The Cross-Border Biotech Blog

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

Monthly Archives: February 2009

Allocating Spending to Support R&D: UK, U.S. and Canadian Approaches

The U.S., Canada and the UK have all acknowledged the central importance of R&D even in these recessionary times.  However, the three national governments have decided to focus their spending on different steps of the R&D equation:

  1. Education: UK Takes the Long View
    British PM Gordon Brown, in a speech this week, identified three priorities: research, education and training, and public discourse.  However, only one of the three, education, was the subject of specific increased targets and spending:  retraining to increase the number of science teachers, a goal to double the number of pupils in state schools taking ‘triple science’, and a new Diploma program.  The U.S. and Canada have increased funding for graduate studies, but the UK effort is focused at an earlier stage, to rebuild the interest and capabilities of domestic graduates. 
  2. Publicly-Funded Research: U.S. Takes the Lead
    The focus of the U.S. R&D spending increases has absolutely been on research.  The increases for the NIH and NSF in the stimulus and the budget will go largely to increasing the volume of publicly-funded research.  PM Brown’s speech also vowed to protect funding for science from competing demands for Government support during the downturn, but did not propose increases over the existing 10-year plan.  Canada’s budget actually cut research funding across the three main granting agencies.
  3. Commercialization: Canada Takes Off 
    Canada’s focus was on commercialization.  The 2009 budget included $200 million allocated to the National Research Council’s IRAP program — $170 million to double the program’s contributions to companies, and $30 million to help companies hire over 1,000 new post-secondary graduates.  It also provided significant additional funding to BDC.  The only comparable spending in the U.S. was the $400 million for ARPA-E, which is allocated to energy programs, and supports research as well as commercialization.  PM Brown’s speech recognized the importance of maintaining the country’s struggling start-ups, and he has reached out to big pharma, but promised no specific action.

What’s still missing:  Stimulating Output

  • Despite calls in the UK, the U.S. and Canada, there have been no major tax policy changes enacted in this round of budgets and bailouts that ease the burden on, or return money to, early-stage technology companies.  Ontario has actually taken some steps in this direction with the Ontario Venture Capital Fund and the Ontario Tax Exemption for Commercialization.
  • Nor have there been many changes that increase the value of outputs: in the bio/pharma area, the UK has probably moved farthest in this direction, with upcoming reforms of the National Institute on Comparative Effectiveness (NICE), while the U.S. has seen decreasing FDA approvals and is allocating new comparative effectiveness funds.  On the other hand, approvals of GE animals, support for personalized medicine and big spending on electronic medical records will provide support to specific industry initiatives.

Stay tuned to our Bailout Page for updates.

Bookmark and Share

Friday Science Review: February 27, 2009

Cool Canadian science developments this week:

Bookmark and Share

GTC Biotherapeutics goes for a Regulatory Double Combo Shot

GTC Biotherapeutics, which recently saw ATryn approved, announced a collaboration agreement with AgResearch Limited, a New Zealand Crown Research Institute. 

AgResearch will develop genetically modified animals capable of producing the building blocks for “biosimilar” versions of existing products that will begin coming off U.S. patent in 2014.

The double combo shot:  the success of the collaboration depends on

  1. a continuing trend of GE animal approvals, as well as
  2. the successful introduction of a biosimilars pathway in the U.S., (which is called for in Obama’s budget).

Bookmark and Share

Bright Spot for Canada in NIH Gains?

You may not know this, but Canadian researchers can compete for NIH extramural funds, and they do so quite successfully.  I reviewed the 2008 data from the NIH budget site, which shows that Canadian researchers were awarded $47.4 million in 2008 (out of a total of $212.4 million total awarded outside the U.S.).  Hopefully this amount will increase in 2009-2010 as the stimulus and budget money for the NIH is allocated.  Considering the research funding cut in the Harper budget was $113 million, the NIH funds are a significant contribution to the Canadian landscape.

Some geographic breakdown: Toronto (69 awards, $18.4 million) and Vancouver (37 awards, $8.7 million) are the largest recipients.

Bookmark and Share

J&J and Basilea to Arbitrate

In case you hadn’t heard, Basilea filed a claim for arbitration under their license agreement with J&J for the antibiotic ceftobiprole, based on the anticipated news, confirmed today, that the the EMEA has halted the EU Commission decision process on ceftobiprole pending EU led GCP inspections.

Brian Orelli has a nice post up on the wider ramifications of the mess that the industry will be in if the FDA has to scrutinize the reliability of every filing.

