts in personnel, spending and programs
• Historically, companies prided themselves on spending 20% of sales on R&D - now that figure is approaching 10 to 11% at companies like Pfizer
• Mergers tend to freeze pipeline advancement -- especially in earlier stages than phase III as merged companies sort out pipeline and "rationalize"
• Enduring large and potentially multiple mergers, with associated stops and starts, has big negative impact on employee morale and motivation

He finishes his discussion by noting Lilly's Lechleiter has eschewed mega-mergers as a growth strategy, and Merck's Frazier has opposed R&D cuts to satisfy short-term return desires from Wall Street.  He hopes other industry leaders will take note.

His final thought is that industry consolidation has resulted in less competition and less investment in R&D. At a time when there is a major need for new treatments for conditions such as Alzheimer's disease, drug-resistant infections and diabetes, such a trend is alarming.  See Nature Reviews Drug Discovery.

Posted by Bruce Lehr Aug 2nd 2011.

Pipelines Emptying, Costs Rising, What's Big Pharma To Do?

From the Pharmalot blog yesterday, Big Pharma is facing the dual problem of emptying pipelines and rising costs for developing new drugs - largely from increasing costs of doing trials. Why? There is increasing competition for trial sites and clinical research organizations that can yield reliable, high quality data, according to a recent survey of 21 drugmakers, 12 biotechs, nine device makers and 23 contract research organizations.

Those surveyed pointed to higher costs for enrolling patients, higher vendor fees and expenses for recruiting trial sites, and technology costs.   Staffing for drug development is also rising.  Phase IV staffing increased by 85 percent from 2008 to 2011, while Phase IIIa doubled. Phase IIIb staffing rose 57 percent, Phase II staffing jumped 106 percent and Phase I staffing spiked 108 percent. 

Average per-patient trial costs across all therapeutic areas, in Phase I, costs rose from $15,023 in 2008 to $21,883 in 2011. In Phase II, the cost rose from $21,009 to $36,070. In Phase IIIa, the cost increased from $25,280 to $47,523 and in Phase IIIb, cost jumped from $25,707 to $47,095. Finally, Phase IV expenses rose from $13,011 to $17.042.

“Everybody is working hard to control those costs. The biggest thing on the horizon is trying to get a handle on earlier go-no-go decisions,” Cutting Edge chief operating officer Adam Bianchi tells us. “The competition for quality sites is creating a lot of headaches. You have a greater number of sites worldwide than ever before, but not all are yielding quality data that companies want.

So we not only can't find enough new drugs, but we are also having trouble finding quality sites to cost-effectively test them.  More cheery news from the drug development front.

Posted by Bruce Lehr July 28th 2011.

 

Target-Approaches Still Miss Bull's Eye

From In the Pipeline today, there is a report on a study that looked at success rates of phenotypic screening (cell or bio assays) and target-based approaches for discovering new drugs -- 100 were discoverd via targeted approaches and 58 through phenotypic screening.  

In examining the results from first-in-class small molecules, 28 were discovered via the screening route and 17 by targeted approaches -- despite a strong preference by the industry for the latter approach.  The authors concluded that without adequate knowledge of the mechanism molecular of action (MMOA), the targeted approaches were not as effective and led to higher failure rates. They called into question the notion that all targets can provide the basis for a drug (industry paradigm).  The extreme focus down this path may result in less effort being applied to develop relevant screenign assays which in fact could be more effective as a discovery tool. 

The blog author (Derek Lowe) concludes that the NIH's translational medicine initiative may be able to add value if it devotes more effort to the development of relevant phenotypic screens.

Posted by Bruce Lehr July 7th 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.

Lilly Goes to Multi-specific Therapies

A Lilly spokesman said the company will invest multi-millions in its biotechnolgy programs in order to develop new multi-specific therapies for a variety of diseases. Multi-specific therapies use molecular biology techniques to combine more than one drug "mechanism of action" on a single drug molecule.  This differs from combination therapies which involve more than one drug.

