The Cross-Border Biotech Blog

Monday Biotech Deal Review: November 9, 2009

November 9, 2009 · Leave a Comment

B&W_BigNickelSome closings, some new deals, some MDS and some PBM all in this week’s deal review.

Keep reading →

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This Week in the Twitterverse

November 8, 2009 · Leave a Comment

For those who don’t follow @crossborderbio and for those who just like everything wrapped up nice and neatly in one post, here’s the Twitter news from the week.  Also, if you’re interested, I made a Twitter list of great Biopharma, HealthIT and Health twits.  Check it out here.

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Bill for U.S. Domestic Production of Medical Isotopes Passed by House of Representatives

November 6, 2009 · Leave a Comment

683px-Schematicky_atomThe shut-down of Ontario’s Chalk River reactor, which used to supply 30% of the world’s medical isotope requirements, and 60% of U.S. isotope needs, has prompted Congressional action in the U.S.

Yesterday, the House passed H.R. 3276 — the American Medical Isotopes Production Act of 2009 — finding that “[t]he United States should move expeditiously to ensure that an adequate and reliable supply of molybdenum-99 can be produced in the United States, without the use of highly enriched uranium.”

Both parts of that finding are important:

  1. supply of molybdenum-99 produced in the United States, because of the heavy impact on U.S. patients (16 million medical procedures annually); and
  2. without the use of highly enriched uranium, because reducing the need for highly enriched uranium is part of the U.S.’ nuclear security agenda. 

The bill would provide funding of $163,000,000 (over FYs 2010-2014) for a program to evaluate and support projects for domestic production of medical isotopes.

In Canada, the latest plan is to spin off and privatize the “reactor business” unit of Atomic Energy of Canada Ltd. (AECL).  The Chalk River reactor is facing $70 million of repairs and/or an uncertain long-term future.

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Friday Science Review: November 6, 2009

November 6, 2009 · Leave a Comment

Just two stories this week – a cancer pathway and innovative dipsticks…

New Relationship between Tumour Suppressor Genes: Knocking out genes in mice believed to play a tumour inhibiting role would intuitively result in rapid cancer development.  However, it was a surprise to McGill researchers that mice lacking the tumour suppressors 4E-BP1 and 4E-BP2 were refractory to cancer growth.  When they deleted another well known tumour suppressor, p53, then they observed enhanced tumour growth more aggressive than knocking out p53 alone.  These results demonstrate for the first time a cooperative effect between 4E-BPs and p53 and highlight the advantages of indentifying individual molecular profiles to predict responsiveness to therapeutic strategies.  Dr. Nahum Sonenberg, who led the research team at McGill University remarks “this is another fine example how basic research, which intends to provide answers to fundamental questions about molecular mechanisms of cell proliferation, leads to unexpected findings that advance our ability to understand and cure human disease.”  The study appears in this week’s issue of Cancer Cell.

Bioactive Paper Sensors: A simple and rapid method to detect pesticides or toxins in food using innovative test strips was recently developed at McMaster University.  These “dipsticks” can sense the presence of small amounts of pesticides in food and within five minutes, a colour change indicates the level of the contaminant.  Future applications of this technology, with a few tweaks,  include detecting for the presence of food borne bacteria such as E.coli, Listeria, or Salmonella.  The practicality, ease of use without the need for large equipment, and the ability to get almost immediate results are huge advantages of the dipsticks to provide rapid screening and could play a role in curbing future outbreaks.  Dr. John Brennan’s team describes their research in the latest issue of Analytical Chemistry.

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Canadian Announcement on Merck–Schering-Plough Transaction Closing

November 4, 2009 · Leave a Comment

Merck closed its merger with Schering-Plough yesterday, following regulatory clearance in China and Mexico.  They held press events yesterday and today, and this morning they appear to have released country-specific announcments.

Here’s the blurb on Canadian operations:

“Canada is an integral part of the company’s expanded global presence. Merck will now market over 530 pharmaceutical, consumer and animal health products, employ over 1800 people, generate over $1.2 billion in pharmaceutical sales and invest over $121 million in research and development in Canada. Merck operations in Canada include research, manufacturing, and sales.”

The Merck Canada website is still being updated.

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Trends Update — IP Constituencies: China On the Rise as an IP Enforcer

November 3, 2009 · Leave a Comment

B&W_BlankMap-World-nobordersWe have been tracking increased innovative activity in India and China as part of this blog’s Trends in 2009 series, because it has the potential to impact the constituencies that negotiate the IP aspects of global trade agreements.  Generally, with this blog’s focus on pharma and biotech, posts have mainly considered commercial collaborations to develop novel products.

Two recent stories focussed on different areas highlight just how far China has come from its perceived role as a country completely neglectful of innovators’ IP:

  1. A Thomson Reuters study released yesterday shows “explosive growth in research output from China,” with output doubling since 2004.  There is no way the developments China is making in physical, biological and chemical sciences will fail to translate into innovation and new demands for IP protection.
  2. The first salvo wasn’t in biotech, as it turns out, but in copyright.  According to a recent Forbes article (H/T @TechLaw_Elman):

    A Chinese writers’ society accused Google of infringing on the copyrights of at least 570 Chinese authors by scanning and uploading their books into Google’s digital library without seeking consent.” and is “soliciting all Chinese writers to voice their opposition before a U.S. court finalizes a settlement at a hearing scheduled for Nov 9.”

Still, these developments move China much farther toward being an enforcer of intellectual property rights both domestically and on a global scale.

