The Big Red Biotech Blog

Innovation as Illustrated by Beer

It's not often that you get a blog post that talks to innovation and uses references to both Homer Simpson and beer to drive home its point.  Today's award goes to the Innovate on Purpose blog for -- well -- bringing us this innovation in writing.

The thrust of the article is that when aspects around the product become the focus - rather than innovations in the product itself -- you know you've reached the point of diminsihing returns.  This kind of hits home in the pharma industry in the past decades where maybe as much effort was put in evergreening through reformulation, new delievery systems and maybe indication extension as was put in developing novel meds in many instances.  Maybe that's why pharma return on R&D has been so dismal the past decade (if not longer).

Time to get back to real innovation with the actual PRODUCT -- for new meds, new mechanisms of action that effectively address unmet needs and perform BETTER than what we have already.  BTW - I think we're starting to move in that direction again.

Posted by Bruce Lehr May 17th 2013.

 

Pharma Need for Adapting to Change

When I was a youngster, my father used to ask us kids in the family a question: Why did the dinosaurs go extinct?  It was an interesting question to us as we all loved dinosaurs and knew a lot about them.  Not long after the question was posed, possible answers started flying around -- an asteroid collision, more volcanic activity, disease, ice age (climate change), movement of tectonic plates, etc.  My father's response no matter the proffered answer was No, no, no, no and no. 

The RIGHT answer was -- Dinosaurs became extinct because they couldn't adapt to changing conditions.

PharmTech Talk » Adapting to Change.

I thought of that when I saw this post this morning.  It deals with the need of pharma and biotech companies to be able to adapt to the changing healthcare climate in order to survive.  The post points out that increasingly, it is not enough to get a drug approved by regulators. To thrive, you need to get the drug accepted by payers. 

As such, companies need to be attuned to Changing Conditions. What is the competitive standard of care out there at any moment in time?  If it changes, can you adapt your clinical trials in progress to examine relevant endpoints to the new standard?  Can you add a drug to a study in oncology, for example, if a new therapy is demonstrated using two or more drugs?

Bascially, you need to think about how to differentiate yourself from competitors.  Can you show enhanced safety, fewer side effects, greater efficacy, lower toxicity, or identify a patient niche where your drug outpeforms?  You need to be able to adapt on the run. 

If you can, you will be set up to thrive under the new conditions.  If not, you (or your therapy) may be the one who next goes extinct.

Posted by Bruce Lehr May 14th 2013.

Supremes Hear Oral Arguments in Myriad v. AMP? Or do they?

I've written about this before, but wouldn't it be nice if the arguments presented before the Supreme court in a potentially pivotal patent eligibility definition case like Myriad, actually contained discussions of science to illustrate the Law? 

We're trying to discern whether isolated DNA should be patent eligible or not.  OK.  Then why do we have to resort to analogies like if the DNA were a tree, sap from a tree, chocolate chip cookie, baseball bat, or a liver or kidney? Huh?  Why can't we discuss isolating and replicating a DNA sequence from say .... DNA?

I know we are science challenged as a Nation at least across the population as a whole -- but you'd think we'd have the ability to discuss the science and that Supreme Court justices could have access to ANY experts that they wished to explain basics to nuances of what was being presented.  I'm not arguing that arcane jargon should be the basis of oral arguments but can we do a bit better than comparisons to baseball bats and chocolate chip cookies?  See Patent Doc blog.

Posted by Bruce Lehr Apr 19th 2013.

Can't See the Forest for the Elephants

This from today's Innovate on Purpose blog.  It talks about why customers can fail to innovate due to limited perspective and personal bias. it counsels that to truly innovate you need to really get to know potential customers and their needs. In fact stating that gaining insight into customer needs is a paramount condition that must be met to innovate.

It further states that "current market reseach or market insight is often-shortsighted, biased and backward looking."  Rather, the need is to engage customers AND PROSPECTS with new perspective and greater empathy, thereby engaging the customer and enlarging the problem set. This is the only means to get past doing what you are already doing (small incremental innovation at best) and find new opportunities for disruptive innovation.

Posted by Bruce Lehr Apr 3rd 2013.

Innovation Lost

Here's the latest epistle from Innovate on Purpose on why innovation desires from the C suite are often lost in translation to the rest of the organization.  Some of the issues discussed include: conflict between near term sales/profitability goals and longer term innovation, prioritization conflicts around activities, and lack of innovation skills in the organization. 

The conclusion is that until the concept of innovation is firmly established and constantly communicated and resourced, it will be hard for firms to innovate consistently. Innovation is not a project but a corporate capability.

