The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Monthly Archives: March 2009

2009 Gairdner Award Winners Announced

This year’s Gairdner International Award winners:

  • Shinya Yamanaka, for making pluripotent stem cells from epidermal somatic tissue;
  • Lucy Shapiro of Stanford University and Richard Losick of Harvard University for their research on how bacteria grow, divide or become dormant; and
  • Kazutoshi Mori of Kyoto University and Peter Walter of the University of California for their work on protein folding.

The inaugural Global Health Award will go to Nubia Munoz, emeritus professor of the National Cancer Institute in Colombia, for work that led to developing cervical cancer vaccines; and

The Gairdner Wightman Award, given to a Canadian who has demonstrated outstanding leadership in medicine and medical science, will be given to Dr. David Sackett “for his leadership in the fields of clinical epidemiology and evidence-based medicine.”

The awards will be presented in Toronto, at the annual symposium, this year from October 28-30. Seventy-three Gairdner winners over the past 50 years have also become Nobel laureates.  Thanks to a $20-million endowment for the Gairdner Foundation from the Canadian government, each recipient this year will get $100,000, compared with the $30,000 prize that each of last year’s winners took home.

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Essex Woodland Health Ventures’ New $900 million Bio Fund

Essex Woodlands Health Ventures closed on its Fund VIII today with $900 million to invest “across the spectrum of drug, device and service companies in North America, Europe and Asia.”  The In Vivo blog points out that this isn’t exactly new news, but it is still good news for companies that are now a big step closer to seeing the money deployed.

One Canadian connection I was able to turn up: Dr. C. Thomas Caskey is an Adjunct Partner to Essex Woodlands and also sits on the Genome Canada Board.

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Angiotech Expands and Reworks Baxter COSEAL Deal (for real)

Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) reworked its COSEAL deal with Baxter International Inc.  For a $25 million one-time payment, Baxter will pick up the rights to COSEAL in Japan, completing a worldwide package, and will add additional fields of use for COSEAL, as well as rights to COSEAL derivatives. Baxter will owe no further royalty or milestone obligations to Angiotech.

Market reaction has been positive, with the stock up 18% so far today.

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Trends Update: ChinaBio and Shantha Biotech

One of our Trends in 2009 posts last week talked about the increasing innovative activity in India and China and increasing generics activity among innovator pharma.  This week starts with a relevant update on each front:

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Facts, Theories and Minister of State for Science and Technology Gary Goodyear

A couple of particularly well-turned phrases in response to the Gary Goodyear evolution flap from an excellent piece in the Globe and Mail by T. Ryan Gregory (author of the Genomicron blog, which has continued to follow the story) explaining facts, theories and everything in between:

Darwin had two objectives: first, to establish that modern species are related through descent from common ancestors; second, to propose natural selection as the primary cause of this “descent with modification.” As scientists put it, he sought simultaneously to establish both the fact of evolution and a theory of evolution. But how can something be both a fact and a theory? The controversy over science minister Gary Goodyear’s comments about evolution shows the need for clarification….

Evolution is not “just a theory,” any more than germs, atoms or gravity are “just a theory.” The common ancestry shared by all life is the unifying principle of biology, making sense of an otherwise bewildering array of diversity and complexity. Our understanding of how this has occurred is, itself, constantly evolving.


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White House Reports on White House Forum on Health Reform*

A post on the White House Blog announced the release today of the Administration’s report on the White House Forum on Health Reform (pdf), about the discussions at the health reform event held March 5th.

* say that 5 times fast!

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There’s No Bailout Like a Good Exit

A Bloomberg article this morning takes a look at the recent boom in Israel’s biotech and device stocks, and credits the government cash infusion (which we noted at the time) for some of the buoyancy; but also attributes much of the gain to speculation that the J&J-Omrix deal is the beginning, not the end, of acquisitions in the well-priced sector.  According to Bloomberg data, bargains still abound in Israel:

Most of the stocks still trade below their initial public offering prices and are valued at less than half of their global competitors relative to cash, according to data compiled by Bloomberg.

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Monday Deal Review: March 30, 2009

The Week Ahead on Capitol Hill

HHS-Secretary elect Kathleen Sebelius will have confirmations before the Senate Health, Education, Labor and Pensions Committee on Tuesday, March 31, followed by the Senate Finance Committee on April 2.  Both hearings should cover topics such as universal health care and comparative effectiveness.  The first hearing would also address issues like public health preparedness and health innovation, while the latter will be more focused on Medicare/Medicaid and the uninsured.

