The Cross-Border Biotech Blog

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

Monthly Archives: January 2009

It’s Raining M&A

Friday Science Review: January 30, 2009

Interesting science developments in and from Canada this week:

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Dare We Compare?

Canada Budget Reax Update

Genome Canada is causing quite a stir this morning, picked up by ScienceInsider this afternoon.  That, plus more budget reaction from a Research Canada press release and a thumbs-down from the CVCA below…

The CBC story on Genome Canada funding has some reaction from Tony Clement:

Minister of Industry Tony Clement, speaking to CBC Newsworld on Thursday morning, disputed that funding had been cut, saying Genome Canada was in the third year of a five-year budget rollout.

“It would not be surprising that they would not get an extra amount in this budget because that was taken care of in the last two budgets,” Clement told CBC News.

So what is the status?

Godbout said that while money from last year’s budget was allocated over the next four years to fund ongoing projects, there no indication that they would receive nothing this year for new initiatives.

He pointed to a project to sequence the genomes of 50 different types of cancer, led by Ontario Institute of Cancer Research scientific director Tom Hudson, as one project that would be $25 million short of funding without further federal support.

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Canada Budget Reax

Wendesday Brain Dump: January 28

Things that caught my eye this week:

The FDA made Geron very happy; Sarkozy made French scientists very unhappy.

Here at home, some regulatory milestones for Oncolytics, Welichem and Pfizer Canada.

Europe’s R&D intensity (spending as a percentage of GDP) was stagnant overall from 2000 to 2006, but at least a few detractors are out of commission.

And last, since we don’t want to dwell on the negative, some advice from PwC on transfer pricing and other more general approaches to weathering the downturn.

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Canadian Budget

Personalized Medicine: Local to Global

Two local developments in personalized medicine in Canada, one at the forefront of global efforts, one making recommendations on how to play catch-up:

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Flu and Stimulus

With new reported cases of avian flu in Canada and China  it’s encouraging to see that the U.S. economic stimulus plan boosts funding for development of vaccines and antiviral treatments for pandemic influenza.

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How *Not* to Cut Back

Hat tip to Paul Carenza

In difficult economic times, managing cash flow is key to survival. However, a recent case serves as a reminder that corporate directors in Canada are exposed to personal liability for the corporation’s unremitted source deductions for income tax, EI and CPP, as well as GST collected, unless the director has exercised appropriate due diligence to ensure the corporation respects its obligations.  (We’ll stipulate that EI and CPP are more relevant in the Biotech context than income tax and GST, which require … well, income and sales; but still…)

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Pfizer-Wyeth in Canada

Following today’s developments, some Canadian stats from the Pfizer Canada and Wyeth Canada web sites:

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Monday Deal Review: January 26, 2009

Trends, Trends Everywhere: Random Gloating II

Trends in 2009: Personalized Medicine … Just Down the Street

Update on U.S. Biotech Bailout

Yesterday the U.S. House of Representatives’ Ways and Means Committee approved the “American Recovery and Reinvestment Plan,” (pdf) which did not include tax stimulus incentives proposed by the biotechnology industry (namely monetizing future Net Operating Losses and future R&D tax credits now in order to forgo those tax assets in the future).

The U.S. House of Representatives package included an enhanced R&D tax credit for up to 20% in R&D expenditures in 2009 and 2010, but limited to renewable energy technology.

The Senate Finance Committee economic stimulus tax bill (pdf) unveiled today extends for 2009 a more general provision that allows firms in a loss position to get cash from the government for research tax credits.

The Senate and House will need to resolve differences with respect to these R&D tax provisons in their respective economic stimulus packages.

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Trends in 2009: You’ve Got a Friend In…

story yesterday reminded me about a movement I think we’ll start seeing a lot more of — funding to commercial entities by disease advocacy foundations.  This will be fueled in 2009 by two factors:

  • a self-perpetuating availability heuristic that will encourage foundations to seek commercialization opportunities; and
  • an economic environment that will have companies looking harder than ever for non-dilutive financing.

