The Big Red Biotech Blog

Zymeworks and Merck Partner on Bi-specific Antibodies

Zymeworks and Merck announced a deal whereby the former's platform technology for the development of bi-specific antibodies will be applied to cancers and autoimmune diseases.  Zymeworks will receive an upfront payment (undisclosed) and have a shot at milestones and royalties that could reach $187 million.

Bi-specific antibodies have binding sites that can recognize two different targets.  The Zymeworks platform provides the means to engineer unique antibodies against multiple targets on a single cell. The proteins can also be engineered to circulate longer in the bloodstream or to induce a stronger immune response.

Merck made a good partner for Zymeworks as it provided some proof of principal data, upfront cash and credibility to draw more investors. It also can complement Zymeworks protein engineerign knowledge with its own drug development expertise and understanding of biology.  Now they both have to make it work as a producers of therapeutics. See Xconomy and Fierce Biotech.

Posted by Bruce Lehr Aug 30th 2011.

 

FDA Gives Guidelines on Companion Dx

Companion diagnostics are being developed to try to identify patient groups (or subgroups) that will respond best to a given therapy.  It is hoped that this will give better results in the clinic for responder populations and will spare non-responders from exposure to potential side effects of drugs that will not work for them.

The FDA recommends that there be early engagment between the agency and developers of such tests. It says it now plans to review the diagnostics and therapies in tandem -- where both exist.  The FDA says it will still approve therapies with no diagnostic for very serious illnesses with no other available treatments.  In such an instance, the companion test might receive later approval.

"These proposed guidelines support the development of innovative new targeted medicines and their corresponding diagnostic tests and are intended to provide manufacturers with greater predictability," said CDRH director Jeffrey Shuren.  See Fierce Biotech.

Posted by Bruce Lehr July 14th 2011.

Pharma Execs Confess Innovation Is Lacking

Here's results from a study commissioned by Quintiles that surveyed 282 senior executives from Big Pharma, including 58% c-suite execs, about their attitudes on the importance of innovation to their organization's success, the effectiveness of their innovation efforts, and the efectiveness of some of their tools to drive and assess innnovation.

Pharma Execs Confess Innovation Is Lacking // Pharmalot.

Survey highlights follow:

• 54% considered innovation to be a leading priority
• 49% considered their overall innovation efforts as even moderately effective
• Only 16% considered innovation as their top priority
• 47% said their R&D model was capable of delivering against corporate needs
• Only 42% said R&D was moderately capable of refilling the pipelines

It is somewhat astounding to me that in an industry that most outside observers believe depends on innovation for sustainability, that only 16% would rate it as a top priority and would tolerate an assessment where only 42% believed the R&D effort could be even moderately successful. Seems like a disconnect versus business needs.

Impediments to improving innovation were cited as:

• 47% cited cost as the leading barrier
• 38% pointed to long product development times
• 33% faulted regulatory restrictions
• 24% cited a lack of talent
• 21% cited difficult corporate structures

This almost sounds like a list of excuses.  It would seem to me that c-suite executives could make changes in these parameters and innovation efforts would in fact be mustered to change some of them if they are in fact impeding corporate success. Certainly a number of these things should be targets for change initiatives.

 The executives also indicated a greater (63%) gravitation to some of the open innovation models and cited the biggest issues were IP control, difficulty in coordination between all parties and research costs that coudl impede effective open collaboration. Internal R&D was still cited as the primary source of new ideas, but academic research was mentioned more prominently. 

In terms of innovation success, the 37% who self-rated their programs as "very effective" have adopted new technology to access and mine data to filter drug candidates.  Innovation leaders say they use internal company data and external data very well to support innovation efforts. The self-styled innovation leaders also said they offered financial rewards (53%) for contributions or gave substantial recognition (47%) for contributions.

Posted by Bruce Lehr July 13th 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.

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.

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.

How Do We Measure Pharma Innovation with Long Timelines?

