The Big Red Biotech Blog

More Opinions on Drug Development Costs and Innovation

The article on "innovation crisis myth", replete with its low estimates for drug development costs, that appeared in last weeks British Journal of Medicine sparked more than a little commentary from various quarters.  As an emotional issue, this one resonates well. 

Here is Derek Lowe's post on this In the Pipeline as well as today's response from the BMJ articles co-author Donald Light. Derek is a vocal critic of the low ball drug development cost estimates.  Dr. Light, as is his wont, sticks to his guns and repeats his claimed cost of $43 M for the "net, median corporate cost of Development". 

You can read both their points and decide who you think is closer to correct.  Despite the heavy qualification of what Dr. Light's figure purportedly represents, I still think he is way low (by a factor of 10). Though he likely is also correct about the $1.3 B industry figure as being grandly inflated -- which of course leads to a ripe ground for controversy. 

PhRMA also has a dog in this fight so I will link to their statement on the debate as well as comments from PharmTech Talk.

Posted by Bruce Lehr Aug 13th 2012.

Towards Pharmageddon?

More salvo's in the battle over whether the "innovation crisis" in pharma is due to inherent difficulties and costs in bringing new drugs to market or whether it is caused by pharma companies choosing to pursue more "sure thing" me-too products. 

The pharma shoots-too-low crowd, Donald Light from the University of Medicine of New Jersey and Joel Lexchin from York University in Toronto, opines in the most recent British Medical Journal that the situation has remained the same for 50 years. The incentives for drug development are wrong and have skewed the behaviour of the industry.

They claim more is spent on marketing (25 per cent of revenues) than on discovering new molecules (1.3 per cent). Drug industry claims that the cost of bringing a new drug to market is £1bn and is unsustainable are exaggerated, they claim. Research and development costs did rise substantially between 1995 and 2010 by $34.2bn (£21.9bn), they concluded, but revenues increased six times faster – by $200.4bn.

Towards Pharmageddon? The last (lost) decade .

They add that up to 80 per cent of drug spending is used by the industry on promotion. The authors call for licensing authorities around the world to stop approving new drugs of little therapeutic value. They suggest large cash prizes should be awarded for genuinely new therapeutic agents in lieu of patent protection.

In a second paper, researchers from the London School of Economics in the UK argue that drug manufacturers should be made to demonstrate that their products are superior to existing treatments before being granted a licence, rather than, as now, superior only to a placebo.  In other words, comparative effectiveness should be used to justify adding new drugs to the approved menu. 

With regard to magnitude of costs/profits, I believe the truth lies somewhere in between.  Drugs do cost a lot to discover and bring to market.  But drugmakers do spend on lot on marketing to justify me-too drugs -- and could channel some of this toward developing more novel therapies with better patient benefits. 

I suspect we will see a coorection as more regulatory and 3rd party payer incentives are put in place toward getting novel drugs to treat unserved diseases.  Economics is going to prevent us from continuing down the me-too route as these drugs increasingly will find it toughter to gain approval and to get reimbursement consideration. 

Do we really need 17 beta blockers or just one new Alzheimer's drug that actually works?

Posted by Bruce Lehr Aug 8th 2012.

FDA Approvals: ‘We Are Back On Track’

The FDA patted itself on the back for meeting its PDUFA review cycle targets (>90%) on New Drug Applications (NDAs) and Biologics License Applications (BLAs) for the past two years.

FDA Approvals: ‘We Are Back On Track’ // Pharmalot.

With PDUFA V just waiting to be signed by the President, the agency is supremely confident in its ability to keep the ball rolling.  Through June 18th this year, CDER has approved a higher percentage of NME applications (12/15) - one third of these for rare diseases continuing a strong trend.

The median approval time for NMEs and NBEs reached 9.9 months in 2011 slightly bettering 10 months in 2010 and beating the 13 months seen in 2009 and 2008.  Faster is better.

Posted by Bruce Lehr Jun 28th 2012

Can Pharma Win the Alzheimer's Lottery?

According to the Wall Street Journal's interview of several wise guys in the institutional investment community? NO.

Wall Street Doubt Pfizer & Lilly Alzheimer’s Meds // Pharmalot.

"These drugs are long shot lottery tickets."  "Not playing. A fool's game. I have no confidence that we are anywhere near the technology to address the disease." "It's too critical not to be there -- risk/reward for the pharma group is still skewed to the upside."