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Monday Biotech Deal Review: November 2, 2009

November 3, 2009 · Leave a Comment

B&W_BigNickelIn this week’s Deal Review: SemBioSys hops on the SIFT Tax bandwagon; new deals from Microbix, OPMEDIC and GeneNews; and good updates from iCo Therapeutics, QLT, Noveko and Oncolytics. Keep reading →

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This Week in the Twitterverse

October 31, 2009 · Leave a Comment

A lot of my tweeting this week was live reporting/commentary/snark from the first ever Canadian Science Policy Conference. The conference was a great success and will hopefully spur continued reflection and action in the coming months.  The highlight for me was moderating a panel on commercialization comprising Tom Brzustowski, Ronald Dyck, Jorge Niosi and Mark Romoff. My thanks to them and to the organizers for the opportunity.

Aside from that, here’s what was up @crossborderbio this week:

  • RT @enochchoi:The 2nd day of #bilpil (#TEDMED ’s sister conference) … livestream via @medpagetoday: http://bit.ly/3CqtJq via @drval
  • #cspc Science Media Centre coming to Canada (exists in UK and Aus) communicates about & for science. Formed 2wks ago launch summer 2010 
  • #cspc2009 new rule: all questions by Twitter. Give us one tweet, Vasily. One tweet only please. 
  • Great #cspc2009 question: enough about science-illiterate public, what to do about public-illiterate scientists?
  • #cspc2009 Don’t need to fill a swimming pool (science literacy) to discuss a specific issue, just a (targeted) bathtub. E.g. Citizen’s fora
  • #cspc2009 Chantal Barriault research on “free choice environments” (science musesums, libraries, etc) shows they R seen as neutral, credible 
  • Ha ha, I think all the #cspc2009 twits are navel-gazing at the media panel instead of covering substance. 
  • RT @davidcrow: RT @rogerchabra: GrowthWorks & Seamark to merge and become Matrix Asset Management: http://bit.ly/2aNAk3 
  • Please make sure your CRM software doesn’t do this: “Dear (null) Jeremy Grushcow”. Thanks for that ego boost, sales guy.
  • Excellent posts from #cspc2009 from @robannan at his Researcher Forum Blog http://bit.ly/2xMsmo Oh, look. He’s tweeting there too!
  • RT @InVivoBlogEllen: Panel at BioInvestor Forum on IPO market. Lots of S-1s being written. Yeah, but will they get filed? 
  • Yay! A hashtag! RT @tdmckee: Canadian science policy conference day 2 going well so far – excellent turnout, plenary 1 underway… #cspc2009 
  • RT @ogilvyrenault: Aeterna Zentaris Completes Second Registered Direct Offering of Common Shares and Warrants http://bit.ly/3C8LKb
  • RT @ogilvyrenault: Nadine D’Aguiar and Jason Markwell speaking at Pharma Patent Law Conference in TO today and tomorrow http://bit.ly/1CJBTF 
  • @jsookman ’s blog: Blogger to WordPress. Rebranded. “Ubiquitous Startups and the VC” is now “Startup Life” http://startuplifeblog.com
  • RT: @LucLalande TVO debate on Canadian universities, research and world-class standing – CarletonU Pres on panel http://bit.ly/2aKc6b video
  • Canadian Science Policy Conference – Bruce Alberts: Science for Policy Nat’l Academy reports are meant to be informative, not prescriptive.
  • Canadian Science Policy Conference – Bruce Alberts: if you want the federal government interested in science, send them to China.
  • Heading to Canadian Science Policy Conference. Keynote by Bruce Alberts + remarks by Ontario Minister of Research and Innovation John Milloy
  • Ontario Hospital Association (OHA) asks to be subject to province’s Freedom of Information and Protection of Privacy Act http://ow.ly/wZMB
  • $QLT authorizes repurchase up to 5% of its shares on the open market http://bit.ly/2cHG4n  
  • RT @nvca: applauds House FinServ Com Passage of HR 3818 w VC exemption from Inv. Advisers Act. 67-1. Major hurdle crossed; still wrk ahead.  
  • RT: @MaRSDD Pls RT SiG @MaRSdd is hiring an Entrepreneur in Residence! Job post here http://is.gd/4Eybd (via @lisatorjman)  
  • Synthetic bio symposium, Vincent Martin: PhytoMetaSyn project – genomic & metabolic info for 75 plants = toolkit for building new pathways.  
  • RT: @FierceBiotech RT @ldtimmerman: Omeros, worst performing IPO of 2009, casts a shadow over other aspiring biotechs. http://bit.ly/dGO4T
  • Synthetic bio symposium, Mads Kaern: cool iGEM project from Edinburgh detects arsenic in drinking water.  
  • Synthetic bio symposium, Mads Kaern: iGEM competitiors use open source “parts” to build cool stuff. Good Canadian participation / leadership   
  • Synthetic bio symposium, Mads Kaern: Biological machinery needs standardized functional components: e.g MIT registry of std biological parts   
  • Synthetic bio symposium, Mads Kaern: 20th century was for chemical engineering, 21st is for biological engineering.  
  • Just made it to the OGI-IDT synthetic biology symposium @MaRSDD. Looking for “build-a-bear” on the program, but not seeing it. Sorry,kids :(
  • Negotiating some docs for a client this morning then joining in OGI’s Synthetic Biology Symposium @MaRSDD. Includes a public forum at 6pm.
  • Peace, Order, Good Government and Bluetooth @miskinlaw Oppressed in Ontario Canada: … and now not allowed to Tweet and drive
  • RT @scotthensley: So here go with public option…Opt out,states,if you want to,but Reid sounds determined,Snowe or not http://bit.ly/4ijj3F 
  • Says ME! Har. RT @CLSD: Vaccines production and use now at record levels, says WHO http://bit.ly/2lAIqP
  • My office neighbour! RT @ogilvyrenault: Evelyn Li is featured on the Sauder Business Club of Toronto website http://bit.ly/4fSa18 
  • Right! RT @genomicslawyer: DTC Disconnect @matthewherper’s post http://bit.ly/2YuNMh See @genomeweb_news re Navigenics http://bit.ly/2uGYLY
  • RT @FierceBiotech: RT @GEstock: Imaging, informatics steer cancer regimen – FierceBiotech IT http://bit.ly/Mom8R $GE $LLY 
  • Canada falling behind in cleantech race, industry insiders say http://ow.ly/wAYs <<Flow-thru 4 #cleantech & #biotech I say http://ow.ly/wAZT 
  • Personal genomics personalized…for docs RT @GenomeWeb_News Navigenics, Beth Israel Team on Personal Genomics Training http://bit.ly/2uGYLY 
  • BioProspecting & Atlantic Cancer Research Institute collaborate on diagnostic (& companion therapeutic) for ovarian cancer http://ow.ly/wwxc 
  • Time for a whole-virus HIV Vaccine? http://ow.ly/wrOq via @themarknews
  • Science dream or re-identification nightmare? RT @GenomeWeb_News: NHGRI Considering New Genomic Data Sharing Policies.. http://bit.ly/Rr8gI 
  • RT @dgmacarthur: #ashg2009 overall impression of 23andMe talk – competent GWAS analysis, still skeptical abt power for disease risk.