I like this post from Forbes Science Business blog. The author, David Shaywitz, cites a new book called Little Bets by Peter Sims, that talks about innovation as resulting from a series of small changes.  Shaywitz notes that it is difficult to apply to drug development due to the long time cycles for approval  -- i.e the ultimate measure of "successful innovation" is whether the drug is commercially successful or not. But how do you know if you are making correct changes if the cycles are so damned long.

He notes you can look at intermediary steps like moving from one drug phase to another (1 to 2, 2 to 3, etc) but this doesn't really say the drug will be successful. That's only known if it makes it to commercialization and does well there.  More troublng, if you look to measuring say cost improvements or decreases in cycle times -- you may get gains in these parameters but no more success.  And, you may in fact stifle innovation in the process.

I find the whole discussion interesting as I've long struggled with this problem. I resorted to some of the same things mentioned -- and it's true that you can save money by reducing cost or cutting cycle time but without achieving the commercial results that you want. In those instances, you delude yourself into thinking this is success (it's success in saving money but not in commercialization).

It's missing the forest for the trees or the operation is a success but the patient has died. Bascially, we're measuring what we can but don't have a good surrogate endpoint. 

Shaywith concludes:

We urgently need a better way to figure out how we’re doing, and reliably assess whether our pipeline is generating successful molecules, so we can make the sort of iterative improvements modern drug development desperately requires.  While I doubt anyone is going to stumble upon a magic crystal ball, it’s possible that refinements in the approaches used to select products and identify patients might help.  If not, the industry appears destined to remain where we are now: developing products of uncertain utility — in an increasingly efficient, quantitatively monitored fashion.

Anybody out there got any ideas on this one?

Posted by Bruce Lehr April 22nd 2011.

Viehbacher: One-man R&D Wrecking Crew

According to Seeking Alpha, Chris Viehbacher, CEO of Sanofi-Aventis and Chairman of PhRMA, is stickng to a familiar theme -- that is remaking the pharma model by de-emphasizing in-house R&D.  He says the industry has failed to get an adequate return on its investment in R&D and therefore needs to tap the greater world of ideas by externalizing R&D. 

"My goal as CEO is never to inaugurate a new research and development center," said Viehbacher.

Instead, Sanofi has outsourced up to $2.2 billion in R&D with Covance over the next 10-years - and cut translational research agreements with Harvard University and The Charite University in Berlin.

This thinking must be catching on.  Readers here will note a post from Matthew Herper's blog yesterday that recounts a loss of nearly 300,000 pharma jobs in the last decade - with more than half of that in the past 3 years. 

The LIfe Sci VC blog carried a post yesterday about the rise of CROs -- and how companies like BMS, Takeda, Sanofi, Lilly, GSK etc have inked deals in the past couple of years to outsource large chunks of R&D work to CRO partners. 

The author, Bruce Booth, goes on to predict "that more and more virtual or semi-virtual biotechs will be funded that require less infrastructure and focus increasingly on an asset-centric model of innovation and less on platform-centric capacity building.  These startup biotechs are only able to "go virtual" by leveraging the emerging breadth, expertise, diversity and cost consciousness of the global CRO industry."

It looks like less Big Pharma R&D is on our horizon to stay.

Posted by Bruce Lehr April 15th 2011.

Safety First: Why I Love Drug Regulation?

Here's a good post by Stewart Lyman in Xconomy.  It points out the folly of blaming primarily (or solely) the FDA for the pharmaceutical industry's lack of recent drug approval success and innovation. It also reminds us that the FDA's chief responsibility is to ensure safety and efficacy. This is good counterpoint given the prevailing winds that sometimes like to blame the FDA (regulation) for lack of innovation (see Viehbacher and Lechleiter comments at PhRMA yesterday as an example).

Why Do I Love Drug Regulation? Simple: It Keeps Us Safe.