The Senate Judiciary has a scheduled mark-up of the Patent Reform Act of 2009 on Tuesday, March 31 at 10am.  Last week, Senator Feinstein expressed doubts about reaching a compromise on damages provisions in the bill, given the high tech industry’s unwillingness to negotiate.  Stay tuned…an updated compromise amendment could be unveiled on Tuesday.

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Friday Science Review: If you want to…

If you want to avoid malaria:  Two PLoS ONE publications by teams in Dr. Kain’s lab at the McLaughlin-Rotman Centre for Global Health illuminate malaria: one by suggesting that inflammatory peptide C5a may contribute to the pathogenesis of Placental Malaria; and one showing that serum levels of angiopoietin-1 and the angiopoietin-2/1 ratio are promising clinically informative biomarkers for Cerebral Malaria.

If you want to understand schizophrenia: try gender studies? Researchers at Fernand-Seguin Research Centre of Louis-H. Lafontaine Hospital studied cerebral activation in people with schizophrenia in terms of emotional processing and cognitive analysis. They show that men with schizophrenia performing the tests display cerebral activation similar to that of healthy women performing the same tests, and vice versa.

If you want to teach the world to sing: head to The University of Prince Edward Island.  UPEI received a 7 year, $2.5 million grant to take a multidisciplinary, international approach to the study of singing.  The grant will fund approaches from the point of view of music cognition, neuroscience, and cultural anthropology, and will look at such questions as the nature of singing, how to teach it better, and its health benefits.

If you want to be three times more likely to meet fitness guidelines: take the subway.*

* I know, I know.  I implied a causal relationship.  So sue me.

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This Week in Texas: One Step Forward, Two-Step* Back

One Step Forward: Earlier this week, Governor Perry of Texas announced $50 million of funding for Texas A&M University System’s National Center for Therapeutics Manufacturing yesterday, following up on his keynote at a conference in February where he spoke highly of the state’s biotech industry. 

Two Steps Back: At the same time…

*Joke, not typo.

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Ontario Budget 2009: Initial Reactions are “Encouraging”

Generally positive reviews of Ontario’s 2009 budget are coming in from the innovation community:

TBI gives a shout-out to the Emerging Technologies Fund:

The Biotechnology Initiative (TBI) would like to credit Premier Dalton McGunity and Minister of Research and Innovation John Wilkinson for their quick response to the looming economic uncertainty by the creation of the Emerging Technologies Fund… The life sciences community in Ontario is greatly encouraged as a result of the creation of this Fund.

Rx&D is also “encouraged”:

Canada’s Research-Based Pharmaceutical Companies (Rx&D) is encouraged by initiatives in the Ontario Government’s 2009 budget designed to fuel innovation and growth in Ontario’s biopharmaceutical and life sciences industry…

“The support in the budget for research infrastructure, genomics, tax incentives for innovation and the increased funding for the Ministry of Research and Innovation demonstrate that the McGuinty Government is strengthening its commitment to make science and innovation a priority.” 

So is the Retail Venture Funds Association:

The McGuinty government has made encouraging policy initiatives that help bring innovative high-tech applications to market more efficiently…  The Ontario Budget released today contained far-reaching initiatives that will help the province’s entrepreneurs, scientists and researchers develop and market new technology here instead of other jurisdictions.

The Ontario Medical Association is…

encouraged that the government is investing $2-billion into eHealth, which is playing an increasingly important role in improving patient safety and efficiency of our health care system. Electronic Medical Records (EMRs) have had a tremendous impact on patient safety, continuity of care, and quality of care. To date, over 3,000 physicians have made the transition to EMRs and by the end of 2009, over 4 million patients will have an electronic health record.

Did I miss any?  Are you encouraged too?  Let us know in the comments

Other: 

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Canadian M&A: Akela Pharma and Nventa to Merge, Akela Shareholders to Own 70%

Akela Pharma Inc. (TSX: AKL) and Nventa Biopharmaceuticals (TSX: NVN) will merge by exchanging 0.0355 Akela shares for each Nventa share, resulting in an approximate 70/30 ownership split between Akela and Nventa shareholders, respectively, in the combined entity. The public company will retain Akela’s name, management, and ticker symbol (AKL).  The arrangement arrangement was unanimously approved by both Boards.  Conditions: approvals from Nventa shareholders, the British Columbia Supreme Court and the Toronto Stock Exchange, and a minimum amount of $1.5M of net cash in Nventa.  Current (post-announcement)  Akela market cap: $3.46 million.

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Duck!