Needless to say, we can be thankful most analysts aren't drug developers. They're not likely to be successful with that skepticism quotient.

In the meantime, Lilly and Pfizer keep plugging away in Phase III studies with solanezumab abd bapineuzumab respectively.  Both are expecting key results late this year.  At that time, we'll see if either has won their bet (as well as the patients targeted for therapy). If not?

The analysts say Lilly stock will drop to $37.40 (12%) and Pfizer will go down to $21.30 (6%).  And Lilly's Elan would plummet 30% to $9.80.  Just some more cheery news for your weekend.

Posted by Bruce Lehr Jun 22nd 2012.

Is Cancer Research Focused on Too Few Targets?

Just when we were all pumped about the news coming out of ASCO this week, leave it to the Life Sci VC blog to throw us a curve by pointing out how concentrated the pharma industry's efforts are with regard to cancer targets being investigated.  And, Bruce's argument is supported by facts and data. I hate that. I try to never let the facts get in the way of a good story.

The blog post notes that of the 990 cancer programs, greater than 20% are aimed at 8 targets, each of which has more than 24 programs in clinical development. VEGF itself has 70!  The data is presented in a bar chart in the post. By Bruce's estimates, $5 B+ has been spent in the past few years on these programs.  He points out that they ALL can't be winners.  This appears to be an egregious waste of resources at the expense of more novel but unproven targets.

This illustrates one of the problems we've been seeing with the lack of productivity of Big Pharma R&D as embodied by failed programs and low ROIs.  There's a lot of me-too thinking that undoubtedly arises out of a desire to reduce risk and increase success -- but the calvary charge of projects concentrated on a few targets virtually guarantees a lot of commercial failures.  Only so many people can fit in the pool before it overflows.

It is an interesting post and I think you should read it for yourself.  He concludes the pieces by saying,

"We need to stop being target lemmings, or our group-think and risk avoidance will run our industry off a cliff."  Now that's something to ponder (and correct if you agree) before it's too late.

Posted by Bruce Lehr June 7th 2012.

 

FDA Tilts Positively Toward Accelerated Approval of "Breakthrough" Drugs

From Fierce Biotech (via Reuters), a new law is expected this year to allow the FDA to approve breakthrough drugs more quickly by allowing applicants to conduct speedier trials with fewer patients. The system would be modeled on the speedy approval process used for HIV treatments decades ago.

The FDA has approved several drugs recently in accelerated fashion, including Vertex' Kalydeco for CF, Pfizer's Xalkori and Roche's Zelboraf for skin cancer. Dr. Woodcock, the FDA's director, has been vocal in her advocacy for giving the agency the latitude to make fast approvals for drugs that show breakthrough promise in the clinic -- particularly for serious diseases with few treatment options.  The drugs, of course, would have to pass safety muster as well.

Posted by Bruce Lehr May 9th 2012.

 

New Drug Development Financing Tool?

Andrew Lo, an MIT finance engineering professor, when he floated idea of funding new drug development with CDOs -- collateralized drug obligations.  The CDOs would be able to invest in a series of drug development projects that would pay returns if they resulted in successful treatments reaching the market.

The idea would be for investors to put up $50 B to $100 B to fund 150 drug projects over 10 years.  Hopefully, this would be another funding mechanism and would relieve pressure on getting all the funding from government sources, weakened VC networks and Big Pharma itself.

Naysayers may point out that the CDO concept didn't work out too well for housing and mortgages -- but Lo counters that he forsees a big funding gap for drugs in the coming years and that this would mean a drop in new treatments. 

Lo says, "If there's a cancer bubble, I can live with that."  I don't know if CDOs are viable but I like the novel thinking to bring an idea like that to the table for consideration. See Fierce Biotech.

Posted by Bruce Lehr May 4th 2012.  

NIH Cuts First Translational Science Deal

Yesterday, Francis Collins announced that the NIH has secured a deal with Pfizer, AZ and Eli Lilly to collaborate on existing compounds to look for new uses (disease treatments) for them. The four-way partnership will be led by the NIH's new National Center for Advancing Translational Sciences (NCATS).  Collins of course has been a major proponent of the center and the need to speed up the pace at which discoveries are turned to medicines.