Wider ramifications aside, it is unusual to see a license and development agreement go to arbitration (as the WSJ Post points out, quoting Credit Suisse analyst Catherine Arnold). 

Based on the description in Basliea’s 2005 annual report (pdf), the agreement with J&J appears to have contained the usual joint committee structure for managing the development process; so it will be interesting to follow the story and see if we can learn any drafting lessons.

Bookmark and Share

EEOC Meeting Kicks off GINA Comment Period

Last year, the Genetic Information Nondiscrimination Act (GINA) became law in the U.S.  Among other things, GINA prohibits discrimination by health insurers and employers based on people’s genetic information, prohibits the intentional acquisition of genetic information about applicants and employees, and imposes strict confidentiality requirements.  The U.S. Equal Employment Opportunity Commission (EEOC)  is charged with issuing regulations by May 21 implementing Title II of GINA, and kicked off the 60-day comment period today with a Public Meeting.  Keep an eye on the meeting page for links to the proposed rulemaking and for the meeting transcript when available.

Bookmark and Share

Wednesday Brain Dump: February 25, 2009

The question this week: a shot in the arm or a kick in the teeth?

A shot in the arm for:

  • Fewer shots in the arm! (har) 
    • British Columbia is the first jurisdiction in North America to offer a children’s vaccine called Infanrix-hexa™, which contains six immunizations in one, resulting in three fewer needles in the overall B.C. infant vaccine schedule, and
    • With the discovery of a constant region of flu virus protein hemagglutinin, a universal flu vaccine may be possible (no more yearly shots);
  • The Naval Surface Warfare Center in White Oak, a suburb of Washington, where the FDA is spending $1.15 billion to consolidate its offices and labs and to anchor a new biotech hub;
  • Pine Island, near Rochester, Minnesota, which could soon be the home to a new biotech research, development and manufacturing park with the help of up to $900 million in funding reportedly pledged by Steve Burrill.  Funding announcements also from Maryland and Pittsburgh;
  • Sustainable agriculture, when the White House announced its nominee for second-in-command at USDA: Kathleen Merrigan of Tufts University, who had been a top choice of the Cornucopia Institute to run USDA’s National Organic Program;
  • The National Science Foundation, from the stimulus (a $3 billion boost) and the budget (a 6.7% increase, to $6.49 billion);
  • Multiple Sclerosis, with Merck, Novartis, Teva, Biogen Idec and Sanofi Aventis all planning to release new oral therapeutics between now and 2012;
  • Conflict of interest disclosure, with a new editorial in PLoS Medicine;
  • Deterrence, with the arrest of four animal-rights extremists;
  • Organ failure biomarkers,
    • with the discovery of liver toxicity-associated MicroRNAs, and
    • with the injection by Pfizer Canada of $1 million to the PROOF Centre to fund research into vital organ failure biomarkers; and
  • Aliens.

A kick in the teeth for:

Bookmark and Share

More Money: House of Representatives Release 2009 Spending Bill

The U.S. House of Representatives Appropriations Committee unveiled its Omnibus spending bill for Fiscal Year 2009 yesterday (pdf). The House is expected to vote on the package this week. For Health and Human Services, the Ombnibus contains $30 billion for the National Institutes of Health (NIH). This funding is in addition to the $10 billion added to NIH in the American Recovery and Reinvestment Act. The Omnibus also includes a new initiative to reduce hospital and clinic infections that cause nearly 100,000 deaths each year, and requires national and state plans to combat infections with $22 million.

Bookmark and Share

From Here to Osgoode and Back Again

IP Osgoode just linked to the Cross-Border Biotech Blog as the “IP Pick of the Week” this week.  Thanks Rex!

The Osgoode IP Law and Technology program is hosting a conference on March 20th entitled “Commercialization of innovative research: Implementing solutions that work for Canada.”

Paul Carenza, a colleague of mine at Ogilvy Renault, is speaking at the conference.  You may remember Paul as the helping hand responsible for our post a few weeks ago on how *not* to cut back in difficult economic times.

Bookmark and Share

The Edison Awards: An Opportunity for Ontario?

In the context of some discussion about the Canadian federal budget, I had blogged about the idea of “an Ontario-based commercialization award of international scope, like the Gairdner Awards, that would seek out and reward internationally outstanding achievement in entrepreneurship.”

A press release from Nuvo Research Inc.(TSX: NRI), a Canadian drug development company focused on topical and transdermal delivery technologies, pointed me to the Edison Awards.  A quick scan of the product nominees this year makes the Edison Awards seem like an excellent model for what I would hope, through our discussions at the Life Science Coalition, to be achievable in Ontario.