Posted by Bruce Lehr Feb 28th 2013. 

FDA's Sprinter Pathway to Possible Approval

The FDA's new "breakthrough" designation may allow drug makers to get their products through to commercialization after only performing enhanced Phase I trials -- of course they have to meet the criterion and actually show their product works.  No small task.  However, this could be a game changer in terms of shortening the path to market and gaining return on investment --- not to mention giving patients a shot at a new treatment much earlier.

Vertex has already expoited this pathway twice in gaining approval for its cystic fibrosis medication Kalydeco and in testing its cobination therapy VX-809.  A third drug also has breaktrhough status and 18 more applications are pending with FDA.  It seems the race is on -- and its a sprint.

This will no doubt have many backers with drug makers, patients, payers and investors.  It offers many potential benefits for novel treatments of diseases with unmet needs in particular.  We'll just have to see if the program lives up to its advertisements.  See Fierce Biotech.

Posted by Bruce Lehr Feb 13th 2013.

Actual Companion Diagnostics Sighting!

Xconomy published today on Qiagen's recent application to the FDA for the approval of a diagnostic test that looks at a mutation in the EGF receptor.  The test is useful in the diagnosis of the speed of disease spread in non-small cell lung cancers (NSCLC) -- 10 to 15 percent of Caucasions and 40 percent of Asians carry the mutation.  The test was developed in conjunction with Boehringer Ingelheim's cancer therapy, afatinib that targets the mutation -- and they've asked the FDA to approve both products simultaneously.

This type of "companion diagnostic" has long been talked about, particularly with cancers, as being advantageous to define the target patient population that will respond to the drug. This helps recruitment for clinical trials and to better ensure the drug will actually be effective in the trial. The proto-type for this concept is Roche's combination Herceptin and the HER2 positive breast cancer from the late 90's. But not much else has really reached the market since then.

With Qiagen's/BI's application, we expect to see a new surge in companion diagnostics-therapeutic combination being developed and brought forth. In fact, co-development of the therapy and the diagnostic is the major difference in these programs now compared to what may have been done in the past where a test was typically developed sometime well after the therapy was available.  The result is that the tests didn't work particularly well and only 1% of drugs in the US actually have a companion diagnostic -- most in cancer area.

That's changing as the FDA has encouraged this approach.  Qiagen says it now has 15 programs in progress -- including with not only BI -- but with big companies like Pfizer and AZ. Last year, Roche had a companion diagnostic it developed with its Zelboraf treatment for melanoma. Pfizer's Xalkori has a companion diagnostic developed by Abbott. Other drug-companion diagnostic programs in progress include the following companies:

• Synadex Pharmaceuticals and Ventana Medical with entinostat & NSCLC's 
• Seattle Genetics/Takeda and Ventana Medical with Adcetris & hopefully various cancers
• Qiagen and Bayer with tests therapies and tests for solid tumors
• Qiagen also has a similar deal with Pfizer
• Astellas Pharma and Roche with Tarceva and lung cancers

The industry and FDA are looking for more of these to be successful -- and would expect clinical trials to flow more smoothly and result in more approved drug applications. It remains to be seen if this will translate into reality -- though the promise is clearly there.

Posted by Bruce Lehr Jan 31st 2013.

 

New Global Academic Alliance To Speed Drug Discovery

Six leading institutions have formed an alliance designed to accelerate the translation of academic research into usable medicines and therapies.  The six include:

• The Centre for Drug Research and Development (CDRD), Canada
• Lead Discovery Centre (LDC), Germany
• The Scripps Research Institute, Scripps Florida, United States
• The Centre for Drug Design and Discovery (CD3), KU Leuven R&D, Belgium
• Medical Research Council (MRC) Technology, United Kingdom
• Cancer Research Technology (CRT), United Kingdom

PharmTech Talk » New Global Alliance Aims To Speed Up Academic Drug Discovery.

The six organizations plan to facilitate international cooperation, develop standards and performance measurements, share best practices, expertise and resources, and collaborate on drug development projects.  Ultimately , they will work together to improve the conversion of global early-stage research into much-needed new therapies. Currently, they have a portfolio of more than 165 innovative therapeutic projects targeting significant unmet medical needs. 

This is yet another shot at improving translational activities.  Lack of good translation seems to be a popular whipping boy as to one major element that plaques the current pharma model. We'll have to see if efforts by this group or others like NIH really have a winning effect. 