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Ontario H1N1 Swine Flu Update October 31: All Indicators Still Increasing. 2 New Deaths, 10 Toronto Clinics

October 31, 2009 · Leave a Comment

B&W_AntigenicShift_HiResCropChecking out this week’s Influenza Bulletin, indications are that the Fall’s Swine Flu outbreak in Ontario is going to get worse before it gets better.  Unfortunately, the vaccine is just starting to become available.  This coming week, there will be 10 public clinics open in the greater Toronto area, but still only for those among the currently-eligible “high-risk” groups.

Sadly, two Ontarians died as a result of the virus this week.  To date (pdf), including over the summer:

“Thirty deaths have been reported among confirmed cases. Almost all of these fatalities (26/28 or 87%) were hospitalized prior to death… Of the fatal cases, 73% (22/30) occurred in individuals over the age of 40 years… [and] 26 (87%) had underlying chronic medical conditions reported.”

So Evan Frustaglio is a very sad exception to the general rule. 

Here’s some of this week’s data:

The graph below shows the total number of swine flu cases. The brown rising line on the left is the current situation (with 553 cases this week), and the green peak on the right is the data from the first swine flu wave this past summer.

Ontario Swine Flu Cases total October 30 2009

This graph shows hospitalizations due to swine flu. It lags a bit because the relevant records have to wend their way into the relevant database, but you get the picture.

Ontario Swine Flu hospitalizations Oct 30

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Friday Science Review: October 30, 2009

October 30, 2009 · Leave a Comment

Regenerative medicine and Cross-border awards…

Gene Therapy Saves Donor Lungs: A technique using gene therapy on donor lungs before transplantation may be used to repair and save damaged lungs, making them potentially suitable for transplantation into patients.  The procedure involves first preserving the lungs at normal body temperature in a protective chamber called the Toronto XVIVO Lung Perfusion System, which continuously pumps a solution of oxygen, proteins and nutrients.  Next, adenovirus gene therapy is used to introduce the IL-10 cytokine gene into the lungs.  IL-10 helps to decrease inflammation, which would lead to improved health and function of the donor lungs and better outcome for the patient.

Dr. Shaf Keshavjee, the project leader at the McEwen Centre for Regenerative Medicine, describes the rationale:

“It’s as if gene therapy turbocharges each individual cell to manufacture many more proteins in its own IL-10 factory.”

“This protein down-regulates or decreases the inflammatory potential of cells injured before and during the transplant process. It also has the capacity to turn down the recipient’s immune system which rejects the transplanted organ.”

The research study is reported in this week’s issue of Science, Translational Medicine.

A Platform to Test Cardiac Cell Therapy:  A model system for evaluating stem cell transplant in cardiac cell therapy to repair damaged heart tissue is described in this study by Drs. Peter Zandstra and Milica Radisic’s team at the University of Toronto.  Using their engineered heart tissue (EHT) as the analytical platform, they applied stem-cell derived cardiac cells and measured molecular and electrophysiological parameters of the EHT.  The system was verified as a predictive strategy to interrogate different cell transplantation conditions for the capacity to survive and functionally integrate into heart tissue.  This tool should help researchers accelerate development of cardiac cell therapy strategies and it can also provide mechanistic insight into the challenges of a successful transplant.  On a personalized medicine theme, an advantage of the system is that the EHTs are customizable and can be derived from individuals for patient specific testing prior to the actual treatment.  The study appears in this week’s edition of the Proceedings of the National Academy of Sciences.

“Cross-border” Cancer Stem Cell Therapy Award: The Collaborative Partnership Program between the California Institute for Regenerative Medicine (CIRM) and the Cancer Stem Cell Consortium (CSCC) in Canada have awarded two internationally recognized Canadian researchers with support to lead their respective cancer stem cell based therapy projects.