I note the Ontario Premier’s Catalyst Awards, along these lines, but they appear to be geographically limited (OBCA and CBCA companies headquartered in Ontario).  The beauty of the Gairdner program is its international scope and caliber, which could stimulate Ontario activity by reputation and example.

Have you heard of other innovation/commercialization awards?  Is this a good idea for Ontario?  Let us know in the comments…

Bookmark and Share

Exciting Day Today

Warfarin and Personalized Medicine

dna_sequenceThe optimal dose of Warfarin for an individual can vary across a 10-fold range, and depends in part on genetic variation in two genes, CYP2C9 and VKORC1.  In 2007, the FDA required a labelling change to warn of patients with increased risk of bleeding due to these variations.  However, population-wide assessments of outcomes based on genetic testing were not definitive.

A paper in the current issue of the New England Journal of Medicine uses retrospective data to build a new dosing algorithm and predicts significant benefit from the use of the algorithm for the 46% of patients who require lower- or higher-than-normal doses.  The algorithm and data used to derive it will be made available via PharmGKB, a database managed by researchers at Stanford, and the research has prompted a full-scale prospective study of the personalized approach.

Frank M. Torti, M.D., acting commissioner of Food and Drugs said that the prospective study

is precisely what is needed to advance the promise of personalized medicine, ensuring that patients receive the safest and most effective drug dose.

Read our other posts on personalized medicine.
 

Bookmark and Share

Being Organic Means Never Having to Say You’re Cloned

The Globe and Mail carried an article last week about the revised Organic Product Regulations that will come into effect in Canada on June 30, 2009. The Organic Product Regulations (as they did in 2006) incorporate by reference the Canada General Standards Board CGSB 32.310 Standards, and it’s those standards that were amended October 1, 2008 to expressly prohibit cloned animals or their descendants (pdf).   The bottom line, as Ted Soudant, chairman of the Organic Council of Ontario said, is

[t]hat [cloning] would be something that wouldn’t really be considered normal or right by the [organics] industry.

U.S. officials decided last year that cloned milk and meat couldn’t claim to be organic under the National Organic Program; so for now, anyone hoping for genetically identical organic steaks in North America would have to keep their fingers crossed for twins.

Bookmark and Share

Monday Deal Review: February 23, 2009

M&A Update 2

Here’s the latest collection of M&A news we’ve found since the last update.  No new mega-deals, although Sanofi is shopping in the €15 billion range and Roche sold $16 billion of debt (which has seen high demand in subsequent trading) in the largest offering ever to raise cash for its Genentech bid.  Also, CV Therapeutics‘ (Nasdaq: CVTX) Board rejected Astellas’ $16 per share bid on the same day CV Therapeutics released its year-end results.

more deal info after the jump…

Sibelius and Biotech

Yes, we have all heard the rumors about Kansas Governor Kathleen Sibelius as the next HHS Secretary. How will the potential Secretary Sibelus impact the biotechnology industry? In her first term, Sibelius signed into law the Kansas Economic Growth Act, which was seen as a way to boost Kansas’ biotechnology industry. The Act allocated $500 million in research and investment capital over the next 10 years.

Bookmark and Share

More Waxman-Pallone Reporting on State Tort Liability, Preemption, Medical Devices and FDA Approval

The NY Times Business section (and the WSJ Health Blog) this morning picked up the story — that we noted last week – that Waxman and Pallone plan to reintroduce legislation essentially reversing the Supreme Court’s ruling in Reigel v. Medtronic.  Those stories also note a Senate version to be introduced by Sen. Kennedy and Sen. Leahy.

The basis for the Supreme Court’s decision in Reigel v. Medtronic is the interpretation of the Medical Devices Amendments of 1976, so by enacting changes that specifically disclaim preemption of state tort law, Congress could effectively moot the Supreme Court’s ruling. 

However, two state-level developments may change the debate:

  1. The Wisconsin Supreme Court’s decision this week in Blunt v. Medtronic, which was dictated by Reigel v. Medtronic, may create additional pressure in favor of federal action and maintaining state tort liability (although note that only two of seven justices signed on to the Wisconsin concurring opinion decrying the result); but on the other hand
  2. The Georgia Senate Economic Development Committee held its first hearing yesterday on legislation protecting Georgia-based businesses or companies with more than 200 employees headquartered out of state from liability for defects in any drug or medical device that has been approved by the FDA.  If this initiative is successful, and is replicated in other states, both the Supreme Court’s ruling(s) and the federal legislation would be moot, since there would be no underlying state tort liability.