2009 Ontario Budget Innovation Highlights

Quick dose of info from the Ministry’s Highlights doc below.  More to come…

  • $300 million in capital funds over six years for research infrastructure, which will be available to leverage funding from the federal Canada Foundation for Innovation
  • $250 million over five years for a new Emerging Technologies Fund that will focus on clean technologies, health and life sciences, and information and communication technologies, including digital media
  • $100 million over four years in operating funds for research performed in the biomedical field, focusing on genomics and gene-related research; this funding, as well as funding for research infrastructure, will be delivered through the Ontario Research Fund
  • $50 million over four years to enhance the successful Innovation Demonstration Fund, through which the government will continue to partner with innovative companies to develop emerging technologies, with a preference toward bio-based, environmental and alternative energy technologies
  • $10 million over three years to the Colleges Ontario Network for Industry Innovation to assist small and medium-sized enterprises with hands-on applied research, technology transfer and commercialization
  • $5 million to support the Ontario Genomics Institute, an important partner in fostering genomics research in Ontario
  • $2 million annually in proposed tax relief to extend the 10 per cent refundable Ontario Innovation Tax Credit to more small and medium-sized corporations that perform Scientific Research and Experimental Development (SR&ED) in Ontario
  • $110 million of tax relief in 2009-10 from paralleling the proposed federal temporary 100 per cent accelerated CCA rate for eligible computers and software acquired after January 27, 2009 and before February 2011.

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Toronto Stock Exchange (TSX) Temporary Relief Extended

The TSX and TSX-V temporary relief measures have been extended through September 30, 2009.  Specifically:

  • Toronto Stock Exchange has extended the remedial review period for delistings from a maximum of up to 120 days to up to 210 days.
  • TSX Venture Exchange’s temporary relief measures include:
    • adding flexibility in how existing continued listing requirements are applied to listed issuers;
    • extending the time within which Capital Pool Companies® can complete their qualifying transactions, and
    • allowing the minimum issuance price per security in certain transactions to be less than $0.05 (but not less than the market price).

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Takeda Comes to Canada

Takeda expanded into Canada today with the establishment of Takeda Canada Inc., which will be headquartered in Mississauga.

Takeda’s primary therapeutic areas include diabetes, cardiovascular disease, CNS disorders, gastroenterology, bone and joint disorders, chronic kidney disease/anemia and gynecological disorders.

Takeda Canada will register and commercialize medicines from Takeda’s portfolio of primary care and specialty products. Takeda Canada intends to file its first New Drug Submission (NDS) by the end of 2009.

Welcome to Canada!

More from the press release after the jump…

BEvERages Tonight in Toronto

I suspect most people in Toronto who read this blog already know about the TBI Pub Night tonight (6pm – 9:30pm, Bedford Academy, 36 Prince Arthur Ave.), but if you didn’t before, you do now.

Come harmonize … some GST and PST! (A little Ontario budget humo(u)r.)

Hopefully see you there!

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Ontario Budget Today

Ontario Finance Minister Dwight Duncan will deliver the 2009 Ontario Budget around 4 pm today.

The Finance Budget page is here, and will contain links to the full budget, highlights and press releases following the release this afternoon.

You can watch the Budget presentation live on a webcast here.

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Roche Tenderly Completes Genentech Deal

The results are in: 84.7% of Genentech’s publicly held shares were tendered and will be taken up by Roche Investments USA Inc. for $95 per share, bringing Roche’s stake up to 93.2% (96.2% with the guaranteed deliveries).  Just a short form merger away from done.

Next challenge: integration without assimilation.

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Wednesday Brain Dump: Around the World Edition

Disclosure, Disclosure, Disclosure

Disclosure issues have permeated the news lately.  Pharmaceutical companies need to do a better job of disclosing adverse clinical trial results and side effects; companies and doctors need to do a better job of disclosing payments; and journals need to do a better job of disclosing author conflicts.

You could view the question of whether to disclose from a lot of different perspectives, but I’m hard pressed to find one that argues in favor of secrecy: economic (efficient markets), legal (Exchange Act, FDAAA, FTC), and corporate (reputational harm) considerations all seem to point to disclosure.

While there will always be some level of outright fraud, and there is risk to individuals who do disclose (risk to future work, inability to publish, etc.), institutions should be moving toward increased disclosure. 

Some have:

  • GlaxoSmithKline is heading in the right direction.  Last year they promised to publish payments to U.S. doctors for consulting and other services starting in 2010, and to cap those payments at $150,000 per doctor a year. Now, the company is planning to expand its disclosure to include money paid to doctors and their institutions to carry out clinical trials, and fees it pays European doctors for advice on developing new drugs.
  • The American Psychiatric Association (pdf) Board of Trustees voted this month to phase out industry-supported symposia along with industry-supplied meals at its annual meetings.