Lilly plans to hire more biochemists and biologists to support this research effort.  Therapeutic areas to be pursued include diabetes, cancer, and autoimmune diseases where often one drug is not sufficient to effectively treat the disease. See Bloomberg.

 

 

Posted by Bruce Lehr July 5th 2011.

Lechleiter goes to Bully Pulpit to Back R&D Spending

Lilly CEO John Lechleiter again spoke out in favor of continued R&D spending to position Lilly for growth by 2014.  In marked contrast to many of his peer CEOs in Pharma, Lechleiter vigorously has resisted cutting R&D and termed it "nuts" to reduce R&D spending in an industry that is "development-based" and meant to look to "long term investment". 

Lilly says it is well positioned to recover (It is expected to see net income go down next year) by 2014 as it has grown the number of mid- to late-stage projects in its pipeline to 33 from 6 only six years ago. Lilly plans to take 10 new drugs into late phase by the end of 2011.

"Our progress in R&D....has built an R&D engine with global reach that can deliver new medicines accepted by regulators, reimbursed by payers, and benefiting patients, while generating a positive return for shareholders over the long term," said Lilly's Jan Lundberg, executive vice president, science and technology.  See Fierce Biotech.

Well, Lechleiter has remained consistent.  He clearly is backing a position that is not shared universally among his peers -- though Merck has similarly maintained R&D spending.  It's a position counter to many/most shareholders lobbying efforts -- twhich is to cut.  Lilly has at least two tough years to negotiate before this program can kick in with increased revenues.  We'll see how it goes.  It should be a bumpy ride but Lilly may emerge looking really good.  Or it may be acquired sometime during the next couple years when it is down.

 

 

Posted by Bruce Lehr June 30th 2011.

R&D Spending In India Is Projected To Mushroom

A recent Boston Consulting Group (BCG) study has projected that R&D spending in India will increase from $2 B last year to more than $25 B by 2025.  Much of this increase will be attributed to Big Pharma in the West shifting work to India.  In BCG interviews with 40 Big Pharma Execs, 70% indicated they were happy with their alliances in India and 75% said they expect to increase activities.

R&D Spending In India Is Projected To Mushroom // Pharmalot.

The reasons behind this shift are not hard to fathom:

• Lower costs.  Trials currently run 60% less than in the US.
• Good pool of treatment-naive patients. India sites also recruit 4x faster.
• Growing pool of qualified researchers

Among drugmakers, Pfizer, GSK, Lilly and Novartis ran the most trials -- together accounting for about 1/3 the total in India.  I guess Lechleiter is Ok with farming out all clinical trials despite all whinging about immigration policy and working in the US.

The most cited impediments to doig even more work in India, include: lack of coordination with alliance partners, insufficient support from senior management [at partners], and differences in executing plans. Regulatory uncertainty and the intellectual property landscape are also viewed as somewhat unsettled. None of this seems to be slowing down current growth -- and you can likely expect that to be maintained until cost advantages start leveling out as compared to the West.

 

 

 

 

Posted by Bruce Lehr June 29th 2011.

 

Pharma R&D: Don't Let Me Down

Well, here's an unwelcomed graph from the In the Pipeline blog.  It depicts R&D productivity in the pharma industry from 1950 to present day in inflation adjusted dollars -- and shows NMEs per $billion R&D spend.  Guess what? 

The trend has never been anything but down, down, down. It's steady, predictable and inexorable.  It would be great if we were talking costs or time to market but we're talking about productivity.  Yikes!  The reaction?  For the first time in 2010, the Big Pharma industry saw an absolute drop in R&D spending.  In 2010, about $68 B was spent as compared to $70 B in both 2008 and 2009.

It makes one wonder if all the talk about R&D models and new means of discovering drugs with academic or biotech partners can reasonably be expected to bear fruit -- at least in terms of higher efficiencies or productivity? 