Bookmark and Share

Friday Science Review: February 20, 2009

Cool Canadian science stories this week…

Bookmark and Share

Teva Decides Not to Wait for U.S. Biosimilars Legislation

In Beni’s post earlier this week on Biosimilars, he identified two major challenges to introducing follow-on biologics into the North American market: technical proficiency, and the absence of a regulatory regime.

Based on the approval of Teva’s biosimilar version of Neupogen in the EU last September, Teva has evidently cleared the first hurdle (and their joint venture with Lonza means their technical capabilities will only increase).

Yesterday, Teva announced that they were not waiting for a Biosimilars regime to be enacted before entering the U.S. market, and instead will take on the extra cost of filing a full BLA for their version of the biologic.

Does this mean we don’t need a biosimilars regime to get biosimilars to market?  Teva itself takes a different position.

Bookmark and Share

Device Liability Preemption: Blunt v. Medtronic

In a 7-0 ruling that it said was dictated by last year’s U.S. Supreme Court ruling in Reigel v. Medtronic, the Wisconsin Supreme Court dismissed a products liability claim against Medtronic relating to one of its defibrillator models. 

Two justices wrote a concurrence (agreeing with the result, but) criticizing the reliance it places on the FDA’s PMA process, citing criticism of that process from within the Agency itself:

It is not at all apparent that the FDA approval process actually guarantees a minimum level of safety for medical devices.

However, the concurring  justices are mistaken to rely on the cited concerns.  The GAO and “dissident” scientist concerns, as I understand them, were about devices approved through the 510(k) process, not the PMA process, but only PMA-approved devices are exempt from State tort liability under Reigel v. Medtronic.   Medtronic v. Lohr specifically denied preemption for 510(k)-approved devices.

That is not to say that as a matter of institutional competence, I believe the FDA is better suited than the courts to assess post-approval device safety.  I don’t think we have the data to make that assessment.  Certainly if the FDA is expected to competently act as the final arbiter of product safety, it would need more funds, and perhaps revisions to post-approval regulations.  Or maybe Waxman will succeed and legislate tort un-reform.

Read our other posts on this topic.

Bookmark and Share

TBI Breakfast: BIO and Biotech in the State of Georgia

I just came back from a very enjoyable TBI Breakfast with talks by Carol Henderson, the Director of the Georgia Department of Economic Development and Graeme McRae, the Chairman & CEO of Bioniche Life Sciences, Inc. which has an Animal Health division facility in Athens, Georgia.

Graeme’s talk, as usual, was very interesting and not very print-able.

Carol’s talk was also great.  Of course, Atlanta, Georgia is hosting BIO 2009, which is moving ahead full-steam.  Georgia also has some interesting capabilities and initiatives

Most interestingly, the State has a life sciences facilities fund that provides low interest loans secured by fixed assets to assist start-ups with finding appropriate space.   Carol mentioned that the program just funded a 15-year loan with deferred interest at 60% of Prime.

Here in Ontario, we have also identified access to facilities as a key area for government support, and the Georgia program is a model that I haven’t heard discussed here.

Bookmark and Share

NIH Stimulus Spending

Some good info from ScienceInsider about how NIH is planning to allocate the stimulus money.  It looks like the vast majority will go to existing grants and already-submitted applications.

Bookmark and Share

Wednesday Brain Dump: February 18, 2009

Good thing I waited until evening, because this week’s post is mammoth.  Funny, right?  So funny, this post may go viral…

And on the topic of vaccines, the U.S. vaccine court issued three different rulings on a group of vaccine-autism claims, and didn’t mince words.  The three Special Masters found the claims “speculative and unpersuasive,” “overwhelmingly contrary” to the evidence and relying on “scientifically flawed or unreliable articles”, respectively.