This pilot program has legal templates established among the players which should clear IP hurdles that could bog things down. The rationale for looking at exisiting drugs is that sometimes a drug developed for one disease does work for another -- e.g. AZT developed for cance rbut was ultimately applied to AIDS.  These existing drugs have many times also undergone previous safety testing so not having to redo safety work can also speed the development process.

Collins is excited to get started. He notes that researchers have identified the causes of 4500 diseases but only 250 have developed treatments.  Collins says, "The future has never looked brighter in terms of the promise of biomedical research, but we have to be smarter than ever, and we have to look for new partnerships."

It is expected that other members of Big Pharma will join the party when the pilot program gets underway and especially if it bears some early fruit.  See Xconomy and Fierce Biotech.

Posted by Bruce Lehr May 4th 2012.

Tufts Report on Academic-Biopharm Partnerships

A new Tufts Center for the Study of Drug Development study shows academic medical center (AMC) and biotech partnerships are increasingly important to basic research and developing new medicines. The study looked at 3000 grants to AMCs from 450 biopharm sponsors through 22 medical schools. Their conclusion is that the nature of these partnerships is continuing to evolve and that they have not yet reached their full potential.

The report looks at 12 primary partnership models of AMC-biopharm collaboration. There is a shift occuring toward more risk- and resource-sharing models rather than the more traditional unrestricted research or fee for service models of the recent past.  Rather a range of partnership models is arising from corporate venture funds to pre-competitive research centers to academic drug discovery centers.

The report concludes that in the face of an increasingly challenging R&D environment (often discussd here) and overall global competition, we are likely to see the continued proliferation of AMC-biopharm partnerships.

See full report. Download Tufts AMC-biopharm R&D study

Posted by Bruce Lehr Apr 30th 2012.  

Big Pharma Revenue Holes: How Low Can You Go?

Derek Lowe reminds us that some of the Big Pharma companies out there have BIG BIG BIG revenue holes to fill between now and 2020.  Take a look at both Lilly and AZ's challenges ahead. Though Pfizer ain't far behind itself. Looks like AZ's whether by his choice or the board's go out while the getting's good.

See here for yourself!  The graph shows Big Pharma's expected revenues through 2020 on its existing product portfolio.  Lilly and AZ?  All we can say is "OUCH".

Posted by Bruce Lehr Apr 30th 2012.

Pharma R&D Follies

Here's a couple of links to blog posts outlining possible reasons that Big Pharma R&D is experiencing such a low return in bringing new products to market --- especially over the last 10 years.  One factor that is discussed is -- CULTURE (see Life Sci VC and In the Pipeline). 

The basic premise?  

Fundamentally, I think the bulk of the last decade’s productivity decline is attributable to a culture problem. The Big Pharma culture has been homogenized, purified, sterilized, whipped, stirred, filtered, etc and lost its ability to ferment the good stuff required to innovate. This isn’t covered in most reviews of the productivity challenge facing our industry, because its nearly impossible to quantify, but it’s well known and a huge issue.

These effects are variously attributed to a multitude of large cross functional committes, with all their associated bureacracy, making all the decisions very s-l-o-w-l-y......, risk aversion (i.e. ass covering) and unwillingness to kill bad projects before they've dragged on past their due date, and mega-mergers or internal reorgs that constantly stall projects while all the new players and pieces get assembled and reassembled. All of this plays havoc on continuity, quick decision making, empowerment of development teams, nimbleness, innovation, blah blah blah --basically all the positive characteristics organizations say they are striving for.

But the basic conclusion, for now, is that Big Pharma's culture is its own worst enemy when it comes to R&D productivity.  There seems to be a need to simplify and empower teams if you really want to see any results in an acceptable time frame.

The stakes are high too. If you doubt that, just look at this article from Fierce Biotech that details the R&D spending of the Top 10 Big Pharma -- which is topping $70 B per annum now.  Then look at the productivity of many of these same organizations as judged by new drug introductions in the last 10 years........not very pretty.

Posted by Bruce Lehr Apr 25th 2012.

 

Open those Drug Freezers!

Francis Collins continued to promote his concepts around translational medicine in comments posted in the WSJ Health blog this week.  He compared the need to connect basic science knowledge with practical  applications useful to treating disease as "less like buiding the Golden Gate bridge across a body of water to more like the obstacles a swimmer, sail boat or tug might face attempting cross that expanse and its hazards (e.g. sharks, reefs, storms, etc) ".

