The Cross-Border Biotech Blog

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

Category Archives: Jeremy Grushcow

Key Quotes from the U.S. Supreme Court’s Decision in Bilski Shows No Current Impact on Biotech

Many expected the U.S. Supreme Court’s decision in Bilski to have a far-reaching impact on methods patents, including biotechnology diagnostics and drug development. That turned out not to be the case, with the Court deciding on narrow grounds that the actual patent at issue was improperly granted and reminding the Federal Circuit that it prefers common law minimalism over broad rule-setting in this area.

A few key quotes give you a sense of where the Court reached consensus. Here was their message to the patentee:

“[A]ll members of the Court agree that the patent application at issue here falls outside of §101 because it claims an abstract idea.”

Here was their message to the Federal Circuit: 

“The machine-or-transformation test is not the sole test for deciding whether an invention is a patent-eligible ‘process.’”

And here was their message to future patentees:

“while §273 appears to leave open the possibility of some business method patents, it does not suggest broad patentability of such claimed inventions.”

Those interested biotech patenting will need to keep an eye on directly-applicable fact patterns.

Monday Biotech Deal Review: June 28, 2010

We follow a number of trends here at the blog, and two of them showed up as Canadian deals this week. Add those to the Biovail-Valeant merger, Æterna’s offering and a whole slew of commercial deals, and it’s been a pretty big week in Canadian deal-making.

check it out after the jump…

This Week in the Twitterverse

Here’s some reading for the weekend from our Twitter stream on @crossborderbio:

Monday Biotech Deal Review: June 21, 2010

This week saw a slew of licensing and commercial deals, including HIV programs for MedMira in Nigeria and Dignitas in Malawi. On the securities side, Aquinox’s $25 million B round headlined a $47 million week. Rounding out the week is Enerkem’s demonstration project funding, which will go towards reducing emissions from biorefineries.

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This Week in the Twitterverse

Here’s some reading for the weekend from our Twitter stream on @crossborderbio:

Health Canada’s Pharmacovigilance Program Provides Consumers with (Consumer-Unfriendly) Form for Direct Reporting of Adverse Effects

Health Canada added a potentially valuable pharmacovigilance tool to its post-market surveillance arsenal today — a web form for direct consumer reporting of adverse drug events.

Unfortunately, the implementation is terrible. The goal was “to make it even easier for consumers to report side effects to drugs and other health products,” but I doubt most consumers would make it past the first page.

Why? The form provided to consumers (direct link) is the exact same form that is provided to physicians (direct link) for voluntary reporting. It is hard to fill out. After clearing the intro screen and the privacy warning, I got stuck trying to figure out what I should use for my “Identifier,” which helpfully notes “for privacy purpose do not use the patient’s name.”

Once If you get to the second page, a note at the top informs you that not all fields are required, just the ones “that have a red asterisk displayed next to them.” Here’s an idea: how about starting with the mandatory fields on the first page?

The best advice, at this point, is in the press release:

Health Canada reminds consumers that all side effects, especially serious ones, should be reported immediately to a health professional. Consumers are encouraged to seek assistance from their health professional to report a side effect to Health Canada.

There are many ways direct reporting could work well: a useable web form, a Twitter hashtag, etc. Hopefully MedEffect will give this some more thought and help make direct reporting a viable supplement to the Canada Vigilance Program.

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Monday Biotech Deal Review: June 14, 2010

This week saw a series of transactions bringing Patient Home Monitoring to the TSXV with an accompanying private placement and a shiny new SEDA from (who else) Yorkville; ConjuChem is (pending court approval) on its way out of CCAA with some cash on hand; and the struggle between Northstar and its ex-CEO continues in the dramatic form of a directors circular. Check out these developments plus a full crop of other Canadian deal activity after the jump…

This Week in the Twitterverse

Here’s some reading for the weekend from our Twitter stream on @crossborderbio:

Monday Biotech Deal Review: June 7, 2010

This week saw a resurgence of deal activity on the Canadian landscape. Lots of good news here, including Resverlogix’s [$9.2m] haul and a $30m exit for Montreal’s Resonant Medical.  Not all was sunny though: Cynapsus downsized its unit price and Amorfix just downsized, while the Bankruptcy and Insolvency Act got its own workout (har) this week. Read more of this post