Last but not least, a few viruses turned up in new and interesting places:

Bookmark and Share

Ups and Downs for Biotech Crops in the EU

Quite an a-maize-ing week (sorry) for biotech crops in the EU:

  • The European Commission announced a proposal to end Austria’s ban on biotech maizes MON810 and T25, saying that Austria had not supplied scientific evidence that the specific nature of Austria’s ecology justified the ban.
  • A report from the French food safety agency, Afssa, saying MON810 is as safe as conventional maize leaked to the press just a few days before Envirmonent Minister Jean-Louis Borloo was due to appear before a committee of European biotech experts to justify France’s ban.   This prompted French Prime Minister Francois Fillon to say Thursday that “France is maintaining the suspension while it awaits a (European) Commission decision which it will respect.”
  • When the committee of experts met Monday, they did not have the “qualified majority” (a population-weighted test) to overturn the MON810 bans in France or Greece, the same result as in December when the voting was to lift similar bans in Austria and Hungary.  Now all four cases will be addressed by the EU’s council of ministers on March 2.
  • This apparently emboldened Germany’s Agriculture Minister, who said the German government may revoke the license it already issued for the GM crop.
  • Last, but not least, today the European Court of Justice issued a ruling that requires EU governments to make the location of GM crop field trials public.  Hopefully long jail terms will deter the “activists” who will no doubt be among those accessing the information.

Meanwhile, in the rest of the world:

Bookmark and Share

Biotech Bailout: Maryland Ask

At a news conference yesterday reported in the Washington Business Journal and picked up by BIO SmartBrief, a group in Maryland expressed their hope that Maryland’s biotech tax credit program, under which

investors receive a tax credit equal to 50 percent of the money they spend

would get the $6 million boost to $12 million initially pledged by Gov. Martin O’Malley (before the budget process), once the State receives the federal stimulus funds from the federal bill.

To qualify for the credit, the company must be based in Maryland, have fewer than 50 employees and be in business less than 10 years.

Interesting that the science funding in the stimulus bill could end up increasing even over the direct amounts via the transfers to States.

Bookmark and Share

Biotech Bailout: Texas Edition

Texas Governor Rick Perry keynoted a conference yesterday on “the challenges and the future of biotechnology in Texas” and “told the group that the biosciences are ‘the next big thing in the global economy.’”

According to the article in today’s Star-Telegram, the Texas Healthcare and Bioscience Institute is encouraging a number of measures this legislative session for bioscience, including:

  • A bill that would reauthorize the Texas Emerging Technology Fund, which was established with $200 million by the Legislature in 2005 to promote and finance innovations in technology.
  • A bill that would make it easier for patients to enroll in clinical trials for life-threatening diseases, which, officials say, is a necessary step in developing new medicines and medical devices.

Also, some jobs data:

There are about 33,000 Texans employed in biotechnology, with an average salary of more than $84,000, according to the Governor’s Office of Economic Development and Tourism.

Bookmark and Share

Personalized Medicine: The “SNP Doctor”

BIO SmartBrief picked up a story today about a device being tested called the mohel Snip Doctor, a hand-held diagnostic device that:

looks for known single nucleotide polymorphisms (SNPs) – single letter changes in the genetic code – that can affect an individual’s response to medical treatment.

While most current approaches to personalized medicine are mechanistic (e.g., HercepTest), this device raises the possibility of a correlative approach.  Of course, it’s only a temporary measure to hold us over until our full genomes are a normal part of our electronic medical records.

Bookmark and Share

Trends in 2009: Facing the Challenges of Introducing Biosimilars or Follow-on Biologics in the North American Market

The so-called biotechnology drugs or biologics (large, complex protein molecules derived from living cells, usually by use of recombinant DNA technology) are among the fastest-growing class of pharmaceuticals. Within the next two years, some market forecasts predict that biopharmaceuticals will amount to more than 50% of newly approved medicines. In addition to a growing market share, a substantial number of major biotechnology-based drugs will come off patent and enable the development of new biologics. The race by pharmaceutical companies to get into biologics, or further support their existing biologics capacities in order to start developing biosimilars or follow-on biologics (FOBs), is illustrated by the rapid pace of recent deals in this sector. The latest of these deals is the acquisition of Insmed by Merck, which was announced last Thursday; however I believe this deal was more about expanding state-of-the-art manufacturing facilities rather than acquiring extremely valuable FOBs.

Read more of this post

Comparative Effectiveness Stimulus Stimulates Reactions

The $1.1 billion in the stimulus bill for comparative effectiveness research has, not surprisingly, generated a good deal of public attention.  Friday’s Washington Post and the front page of today’s New York Times both have stories covering the political jockeying.

Although both pieces focus on potential problems from the lack of individualization, either from libertarian or advocacy perspectives, neither has picked up our strain that personalized medicine, also favored by the Obama administration, will change the shape of the entire comparative effectiveness debate.
More on a recent example after the jump…

Monday Deal Review: February 16, 2009

An interesting collection of goings-on in this week’s special President’s Day / Family Day edition of the Monday Deal Review after the jump…

Follow

Get every new post delivered to your Inbox.

Join 126 other followers