He opined that translational efforts could be speeded by encouraging all drug comanies to "open their drug freezers".  That would allow the world to test all compounds that have already been found to be safe and active against other targets (since they failed against their original targets) in an attempt to repurpose these drugs.  Having passed the safety hurdle, the drugs could then slot into phase II trials for the new indications.

Nice idea were it that simple.  It would be an interesting experiment to see if it actually did result in new therapeutic options.  Alas, the IP questions that abound from the major pharma companies keeps this experiment on the drawing board for the moment.

The NIH has a drafted a model agreement and they’re working to get drug companies to sign on, he said.  I, for one, would like to see this idea tried if for no other reason than to satisfy my curiosity as to whether it could work. It sounds almost too good to be true -- that we could actually benefit from a lot of science that has already been completed and paid for....

Mr Big Pharma, Let Those Drugs Go. Tear Down that Wall.

Posted by Bruce Lehr Apr 12th 2012.

Is it Safe to go FAST with Drug Approvals?

Xconomy's Luke Timmerman wrote a post today in his blog about the FAST (Faster Access to Specialized Treatments) legislation that is currently in the House. Advocates of FAST are pushing for more drugs to be approved sooner by FDA for serious diseases -- that is after they've been shown to be safe and likely with some sort of surrogate endpoint data pointing to their possible effectiveness. Proponents liken this to speedier approvals given to AIDs drugs during the early days of that crisis.

The conundrum for regulators of course is if they approve drugs more rapidly without as much efficacy data, there is a possibility that the drugs may not perform as advertised in real (and usually larger) patients populations (ala Avastin for breast cancer).  The quid quo pro for this type of program therefore has to be the industry's diligence in doing and reporting post-market follow up.  Less than sterling drugs could then have their approval revoked.

The post also quotes people like Alnylam's CEO, John Maraganore, as being an advocate as it may offer his company a way of getting drugs to market faster and at less expense in more abbreviated clinical trials. Maraganore argues this in turn woudl make investing in smaller and mid-sized biotech's more attractive -- due to lower costs and heightened regulatory predictability. 

An In the Pipeline piece this week, points out the problems the drug industry has had with it's productivity as fewer and fewr drugs are introduced at greater and greater expense -- a sort of reverse Moore's law or Eroom's Law as th epost explains.

In addition to FAST in the House, the Senate has its version too, known as TREAT (Transforming the Regulatory Environment to Accelerate Access to Treatments). It looks like this idea's time may have come - and with desires to reduce health care costs, and boost the health of the US Biotech industry momentum is building to give this idea a try.

Posted by Bruce Lehr Mar 12th 2012.

More Drug Repurposing Success?

This is an interesting post from Fierce Biotech this morning. It seems investigators tested the Novartis cancer drugs Gleevec and Tasigna against Ebola virus.  Surprisingly (perhaps -- this must have chosen to test for some reason), the drugs did show some effectiveness against the virus.  Tasigna slowed viral reproduction by 10,000 fold.

Both drugs block the activity of the Bcr-Abl protein (tyrosine kinase) in cancers which seems to slow spreading of the disease.  In the case of Ebola, the drugs block the c-Abl1 tyr kinase and thus blocked the spread of viral particles. 

The hope is that new similar drugs can be made to more specifically target c-Abl1 to further slow the disease and perhaps give the body's immune response a chance to stave off the infection enough to prevent death.  Currently 9 of 10 Ebola victims succumb. 

I think it is another interesting example of how know medicines might be repurposed to treat diseases that they were not orginally intended to battle.  With enhanced screening capabilities - real and virtual - we may be able to conitnue to find existing medicines that can be applied to the treatment of diseases without good alternatives.

Posted by Bruce Lehr Mar 5th 2012

GSK DPU Score 4-3 (or was it 6-5)?

GSK management today announced the results from its first 3 year review of its "novel" Discovery Performance Units.   DPUs were formed in 2008 as a means of focusing drug discovery activities in some defined areas and were intended to bolster the pipeline, control costs, and increase ROI in R&D.  GSK has touted them from time to time ever since, so how'd they do in this very first time review?