This Week in the Twitterverse

Here’s some reading for the weekend from our Twitter stream on @crossborderbio:

Monday Biotech Deal Review: May 31, 2010

Things are picking up a bit this week, with a few new financings, some collaboration agreements and a deal in the venture capital community that coincided with the CVCA’s annual meeting. Read more of this post

This Week in the Twitterverse

Here’s some reading for the weekend from our Twitter stream on @crossborderbio:

Patent Cliff Will Not Save Biotech: Abbott Buys Indian Generics Company Piramal Healthcare

I often hear how the upcoming loss of patent protection for current blockbusters creates an insatiable demand at pharma companies for new pipeline products from biotechs. Here’s an example from 2007. Here’s one from last week. This is not true. Upcoming loss of patent protection creates a insatiable demand for revenue, but new products are not the only source of new revenue.

Abbott’s $3.7 billion deal for a unit of India’s Piramal Healthcare last week is a perfect case in point. This deal, which follows Abbott’s license of a slew of products from Zydus Cadila, will feed the company’s new “established products division.” Abbott’s purchase of Solvay in February also built its emerging markets revenue, which now accounts for over 20% of the company’s business.

Abbott is far from alone: Sanofi is the biggest generics manufacturer in Latin America, Pfizer also has an established products division, Novartis is diversifying into eyecare and has long sold generics, Merck is into follow-on biologics and GSK tapped South Africa’s Aspen Pharma for emerging markets growth through branded generics. These alternatives look even better as payors worldwide are setting more demanding standards for reimbursement, the placebo effect is mysteriously strong, and personalized medicine makes clinical trials even more expensive.

My bottom line? Emerging markets and generics opportunities create plenty of growth, thank you very much, with a far lower risk profile than most product in-licenses or biotech acquisitions (even the option deals). As big pharma gets more comfortable with “established products” and biosimilars, biotechs are going to have to demonstrate even higher value. Plenty of companies are being built and funded with that in mind; but anyone counting on pharma’s desperation will be disappointed.

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Monday Biotech Deal Review: May 24, 2010

The lead up to the long weekend here in Canada (Victoria Day, in case you’re wondering where we all went) saw only one new financing and two new commercial deals. A few more deals that were launched earlier closed this week, including MethylGene’s SR&ED financing; but stay tuned for an uptick next week as we move fully out of earnings reporting doldrums. In the meantime…

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This Week in the Twitterverse

Here’s some reading for the weekend from our Twitter stream on @crossborderbio:

Trends Update — Synthetic Biology: JCVI’s First Synthetic Cell (or, A Goat Walked Into a Lab)

World, meet "Mycoplasma mycoides JCVI-syn1.0", 1.08-Mbps of synthetic life.

Today’s issue of Science contains an article by scientists at the J. Craig Venter Institute, who have synthesized a Mycoplasma genome from scratch and transplanted it to a recipient cell. Those recipients have since reproduced using entirely the synthetic DNA.

In the quest to create novel organisms from scratch, Mycoplasma have been the tools of choice. Their small genomes suggest that they stick to the minimum genetic requirements for life (though they may contain unexpected complexity). Still, a megabase is a lot of DNA to assemble, so the JCVI gang uses a cool trick that combines long synthesized oligonucleotides by alternating between yeast and bacterial hosts to stitch the oligos into longer and longer segments. The host cells are controlled by, and exhibit the distinct characteristics of, the synthetic genome.

Venter, noting that the strain they made is a Mycoplasma that exists only in goats, is happy to illustrate the containment features:

"Unless a goat walks into the laboratory, or somebody walks out of our laboratory and injects a goat, we’re probably pretty good."

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Monday Biotech Deal Review: May 17, 2010

Lots of quarterly earnings announcements this week means a dip in deal activity. Still plenty of interesting stuff, though, including a new partnership and new listing plans for Tekmira. Meanwhile, for Medicago it’s graduation day, with a $10m present standby deal from Mom and Dad Yorkville Advisors on offer as it takes its symbol to the TSX big board from the venture exchange.