One project will develop agents to directly target leukemic stem cells that are resistant to current therapies.  This will be co-led by Dr. John Dick, Princess Margaret Hospital and Dr. Dennis Carson, University of California San Diego.

The other project will develop small molecules targeting cancer-initiating cells within solid tumor cancers and will be co-led by Dr. Tak Mak, Princess Margaret Hospital and Dr. Dennis Slamon, University of California, Los Angeles.

The awards offer each project up to $40 million (USD) over four years, with funding for the Canadian investigators contributed by Genome Canada and Canadian Institutes of Health Research through the CSCC and funding for the Californian investigators contributed by CIRM.

Congratulations to Drs. John Dick and Tak Mak!

Top 10:  The Scientist magazine ranked Dalhousie University in Halifax and the University of Toronto in the top 10 best places to work in academia outside of the U.S. Based on a web survey of scientists regarding job satisfaction, pay, research resources and relationships with their peers and management, Dalhousie ranked 5th and U of T came in at 10th place.  It is very nice to see Canadian institutions and our great research environment recognized by peers around the world.

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Gairdner Breakfast: Nobel and Gairdner Winners Discuss Biotech and Pharma’s Pipeline Problems

October 29, 2009 · Leave a Comment

As part of the  Gairdner Foundation’s 50th anniversary celebrations this week, there was a breakfast panel this morning with a lot of brainpower (even for MaRS). Cal Stiller lead a discussion by David Baltimore, Phillip Sharp and Corey Goodman who between them have three Gairdner awards and two Nobel prizes.

These top-notch scientists also have truly impressive corporate expertise: Board members of Amgen, Biogen and Limerick BioPharma. They turned their attention to “unclogging the pipeline.”

David Baltimore discussed reasons we’ve seen fewer approvals:

  1. Higher regulatory safety barrier.
  2. Low-hanging fruit is gone. A lot of targets are for diseases that are not fatal in the short term, which (see #1) creates a high safety barrier. Also, he says the molecular targets are harder.

Baltimore also identified potential areas of success: a subject area (immunotherapy) and a structural area (UCLA medical center’s translational research institute).

Phillip Sharp talked about the changing structure of early stage and translational funding.

  • VC is re-thinking their model, but pharmas are reaching out earlier in the pipeline with incubators and academic outreach; and there is more public funding available to move products further along the pipeline.
  • Trends he identifies: personalized medicine (patient-driven with $1000 genome); and a huge role for engineers and incremental improvements.

Corey Goodman starts with some stats:

  • current success rate is closer to 1 in 25, not the 1 in 10 number still cited from the 1990’s
  • cost of a new drug (R&D dollars divided by successful approvals) around $3 billion.

Nevertheless, Goodman sees upside due to huge unmet medical needs, deficient pipelines and vast academic output.

Panel discussion:

Will healthcare reform plans interfere with the United States’ (hidden) subsidization of global drug development through high prices?

  • Baltimore points to $80 billion pharma deal that avoided price controls, but says prices are unsustainable.
  • Sharp agrees that costs can’t be a bigger part of GDP, but it’s a big bucket even at current levels and there is room for efficiencies that don’t impact reimbursement.
  • Goodman says importation can’t be prevented long-term based on a safety argument, so we’ll have to deal with pricing more globally [regardless of U.S. health reform efforts].

Aren’t early-stage acquisitions still (and permanently) the outliers?

  • Baltimore thinks there will be a number of early-stage transformative technolgies that yeild early successes, but VC and other early funders need to be more stringent and keep an eye on the long term potential of even very early stage products.
  • Sharp thinks that academia is not well-suited to disciplined discovery, and if the policy goal is to develop more products, we’ll need structural changes in academia.

The panel wrapped up on an optimistic note.  Not surprising — how can you not feel good in Gairdner season? Speaking of Gairdner season, don’t forget to check out this year’s winners.

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Bruce Alberts’ Two Strategies to Promote the Impact of Science on Policy

October 28, 2009 · Leave a Comment

In Bruce Alberts‘ keynote tonight kicking off Canada’s first Science Policy Conference, he highlighted two approaches to increasing the role of science on policy decisions. Here they are:

  1. To spread science, we need to spread scientists. Scientists in government, pre-college education, law, media and business can bridge cultures. Academic programs need to encourage alternate careers. He strongly recommends a National Academies-type science fellowship program for Canada.
  2. Outreach and aid internationally to build strong scientific organizations/academies in other nations. E.g., Canada’s efforts through the International Development Research Centre.

These actually sound like one strategy to me: dispersal.  It just has two axes. One is dispersal of scientists among careers, and the other is dispersal of scientists among nations.  Count my vote for multi-dimensional dispersal of scientists.  The more empiricists, the merrier.

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Ontario H1N1 Swine Flu Update October 27: Vaccine is on the Way

October 27, 2009 · 1 Comment

B&W_AntigenicShift_HiResCropThe latest actual figures on Ontario Swine Flu are in Ontario’s weekly “Influenza Bulletin”. See below for some interesting data from last Friday’s edition.

While you’re perusing those, note that vaccine is on the way.  The message from Deb Matthews, Ontario’s Minister of Health and Long-Term Care is: “Get vaccinated when it’s your turn.”  

First in line:

  • People under 65 with chronic conditions;
  • Pregnant women;
  • Healthy children 6 months to under five years of age;
  • People living in remote or isolated communities;
  • Health care workers; and
  • Household contacts and care providers of persons at high risk who cannot be immunized or may not respond to vaccines.