I vote for more.

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OVCF Scoreboard: Commitments 1, Biotech/Cleantech 0

The Ontario Venture Capital Fund (OVCF) announced its first commitment yesterday: $15 million to Georgian Partners Capital, which according to its website invests in “growth and later-stage enterprise software companies.”

No announcement yet on the anticipated commitment to Mayfield Capital.  Maybe wiser to roll out a commitment to a local fund first.

We’ll continue to follow OVCF activity.  You can find other OVCF coverage here; and other (future) scoreboard posts here.

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Science and Technology in India’s Election

Trends in 2009 post this week noted the increasing innovative activity in India and China.  Further evidence of that trend comes from a ScienceInsider report today that support for science and technology has taken a prominent place in the ruling Congress Party’s election manifesto.  The party notes that in the last two years it has opened:

eight new Indian Institutes of Technology, seven new Indian Institutes of Management, five new Indian Institutes of Science Education and Research, 30 new Central Universities, 20 new Indian Institutes of Information Technology, and 374 new colleges in educationally deprived districts.

Onward and upward in the IPRI Report

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New Merck Serono Biotechnology Ventures Fund

Merck KGaA, the Darmstadt-based company (not part of Merck & Co. Inc. of the U.S.),  is starting a biotechnology venture capital fund that will invest €40 million ($55 million) in emerging biotech companies during the next five years, with a focus on the core therapeutic areas of Neurodegenerative Diseases, Oncology, Autoimmune & Inflammatory Diseases, Endocrinology and Fertility, as well as enabling tool and discovery technologies.  Companies wishing to submit proposals or receive additional information can contact Merck Serono Ventures via their website.

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Monday Deal Review: March 23, 2009

A relativley light week for Canadian deal and company info this week, but we have all the news that’s fit to print (if not necessarily fit to distribute in the U.S.) after the jump…

Trends in 2009: Shifting IP Constituencies as Innovator Pharma Buys Generics and Asia Turns to Innovation

Growing industrial and geopolitical realignment of economic interests has the potential to re-define intellectual property constituencies in 2009.

1.  Industrial realignment: the entry of innovator pharma companies into the generics business.

This year has already seen Merck get into follow-on biologics by buying Insimed and Pfizer build its generics business with its Aurobindo deal.  As traditional innovator pharma companies become more invested in follow-on biologics and small molecule generics, they will have a greater (self-)interest in a functioning subsequent entry pathway. 

Watch how this is playing out in the follow-on biologics arena as two competing FOB bills make their way through Congress.  Right now, the 12-year exclusivity period in the Eshoo-Barton FOB bill and the 5-year exclusivity period in Waxman’s FOB bill are duking it out, and we’re already seeing increased industry flexibility.  Innovator pharma has historically insisted on a 14-year exclusivity period to accompany follow-on biologics legislation, but BIO has already indicated some willingness to support Eshoo-Barton, as has PhRMA

Dani’s the expert, but my layman’s guess is that we get a FOB pathway this time around, and that the exclusivity number lands somewhere in the 8-10 year range.  This is consistent with a Teva-promoted analysis and it’s easy to see that it covers the arithmetic middle ground.

2.  Geopolitical realignment: increasing innovative activity in Asia, which has historically focused more on generics.

In China, a recent deal between Lotus Pharmaceuticals, Inc. (OTCBB: LTUS) and Beijing Yipuan Bio-Medical Technology Co., Ltd. (“Yipuan”) to acquire the drug Yipubishan points to China’s interest in promoting innovation.  Yipubishan, which is used to treat the symptoms of gastric ulcers and hemorrhages of the upper digestive tract, was partly funded through the use of grants from the Innovation Fund for Small – Medium Technology Based Firms of the Ministry of Science and Technology of the PRC.  Yipubishan became the first prescription drug of its kind developed in China to be included in the National Torch Project, which recognizes and promotes commercialization of high-tech discoveries and encourages companies to use high technology.  The Torch Project is one of a series of PRC Science and Technology initiatives.

In India, Wockhardt’s pioneering efforts in biotechnology are among many signs of increasing innovative activity, and have attracted interest from Pfizer and Sanofi.  Wockhardt has set up a global-scale biopharmaceuticals manufacturing powerhouse, the Wockhardt Biotech Park, in Aurangabad, India. This state-of-the-art complex comprises six dedicated, manufacturing facilities, and is designed according to US FDA and EMEA standards. It will also house new biotechnology products that are currently in various stages of development. The complex has the capacity to cater to 10-15% of global demand for major biopharmaceuticals.