 

Posted by Bruce Lehr June 28th 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.

PATH and GSK Team Up on Malaria

PATH, the non-profit group working to develop vaccines for developing countries, scored again with an announced collaboration with GSK for a vaccine against Malaria. The second generatin vaccine with combine a single dose vaccine from J&J's Crucell followed by two doses of GSK's RTS,S vaccine.  This is known as a 'prime-boost' strategy. See Xconomy.

Previously I've written about PATH's success in developing a meningitis vaccine and its subsequent deployment in African populations with the funding assistance of GAVI.  Now PATH is -- dare I say it -- moving down the path to attack malaria.

 
Posted by Bruce Lehr June 7th 2011.

 

Foundation Medicine Cuts Another Deal -- This Time with Celgene

Xconomy tells us today that Foundation Medicine has established a 2-year deal with Celgene to develop advanced cancer diagnostics - a deal very similar to one cut earlier this year with Novartis. The concept behind the Celgene deal is to develop tests that will help Celgene idenitify patients who are most likely to respond to the company's cancer therapies -- basically a companion diagnostics deal.

The deal will enable the two companies to chase the developing paradigm that new cancer therapies (and therapies for other diseases) should be tailored to individual patients.  Said Michael Pellini, Foundation's new CEO, "This test is not a static offering. As our knowledge changes, we will continue to refine it. What Foundation is doing is the next generation of cancer diagnostics. It's a taste of things to come in our industry."

I believe that sentiment is correct. All forces seem to be driving drug companies to make more targeted therapies that show clear patient benefits -- to receive regulatory approval and third party reimbursement.  These type of partnerships should become more common. 

Posted by Bruce Lehr May 17th 2011.

Big Pharma Deals Made to be Broken

Today Fierce Biotech published a piece from BioWorld that shows an analysis of Big Pharma deals with Biotechs for drug development that have been terminated since Jan 2011 - so far there have been 13 this year.  This represents an increase from 8 over the same period in 2010.  Four partnership dissolutions have been announced this week alone (which nearly accounts for increase total over 2010).

The analysis for "done deals" was performed at Deloitte Recap LLC coverign the period 1977 to 2010 and looked at 474 alliances that were terminated prior to reaching commercialization.  The reasons cited for termination can be grouped:

• 38% of deals were stopped due to reprioritization by the pharm partner
• 37% had an issue with either efficacy or safety of the product in clinicals
• 7% were stopped for "lack of diligence" - code for not enough commercialization effort beign made
• 7% were due to M&A activity - usually the biotech involved was acquired and pharma took opportunity to back out
• 15% were stopped for the dreaded "other" -- usually lack of progress with one partner buying up project

Most projects died in phase II (29%) or in phase III (35%).  However dissolution of the partnership didn't mean the project died.  In fact, 55% of the drugs involved in these failed marriages are still alive -- which 42% of that total finding a new partner.  So nearly 25% found new backers.

Analysts say more of this can be expected as Big Pharma continues to scrub its pipeline and cut costs.  They note that many of the projects were started many years ago and are just reaching phase II or phase III where some attrition will occur. With cost-cutting, pharma isn't waiting as long for bad news and is cutting its perceived losses earlier rather than fund "higher risk trials".  A penny saved is a penny earned so to speak.

Posted by Bruce Lehr May 16th 2011.

Pfenex and MedImmune partner on early stage proteins and vaccines

Pfenex and MedImmune will partner up in a three year pact to use Pfenex Expression Technology to develop bioprocesses for MedImmune human therapeutic proteins and vaccines.

Pfenex expression technology to engineer production strains for MedImmune's proteins and vaccines.

Pfenex will engineer production strains, using its Pseudomonas fluorescens organism, broad tool box, and high throughput robotically enabled strain screening platform, to express MedImmune lead molecules. Pfenex claims that it routinely can go from DNA to an identified production strain within 8 weeks.  MedImmune will carry forward preclinical and clinical development. 

