The Cross-Border Biotech Blog

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

Monthly Archives: July 2009

Ontario’s $250 million Emerging Technology Fund Launches!

Friday Science Review: July 31, 2009

My first post… a two week round-up.

New direction for treating obesity:  A study headed by Dr. Hans-Michael Dosch’s group at The Hostpital for Sick Children in Toronto demonstrated that killer T cells in visceral fat are activated to destroy fat cells and control insulin resistance.  With increasing weight gain, however, the killer T cells become overwhelmed as fat cells grow and inflammatory T cells move in.  Although these studies were performed in mice, it appears that humans also have a similar system in place.  The good news is that treatment with an anti-CD3 drug can give the immune system a boost and help reduce inflammatory T cells.  Even better news is that this drug is already in clinical use to protect against organ rejection, which means clinical trials to combat obesity may start as early as next year.  The article was published on-line this week in Nature Medicine.

Cool headed Toucan.  After decades of speculation over the purpose of the toucan’s over-sized beak – from sexual ornament to feeding purposes – researchers at Brock University in Ontario, in collaboration with scientists in Brazil, published an article in Science showing that the toucan’s beak acts as a highly efficient cooling unit.  They have the greatest beak-to-body size ratio and use this large surface area as a heat exchanger (akin to elephants’ ears) to regulate body temperature by modifying blood flow.  If only we had a ‘heat wave’ problem this summer…

Setback in Huntington’s Disease research.  A decade long study concluding with disappointing results was reported in PNAS this week.  Researchers at Laval University and University of South Florida analyzed the brains of HD patients who had undergone neural transplantations about ten years ago as a potential treatment.  Although there were mild clinical benefits, the grafts were short-lived and also had undergone disease-like degeneration.

Barcoding Nemo. As part of the International Barcode of Life Project to identify all plants and animals based on signature DNA sequences, spear-headed by Paul Herbert at the University of Guelph, the ornamental fish was added to the list.  Accurate identification of ornamental fish is important for establishing regulations, conservation practices and tracking origins.  The DNA barcode reference for these fish is based on the cytochrome c oxidase subunit I (COI) gene where 98% of the fish have distinct barcode clusters.  The article was published in PLoS One last week.

Funny etiology: two curious New York high schoolers initiated the project and recruited the Guelph lab, sparking headlines last summer when they discovered that some sushi restaurants were mislabeling cheaper fish as more expensive types.

Other DNA barcoding projects include other fish, butterflies, and birds.  To find out more, visit the Canadian Centre for DNA Barcoding or the International Barcode of Life Project (iBOL).

Welcome to Richard Chan!

The Cross-Border Biotech Blog welcomes Richard Chan as a regular contributor and our new Science Writer.  Richard has a Ph.D. in molecular biology and biotechnology and has done postdoctoral research on cancer signaling and proteomics at Beth Israel Deaconess Medical Center/Harvard Medical School in Boston and at the Ontario Cancer Institute in Toronto.  He currently works as a science consultant at R&D Funding Management.  Among his other duties as our Science Writer, Richard will be taking over the Friday Science Review.  Check out his first one here.

Nice to have you on board Richard!

Globe and Mail Story on Patheon-JLL Battle

Hockey_fightBoyd Erman at the Globe and Mail wrote about JLL’s long battle for Patheon in this morning’s paper, following yesterday’s dueling press releases (which I tweeted about @crossborderbio, also appearing to your right on this blog). 

Particularly if you’re new to this saga, I encourage you to read the whole article; but for those who have been getting their info here, I’d note a few particular tidbits about the long and previously good history between the parties:

“… it was JLL’s investment of $150-million in Patheon two years ago that enabled the company to restructure and get through tough times …”

and

“… Patheon was struggling in large part because the 2004 acquisition of a Puerto Rican drug maker called MOVA had gone sour, becoming a big money-loser …”

and notably, clarifies that Viso was the former owner of MOVA.