Here’s the data for new confirmed cases.  The big bump is the summer’s wave, the rising bars on the right are where we are today.

Ontario Swine Flu Cases October 21 2009

Here’s a view of how this Fall stacks up historically.  That early-riser on the left is 2009. Not encouraging.  Wash your hands, and go get vaccinated.  Then wash your hands again.

Influenza A Historical

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Trends Update — Electronic Medical Records: Pogue Mugs On CBS and Interviews Blumenthal While Australia Shows How It’s Done

October 26, 2009 · Leave a Comment

floppy-disk1David Pogue waded into the EMR narrative this week, with a piece on CBS News that took a look at the U.S. efforts with an interesting focus on Kaiser’s EMR efforts. Pogue follows up with a blog post containing a transcript of his full interview with David Blumenthal.  Interestingly, the main negative angle in his CBS piece is cost; but as we’ve noted, many providers are offering loans or guarantees or both to cover the cost until the federal payments kick in.

Meanwhile, Australia is only three years away from a full national EHR system, complete with a lifetime ID and scary music for the privacy-related segments:

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Monday Biotech Deal Review: October 25, 2009

October 26, 2009 · 1 Comment

B&W_BigNickelA very busy deal week coincided with a very busy work week (for those of us with day jobs), so allow me a particularly grateful thank-you to Jacob Cawker, who’s been an invaluable help with the Deal Review this and the last several weeks.  After the jump, licenses both inbound, outbound and just tied up (optioned); securities extended and accelerated (plus an actual common share offering, with the word “units” banished for one special week); and last but not least, a good volume of Canadian M&A (M&Eh?) from private to public to “just browsing.”  Keep reading →

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A Third REMS Advantage? Allergan Says REMS for Botox Requires Off-Label Communication

October 25, 2009 · Leave a Comment

Allergan sued the FDA earlier this month, claiming that the FDA’s prohibition of off-label promotion violates Allergan’s First Amendment rights by preventing Allergan from communicating about BOTOX’s REMS restrictions to physicians who need the information to properly treat off-label.  As the Allergan press release says:

“To serve the objectives of the FDA-mandated REMS program for BOTOX(R) and to assist physicians in evaluating the benefits and risks of the product, Allergan seeks a judgment that would permit it to provide currently available and truthful information to doctors for common off-label uses of BOTOX(R)”

I.e., the REMS forces Allergan to discuss the off-label uses.  Hrm.  The In Vivo Blog picks this one up and runs with it:

“the simple truth is that FDA now has the authority to do exactly what Allergan wants—allow, or indeed, require greater communication about off label uses. The suit focuses on the fact that FDA is not allowing as complete communication as Allergan wants—but the fact is that FDA could allow that under the existing law and in some sense “approve” an off-label promotion campaign.”

We’ll keep an eye out for the decision, but we don’t expect the District Court’s word to be final.  Meanwhile, having a product subjected to REMS ”restrictions” is looking better and better.

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This Week in the Twitterverse

October 24, 2009 · Leave a Comment

Interesting items this week that were too short for their own post:

Follow us on Twitter @crossborderbio!

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Friday Science Review: October 23, 2009

October 23, 2009 · Leave a Comment

A lucky find and two very different genomics projects…

Connective Tissue Disorder Linked to Defects in Ltbp4:  A McGill University researcher collaborating on two independent projects, one from Washington University School of Medicine and the other from New York University School of Medicine, made the coincidental link between the two after realizing that the tissue defects were identical.  Dr. Elaine Davis, an electron microscopy expert at McGill, analyzed tissue from children born with abnormally developed lungs, gastrointestinal and urinary systems, skin, skull, bones and muscles.  The underlying cause is a connective tissue disorder called cutis laxa that also causes skin to hang loosely from the body.  At the same time, Dr. Davis was analyzing tissue taken from Ltbp4 gene knockout mice from New York University when she realized that the connective tissue defects in the human and mouse samples were identical.  This connection was confirmed when they sequenced the Ltbp4 gene in human patients and discovered recessive mutations.  With this discovery, they now have a molecular target to understand the disease and to design therapeutic strategies.  The study is reported in The American Journal of Human Genetics.

A Deep-sea Microbe Genome: The microbe, SUP05, lives in the deep ocean “dead zone” where oxygenated water is minimal. It survives by using other compounds instead of oxygen, such as nitrates, sulphates and metals.  A recent surge in population suggests an expanding low-oxygen ocean ecosystem and is an indicator of global climate change.  University of British Columbia professor Dr. Steve Hallam and his research group analyzed the entire genome of SUP05 and identified a number of genes mediating carbon assimilation, sulfur oxidation, and nitrate respiration.  This study provides the first insight into the metabolism of these microbes and their effects on nutrients and gases in the deep-ocean ecosystem and will also lead to further understanding of their ecological and biogeochemical role.  The report appears in this week’s edition of Science.

Allelic Expression Genomic Map: Illumina genomics technology was used in this study to map global allelic expression differences associated with cis-acting variants.  Cis-acting elements can affect gene expression and variations due to single nucleotide polymorphisms (SNPs) explain a large percentage of the phenotypic differences in the population.  It is very informative to have this global map of the cis-acting variants and helps researchers identify variants associated with diseases.  To demonstrate this, they finely mapped cis-regulatory SNPs in a region in chromosome 8 associated with lupus.  The study was performed by Dr. Tomi Pastinen and his Genome Quebec team at McGill University and the report was published in Nature Genetics.