MedImmune senior vice president of biopharmaceutical development, Gail Wasserman said "Pfenex's scientific approach to strain development and protein expression is robust and aligned with the way  we work at MedImmune."

The Pfenex system utilizes defined development and production media that are free of animal proteins. The platform has been accepted by US and international regulatory agencies in multiple human clinical trials up to Phase III currently in progress.

 

Posted by Bruce Lehr May 12th 2011.

Pfizer says R&D Should Shrink

This from the In the Pipeline blog quoting Peter Corr, former Pfizer head of global development. "Big Pharma should get smaller."  That's an $8 billion dollar education speaking for the school of hard knocks.

Corr further expands on this, "We needed .....[to] keep smaller R&D sites and let them go on their own. Let them be funded independently.  Let them define how they can work best at their particular site as opposed to manage all of these sites around the world and pretend that we knew what was actually going on."

In other words, Pfizer should have followed this Elizabethan business model for pharma:

 
Big Pharma they say has lost its way.                                                                             And can't tell how to find it.                                                                                     Leave them alone and they'll come home.                                                                       Bringing more drugs to market.

Posted by Bruce Lehr April 25th 2011.

Sanofi and Stanford Form Alliance

Sanofi has signed another development agreement with a university (to go with deals at Harvard University and The Charite University in Berlin), this time with Stanford's Bio-X program.  

Sanofi, Stanford Form Alliance.

The multi-year deal calls for a Stanford and Sanofi-Aventis joint steering committee to fund up to five programs per year. Sanofi may also host post-doc fellows at the company while Stanford may invite Sanofi researchers to be visiting scholars. Sanofi will also fund an annual research forum to bring the two groups researchers together.

"Our approach to research and development must ensure we are at the center of the most innovative science, whether inside our own walls or through external partnerships, in order to continue to advance scientific knowledge and address patients' unmet medical needs," said Dr. Paul Chew, Senior VP, US CSO and CMO, Sanofi-Aventis US.

These is in keeping with CEO Chris Viehbacher's public statements that Sanofi will continue to look to outside partnerships to increase R&D innovation and will de-emphasize doing it all internally as in the past.

Posted by Bruce Lehr April 18th 2011.

Pfizer Releases Top Line Data on Novel RA Drug

Pfizer got some good news from the clinic on its novel rheumatoid arthritis drug, tofacitinib,which met its primary endpoints in a phase III study. Patients symptoms improved signifcantly and structural joint damage was slowed.

Pfizer Releases Top Line Data on Novel RA Drug.

The novel drug, a JAK inhibitor, will move into an area currently dominated by TNF inhibitors like Enbrel (Amgen), Humira (Abbott) and Remicade (J&J/Merck).  Pfizer will release more data at an upcoming meeting. It will be interesting to see how analysts rate this drugs revenue chances versus formidable competition in the RA arena.  Regardless it is good news for Pfizer I'm sure to have one perform well in phase III.

 

 

Posted by Bruce Lehr April 15th 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.

 

Vertex and CF Foundation Team Up

The Cystic Fibrosis Foundation today agreed to fund two CF drugs in Vertex Pharmaceuticals pipeline to the tune of $75 M.  The deal is for 5 years and will support R&D activities on two drugs, VX-661 and VX-809. In return, the CF Foundation will also receive royalties on future drug sales.

VX-661 will enter phase II trials later this year and VX-809 is at an earlier stage of development. Both drugs seek to increase CF transmembrane conductance regulator (CFTR) protein function by increasing the protein's movment to the cell surface.  Missing or defective CFTR proteins are the underlying cause of CF.  See Fierce Biotech.

In February, Vertex announced good results with its CF drug VX-770 in a phase III trial conducted with a subtype of CF patients -- who account for about 4% who have the disease.  Vertex expects to file an NDA on this drug later this year.

 

 

Posted by Bruce Lehr April 8th 2011.