The Big Red Biotech Blog

Sanofi Continues to Spend Faster than a Drunken Sailor

Fierce Biotech and Xconomy reports on Sanofi's latest acquisition of TarGen for $75 M down and with a total deal possibility up to $560 M in milestone payments. Wow! This continues Sanofi's spending spree since Chris Viehbacher took over as CEO.  The Company has also inked licensing deals up to $750 M with Regulus for microRNA and a $375 M deal with Metabolex for a diabetes target.

The TarGen deal gives Sanofi access to the JAK2 marker seen in a host of myeloproliferative disorders. This puts them in competition with Incyte, Novartis and AZ versus this target. Targen has a drug (TG101348) that reportedly is more targeted (selective) for JAK2 with no broad immunosuppression side effects. TarGen was able to bring this to clinical trials in less than 18 months with the help of China's Wuxi Pharmatech.

The acquisition strengthens Sanofi's portfolio in oncology and specifically with hematological malignancies to further the company's strategy of providing "breakthrough medicines". TG101348 (catchy name) has the possibility of being best in class.

And while we're talking about spending money, Sanofi also announced that it will be building a new 35,000 sq. ft. manufacturing plant for antidiabetics and cardiovascular drugs in King Abdullah Economic City (KAEC) Saudi Arabia.  The plant will supply drugs to the local market which is estimated to be worth $400 M annually. See in-Pharma Technologist.com story.

Sanofi may be spending faster than a drunken sailor but with much greater prudence and following a strategy that looks to deliver a better ROI!

Posted by Bruce Lehr June 30th 2010.

FDA Oversight - A Difficult Balance

This from the PharmTech talk blog yesterday is a follow up on the HHS report on foreign clinical trials that was discussed here on June 23rd.   

PharmTech Talk » A Difficult Balance.

The PharmTech post asks if it makes sense to force the FDA increase its scrutiny of clinical trials in foreign countries, not conducted by INDs, given the global nature of the pharma business now. Or should a different regulatory model be developed?  Should a different set of rules apply to drugs than to other consumer products?

It is noted that the FDA has limited oversight and financial resources to oversee trials in other countries.  Should drugs destined for the US market be required to be clinically tested or manufactured locally?  In effect, placing a safety/regulatory driver ahead of perhaps an economic one.  Free trade anyone?

As a safety move, the FDA has added offices in China, India, etc. to increase oversight capability. But, does this encourage off-shoring even more clinical trials? I never thought of that. It's a chicken-egg question.  I tend to think the economic factors motivate this behavior but does having FDA resources outside the US actually further encourage more activity outside the US?  Interesting perspective.  Is that something the US Govt (ie. taxpayer) really wishes to support?  Are we pitting increased public safety vs decreased domestic jobs?

Upon reflection, I think we're better off supporting a global economy.  It makes sense to me to allow development, trials and manufacturing go where it makes most sense economically rather than force the issue with regulatory edicts for domestic manufacture or tariff barriers -- assuming there is relativley open access for all to all markets.

But I also think it makes sense for the US Govt to put favorable policies (i.e. carrots in the form of tax incentives, R&D credits, science infrastructure investment, immigration policy) in place that would entice manufacturers to want to stay in the US and make it more economically feasible to do so.

Then maybe 80% of all drugs won't have clinical trial work from outside the US.

Posted by Bruce Lehr June 30th 2010.

Getting Provenge like Getting a New Kidney or Heart

As reported below in Bloomberg article via Pharmalot blog, now that Provenge is approved, Dendreon does not have enough current manufacturing capacity to serve more than 2% of the expected patient demand.  That's bad (even worse) news if you have advanced prostate cancer.   

Dendreon’s Provenge Vaccine Faces Rationing // Pharmalot.

The situation is not expected to improve much until well into 2011 and maybe a bit further out than that. We may need to see if a Big Pharma player comes in to scoop up the Company and then is in the position to speed an investment in manufacturing. 