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This Week in the Twitterverse

Here’s some reading for the weekend from our Twitter stream on @crossborderbio:

Grand Challenges Canada to Mobilize $225 Million Over 5 Years For Global Health

A new nonprofit organization called Grand Challenges Canada has been formed to deploy the Canadian government’s $225 million Development Innovation Fund. In a fabulous marriage of theory and practice, Grand Challenges will be run by Peter Singer, who is also the Director of the McLaughlin-Rotman Centre for Global Health. It also draws on an impressive international scientific advisory board.

The program will identify and launch five “grand challenges” over a 5-year period. The first is

“to create a new class of point-of-care (POC) diagnostics that will be easy to use, low cost, multiplexed and able to assess disease stage and provide information on prognosis.”

Information on the RFP, policies and forms to apply for funding are here, and the deadline for this round of applications is July 12, 2010 at 11:59 pm EST.

Grand Challenges Canada is independent, but is being run in partnership with International Development Research Centre (IDRC), the Canadian Institutes of Health Research (CIHR), the McLaughlin-Rotman Centre for Global Health and with support from the Bill & Melinda Gates Foundation.

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Monday Biotech Deal Review: May 10, 2010

Some people were on the move this week — not only did Sanofi Canada announce 70 R&D job cuts, but BioMS took on a new banker and Labopharm, CardioComm and GeneNews all get new faces. Despite the fact that it seemed half of the country’s companies and deal-makers were at BIO in Chicago this week, there was still a fair amount of positive deal activity including numerous private placements, commercial agreements and a bit of M&Eh.

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This Week in the Twitterverse

Here’s some reading for the weekend from our Twitter stream on @crossborderbio:

  • RT @PharmProEditor: Intellipharmaceutics plans Effexor generic http://bit.ly/aKNOMp
  • RT @CVCACanada: VC deals: Montreal based Enerkem announces funding from Alberta Energy http://bit.ly/aznzgC
  • BELLUS Health ends NC-503 diabetes development program following Phase II results http://viigo.im/3q8b
  • Aeterna Zentaris Receives Orphan-Drug Designation from the FDA for AEZS-108 in Ovarian Cancer http://viigo.im/3q7M 
  • RT @tdmckee: A paper from my lab is online in Nature, and today’s Toronto Star! http://bit.ly/9lwRSa << Awesome! Congrats!
  • RT @nvca LP Panel: there is optimism for venture equal to late 1990s
  • SickKids is building a $400 million, 21-storey, 750,000 square foot Research & Learning Tower at Bay & Elm http://viigo.im/3psl
  • Sanofi-aventis Canada announces 70 jobs cut by July, criticizes Canadian IP and access to medicines policies. http://viigo.im/3prD
  • RT @FierceBiotech: Live from BIO 2010: Hamburg discusses advancing regulatory science. http://is.gd/bVgWp
  • RT @jensmccabe USAToday joins hospital stats game – see hospitals death/readmission rates for heart attack, heart failure, pneumonia at health.usatoday.com 
  • RT @SternIR Burrill: 09 best yr ever for biotech capital raise – just when Burrill etal were declaring biotech dead of capital starvation. #bio2010
  • BioMS is changing its name to MedWell Capital and hiring ex-Desjardins banker Nitin Kaushal as EVP/MD http://bit.ly/a8uNNp
  • RT @CVCACanada: From out of the ashes – blog by @davidcrow on Canadian VC rebirth http://bit.ly/9daSeQ via @startupnorth 
  • E&Y: 7 of 9 deals over $1B involved non-US buyers #bio2010
  • New Post: Biotech Trends Update: Non-Dilutive Financing and Fundraising by Partnering with Nonprofits http://ow.ly/17fTXj
  • RT @FierceBiotech: E&Y: In 2009, 14 percent of biotech companies closed their doors. Far less than the 25% to 33% expected..
  • Report on the Non-Dilutive Financing and Fundraising by Partnering with Nonprofits panel at #BIO2010 http://ow.ly/1GuqA
  • RT @curlygh RT @BIOConvention: Our nation faces growing racial disconnect between those that seek care & those that provide it. -Surgeon Gen
  • Latest data on biotech jobs and state initiatives from BIO and Battelle session at BIO 2010 http://ow.ly/17fGuN
  • Note to #bio2010 peeps from warmer climes: not too late to mutate. Mammoth hemoglobin released O2 equally at all temps! http://bit.ly/c36ggv