Before The Whip Comes Down via Innovation

The Innovate on Purpose blog points out that the buggy whip manufacturers serve as the whipping boys (pardon the pun) of academics and business people as businesses who failed to recognize market disruption and the need to innovate. This of course led to their rapid extinction and their now infamy as poster boys who failed to change with the times.

But as the post goes on to explain, we shouldn't be feeling too safe ourselves as most (not all) leading businesses tend to strike defensive positions in their markets that are more geared to defending their positions by counting on being able to fall back on their efficiencies, size and market share position.  That's great as long as you can see the attackers from a distance andthey have to cover the same groudn to reach you, and that the attackers will have to take time to build up the critical mass to attack. Unfortunately, that may not be the case anymore and may become even less so in the future.

The post goes on to delineate many major structural, political and social changes that are taking place right now that accelerates the changing rules of engagement (e.g. internet, Euro-zone, Arab Spring, Russia and China policy, US Government borrowing to meet budget, etc). It also goes on to offer an observation on how traditional business building is declining in effectiveness. 

If you look at the Return on Invested Capital over the last 50 years for the 20,000 top US firms, it is on steady decline.  It has dropped from about 5% to 1%. The writer takes this to imply that there is much more new competition, substitutes and alternatives in the market than ever before and that the capital investors can no longer command high prices - a signal the firm is focused on defense and cost cutting while the market shifts. The average lifespan of a Fortune 500 company is only 15 years now and falling Uh-oh!

Attacking firms on the other hand are creating new products that command higher margins and forcing their competition to respond to them -- kind of like Dexter last night "I don't run. I make other people run".  Innovation must become a core competency to and not an occasional activity to survive in this environment.   And if you don't innovate?  You may become the next "buggy-whip" manufacturer in the business school of your choice's new case study. 

Posted by Bruce Lehr Oct 22nd 2012.

 

Lechleiter Touts the Value of Biopharm Innovation on the Economy

Lilly's CEO John Lechleiter takes to the bully pulput again to inform the Presidential candidates to not forget the importance of the biopharm industry to a healthy US economy.  He wants data exclusivity provisions (similar to US Affordable Care Act) included in the new Trans-Pacific Partnership agreement.

PharmTech Talk » Eli Lilly Chairman Stresses the Importance of Biopharmaceutical Innovation on the Economy.

Lechleiter believes TPP is a vital channel to allow US pharma to shine across Asia and its expected large and fast-growing markets.  But, investors will only play in supporting this if US IP is protected.  With this protection, investors will invest to fuel job growth,help maintain US global leadership and to extend life-saving medicines to the rest of the world. The TPP participants will also be setting the standard that non-participants like China must meet.

If we want to build on the 4 million plus jobs of the US biopharm industry, we need to support it through reasonable IP protection in balance with free trade.

Posted by Bruce Lehr Oct 19th 2012.

 

FDA Signals Possible Endorsement of "Special Meds"

Margaret Hamburg's comments this week indicate a predisposition in the FDA to consider accelerated drug approvals for "special medicines" that provide societal benefits despite their possible risks.  These would include treatments for conditions like obesity or life-saving antibiotics. 

In keeping with recommendations handed down by a White House advisory committee last week, Hamburg told scientific advisers that the agency is considering letting makers of such products conduct faster trial with smaller patient groups.  The idea is to get drugs faster to patients in dire need.

The plan would also allow drug companies to get products on the market quicker and may provide some level of respite to companies who need to fill revenue holes due to patent expirations of top selling products.

"This is an issue of having the right science and data to assess risks and benefits but also a broader societal discussion about risks and benefits that individuals and communities are willing to take on and under what circumstances," said Hamburg.

I like the idea of trying.  In particular, I'm intrigued by passing some responsibility for risk to certain high risk patient classes for diseases like obesity treatment.  It is interesting to me because many obesity issues relate to patient [high risk] behaviours in the first place.  Getting treatment for some of these type of patients might provide high levels of benefit. 

Still, we need to look at the science to make sure risk is not ridiculously high in approving these drugs, and post-market surveillance will need to be bolstered too.  Regardless, I think it is an idea that I would like to see tried on a pilot basis. See Bloomberg News.

Posted by Bruce Lehr Oct 12th 2012.

Do Pay Attention to the Data Behind the Curtain

Today, GSK announced it will part the curtain that previously obscured access to data from clinical trials.  In a move aimed at boosting transparency, GSK has pledged to make its clinical trial results available on a public website.  It has already published summaries of 4500 trials.