In the meantime, the WSJ blog reports that treatment centers around the World are using techniques derived from transplant programs to prioritize patients who will receive the vaccine first. Some institutions, notably MD Anderson, are even considering a lottery system. Unfortunately, the ability to pay the expected $93,000 for a course of treatment may also be an important criterion on who gets the first treatments.

Posted by Bruce Lehr June 28th 2010.

Pharma Facilities Springing Up Like Weeds

Let's catch up on some of the new facilities announced in the Pharma industry the past couple weeks.

Fierce Biotech reports that Eisai will build a new R&D center in India.  It will be their first R&D building outside of Japan. The facility is budgeted at $50 M and will employ 100 focused on formulation development.

in-Pharma Technologist.com reports that Tanabe Reesearch Labs will open a new facility in San Diego.  The site will focus on mAbs and other biologicals aimed at autoimmune diseases - diabetes & RA. The new site is part of the parent's, Mitsubishi Tanabe Pharma, global R&D expansion plan which calls for aggressive in- and out-licensing in US and Europe.

That gives us stories in India and the US, now another from Europe.  Again, in-Pharma Technologist.com reports that Baxter will expand its European R&D operations into Belgium. Located in Alliance Park Braine l'Alleud, Belgium, the new facility will house scientists working onnew projects from "conception to registration". These will be plasma based therapeutics, vaccines and packaging and delivery systems.

Posted by Bruce Lehr June 28th 2010.

Tips on Expediting Cell-Line Development

An article written by Angelo DePalma under same title appears in the latest issue of GEN. In it, I get the chance to pontificate a bit on the use of zinc finger nuclease (ZFN) technology by SAFC to create platform production cell lines in CHO. 

As the article points out, SAFC can provide a willing customer the ZFNs to knock-in, knock-out or modify specific genes of interest in their cell line.  Or, we can create a cell line for the customer using ZFNs on either a parental line of our choosing or the customer's preferred parental line. 

Additionally, SAFC is working to create a platform cell line optimized with chemically-defined media and feeds, and a fed-batch bioreactor protocol for expressing recombinant proteins. Currently, we have dhfr and GS clones available for beta testing.  Addtional cell lines will become available by the end of 2010.

The ultimate platform line will likely have stacked traits (i.e. more than one modification).  For  example, it may be GS modified and have modifications to glycosylation genes or apoptotic genes to confer properties of interest.  Our current GS clones grow better in bioreactors and we can select clones without having to use MSX selection.  This adds speed.

The article mentions that the platform will be of more interest to CMOs and 2nd tier biotechs, as well as biosimilar manufacturers.  The first tier biotechs tend to have the internal resources to create their own platforms - but they do also have an interest in ZFN technology to help solve specific issues.  We've worked with these type of clients to remove HCPs that co-purify with their target therapeutic, to remove endogenous viral sequences, to help reduce aggregation, to prevent reduction of mAbs, etc.

Top tier groups are also very interested in how ZFNs can be applied to targetted integration - especially within their platforms. In fact, this is a very hot area of inquiry for us right now. All of these applications represent good opportunities to advance cell engineering within the industry.

Stay tuned.

Posted by Bruce Lehr June 28th 2010.

Pharma Dictum: Out with the Old Drugs and in with the Older?

This piece from the Guardian via the venerable PharmaGossip blog.  Big Pharma's new drugs have only contributed 7% of total revenues for products launched in the past 5 years.  Yikes!  And you thought patent cliffs were bad - this makes them even worse.  The late stage failure rate has doubled in 2007-2009 when compared with 2004-2006. 

PharmaGossip: The new drugs don't work for big pharma, report shows | Business | The Guardian.

Time to crank up those highly paid brains and get some innovation going in the industry once more.  This is particularly needed as total industry-wide R&D spending has declined over the past two years as well. Time to make more from less. That requires new ideas and new models.

Posted by Bruce Lehr June 27th 2010.

Zinc Fingers knock out Bax/Bak in CHO

An article in Biotechnology and Bioengineering details the knock out of the Bax/Bak genes in CHO using zinc finger nucleases (ZFNs) to yield cells that are apoptosis resistant.  The cells continue to grow normally in a scaled down bioreactor model and were resistant to apotosis induction by starvation, staurosporine and sodium butyrate.  Under the conditions of this investigation, the Bax/Bak deleted cells produced 2 to 5 fold more protein than wt CHO cells.