Drumroll please. Well of the 38 DPUs, 3 will be terminate and 4 new ones will be formed (so now we have 39).  Six (6) DPUs will receive and increased budget and 5 will have their budgets cut. GSK CEO Andrew Witty says he is "quite satisfied" with the results so far.  GSK reports that's its R&D ROI rose from 11% to 12%, while their target remains at 14%. The overall R&D budget meanwhile is supposed to stay flat at $3.7 billon.

More to the bottom line, GSK plans to file for approvals on 4 new drugs and vaccines in 2012, including Relovair for COPD, Promacta for hepatitis C, and trametinib for melanoma.  Six other DPUs have late stage projects. In the next three year cycle, 30 more programs are targeted to move into late stage development. See Fierce Biotech and In Vivo Blog.

Per usual in this industry, the jury will remain out on DPUs until more than a 3 year track record is established and until several high revenue generating drugs actually hit the market.  One might be cautiously optimistic at present.

Posted by Bruce Lehr Feb 7th 2012.

Sigma-Aldrich differentiates to HPAPIs for future

The market for production of small molecule APIs is becoming much more competitive - especially as these become more genericized and manufacturing moves to lower cost (for now) Asian suppliers.

Sigma-Aldrich looks to HPAPIs as generic sector heats up.

As a result, SAFC is moving its focus away from these more generic APIs and is focusing its efforts on the product of high potency APIs (HPAPIs).  SAFC has several new facilities that are geared toward this type of higher value more difficult manufacturing -- which separates its right away from some of the lower cost, less specialized manufacturers.  This capability allows SAFC to cater to drug developers working in cancer therapeutics with both HPAPIs and antibody drug conjugates.

Sigma-Aldrich CEO Rakesh Sachdev commented on this approach at the recent JP Morgan Healthcae Conference, "A greater percentage of [custom pharma] will become highly specialized offerings."  Sigma's focus will be "on very unique products" and this is driving our expansion in the high potency area to give ourselves a competitive advantage.

Posted by Bruce Lehr Jan 18th 2012.

 

Revenue Challenged Big Pharma Reveal Hopes to Cope

Both Merck and Eli Lilly were in the news today as two companies extremely revenue challenged due to expiring drug patents on top sellers with replacments not ready for prime time to pick up the slack.

Merck CEO, Ken Frazier, maintained that he was pushing his licensing group to pick up the pace to help fill in pipeline gaps -- and indicated he thought this was the future of the industry. He said Merck would be looking for early stage deals and in particular was interested plumbing the hepatitis C arena for new opportunities.  Merck is banking on its big bankroll in helping it see its was through this pipeline dip. See Fierce Biotech.

Lilly CEO, John Lechleiter, was more reduced to grasping at his pipeline to save him.  Lilly announced today that it expected to see a $3 B revenue drop from loss of patent protection on Zyprexa as the generics moved in.  Lechleiter continues to eschew big mergers and is banking on the 12 late-stage drugs Lilly has in its pipeline.  This did not prevent a price hit to its stock today however.  One big pipeline test that looms is for Lilly's Alzheimer's drug, solanezumab -- that's trial results should be shared in Q3.  There is a lot riding on this and one wonders what might happen to Lechleiter's plan (or even Lechleiter) should some of these key dozen projects go down. See Fierce Biotech.

One must remember though that Hope is not a Strategy.

Posted by Bruce Lehr Jan 5th 2012.

 

Amgen and Watson to Team on Cancer Biosimilars

As reported in Xconomy, Amgen and Watson have announced a pact to produce and sell cancer biosimilars together.  The companies didn't say which drugs they would be targetting other than to say they wouldn't be going after Amgen's drugs. 

Who does that leave? Roche's (Genetech's) Avastin? Herceptin? Rituxan?

“This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model, and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients,” Amgen and Watson said in their joint statement.  The products that this team introduces will be sold under a joint label.

Let the Games begin. Teva, Samsung/Biogen, Merck, Pfizer, Sandoz can't be too far in the distance.....

Posted by Bruce Lehr Dec 19th 2011.

 

Venture Funding Decrease is Big Pharma's Gain

From Fierce Biotech, it seems that big pharma has happily stepped into the funding void created by the collapse of venture funding for biotechs to do more deals earlier and cheaper than before.  Says Dan Zabrowski, head of Roche's drug partnership unit,  "We are doing around 50 to 60 partnership deals a year now, compared to around 30 deals per year before the crisis [of 2008]. Today, we start deals earlier with less upfront payments and share the risk with our partners."