DNA Repair Suppresses c-Myc Lymphoma:  Overexpression of c-Myc in B cells is associated with lymphomas but requires secondary mutation events for the disease to develop.  In this study, immunologist Dr. Alberto Martin and his research team at the University of Toronto identified that the DNA repair protein, Msh2, plays an important role in mitigating c-Myc associated cancer.   To demonstrate this, they generated mice that overexpress c-Myc but with Msh2 mutations such that they are deficient in DNA mismatch repair.  These mice rapidly develop B cell lymphomas, which suggests that Msh2-dependent DNA repair actively suppresses c-Myc associated oncogenesis.  The report appears in the early edition of The Proceedings of the National Academy of Sciences.

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Preventing Bias in Comparative Effectiveness Research

October 20, 2009 · Leave a Comment

Comparative effectiveness research has the potential to avoid wasteful spending and create net benefits for patients if approached properly, but it’s expensive.  Many of the large-scale comparative effectiveness studies include industry funding, and benefits managers are no strangers to the game, but giving those partners a say in study design risks introducing bias. 

An interesting example comes from today’s report that pharmacy benefits giant Medco is planning a head-to-head study of nearly-off-patent Plavix versus brand-new Effient.  The interesting tweak here is that the study will exclude people with a genetic variant (of the CYP2C19 polymorphism) who can’t metabolize Plavix.

This seems like another great example of personalized medicine informing a comparative effectiveness decision.  But, as the In Vivo Blog pointed out in an August post about Plavix and Effient, the effect of the CYP2C19 polymorphism on Effient efficacy is unknown.

So the PBM, with cost-saving incentives, is setting up a study to make payment decisions in which the efficacy of the (cheap) generic is boosted by excluding patients with the CYP2C19 polymorphism, with the validity of the comparison based on the untested assumption that there is no systematic bias to the branded product’s efficacy in the excluded population.  Am I missing something here?

The moral of the story: fund comparative effectiveness research through neutral parties and keep a careful eye on genetic and phenotypic subgroups to maximize the value of these important studies.

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Dreaming of REMS: A Second Reason Why FDAAA Risk Evaluation and Mitigation Strategies Might Be a Benefit to Drug Developers

October 19, 2009 · 1 Comment

Over at The In Vivo Blog, Michael McCaughan has another thought-provoking piece on REMS — the FDA’s Risk Evaluation and Mitigation Strategies that impose tight controls on the distribution channels for certain drugs.

Michael compares two drugs for the same indication — opioid-induced constipation therapy, if you must know — and though they have similar mechanisms of action and were both developed by small biotechs and picked up by big pharmas, they met different ends (har).

Wyeth gave Progenics back the rights to Relistor last week, paying $10 million to do so; but GSK is continuing to market Adolor’s Entereg.

The difference? According to Michael, Wyeth was facing big marketing commitments, but GSK was not. Here’s the rub: GSK’s marketing commitments were limited because Entereg is marketed under a REMS that limits its use to an “ultra-restrictive indication.”

So, we now have two situations where REMS confer an unexpected benefit:

  1. Limiting marketing expenditures for a marginally successful partnered drug (the partnered part is key — without that, marketing budgets can be adjusted at-will, without regard to minimums); and
  2. As previously noted by Michael and discussed here, limiting generic competition for off-patent drugs (REMS don’t die or fade away, they just complicate life for generics).

In each case, I’d leave it to the math guys to calculate whether the benefits outweigh the costs of the sales limitations that come with a REMS (not to mention the direct compliance costs); but if your partnered product isn’t looking like a blockbuster or is closer than you’d like to patent expiration, maybe it’s a good time to look over the FDA’s recent draft REMS guidance — a “useful blueprint for how to develop these important safety strategies.”

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Monday Biotech Deal Review: October 18, 2009

October 19, 2009 · 1 Comment

B&W_BigNickelThis week’s deal review has a big bought deal for IMRIS (and RBC), the details of Cardiome’s successful offer, and some follow-through for MethylGene and BioSyntech.  Keep reading →

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This Week in the Twitterverse

October 17, 2009 · Leave a Comment

Tweets we tweeted this week, in case you don’t follow us on Twitter.  Here’s what you missed:

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Friday Science Review: October 16, 2009

October 16, 2009 · Leave a Comment

A mixed bag of research reports but nonetheless important and significant…

How MS Drug Works: Glatiramir Acetate (COPAXONE®, Teva Pharmaceuticals) is used for the treatment of patients with Multiple Sclerosis, however, it is not clear how this drug works.  In this new study, researchers demonstrate that glatiramir acetate can regulate the formation of myelin, the protective sheath around nerve fibers that is compromised in MS patients.  Glatiramir acetate induces the formation of helper immune cells that produce nerve promoting molecules, which in turn stimulate the myelin repair process. The study was led by Dr. V. Wee Yong at the University of Calgary and appears in this week’s issue of The Proceedings of the National Academy of Sciences.

New Target to Fight Diabetes: In genetic knockouts of the Lkb1 gene specifically in beta cells, the insulin producing units in the pancreas, the knockout mice exhibited an increased number of beta cells that were also larger than normal with greater amounts of insulin.  When they challenged the knockout mice with a high-fat diet to try to induce diabetes, the mice responded and kept blood glucose levels down.  Lkb1 is a tumor suppressor gene that was also known to be involved in energy metabolism but it was unclear whether the Lkb1 protein was associated with diabetes.  Dr. Robert Screaton’s group at the Children’s Hospital of Eastern Ontario Research Institute answered this question in a report appearing in this week’s Cell Metabolism.  Also noteworthy is that a research team from Israel published a similar study leading to the same conclusions.  With these surprising and dramatic results, Lkb1 may represent another therapeutic avenue to treat or prevent diabetes.