Posted by Bruce Lehr June 27th 2010.

Good Luck to USA vs Ghana

The USA will play Ghana today in a knock-out match with hopes of reaching the Quarter finals in World Cup play.  The game starts at 1:30 pm Central time (where I live) from Royal Bafokeng Stadium in Rustenburg. The US side has fared well here in previous matches vs Egypt and the UK. 

Good luck to the Team this afternoon.  I hope we can cope with Ghana's quickness and no doubt will be battling strong home town African support.  This is our chance to reverse the outcome of the 2006 game vs Ghana.

US fans are stoked.  Football (soccer) is top of mind right now for many and networks are expecting to top the record 13.7 M viewers set during 1994 loss to Brasil. 

Prediction: US 2 Ghana 1.  No PKs please!

Posted by Bruce Lehr June 26th 2010.

Wal-mulin?

Cliff Mintz reports in his BioJobBlog this morning that Eli Lilly and Wal-mart will team up to sell Humulin as a co-branded product in Wal-mart stores?  Huh?  Did I get that right?

I've been advocating that Big Pharma needs to change its thinking, business models, etc to face a brave new world.  This is a reminder that "innovation" doesn't necessarily mean new and different products - it can be innovation around how the product is sold and brought to market as in this case. 

We appear to be in for some changes.

Posted by Bruce Lehr June 26th 2010.

Son of Innovation Crisis in Biotech

Late last week I posted comments by Lilly's CEO John Lechleiter stating that there was an innovation crisis looming in the US and we needed to make 4 key policy changes to combat it. These were:

• Broad improvement in science and math education
• Immigration laws that permit top foreign scientists to work in the US
• A well-funded basic research infrastructure in academic and government labs
• Tax policy that fosters innovation

Today, I came across this article by Chris Rivera, President of the Washington Biotechnology and Biomedical Association, in Xconomy.  In it, a recent study by Batelle, commissioned by the Council for American Medical Innovation, states there are 4 major areas that policy needs to address to maintain America's medical innovation world leadership position.  The Council is Chaired by former House Majority Leader, Dick Gebhardt (I'm a St. Louis constituent from his district).

Biotech Must Have Predictable Regs, More Capital, More Talented Workers to Thrive.

The four areas of challenge for our medical innovation ecosystem (government phrasing) were outlined as:

• Lack of consistency and predictability in US FDA regulatory review and uncertainty in reimbursement
• Inadequate private investment for company formation and R&D growth
• Gaps in translating research innovations to commercial new treatments
• Limitations in the US bioscience talent pool

Read the Batelle report here - Download Gone_Tomorrow (I didn't name it!).

How should we meet the challenge?  Interestingly, Lechleiter's four suggestions probably would help address issues 2-4 identified by the Council to some degree and resemble some of the Council's own recommendations.  His promoted changes probably would not address the regulatory and reimbursement challenge identified in the Batelle report.

The Council's recommendations for these 4 Challenge areas:

Regulatory Policy

• Support FDA's Advancing Regulatory Science Initiative to improve science based risk-reward analysis
• Fund FDA to support more complex science and increased jurisdiction
• Expand ICH efforts to spread best practices re: Technical Requirements for Registration of Pharmaceuticals for Human Use and increase use qualified expert input
• Adopt policies that encourage new medical technology under reimbursement policy and don't penalize early adopters of technology

Increase Private Investment

• Strengthen the federal R&D tax credit by making it permanent and globally competitive
• Adopt tax and economic incentives to boost manufacturing
• Encourage venture financing from formation through IPO by creating federal angel investment tax credit, incentives to foster capital pools, and promoting alternative stock market methods for IPOs
• Private federal financing support for bioscience R&D infrastructure