I recommend that you give this a read and reflect on a history of bad company behavior's in the past and not so distant past that led to the foundation of the FDA and its regulatory role in ensuring safety and efficacy. There is a good reason that it exists -- to protect you and me from charlatans and bad science.  KInd of reminds me of people who rail against Unions -- but there is a very legitimate set of reasons why they came into existence - of course institutions do need to continue to evolve and the FDA is no different in that respect.   

Lyman finishes his article:

The problem facing the pharma and biotech industry isn't excessive regulation; it's a lack of inducements in the midst of a drought (ed note: self-inflicted I might add) of innovation.  Let's create significant new incentives that will reward companies for generating new drugs to combat the problem.  Among the possibilities are significant tax breaks, longer patents, and guaranteed pricing tied to effectiveness.

I tend to back tax incentives and particularly pricing premiums for drugs that actually work and provide real patient benefit. I'm much less enthused about extended patent lives. But that's me.

Posted by Bruce Lehr April 15th 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.

 

Merck Inks Own Anti-inflammatory Deal with Lycera

Merck announced a deal with Lycera for its anti-inflammatory drugs that target T-helper 17 (Th17) cells and block or reduce production of the inflammation-inducing IL-17 cytokine. The deal calls for Merck to give Lycera $12 M upfront and could allow them to earn as much as $295 M additionally for reaching milestones.  The drugs developed could be used to treat diseases such as rheumatoid arthritis, psoriasis, inflammatory bowel syndrome and multiple sclerosis.

"We are delighted to be working with Merck, which brings industry leading expertise in drug discovery, development and commercialization to this collaboration," said Gary Glick, Lycera founder and CEO, "This is arguably one of the hottest targets out there."  See Fierce Biotech.

 

 

 

Posted by Bruce Lehr March 4th 2011.

 

Lilly hails progress of new R&D approaches

Lilly says two of its experimental approaches to re-designing R&D are beginning to pay off. The first is called the "Mirror Portfolio" and involves funding external R&D through independent VC funds.  The idea is to give Lilly access to innovation being developed on the outside. Its VC funds have now acquired two molecules for development - one for congestive heart failure and for bone healing in cancer.

Lilly hails progress of new R&D approaches | InPharm.

The second new R&D approach is called Chorus - a small interdisciplinary drug development group within Lilly using a virtual model.  The group focuses on development plans that progress compounds from candidate selection to proof of concept in human clinical trials. Chorus has been able to reach decisions 12 months earlier and at about half the former cost. The group has rendered decisions on 17 molecules with 6 resulting in positive proof of concept data. Lilly has now cloned the Chorus model in several other sites around the globe.

 

 

Posted by Bruce Lehr Feb 18th 2011.

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

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

Obama's generics plan criticised | InPharm.

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

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

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

 

 

Posted by Bruce Lehr Feb 18th 2011.  

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.

 

Lilly CEO Promotes Regional Innovation Clusters

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

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

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

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

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

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

 

Posted by Bruce Lehr Feb 9th 2011.

 

Lilly Ties Employee Bonus To R&D Pipeline

As recounted in Pharmalot blog, Lilly has established a new "research metric" that will be one factor in calculating bonuses.  It is intended to measure progress of its products through the development pipeline as an indicator of "output and sustainability" for the company.  

Lilly Ties Employee Bonus To R&D Pipeline // Pharmalot.

The research metric will be in addition to usual measures around EPS and sales growth.  Lilly of course has had several celebrated failures (most notably its Alzheimer's drug) in late stages this year and is facing one of the industry's steepest patent cliffs. It remains to be seen how directly most employees can affect this development goal - especially in the near term. 

I will be interested to see how this metric resonates within the company as it rolls out. Also, I don't know the weight of the "research metric" versus the usual sales, profitability, etc type goals that companies usually follow.  Hopefully, we'l hear some feedback on how this is perceived and how it works in practice.