Sialyltransferase Crystal Structure Solved: Many important proteins, lipids or sugars are modified by the addition of sialic acid and these steps are essential for a number of processes including cell recognition, cell adhesion and immunogenicity.  The key enzyme responsible for catalyzing this reaction is a set of related sialyltransferases (ST).  In a Nature Structural and Molecular Biology report published this week, Dr. Natalie Strynadka (University of British Columbia) describes solving the crystal structure of ST and provides the first detailed understanding of the enzyme.  Without getting into any molecular jargon, suffice it to say that the structural data brings insight into how the enzyme works and how it achieves specificity, which is useful knowledge for developing prospective inhibitors.

Power of Pheromones: Researchers removed the pheromone-producing cells in fruit flies (male or female) and found that these flies were extremely attractive to normal male fruit flies and also flies of other related species.  This contradicts the notion that these chemical signals simply attract one individual to another.  Instead, they are part of a complex signaling system used by the flies to recognize and distinguish sexes and species.  Other unusual behaviour by male fruit flies without pheromones included trying to copulate with each other’s heads.  Dr. Joel Levine and his team at the University of Toronto (Mississauga) describe their research in detail in this week’s edition of Nature.

Beta-globin Switch: A proteomics screen was used to identify the enzyme G9a as the interacting partner of NF-E2, which act together to control expression of the beta-globin genes in red blood cell development.  This study provides a clearer understanding of the molecular determinants controlling embryonic expression of beta-globin where G9a acts as a repressor and its transition to adult beta-globin expression where G9a promotes expression.  The research team at the Ottawa Hospital Research Institute was lead by Dr. Marjorie Brand and the study appears in the early online edition of the Proceedings of the National Academy of Sciences.

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Trends Update — Biosimilars: The State of Play of U.S. Follow-on Biologics Legislation

October 15, 2009 · Leave a Comment

With the Senate Finance Committee voting this week in favour of its health reform bill, the legislative process will now move on to an attempt to reconcile the House bill and the two Senate bills in conference.

What does this mean for a biosimilars pathway?  Will there be one?  What will the exclusivity period be?  The Senate Finance bill is silent on the topic, and the two other bills both include a biosimilars pathway with a 12-year exclusivity period.

Twelve years makes the Biotechnology Industry Association (BIO) and the National Venture Capital Association pretty happy, but the Obama administration and  the FTC argue in favo(u)r of a much shorter period.

Today, a new opinion piece in the New England Journal of Medicine generated a lot of buzz, mostly because it argues for a 5-year exclusivity period (but also because it was an odd roll-out for NEJM’s new conflicts disclosure policy).

When the In Vivo Blog polled the question earlier this year, the majority vote was for 10-12 years; but me and some peeps on twitter (hi @InVivoBlogChris and Maureen @FierceBiotech) and in real life (anonymous) thought at the time the number would land under 10 years.  I’m sticking to that bet.

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Planned UK Bioscience Park Features “Open Innovation,” is Brought to You By GSK, the UK Government, The Wellcome Trust and the EEDA

October 14, 2009 · 1 Comment

A new biotech “hub” (aka campus, park, centre, cluster…) is being planned at GSK’s Stevenage Campus in the UK.  Whatever you call it, the organizers are pitching two novel features:

  • An “Open Innovation” model; and
  • Access to GSK management and expertise.

I’m not sure how far “open innovation” could really go, in an industry that depends on patents and compliance, but in this particular case the description from the reports on this new park sounds mostly like a good set of core facilities:

“shared access to specialist skills, equipment and expertise to stimulate new innovation in drug development”

It will be interesting to see how far the “open innovation” really goes.  It will also be interesting to see how often “access to GSK” turns into “access for GSK.”  As the Telegraph article says, the park will:

“provide the UK’s largest drug company with first-hand evidence of business projects in the biotechnology sector, which GSK could then choose to acquire.”

Why invest in this project?  The pitch to the government funders is the usual one: jobs.  Up to 1,700 jobs.  No, wait, up to 3,000 jobs!  The total funding of around £37.6m comes from the UK Strategic Investment Fund (£11.7m), GSK (£10.9m), the Wellcome Trust (£6m), the Technology Strategy Board (£5m) and the East of England Development Agency (EEDA) (£4m).

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A New Online Resource for Canadian Patients: MedSchoolForYou.com

October 13, 2009 · Leave a Comment

MedSchoolForYou LogomdBriefCase Inc., which provides online education for Canadian medical professionals, is branching out into the consumer market.  Their new website, MedSchoolForYou.com, will provide Canadian-specific online medical information for patients. 

With different drug nomenclature and different regulatory and reimbursement environments, a Canada-specific health resource could be extremely helpful.  At launch, the new site is limited to “Pain Management” information, but there are lots of “coming soon” labels (hopefully a better homepage design and a functioning search box are also pending).