Translational Research

• Commit to 10 year growth budget strategy for NIH with more emphasis on applied research
• More specific university-industry collaboration approaches following model of National Science Foundation or Department of Energy for "innovation hubs"
• Protect university technology transfer as set out in Bayh-Dole act (cost of patent recovery, overhead support, etc)
• Funding for the Cures Acceleration Network to support innovation for rare disease
• Reform SBIR & STTR programs to address "valley of death" challenges in commercialization
• National policies to encourage participation and retention in US-based clinical trials

Talent

• Federal support for K-12 science, technology, engineering, and math efforts
• Funding for vocational, technical schools, community colleges and industry consortia to retrain existing workforce in biomedical careers
• Increase number of US and foreign students pursuing graduate degrees in biosciences in US - could include scholarships and loan forgiveness for US student in technical fields; and a streamlined green card process for foreign grads of US universities at master's and Ph.D level

At face value, this looks like it will cost some money - finding the budget with all the other federal commitments is undoubtedly a big issue.  However, investment in biomedical innovation does pump needed support into an industry where the US can claim leadership.  It is a major engine of economic growth and a source of better paying knowledge based jobs.  It is vital to the health of healthcare and ALL its ancillary benefits to the US population.

I think a key is to get more public-private investment and to leverage collaboration between those two sectors. It goes back to exploiting more open innovation models in pursuit of new biomedical discovery - a historic US strength and an acknowledged source of our current leadership position.

If the government is to invest in an industry, this would seem to be a good choice given a current level of high competence and leadership, and with good prospects of offering a long term payoff.  The payoff coming not only for the industry itself but for the public it serves as we're ultimately taking about delivery of healthcare and quality of life.

As the report states, 'global leadership in medical innovation and biomedical development is "ours to lose"'. As I posted yesterday in the Innovator's Paradox, the best time to invest in innovation is when you are in the lead.

Posted by Bruce Lehr June 25th 2010.

The Innovator's Paradox

I like articles on Innovation.  This is a good one by Scott Anthony in the HBR blog.  I pass it on as a cautionary tale that really can be applied to any big successful company in any industry. Those of us who have spent careeers in large organizations can recognize a few of these observations and behaviors - I hazard to submit.

 

This might be a good time (if not already too late) for executive leadership teams throughout pharma to ponder some of these weighty questions.

Posted by Bruce Lehr June 24th 2010.  

How do you spell writer's faux pas?

T-A-N-E-Z-U-M-A-B! Ouch!

Earlier this week, I touted this drug as likely to receive expedited approval and be the first biologic pain reliever to ever be approved.  Now, a few days later, Fierce Biotech reports that Pfizer has been forced to suspend clinical trials.  The drug has caused serious enough side effects in some osteoarthritis patients as to require them to seek joint replacement surgery.

The Pfizer news release can be accessed here.  Pulling a potential winner off the table like this really is a PAIN!

Posted by Bruce Lehr June 24th 2010.

BioSimilars Likely Hit List!

Keith Bradbury wrote a good piece in the Biotech blog summarizing the expected near term future state of biosimilars. The recently enacted Patient Protection and Affordable Care Act (gotta love the names of these bills - that's marketing!) creates a pathway for biosimilars to be approved in the US - and can be viewed somewhat analogously to the Hatch-Waxman Act that created a path for generics. 

Under the biosimilar Act, the reference product manufacturer will enjoy a 12-year period of data exclusivity for data used in the submission.  The clock starts running at the date of FDA approval.  Despite this concession to novel entity producers, a concession that was not received with open arms by generic producers, there are still a number of drugs/therapeutic categories that can be expected to see biosimilar competition between now and 2015.  That's because the patents have expired on some of these already. Drugs or drug categories that are expected to be more competitive with regard to biosimilar introductions over the next 5 years include:

• Human growth hormone. Patents expired and among first biologics in market ever.
• Recombinant insulins. Again patents expired and should be relatively easy to manufacture.
• Epoetin alfa. May require some additiona safety data with regard to cardiovascular risk.
• Leukine. Could see competition by 2014.
• Neutropenia drugs. Teva has already introduced a competitor and patents expire in 2013.
• Interferon-alfa. Many patents expired. Long history on market with a variety of diseases.
• RA drugs. This group would expect to see its greatest competition starting in 2014.