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Bailout Bedfellows

A brief was released jointly last night (pdf) by 7 Canadian national organizations:

  1. Association of Canadian Academic Healthcare Organizations(ACAHO)
  2. Association of Faculties of Medicine of Canada (AFMC
  3. BIOTECanada
  4. Canada’s Research-Based Pharmaceutical Companies (Rx&D)
  5. Health Charities Coalition of Canada (HCCC)
  6. MEDEC – Canada’s Medical Technology Companies
  7. Research Canada: An Alliance for Health Discovery

Update: the Brief calls for Government action in four areas:

  • Tax policy (the BIOTECanada asks, plus measures to encourage charitable contributions);
  • Continued investment in world-class infrastructure;
  • Support for research and management talent in research and innovation; and
  • Increased investment in discovery research (granting councils and a $100 million increase for CIHR)

More info from the press release after the jump:

Friday Science Review: January 23, 2009

Interesting science developments in and from Canada this week:

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New MOPOP Chapter 17 re Biotechnology

From Inaugural Guest Blogger Brian Gray, setting a high bar:

On January 14 CIPO issued the revised version of chapter 17 of its Manual of Patent Operating Procedures (MOPOP) re biotechnology (pdf). Obviously a lot of work has gone into this. Interestingly enough, while the previous chapter 17 (pdf) dealt mainly with the formalities of filing sequence listings and other technical issues relating to biotechnology, this chapter attacks the more meaty issues of subject matter, utility, sufficiency and novelty as they relate to biotechnology, matters that had previously been and still are covered by chapter 12, a chapter that is still waiting for revision and is probably hung up on policy issues relating to business method patents and other abstract methods and elsewhere in MOPOP.

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Oops!

Not Biotech, but an interesting story about NDAs, and why you need to pay attention to them.

Inauguration Links

Watch live at MSNBC FOX CNN.

Listen live at NPR.

Here’s a great This American Life episode on the inauguration from the past weekend.

Updated: Missed it?  Here’s the Inaugural Address from CNN.

Trends in 2009: Random Gloating

Remember way back Monday when we identified Comparative Effectiveness as a trend to watch in 2009? Well, here it is, showing up as part of the bailout bill. More on the bailout bill’s Bio provisions to come. AAAS is running continually updated coverage of the bill and its R&D provisions here.

Money = Jobs

As various constituencies make their arguments for bailout funding, the supporting materials have a common, unsurprising, theme: Money = Jobs.  How many jobs?  A collection of the data we’ve found after the jump:

News: FDA Launches Secure Supply Chain Pilot Program

The FDA announced a new pilot program, which will select 100 applicants who will get expedited import clearance for up to 5 of their drugs that have a demonstrably secure supply chain.  Think of it as NEXUS for (FDA-approved!) drugs.  The idea is to decrease overall risk associated with imported drugs by allowing the FDA to focus resources on imports that are not part of the program.

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Threats in 2009: Patent Reform

The United States Congress is expected to take up patent reform legislation again in 2009. For biopharma companies, it is safe to say that last year’s version of the bill would not bode well for industry innovation and investment.

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News: FDA Off-Label Guidance

The FDA released updated guidance today on the use of journal articles to promote off-label uses.  Here is a link directly to the FDA guidance.

Here is the Reuters story, which notes some Congressional (Waxman) and consumer (Public Citizen’s Health Research Group) opposition, and PhRMA support.

One concern is that a permissive approach to off-label promotion will decrease incentives to file for approval of new uses.  We’re watching  to see if Wyeth v Levine will provide some new incentives in the opposite direction.

Comments on the new guidance?  Do you think it will survive in the new administration?  Discuss…

Trends in 2009: Comparative Effectiveness and Personalized Medicine

Two potentially conflicting trends may see a dramatically increased profile in 2009: Government Bailouts and Free-Market Capitalism Comparative Effectiveness and Personalized Medicine. Both have been highlighted by the incoming Obama administration.  Details and analysis after the jump…

Bailout Bonanza!!

bailout-pic1With every industry under the sun seeking bailout money, Biotech is not about to be left out. And with a record number of biotech companies with less than 6 months’ cash in the bank, there is good reason to fear that promising ideas could be lost before the credit markets thaw. There are, however, an abundance of views on what form help for the industry should take.

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