Now in a further, and unprecedented move, GSK will also seek to publish the results of all its clinical studies -- regardless of results -- in peer-reviewed journals. It will also create a system where researchers can access anonymous patient level data from clinical trials. This will enable researchers to examine data more closely and to combine data across studies to conduct further research. 

This is great.  Transparency is always good in my view.  It's nice to have a summary but even better to be able to see the raw data so you can do independent analysis and draw your own conclusions -- which may differ from those in a summary.  This is a step forward in openess and will put pressure on other Big Pharma peers to follow suit.

See Fierce Biotech and In the Pipeline for more details.

Posted by Bruce Lehr Oct 11th 2012.

Will Biosimilars Drive Process Innovation?

Interesting hypothesis discussed in the Bioprocess Blog.  The author opines that biosimilars manufacturers will need to become experts in process and analytical development -- and in fact will drive the state-of-the-art.

Will Biosimilars Drive Process Innovation?.

The reason cited is that these manufacturers will need to produce molecules that are "highly similar" to a reference product and essentially will need to have a process that will deliver this prior to Phase I trials -- a standard not as dramatically imposed on innovative product producers.  

The key thought being "Without the ability to proceed rapidly through clinical development using a robust commercial manufacturing process, much of the economic and speed advantage of developing a biosimilar product will be lost." 

Therefore, it is argued these manufacturers will need to come up with innovative technologies to speed process and analytical development to deliver reliable scale up and cost-effective manufacturing.   

I'm not so sure.  Biosimilar producers can work with serviceable processes as long as they can get to market and produce.  They may not be optimized at introduction -- but if they are first to market -- I think they'll still make money.  And, they can then work on improvements to their processes after the fact just like innovators regularly do now.

However, being a process and analytical innovator will confer advantage and it would be a good business model to pursue to differentiate oneself competitively in the biosimilar arena.  It's somewhat counterintuitive to think about biosmilars producers being innovators -- but this idea certainly has its merit if they can pull it off. 

I don't think it is unreasonable for someone to try. I see some evidence now that some biosimilar producers are trying their "own" production systems to make their "similar product" and aren't necessarily trying to mimic what the "best guess" innovator process is -- if that doesn't really fit their experience and expertise.   Of course, many are also trying to mimic the "best guess" process too under the theory that it is most likely to match the innovator molecule. We'll see which works best.

Posted by Bruce Lehr Aug 29th 2012.

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.

John Cleese on Being Creative

For all or you who are seeking more innovation in your work or private life, here is a talk on "How to be more creative" by Monty Python's John Cleese.  Creativity is not exactly equal to innovation but for me shares many elements and is close. Remember - Space, Time, Time, Confidence, and Humor.

PharmaGossip: John Cleese on how to be creative - Boing Boing.

This lecture is excellent -- with lots of good suggestions and information -- and of course some humor. I especially liked the last 2 minutes which has to do with "How to Make Sure You Stamp out ALL Creativity in Your Subordinates."  See how many of these techniques you already use -- : ).

Posted by Bruce Lehr Apr 15th 2012

Innovation - Don't Let It OUT!

Here's a nice post from the Innovate on Purpose blog comparing senior executives feelings about innovation and Pandora's box.  It's seems top execs treat Innovation as good -- only if you can control it  and put it back in it's box when it is time.  Otherwise, it can be a frightening prospect to release on your company if it can't be controlled.  Unfortunately, most innovation only works under the latter circumstances.  And if you want a culture of innovation to take root and grow  -- you need to let it loose.

 

Posted by Bruce Lehr Mar 29th 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

Is the US Facing a Pharmaceutical Manufacturing Gap?

Here's a post from PharmTech Talk discussing recent testimony by FDA's Margaret Hamburg before the House Committee on Energy and Commerce as it considered extending PDUFA (for the fifth time). 

Is the US Facing a Pharmaceutical Manufacturing Gap?.

Hamburg cited numbers to show that the FDA had approved more new druigs for launch first (70% of last year's 35 new drugs) than other agencies in the world.  In fact, 75% of the new drug approved in US and EMA between 2006 and 2010 hit the US first.

PharmTech noted that the US is the largest drug market at 36% of the world's total in 2010, while the top 5 EU markets accounted for another 17%, and the BRIC countries another 18%.  But the question arose, does the US manufacture enough given its market position and importance?  It turns out that 40% of the drugs consumed in the US are made outside the US, and 80% of the APIs used within are made ex-US. 