Big Pharma companies like Merck, Eli Lilly and AstraZeneca have stated their intention to compete in some of these biosimilar therapeutic categories.  I don't think this list is in any way exhaustive.  My contention is that in the future state of pharma, the biggest competitors will have a mixed portfolio of novel small and large molecule entities as well as generics and biosimilars.  There will be a lot of cross licensing and co-marketing partnerships as well in my view. Companies ought to get busy building their collaborative networks of partners and their portfolios.

With biosimilars expected to offer US consumers up to 30% in savings, CBO projects $25 B in savings from 2009-2018, over the reference drugs, there is NO WAY the tide will ever be turning back.  Successful companies will need to build this part of the offer into their long-term strategy.

Posted by Bruce Lehr June 24th 2010.

Supply and Demand for New Drugs?

Mike Wokasch's Pharma reform blog asks if the demand of new late stage drug projects is going to greatly outstrip the supply?  The conclusion seems to be YES!

Succinctly, new Pharma drugs historically have come from big pharma R&D, academia, and small/mid-size biotechs.  Big Pharma R&D has hit the wall and currently is being downsized and outsourced. Pharma is trying to buy late stage projects with known clinical utility and lower risk of failure.  How many of these exist?  Aren't all the companies, who have adopted this model, going to be fighting with their checkbooks over this limited pool?

Academia might be able to supply new candidate molecules but don't have wherewithal to take to proof of concept or generate clinical data packages to become "investment worthy". Similarly, with down economy the past couple years, most biotechs are cash strapped to do this type of work as well.  Just look at a few message boards or communities out there where small guys are bemoning lack of capital available to do the work to attract Big Pharma money.

What to do?  Big Pharma could assume more risk and invest earlier.  I'm not sure that I see that happening right away - if you are going to do that why not invest in your own R&D department's efforts - unless you're convinced that you are dry.

Perhaps it is time Big Pharma engaged in more collaborative development and investment models.  Resources can be pooled to acquire properties, share risk and development, and then share commercialization.  This might be a more palatable way for the Big Guy's to invest earlier in the process and acquire more candidates - but at a cost acceptable to investors.  It could also bring more academic centers and biotechs to the party.

We may need this type of pooled/collaborative model to get more of the early stage candidates fully invested in the pipeline. It could also have the benefit of lowering competition somewhat for all the late stage projects and make those somewhat cheaper as well -- as companies were more willing to share risk and develop more diverse "aged portfolios" of drugs at different stages in their pipelines.

Creating these more diverse portfolios may also allow companies to better stock their pipelines with a higher percentage of novel compounds to somewhat offset the expected onslaught of biosimilars.  I don't expect this would eliminate biosimilars (nor should it) but could serve to balance each company's portfolio of novel early, late and biosimilar drugs.  

Clearly some newer model will need to be reached besides everyone clamoring for late-stage, clinically proven candidates in a bidding war environment - where there are not enough drugs to go around and where good ideas are left unfunded at early stages.

Posted by Bruce Lehr June 23rd 2010.

First Supply Chain, Now Drug Trials Under Scrutiny

Undoubtedly, we're all critically aware of quality issues with supply chain for raw materials, excipients and even APIs - particularly from developing countries like China.  Clearly there is work to do across vendors to raise quality standards and oversight for critical materials to be used in drug (& food) manufacturing.

Now we have a new HHS report that calls into question clinical trial results as well from some of these developing areas - China and Russia in particular were identified.   It likely is not a surprise that clinical trial work is being outsourced to areas besides the US and Western Europe due to much lower costs. It may be a surprise to what extent this is occuring.  The HHS report found that 80% of all drugs approved in the US in 2008 relied on some foreign trial data, 78% of all study enrollees were at foreign sites, and 10 new drugs had no US derived data at all. 

This is seen to be a dangerous situation by some.  Congresswoman Rosa DeLauro of Connecticut states, "By pursuing clinical trials in foreign countries with lower standards and where FDA lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of the public health."