Maher Yaghi, an analyst at Desjardins Securities who Erman quotes several times in the story, takes a Solomonic approach, reportedly pegging the valuation at $3.75/share which splits the difference between JLL’s USD$2 offer and the $5 valuation Patheon is sticking to (so far).

Share Button

UPDATED Merial in Canada: Sanofi-Aventis to Buy Merck Out for $4 Billion, May (Re)Combine with Intervet Post-Merger

The New York Times’ DealBook blog reports that regulatory concerns about Merck’s purchase of Schering-Plough, presumably Schering’s Intervet animal health subsidiary, required Merck to divest its stake in Merial — its animal health JV with sanofi-aventis.  Sanofi is kindly obliging, for $4 billion.

Interestingly (given DealBook’s reporting that the JV divestiture is antitrust-driven), Merck, sanofi and Schering also entered into  a call option agreement (pdf), giving sanofi-aventis the option to combine Intervet with Merial following the Merck-Schering merger to form a new animal health joint venture with post-merger Merck.

The blurb on Merial Canada, which has what appears to be a small presence in Baie D’urfé Québec, is available for your viewing pleasure after the jump…

Trends in 2009: Direct-to-Consumer Genetic Tests Come to Canada

B&W_DNA_sequenceThis week saw the introduction of what I believe is Canada’s first personal genomics service offering.  Toronto’s Medcan Clinic paired up with California-based Navigenics to scan individuals’ genomes for a variety of disease markers.

Personal genomics is a burgeoning trend this year, which according to a special report in April’s Economist, will only be further boosted by a Moore’s Law-type improvement in sequencing power and price.  Available service offerings range from whole genome sequencing (e.g., Illumina and Knome) that costs tens of thousands of dollars to targeted scans typically offered for under $500 by a much wider variety of providers (Navigenics, 23andMe, deCODE and Pathway Genomics).

Regulation of DTC Testing:

In the U.S., the regulatory environment has settled down somewhat over the last 6 months, with most U.S. states regulating DTC genetics companies as clinical labs and the providers registering as such on a regular basis, including CLIA certification.  However, the HHS Secretary’s Advisory Committee on Genetics, Health and Society is due to meet in October to further discuss whether DTC genetic tests should be regulated as medical devices.  The CDC has released a report entitled “Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions” setting out best practices both for testing and interpretation.

In Ontario, there are a number of regulatory considerations (thanks on these points for input from Will Chung, of our renowned Life Sciences team):

  1. Private labs and specimen collection centres require licenses and are governed by the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA). However, blood collection at such facilities is governed by separate legislation which controls who may draw blood and for what purpose.
  2. The LSCCLA requires that only “legally qualified medical practitioners” are permitted to examine specimens, which means that patients may not directly order testing of their own blood at private licensed labs.
  3. Ontario’s Regulated Health Professions Act stipulates that communicating a “diagnosis” is a “controlled act” which may only be performed by a person authorized by a health profession Act, although it is not clear that DTC genomics results are a “diagnosis.”

Medscan seems to have navigated the regulatory waters, but time will tell how these laws are applied and/or modified.

In the EU, the European Society for Human Genetics advocates for pre-market review for “truthful labeling and promotion” as well as post-market evaluation of DTC genetic tests. In May, Germany passed a law restricting the availability of DTC genomics services by requiring testing to be carried out by a licensed doctor following the patient’s consent.”

How much protection do consumers need?

Many commentators are concerned with the public’s ability to understand these tests and distinguish between those that are clinically meaningful and those that are more … snake-oily.  Others object on the basis that there is little value added absent any available treatment — many preventive measures are things we already know we should do, like eat well, exercise, etc.  A number of groups, including advocacy group Genetic Alliance and the Genetics and Public Policy Center at Johns Hopkins University have called for a national registry of DTC genetic tests that would include performance data.