Who says a funding crunch is so bad?  This is not exactly a hardship for big pharma.

Posted by Bruce Lehr Dec 12th 2011.

Glaxo Scientists ‘Live or Die’ With Project in Research Overhaul

Related to the previous post no doubt, three years ago Glaxo reorganized its R&D department into smaller, presumably more empowered and entrepreneurial units (called DPUs) to hopefully improve the level of success.  The catch?  The Discovery Performance Units are evaluated every three years to determine how well they've met milestones.

Glaxo Scientists ‘Live or Die’ With Project in Research Overhaul - Businessweek .

If they haven't met their goals?  Then they can lose funding, be disbanded and reassigned to other projects. It's the sink or swim approach to R&D.  The first three year cycle evaluation is upon us so we will get some idea as to how this is actually working -- or if it is working. Some rivals say the three year time line is too short.  We shall see.

Posted by Bruce Lehr Dec 4th 2011.

Drugmakers Go From Abundance To Scarcity

A new report from Oliver Wyman puts numbers to the dismal trend seen in Big Pharma R&D from 2005-2010 as compared to "boom" years of 1996-2004.  The down period was named the "drought" years and some of the more disturbing statistics appear below:

Drugmakers Go From Abundance To Scarcity // Pharmalot.

• R&D spending doubled to an average of $125 billion during the drought period, from $65 billion in better times. And the ROI dropped like a stone to an average of $75 million in sales during a product's fifth year for every $1 billion spent on R&D, down dramatically from $275 million in better days.


• The development drought also led to a declining economic value of approved drugs, to an average $430 million from $515 million. 


• Drug approval itself plunged about 40% in the dry years, amounting to 22 FDA approvals per year on average, versus 36 in the better years.


• Drugs produced an average of $9.4 billion in fifth-year sales in the dry period, half of the $18.3 billion during the more productive years. Fewer blockbusters and fewer new drugs overall contributed.


• In all, 17 of the 20 companies faced productivity declines, though Novo Nordisk, Bristol-Myers Squibb and Johnson & Johnson did better than most.  Dips in high levels of productivity hit everyone though.

What to do about it?

The paper's authors recommend raising standards for product innovation and working more closely with payers as they face pressures to hold down costs. They also want companies to treat new compounds as rare (don't take development success for granted), with focused investments that don't rely as much on speed to market, .i.e. actually create better products and understand more about their mechanism of action in treating disease.

Another recommendation: Play to win. This means using strategies like closely assessing the competition (to create novel products), seeking alternative financing and joint R&D efforts with other parties (including rival drug makers), and making everyone focus more on business development. (See Fierce Biotech).

Posted by Bruce Lehr Dec 4th 2011.

 

Those Returns On R&D Are Falling Fast

Here's one post (of many) reporting on the results of a new Deloitte study on the R&D productivity of the world's 12 largest BIG pharma companies.  As would be expected if you have been paying attention to talk of patent cliffs and dry pipelines, the results are not too pretty. 

Those Returns On R&D Are Falling Fast // Pharmalot.

Let me hit you with the Reader's Digest version of Deloitte's findings from last year:

• The average cost of bringing a drug to market rose by 25% to more than $1 B up from $830 M (note these figures are hotly disputed by others as "grossly inflated" and several posts on this site discuss the controversy)
• The number of late stage drugs in development dropped from 23 to 18 (22% decrease) per company on average
• Ten of twelve firms saw R&D ROI decline resulting in a group drop from 11.8% return to only 8.4%
• Two-thirds of the top 12 did realize "more value" from product commercialization than they lost in late stage failures (Thank God for minor blessings)
• Non-R&D costs declined across the top 12 to free up cash to go back into R&D

This analysis should be viewed as a snapshot and may or may not reflect a trend. Deloitee stated that more improvments need to be made, and suggested that "more collaboration" occur between companies to "pool" disease knowledge. In particular, sharing knowledge on failed molecules and approaches could be very helpful to industry learning. Drugmakers may also share "non-competitive" areas of R&D to reduce costs for all.  See more in PharmaGossip and Fierce Biotech.