BIO 2010 Summarized In Song

To the tune of “It’s a Small World“…

It’s a world of swag
A world of beers
It’s a world of sessions
And a world of careers
There’s so much that we share
That the Fail Whale’s not rare

It’s a small world after all

There is just one room
Where the keynote’s done
BIO’s counter-programming
Reporters shunned
Though the press corp’s outside
Twitter can’t be denied

It’s a small world after all… [Chorus]

BIO Panel on Comparative Effectiveness Research Notes “Silver Lining” of Personalized Medicine

Speakers Daniel Todd, from EMD Serono, and Steve LaPierre, from Boston Scientific, were led by Foley Hoag lawyer Jayson Slotnik in a discussion of the final CER legislation and predictions about implementation. The overall tone was skeptical — the panel noted the potential for CER data to ultimately contribute to CMS coverage decisions, and worried about the cost of prospective randomized trials and about potential impacts on the FDA approval process.

They were, however, optimistic about the role of personalized medicine in the CER implementation. Steve LaPierre expects it to be helpful, and Daniel Todd advocates using the reference to molecular and genetic subtypes in the legislation to push for personalized analysis if a product is selected for a CER study. He calls personalized medicine a silver lining.

The panel also noted positive structural aspects, including helpful governance provisions in the CER legislation. Specifically, they were impressed with the public reporting and audit provisions and the availability of comment periods to allow private sector input.

In looking at how CER will shake out, the panel expected progressive adaptation of the program over the next 3-7 years.

Daniel Todd emphasized the importance of picking a first recommendation to establish credibility. The controversy this year about breast cancer screening recommendations shows the loss of credibility that can come from a debatable result, so they expect CER to ramp up over time.

He also predicted that dissemination of CER results through social media may drive bottom-up adoption of findings, and that defensive medicine may also contribute to adoption.

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Biotech Trends Update: Non-Dilutive Financing and Fundraising by Partnering with Nonprofits

As noted in the lead up to BIO, several of the conference sessions touch on industry trends we’ve been following here on the blog. One of these was today’s session entitled “A New Kind of Non-Dilutive Financing and Fundraising: Partnering With Not-for-Profits,” which we’ve been following as commercialization by non-profit foundations. Our coverage of that trend started off focusing on the financial advantages to companies of finding a commercialization-minded nonprofit partner, but recently we’ve also noted the strategic advantages of these collaborations.

At today’s panel discussion, Genzyme’s Jim Geraghty added to the list of strategic advantages of nonprofit collaborations, echoing Avila’s CEO Katrine Bosely who recently acknowledged the value of the Leukemia and Lymphoma Society’s network of clinician and patient relationships. Geraghty added:

  • access to scientific data that may have benefits to other company programs; and
  • relationships with governments and other clinical gatekeepers.

Most interestingly, Geraghty noted the contribution that nonprofit collaborations can make to employee goodwill and morale in an environment where pursuit of profit can run contrary to the norms that attracted employees to the field of biotechnology in the first place.

The panel also drove home the enormous role the Bill & Melinda Gates Foundation has played in changing the way nonprofits think of their roles in health. Gina Rabinovich from the Foundation was unwavering in stating their commitment not to publications or conference output, but to measurable health outcomes like reducing infant mortality. Kudos.

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Battelle-BIO Data on Biotech Investment and Jobs

I just came from a breakfast meeting between Ontario’s Ministry of Research and Innovation and the Governor of Victoria, Australia. Everyone agreed on the importance of quantitative assessment of the biotech industry, and everyone agreed that finding and measuring (and communicating) success is difficult.