Concommitant with this new metric announcment, Lilly Executive managers did take some paycuts for 2011 - albeit from a position of considerable altitude.  We'll see how that affects perceptions as well.

Posted by Bruce Lehr Feb 7th 2011.

How are Pharma CEO's like the Ostrich?

Can you guess from this photo?  Here's the rest of the story from PharmaManufacturing.com.

Posted by Bruce Lehr feb 3rd 2011.  

ZFN Technology Gets Vote as Biotech Platform of Future

Seeking Alpha wrote a piece today about Sangamo's zinc finger nuclease technology as perhaps providing the basis for the next platform technology to do targetted gene manipulation -- which could serve as the means to develop a plethora of new therapies. 

Therapeutic areas cover a span from gene therapy and regenerative medicine to more conventional development of protein-based biotherapeutic drugs. Sangamo is in fact pursuing therapeutics to address diseases as disparate as diabetic neuropathy and a "functional cure" for AIDs. 

 

SAFC has a licensing deal for the Sangamo technology to apply it to the development of cell lines - particularly CHO cell lines for the production of biotherapeutic drugs.  The ability of ZFNs to knock out, knock in or modify very specific genes of interest is critcally important in this application. It allows SAFC to help pharma and biotech customers alter genes of interest to them to improve the performance of their biotherapeutic production cell lines (platform lines). 

Thus cellular properties like enhanced growth, decreased cell death, enhanced proten production can all be altered and manipulated simultaneously with ZFNs.  This can lead to the development of a "Super CHO" production cell line.  Cell genes that can change glycosylation patterns or produced proteins can also be changed to confer greater clinical efficacy or reduced clearance of the final drug protein. Viral or cellular proteins that might co-purify with the desired protein drug can also be eliminated by use of ZFNs. 

SAFC has recently introduced ZFNs to allow customers to alter the dhfr and GS selection marker in their system.  ZFNs that affect and control glycosylation are coming this year as well as ZFNs for genes that affect culture productivity and growth. Platform cell lines with either the dhfr or GS knock out will be available and adapted to chemically-defined, animal component free media. These should be available about mid-year 2011.

The technology is very versatile and truly enabling in many new applications -- only a few of which are discussed here.

 

Posted by Bruce Lehr Feb 1st 2011.

BIO Supports Obama's Call for Biotech Innovation too!

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

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

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

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

 

 

Posted by Bruce Lehr Jan 28th 2011.



It's Not 'Me-Too', It's Really a Failed Race for First-in-Class

This is another interesting post from the In the Pipeline blog.  It reviews some interesting spin on the old   "me-too" drug debate.  We've all heard (especially us bloggers who regularly promulgate this stuff - just read through this blog) the knocks on drug makers for - lack of innovation, seeking easy profits at the expense of chasing the tough medical challenges, putting marketing over science, employing defensive strategies to fend off competition rather than blazing a new trail.

But this post, pulls out some interesting data to consider for an article in Nature Reviews Drug Discovery.  The article examines first-in-class drugs from 94 different therapeutic classes over 40 years. Several observations emerge:

• Over that period the time it took a second entry to enter a therapeutic class dropped from 9 years to only 1.7 years - same with 3rd or later entries
• That means the so-called 'me-too' drugs had to have been started prior to approval of the first-in-class drugs
• Since the 90's, the second drug in a class has already been filed into clinical trials before the first is approved - 64% of the time it has already begun phase III
• Patent data also show the follow-on drugs have been filed before the first-in-class drug was ever approved

The upshot of the data and the post is that what we really have is a race to be first-in-class and that many of the so-called 'me-too' drugs are simply the also-rans in this race.  Now that same thinking likely doesn't hold for the 13th beta-blocker to seek approval but we can likely apply the benefit of the doubt to the first two or three followers.

First-to-market and first-in-class does mean something economically -- but the second and third guys may not be copy cats in the strictest sense - merely losers in the sprint to the finish line.  So, do drug companies copy each other's successes or do some merely win the race to be first?