Not too comforting if it can be taken at complete face value.  It would be nice to see exactly what quality corners are being cut to assess that portion of the claim. Aparently, there is less liability to worry about in these countries and informed consent is more "cloudy" shall we say.

One of the problems with cost is that many US and Western clinical investigators don't want to do trials anymore - trial investigators have dropped by 5.2 and 6.1 percent respectively in each geography. While numbers have blossomed in Eastern Europe (up 16%), Asia (up 12%) and Latin America (up 10%).   US investigators want to make money and don't want increased reporting requirements - especially income disclosure requirements imposed by new sunshine legislation - 24% say they are less likely to participate in a trial as a result of financial disclosure.

Hmmm!  Sounds like we're not going to be seeing a change in this trend anytime soon. 

By the way, PhRMA disputes that there is any difference in regulatory standards for clinical trials regardless of location. See PhRMA website for the complete statement.

Posted by Bruce Lehr June 23rd 2010.

Chemistry World Interview - Raw Materials & Supply Chain Integrity

I actually got interviewed in an article just published online with Chemistry World, a publication of the Royal Society of Chemistry.  It is a piece detailing some of the recent problems seen with pharmaceuticals resulting in recalls or low product availability.  Most of these resulted from issues with raw materials and in some cases may have been compounded by the manufacuring and quality system lapses too.

My comments have to do with the integrity of the supply chain and the need to really interrogate the whole system - including stepping up with enhanced understanding of your raw materials and their suppliers.  This is in line with my Raw Materials Detective series and our the SAFC Raw Material Characterization initiative.

 

 

Posted by Bruce Lehr June 23rd 2010.  

No BRIC Without Russia

Again, another post pulled from Ed Silverman's Pharmalot blog.  This one reminds us that the pharma market in Russia is every bit as active as those seen in India and China - perhaps more so - Russia is expecting 18% growth in 2010.

To Russia, With Drugs: The Russian Market Expands // Pharmalot.

What's more? A large number of MNCs have stated they are considering plans or are underway in building new manufacturing capacity in Russia. These include AZ, GSK, Novartis, Novo Nordisk, Nycomed, Pfizer and Servier with about $1 B in investment under consideration. The Russian government plans to spend another $4 B on local industry players to boot.

Za Vas!

Posted by Bruce Lehr June 22nd 2010.

Which Drugmaker Does The Most For The Poor?

This post from the Pharmalot blog details companies that have done the most to make drugs available to developing companies.  Not surprisingly (to me anyway), European companies led their US counterparts.  The number one company was GSK.

Again, I wasn't too surprised by this. I figured perhaps something must have rubbed off from the Wellcome acquisition - as that company certainly represented a more charitable disposition historically.   

Which Drugmaker Does The Most For The Poor? // Pharmalot.

It is good to see that someone is creating this type of Access to Medicine Index (2nd since 2008).  If you saw my post on Betterness is Good Business - and more importantly Umair Hague's HBR article on this topic - you would learn that a better social conscience and stewardship has historically resulted in better ROIs for Companies practicing that philosophy.

That may speak to investment opportunities with GSK, Merck, Novartis and others at the top of the list.  The index exists by the way to allow investor's to assess these pharma companies on their social responsibility score.

 

Posted by Bruce Lehr June 22nd 2010.

FDA Comments on Its Role in Rare Diseases & Orphan Drugs

In an effort to be more visible to the public, the FDA now publishes its own 'transparency blog".  This post deals with their role in regulating orphan drugs in service of the 7000+ rare diseases.

Link here.  

Posted by Bruce Lehr June 22nd 2010.

Smart Kid Explains Orphan Drugs, Pricing and Profits

This is from the Biotech Blog. It is a paper by Nate Hafer, a student participating in the NIH Foundation for Advanced Education in the Science's Tech 366 -- Biotechnology Management course. It's his final paper, entitled "Profitability and Orphans: The Role of Price and Incentives in Four Different Markets".

I think it is worth reading and thinking about in context of predictions by groups like Frost & Sullivan that there will be a large upsurge in interest in the Orphan drug markets and applications.  We also have recent reports that companies like Pfizer and GSK will start up rare disease units & enter domains previously occupied only by companies like Genzyme.