So I was glad to be able to head straight for the Battelle-BIO session presenting data gathered by Battelle, BIO and PMP Public Affairs Consulting tracking “the development of the U.S. bioscience industry on a state and metropolitan area basis .. since 2004.” Much of the data in this year’s report ends at 2008, so it predates the worst of the recession and much of the recent pharma M&A (and associated synergies R&D job cuts). Still, there is some interesting hard data on jobs, investment and best practices to add to this blog’s collection of biotech statistics. Notably:

  • The only job growth 2001-2007 has been in “Research, Testing & Medical Labs,” which Battelle says includes CRO and startup jobs. Jobs have been flat at best in Ag, Drug/Pharma, and Med Device. Reflects increased pharma outsourcing.
  • This data shows a high multiplier, with 5.8 other jobs created per new bioscience job.
  • 27 states have grown at least 1,000 jobs since 2001.

What are the policy initiatives that stand out?

  • 38 states have R&D tax credits, with 7 of these being refundable programs and 4 allowing transfer of credits.
  • 20 states offer tax credits to investors in angel and/or early-stage VC funds.
  • 13 states have fund-of-funds programs, 10 states have made direct LP investments and 14 states have made direct investments in bioscience companies.

Here’s a link to the full report: http://www.bio.org/battelle2010

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Monday Biotech Deal Review: May 3, 2010

I guess the excitement of BIO was driving deals this week. To the delight of the economic development folks, government was in on the action — Ontario announced a BIP investment and announced a whole new strategy, and OICR funded three equity deals. The private sector was also out in force, with four new licensing deals (including some interesting structures) and more securities than the week might otherwise … warrant. Keep reading after the jump…

PubMed Central Canada Opens for Business: Free Online Access to Life Sciences Journals

The PubMed Central Canada project (noted here last July) is now open for business at http://pubmedcentralcanada.ca/ This collaboration — between the NRC’s Canada Institute for Scientific and Technical Information, the Canadian Institutes of Health Research (CIHR), and the U.S. National Library of Medicine — “aims to provide a freely accessible, Canada-based archive of biomedical and health research findings.”

It also allows CIHR-funded researchers to comply with the Institute’s Policy on Access to Research Outputs, which requires grantees to make their peer-reviewed publications freely accessible online within six months of publication. There’s a login-based manuscript submission system, but since I’m not CIHR funded, I can’t check it out. If you are, and you do, let us know how it works.

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This Week in the Twitterverse

Here’s some reading for the weekend from our Twitter stream on @crossborderbio:

Ontario’s New Life Sciences Commercialization Strategy Announced by Minister of Research and Innovation John Milloy

At a press conference in London today, Ontario’s Minister of Research and Innovation, John Milloy, is scheduled to announce the Province’s new $161 million Life Sciences Commercialization Strategy.

The bulk of the money ($114 million) is allocated to the Global Leadership Round in Genomics & Life Sciences (GL2), though $100 million of that was announced last year. Recent announcements under this program include $8.1 million for the International Barcode of Life Project, an $8.8 million grant to SickKids for autism genomics research, and $24.8 million to a posse of University of Toronto genomics researchers.

Of the remaining new money:

 The Ministry is also planning to:

  • Build out investontario.com, and
  • Initiate a Life Sciences Partnership Council to facilitate inter-ministry communication with industry

Other than the shut-down of BIP (not before a last hurrah), no program changes are being made right now.  OETF, OVCF and OITC will continue in their current form.

Here’s a link to the full strategy document (pdf).

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Biotech Trends at BIO 2010

As I’m preparing for the BIO conference in Chicago next week, I’m excited to see that several of the biotech trends we’ve been following on the blog are showing up as conference sessions.

  • Interested in “A New Kind of Non-Dilutive Financing and Fundraising: Partnering With Not-for-Profits”? Get an early start at our trends page on Commercialization by non-profit foundations!
  • Does “Comparative Effectiveness Research and the Government Role” or “Transforming Health Care Through Personalized Medicine” catch your eye? Check out the stories we’ve highlighted on Comparative Effectiveness and Personalized Medicine!
  • Of course, with the new regulatory pathway created by Health Reform legislation in the U.S., Follow-on Biologics (aka Biosimilars) are all the rage at BIO this year.
  • and the whole thing kicks off with Lilly’s General Counsel speaking on “Leveraging IP to Spur Global Biotechnology Innovation, Investment and Jobs” – emphsizing the link between IP Constituencies and Global Innovation that we have been following for some time.

Stay tuned for news from these and other sessions as we hit the conference next week!

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