The writer questions should the US support its internal manufacturing of drugs more?  I would say, Yes, but with particular regard to supporting biomanufacturing.  A lot of the drugs and APIs cited above are small molecules that have moved to generic status and have therefore graduated to lower cost (at least currently) areas of manufacturing outside the US.  While it may be nice to retain some of that volume, I think it is more critical to keep the bio-drugs as a major focus in the US. 

I think US government policy should look for ways to continue to support biotechnology in both discovery and manufacturing to help maintain our leadership position. 

Posted by Bruce Lehr Feb 6th 2012.

 

Old "Car" Model Applied to "New" Pharma Industry

Fierce Biotech reports that some Pharma manufacturers are looking to the car industry for ideas on how to adjust their business model to be more profitable as well as perhaps shorten drug delivery times. Auto makers are very familiar with outsourcing many aspects of manufacturing and primarily concern themselves with design and marketing.  The pharma equivalent might be drug R&D and marketing.

GSK and AZ in particular were cited as two big pharma picking car makers' brains, drawing on companies like McClaren, Jaguar and Renault. In addition to outsourcing expertise, Porsche (for one) has crowed that it reduced product development time by 28%.  Contrast this by industry watchers claims that Big Pharma development times have increased by 31% -- there might be something to learn here.  Porsche actually has a consulting arm that is starting to market to pharma.

One big caution though -- auto makers haven't historically always been able to recoup their costs of capital -- not exactly a ringing endorsement for someone who wants to compete in pharma industry with dwindling capital markets to support it. Auto makers may have the most to teach in manufacturing and reducing costs there.

Interestingly, Pharmalot reported yesterday that 38 manufacturing plants were closed in the US this past year as pharma looked to downsize (and outsource like autos?).  While, Fierce reported on comments by Merck's CEO Ken Frazier indicating he would buck the Pharma R&D downsizing trend to continue to invest in R&D (consistent with auto internasl development model?) instead of cutting back R&D more severely (to also outsource) like GSK or Pfizer. The debate will rage as to which is best until more data emerges supporting a winner.

From an innovation standpoint though, it is good to see companies willing to consider other tried and tested business models for applicability to their situation -- especially cross industry like this.

Posted by Bruce Lehr Dec 15th 2011.

Innovating Fast and Motivatng More Speed

Sometimes two concepts just come together for me.

First from the Innovate on Purpose blog, a post dealing with why firms have trouble innovating quickly.  They don't have models that allow them to prototype quickly.  This retards their learning and slows progress toward an innovative result. Short, rapid experiments with imperfect prototypes is the key.  Plus the ability to plow learning back into more protyping quickly.

Then by happenstance, a piece from In the Pipeline blog dealing with management's motivation of speed. You'll find the answer is surprisingly simple.  Simple enough that it might work.

Posted by Bruce Lehr Nov. 15th 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

 

iBio produces Rituximab in plants

iBio successfully expanded the use of its technology to biosimilar mAbs by producing rituximab in non-transgenic green plants, thereby expanding its use beyond production of viral antigens for vaccines.

"The production of functional rituximab in plants suggests that many if not all mAbs can be produced using the iBioLaunch system," says Terence Ryan, senior vice president. 

iBio says that the rituximab produced in plants underwent a number of preclinical tests to evaluate efficacy.  The plant-derived treatment showed similar target cell cytotoxicity and antigen recognition to rituximab produced in mammalian cells.  No word if the products were compared under similar guidelines used by the EMEA to judge a biosimilar versus the approved reference product -- or not.

Rituximab success paves way for plant produced mAbs.

That's it.  Run get your gardening gloves and shovel.  Order some mulch and fertilizer.  Cell culture is DEAD!  Or perhaps word of its death is greatly exaggerated.

 

 

Posted by Bruce Lehr Oct 10th 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.

 

Jennerex Goes i.v. With Cancer Fighting Virus

Jennerex Biotherapeutics is reporting a breakthrough that will allow it to deliver its anti-cancer oncolytic viruses via an intravenous route of injection -- as contrasted with the need to directly inject the viruses into a tumor. In a Nature article this week, Jennerex reports it oncolytic viruses injected i.v. were able to migrate from the bloodstream to the tumor site. Eureka!

"The idea has been around for decades, but nobody has been able to show you could deliver [an oncolytic virus] through an IV. If you can achieve IV delivery, it opens up the possibility of treating 10-fold mor tumors," says David Kim, Jennerex CEO.  See Xconomy.

There are no approved products using oncolytic viruses or this iv delivery concept but let's give them hand for the latest success. Hopefully, this will work and provide another possible way to go after tumors.

Posted by Bruce Lehr Aug 30th 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.