I think some of the economic incentives in the paper help explain why this markets should become more interesting to more players and more competitive.

Posted by Bruce Lehr June 19th 2010.

See This Open Innovation Review

The Innovate on Purpose (still love this blog's name! & content) blog just published a review of Stefan Lindegaard's book The Open Innovation Revolution.

Open innovation is another new favorite topic of mine.  I'd like to see the pharma industry figure out how to apply it more actively - especially given some of the challenges with the so-called innovation gap (see Lilly CEO recent comments) and patent cliffs. There certainly are open innovation projects ongoing in big pharma now, and several major companies have programs.  It just needs to become more 1st nature for most of these firms. But it can be tough to deal with "invented here" and "IP is all mine" type training we often receive in course of our careers.

Here's your chance to learn.  This book is meant to help companies from the ground up to consider and implement and open innovation approach.  You can also read more on this topic on Stefan's website www.15inno.com

Posted by Bruce Lehr June 19th 2010.

 

Myriad Files Its Appeal of the Judge Sweet BRCA Gene Decision as Expected

Readers here know that I've been following the Myriad Genetics and other gene patenting cases closely. I think it is an important issue that needs to be settled in the biotechnology arena.  Should genes be patented or not? Under what circumstances and for what applications?  What rights of exclusivity should be granted and what licensing rights should be available?  Should we have patent pools? Questions like that.

As reported in Kevin Noonan's Patent Docs blog (which I think is excellent), Myriad did file a Notice of Appeal for itself and the Directors of University of Utah Research Foundation.  The Sweet decision will now be reviewed by the Federal Circuit court and ultimately we may see this one in the Supreme Court someday.

Stay tuned.  We've only just begun.

Posted by Bruce Lehr June 19th 2010.

Melamine testing of Excipients Webinar June 29th

Angie Drakulich in the PharmaTech Talk blog announced that Pharmaceutical Technology will be sponsoring a webinar on June 29th that will address topic of melamine screening - particularly for pharmaceutical excipients. 

Presenters for the webinar include the FDA's Steven Wolfgang, Recall & Shortages Branch, FDA's Brian Hasselbalch, Division of Manufacturing and Product Quality, and Dave Schoneker, IPEC. 

The seminar will touch on recent movements with melamine testing and screening.  USP has been working with a coalition consisting of IPEC, PhRMA, GPhA, CHPA, and SOCMA to look a monographs for melamine testing. USP has also been exploring use of infrared spectroscopy and gel permeation chromatography in screening excipients - which should help melamine detection.

See previous Big Red Biotech Blog post for SAFC approach to melamine screening and risk assessment.

Posted by Bruce Lehr June 19th 2010.  

Roche hits pothole with taspoglutide

Fierce Biotech reports that Roche has suspended its trial with the highly touted diabetes drug taspoglutide. Only a few months ago, Roche CEO Severin Schwan was highlighting taspoglutide as a best in class drug during Roche's pipeline review. 

Roche expects Taspoglutide to be a blockbuster that will outcompete Amylin's recently approved Bydureon. However, the late stage trials have now been suspended for an expected 18 months due to patients experiencing hypersensitivity reactions, stomach pain, heart and respiratory symptoms.

Roche's plans for filing in 2011 are gone and the company may now have to wait until 2014 for approval (if ever).  The delay has caused industry analysts to revise sales for this drug in 2014 down from $2.8 billion annually to a mere $490 M.  That's a big bump in the road.

Posted by Bruce Lehr June 18th 2010.

How do you spell relief?

Soon it may be T-A-N-E-Z-U-M-A-B! 

Pfizers new biologic for treatment of pain associated with osteoarthritis.  The new therapy just hit its endpoints in a phase III study with 690 patients who did not receive sufficient relief from NSAIDs or Cox-2 inhibitors.

Results are so good that Fierce Biotech reports that this drug is now the leading candidate to become the first mAb (and large molecule) to be approved for pain relief.  This news has got the folks at Pfizer and its partner Xoma feeling no pain.

Posted by Bruce Lehr June 18th 2010.