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Monday Biotech Deal Review: October 12, 2009

October 12, 2009 · Leave a Comment

Here’s the roundup for today. It’s the Canadian Thanksgiving weekend, but there’s not a turkey in the bunch.  Keep reading →

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This Week in the Twitterverse

October 11, 2009 · Leave a Comment

Tweets I tweeted this week @crossborderbio:

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Friday Science Review: October 9, 2009

October 9, 2009 · 1 Comment

Breast cancer, genomics and two cover stories in prestigious journals…

Cancer Evolution and Progression:  Scientists at the BC Cancer Agency have sequenced and compared the entire cancer genome of a metastatic tumour versus the primary breast tumour that originated nine years earlier.  They used next generation DNA sequencing technology to reveal 32 mutations in the metastatic cancer but surprisingly only five of these were present in the original tumour.  Six mutations were present at lower frequencies in the primary tumour, 19 were not detected and 2 were undetermined.  These differences may provide clues about how cancer becomes resistant to therapy or how a tumour switches to aggressive metastasis that spreads to other sites in the body.  The study demonstrated that cancers evolve and that there may be significant heterogeneity within the tumours.  These findings emphasize the importance of ongoing research efforts to sequence all cancer genomes and buttress arguments in favour of personalized medicine.

The study was lead by Dr. Samuel Aparicio at the BC Cancer Agency and appears as the cover story in the latest edition of Nature.

Honey, I shrunk the lab: The “lab-on-a-chip” concept has been in use for a number of years but Dr. Aaron Wheeler’s Microfluidics Laboratory at the University of Toronto has designed a new module for use in breast cancer detection and care.  The hand-held sized device can extract and quantify estrogen in a very small sample size – as little as a 1 microliter sample of tissue or blood – by using electrical charges to move liquids around in a precise manner over a microchip.  Current methods require a much larger sample, about the size of a penny, which is often impractical to obtain.  Since elevated estrogen levels are associated with breast cancer risk and pathogenesis, this new device could be used at point-of-care to screen at-risk patients or to monitor therapies and provide results within minutes instead of days.

Dr. Wheeler collaborated with Dr. Robert Casper (University of Toronto and Samuel Lunenfeld Research Institute) on this project, which garnered the inaugural cover story in the new journal, Science Translational Medicine.

Genome Map Upgrade: Researchers have generated a comprehensive structural map of the human genome in identifying and marking regions that are duplicated or deleted, the so-called copy number variation (CNV).  Genetic variation is what makes us different and certain areas of the genome reflect these differences whereas other genetic regions show very little variation and are likely essential function genes.  It also provides important clues to understanding evolution and provides the foundation for future research in developing personalized medicine.   The international study was co-lead by Dr. Stephen Scherer at The Centre for Applied Genomics (Hospital for Sick Children, Toronto) and provides the following comments:

“The scale of this current project is 100 times the scale of all others.”

“Previous work in this field would be like a paper fold-up map; this advancement is like a GPS that takes you where you need to go. It allows you to navigate the landscape of the genome, from its peaks where there is vast genetic variation, to its valleys devoid of it.”

“Variation is indeed the spice of life and we now know that nature buffers this variation by using CNVs. We are harnessing this knowledge to fight disease.”

Dr. Scherer is also involved in maintaining the Database of Genomic Variants, which provides researchers around the world access to a curated catalog of CNVs.  Details of the research report appear in the advanced on-line edition of Nature.

Congratulations to McGill University alumni Jack Szostak and Willard Boyle for winning the 2009 Nobel Prize in their respective disciplines.

Dr. Jack Szostak started at McGill when he was 15 years old and graduated in 1972, specializing in cell biology.  This was the start of a brilliant research career where he co-discovered how telomeres and telomerase protects chromosomes from losing genetic material during cell division.  He shares the 2009 Nobel Prize for Medicine.

Dr. Willard Boyle completed his BSc (1947), MSc (1948) and PhD (1950) from McGill.   He shares the Nobel Prize for Physics for the 1969 co-invention of the charged-couple device (CCD) that is used in today’s digital photography technology.

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Québec’s $122 million New Biopharmaceutical Strategy Includes $30 million for Genomics, May Include SR&ED Tax Credit Financing

October 8, 2009 · 1 Comment

mdeieThe Province of Québec rolled out a new “biopharmaceutical strategy” Thursday that they say aims to provide “development support for biotech and biopharmaceutical firms.”

The Roll-Out:

The announcement was beautifully coordinated with the relevant constituencies, as illustrated by the near-immediate chorus of support:

The Big News:

BIOQuébec can’t help bragging a little that “the Minister has retained some of the recommendations made by BIOQuébec.” The pride is justified, though.  Biotech advocates have been asking — since before the last federal budget — for a way to monetize the refundable tax credits they’ve been banking.  As part of the new strategy, BIOQuébec says the government will allow

“biotechnology companies within the human health industry [to] benefit from a short term support measure thanks to the quarterly financing of their tax credits.”

Interestingly, BIOQuébec appears to have some information about that initiative that is missing from the government publications (nope, not even in the French version), which only say it aims to “implement new methods of funding R&D tax credits adapted to the specific needs of health-related biotechnology firms.”

Money Talks:

On the financial front, the initiative also highlights a 10-year tax holiday (sparse on details, but expect it to look a lot like the OTEC in Ontario) and Teralys Capital.

Finally, the strategy notes ”three specialized start-up funds aimed at the technology sectors” with $41 million each that will be supported by “private-sector partners.”  Is the Pfizer-FRSQ Innovation Fund one of these?  Wednesday, that fund announced grants totalling $2.3 million for genomics studies of inflammatory bowel disease and metastatic colorectal cancer.

My Bottom Line:

This looks like a broad set of initiatives that aims to improve everything from student recruitment through R&D and commercialization to purchasing and reimbursement decisions.  I particularly can’t wait to see what the SR&ED monetization program looks like.  Hopefully we’ll learn in time to work with other governments *cough*Ontario*cough* as they start 2010 budget processes.

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