India and China are in the 3rd quintile of countries in the 2009 IPRI Report, with India ranking 46/115 and China ranking 68/115 but they are steadily increasing their innovative activity. 

Within a short span, I would expect them to rank more like Israel, which has a world-class innovative industry as well as a strong generics industry (Teva), or Taiwan, which recently announced an initiative to boost cleantech and biotech.  Both Israel and Taiwan are ranked 29/115 in the 2009 IPRI Report. 

Friday Science Review: March 20, 2009

I had a hard time finding news-making Canadian science stories this week; but in the meantime, here’s a  “numbers” edition of the Friday Science Review:

  • Number of Canadians with cancer: Statistics Canada released its latest figures, showing that of all persons living in Canada on January 1, 2005, 695,000 had been diagnosed with an invasive cancer at some point in the previous 10 years.  That includes the 1 in every 111 women diagnosed with breast cancer, and the 1 in every 118 men diagnosed with prostate cancer.  The headline number shows an increase in the number of Canadians living with cancer; but that’s due to the earlier detection of cancer and improving survival.
  • Number of Canadians who could be helped by nanotech packaging: 11 million Canadians suffer from food-borne illnesses, some of which could be prevented by rapid nanoparticle-based testing.  Nanoparticles could also be used in packaging to signal when food has passed its best-before date.
  • Number of centimeters long you have to be to qualify as the “T-Rex of the Cambrian Period”: twenty.  At the time, most creatures were no bigger than a fingernail … although how could you tell, since there were no fingernails at the time?!? (har.)
  • Number of mussels needed to make a tube of a new medical adhesive: mussels don’t make adhesive, people make adhesive.  Duh.  Here’s a cool story, though, about a new adhesive based on a protein that marine mussels use to stick to rocks.
  • Number of volunteers needed for a 3-way crossover study to show bioequivalence: twenty-three, at least for SemBioSys Genetics Inc.’s trial of its plant-produced human insulin.

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The Gary Goodyear Evolution Story, As it Has Evolved So Far

Gary Goodyear, Canada’s minister of state for science and technology, has drawn international attention this week for his highly defensive, arguably obfuscatory, chronologically incorrect and possibly creationist statements about evolution.

Tuesday, March 17, the Globe and Mail reports Goodyear responding to a question about evolution by saying “I’m not going to answer that question. I am a Christian, and I don’t think anybody asking a question about my religion is appropriate.” (er, that was a science question!) Later Tuesday, appearing on a CTV News show, he said “Well, of course, I do, but it’s an irrelevant question” and went on to say “We are evolving every year, every decade.” (speed-volution!) Wednesday Morning, and since, he has stuck to the position that his view on the matter “has no relevance.” (keep evolving that position, Mr. Goodyear!)

There are now several schools of thought:

  1. Mr. Goodyear is a creationist whose beliefs are influencing science funding decisions;
  2. Mr. Goodyear has compounded a bad gaffe with a worse strategy, but the science funding decisions have nothing to do with his beliefs;
  3. His failure to properly articulate examples of evolution show that he lacks understanding requisite to do his job;
  4. His failure to properly articulate examples of evolution were a further attempt to prevaricate — he claims to believe in evolution, but doesn’t mean the same kind of evolution that scientists refer to; plus a special bonus…
  5. The whole thing is a librul witch hunt and it would be perfectly okay to have a creationist minister of state for science (sic) and technology.

I have been unable to locate a description of the minister of state’s mandate, so I can’t judge whether he’s effectively meeting those expectations.  I can say that his behaviour, between this episode and his shouting match with professors a couple of weeks ago, has done nothing constructive to address the urgent problems facing our research, development and commercialization industries.

Is that irrelevant?  Well, Mr. Goodyear…

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$250 million Ontario Emerging Technologies Fund Seen, Raised by $825 million Quebec Venture Capital Fund

Ontario announced the $250 million Emerging Technologies Fund yesterday … pretty much exactly what Monday’s letter to McGuinty from the CVCA requested. That has got to be, by the way, either:

  1. the world’s first psychic government relations campaign, or
  2. the world’s fastest government stimulus.

Not to be out-done, the Québec budget today included an $825 million venture capital fund.  The government is teaming up with the Fonds de solidarité FTQ (english), the investing arm of the province’s labour federation, and the Caisse de dépôt et placement du Québec (english).

It will be interesting to see whether VC funds who receive OVCF money will also be eligible for the ETF matching.  The Ministry says that full guidelines will be posted on the MRI web site before the end of June 2009.

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