Finally, In the Pipeline had an interesting post the same day talking about "what if" the principles espoused in Moneyball could be applied to the Big Pharma pipelines?  It's an interesting thought and one I'd like to see undertaken (at least do the math and assess predictive value as theoretical exercise).  Anyone got Bill James' phone number?

Posted by Bruce Lehr Nov 29th 2011

 

 

Novo Nordisk Stays True to China R&D Aims

Novo Nordisk senior execs state that their strategy to build a presence in China is centered on developing innovative new therapeutics. Staying true to that aim, they'll continue to steer clear of any big acquisitions in the growing Asian market.

Ronald Frank Christie, president of Novo Nordisk (China) Pharmaceuticals, says "We are not interested in bringing in generic (products). We are only interested in bringing new drugs to the market, to make a difference."

Its $100 million plan to grow a sizeable R&D program in Beijing and to boost the ranks of its Chinese scientists to 200 is its biggest research effort outside of Europe.  Recent market research indicates that the fast-growing number of diabetics in the country will help feed Novo's growth plans. The International Market Analysis Research and Consulting Group has estimated that the market for diabetes therapeutics will grow from $642 million to $2.8 billion in 2015.  Novartis also has plans to grow its manufacturing base in China. See Fierce Biotech.

As an aside, this is just another example of Western Big Pharma investment in China -- development and manufacturing.  It continually makes me question the wisdom of any pharma companies looking to eliminate China from their raw material supply chains.  It seems evident to me that China will become a major manufacturing center and a quality local supply chain will be needed to support this.  Efforts would be better placed to bring up local quality standards in manufacturing and quality assurance to support this obvious consequence (to me at least).

Posted by Bruce Lehr Nov 3rd 2011.

 

Sanford-Burnham Joins Pfizer's Translational Medicine Partners

Sanford-Burnham Medical Research Institute in La Jolla, CA has joined a growing list of scientific groups to team with Pfizer on its effort to spur translational medicine programs for early-stage research.  Pfizer will now open up its compound libraries, screening techniques and antibody development technologies to Sanford-Burnham investigators.

"The 'open innovation' model of the CTI is a perfect fit for Sanford-Burnham," said Sanford-Burnham CEO John Reed, M.D., Ph.D. "The Institute's culture of collaboration is enhanced by the opportunity to work side by side with Pfizer researchers to accelerate our ability to translate our research more quickly into the development of biopharmaceutical products."

Sanford-Burnham has expanded significantly in recent years. The National Institutes of Health awarded Sanford-Burnham a $97.9 million grant in 2008 to establish a high-throughput screening center. It was renamed as the Conrad Prebys Center for Chemical Genomics in 2009 when San Diego philanthropist Conrad Prebys agreed to donate $10 million to the institute. Philanthropist T. Denny Sanford prompted a similar name change for the institute itself when he pledged $50 million and the research center became the Sanford-Burnham Medical Research Institute.

Pfizer isn't the only big pharma to explore models working more closely with academic groups and research institutes. GSK, Sanofi  and others have been fostering their own initiatives after growing increasingly disenchanted by the poor productivity of their in-house groups.  In general, investors and analysts have further encouraged (without seeing if they actually work) such efforts.  Its the trend du jour in R&D for now. See Fierce Biotech and Xconomy.

Posted by Bruce Lehr Nov 3rd 2011.

New Hope for Neglected Diseases

Here's an interesting post from the PharmTech Talk blog, speaking about a new UN initiative called WIPO Re:Search.  Is a forum for public and private organizations to share IP to help develop new drugs and vaccines to treat neglected tropical diseases, malaria and tuberculosis.  Sharing occurs through a public access database.

The National Institutes of Health as well as pharma companies like AstraZeneca, Eisai, GSK, Novartis, Pfizer and Sanofi have agreed to work with the group.

PharmTech Talk » New Hope for Neglected Diseases.

WIPO Re:Search members agree to license IP to researchers royalty-free in many, but not all, cases.  Royalty-free licenses are really extended to the very poorest countries of the developing world and not to all countires where these diseases are prevalent. 

For example, Chagas disease affects 21 countries in the America's but only Haiti (a non-endemic site) actually gets royalty-free status. In looking at the Chagas example (transmitted by black flies), it would seem the goals of WIPO Re:Search are laudable but there still seems to be room to get the bugs out in implementation.

Posted by Bruce Lehr Oct 31st 2011