 
Posted by Bruce Lehr Jan 26th 2011.

 

More Discussion of Longer Data Exclusivity and Innovation Incentive

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

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

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

Posted by Bruce Lehr Jan 21st 2011.

 

India Rising!

There is no doubt that India is a coming force in biotechnology -- not only in biosimilars and generics - but in contract research and manufacturing as well.

India Rising - PharmaTech Talk .

Here we have a post in PharmaTech Talk written by Kiran Mazumdar Shaw, Chairman of BioCon, one of India's leading biotechnology entrants.  She notes that India has long strived to be recognized on the world's biotech stage -- and now it is here.  Shaw can lend that historic perspective.

She sees the big opportunity that biosimilars afford India biotech where it can grab a competitive advantage by streamlining an approval process that will be both rigorous and timely.  Shaw further notes that because India long lacked capital to fund drug discovery, it developed on a service model.  Now that model is well positioned to become a major player on the world stage as MNCs look to outsource -- and many Indian firms present themselves to be strong development partners.

India is on its way to being a global destination for biotechnology.

 
Posted by Bruce Lehr Jan 14th 2011.

CHARGE! Everybody after Biosimilars now

According to a report in Reuters today, we have more and more Big Pharma companies jumping on the biosimilars bandwagon.  Written from the JP Morgan healthcare conference in San Francisco, Amgen, Merck, and Biogen Idec all declared themselves to be pursuing biosimilars.

Amgen says it will concentrate on emerging markets in Asia and South America.  Merck plans to work with Parexel to have 5 biosimilars in phase III trials by 2012.  Biogen Idec's CEO said that the company was perfectly positioned to pursue this market and characterized it as a "low risk" way to generate substantial revenue. Pfizer has previously announced its intention to have a biosimilars program.  Novartis' Sandoz unit already claims to be the world leader in the supply of biosimilars.

Amgen noted it should pursue biosimilars in a "controlled way" as to not disturb its core business. Biogen Idec called out Amgne's Enbrel as one of the first targets on the list and the next as Avastin as both near patent expiration.

Roche's CEO Severin Schwan, an outspoken critic of Big Pharma pursuing non-innovative drugs like biosimilars, must be rolling his eyes about now.  Schwan preaches continued innovation.  A Roche spokesman did say the company plans to defend its position against biosimilar competitors but declined to give details.

In the meantime, the rest of the industry appears to be preparing for a headlong charge into the biosimilar fray.

 

 

Posted by Bruce Lehr Jan 13th 2011.

Merck: Innovation Requires "Tough" Spending Decisions

In an interview reported in Fierce Biotech, Merck CEO Kenneth Frazier said the company will make "tough" spending decisions to fuel development of innovative products.  That means - kill less promising drugs quickly to feed the more promising ones.

Merck, like most of Big Pharma, faces revenue losses due to expiration of patents that allow generic competition in the door.  It has new competition for its drugs, Cozaar and Hyzaar, that booked $3.6 B in sales in 2009. 

New innovative products in its pipeline need to be brought forward to make up the difference. One of its most talked about products is anaceptapib - a cholesterol treatment.  Clinical results reported earlier this year showed the drug raised so-called "good cholesterol" by 138% and lowered "bad cholesterol" by 40% in the trial subjects - who were already taking statins.

As reported in an earlier post today, Merck also got a small shot in the arm when it announced its application for its new hepatitis C drug had been accepted for accelerated review by the FDA and the EMA. Frazier says bringing innovative products to market regularly is the only way to sustain business growth and profits.

Frazier also indicated that Merck would pursue more partnerships in the future rather than acquire companies.  Partnerships in the emergin markets are current Merck targets.  Partnerships are preferred as Merck will not have to pay a premium for assets and it can capitalize on the market knowledge the local partner brings to the emerging market. 

 

 

Posted by Bruce Lehr Jan 7th 2011.