Others (and not just 23andMe’s founders) take a more libertarian view.  Ronald Bailey, the science columnist at Reason, agrees that people probably don’t need to be “protected against learning such information without the guidance of a knowledgeable physician or genetic counselor.”  In fact, a lawsuit in May brought by a girl born with Fragile X syndrome against the sperm bank that didn’t test for the predisposition may drive  higher demand for genetic testing in the fertility context which may in turn drive supply of services and diagnostic tools and may contribute to normalizing broader parental testing and pre-implantation screening.

Interestingly, a NEJM report a couple of weeks ago showed no lasting psychological damage from a genetic prognosis of increased Alzheimer’s risk.  By the time a year passed after the results, subjects who had an increased Alzheimer’s risk were no more depressed, anxious, or distressed than when they started the study.

Most importantly, 98% of patients in the Alzheimer’s study who tested positive said they would still get tested if offered the choice again.  98% is a lot. It suggests that DTC services will be increasingly popular, particularly as the price drops and the quality of the data, the analytics and the available counseling continue to improve.

Stay tuned to this page for further DTC genetics news and analysis.

Share Button

StartupNorth’s Series on Startup Funding Sources in Canada

StartButton by Flickr user crowbertJonas Brandon and Jevon MacDonald’s blog, StartupNorth, is running a series of posts by Craig Hayashi, a board member of Maple Leaf Angels on various funding sources for Canadian startups.  The first post is on Maple Leaf Angels itself, and the other options that have been covered so far are: Ontario’s Investment Accelerator Fund; and The National Angel Capital Organization. Stay tuned for more in the series here.

Share Button

*Photo modified from pic by Flickr user crowbert.

Monday Deal Review: July 27, 2009

B&W_BigNickelWell, July is wrapping up with no sign of summer, or of the summer doldrums.  Read on for all the rainy-day deals we found this week after the jump…

Toronto-Based PE Fund Imperial Capital Raises $126 million, Invests in IRB Company Schulman

Imperial Capital, a private equity fund in Toronto, Canada, closed its fourth fund yesterday with $126 million.  Interestingly, they kicked off Fund IV with an investment in Schulman Associates, an independent Institutional Review Board (IRB) company based in Cincinnati, Ohio, that provides:

“IRB services for a variety of study types (primarily Phase II and III multi-site clinical trials) within the United States, Puerto Rico, and Canada”

which will hopefully avoid any Coast-like problems.  Imperial Capital’s other current investments are in cosmetics, hair care and paintball. 

H/T to @CVCACanada.

Bristol-Myers Squibb Strikes $2.1 billion Deal for Medarex

light at the end of the tunnel smallGreat news for Medarex shareholders from BMS’ $16/share offer yesterday, which clocks in at a 90% premium over Wednesday’s close.  Reports cite the value of ipilimumab, a late-stage cancer therapy being advanced as a new treatment for metastatic melanoma, as well as the value of Medarex’s transgenic mouse platform to make human antibodies.

However, the deal is better for BMS than the headline price per share indicates. 

First, discount $300 million of the $2.4 billion that pays for Medarex’s cash and liquid securities.

Second, look at BMS’ cost savings here, since they were already partnered with Medarex on ipilimumab.  According to reports at the time the partnership was struck:

“Medarex has an option to co-promote ipilimumab in the U.S., where the company would receive 45 percent of profits. Bristol-Myers Squibb would get the rest and pay an undisclosed royalty back to Medarex on overseas sales. The company received an initial $50 million payment and could earn up to $480 million in regulatory and sales milestones.”

Figure the NPV of the $480 million is a lot higher now than it was in 2005, add in 45% of the U.S. market, and the 90% premium shrinks considerably.  I also wonder if the value of Medarex’s deal with Lonza is (a) transferable (more change-of-control clause fun) and (b) higher to BMS than it is to Medarex.

Other good news: This continues the “biotech is a good investment” meme shaping up this week.  Forbes asks “who’s next” in what DailyFinance calls “[t]he heated-up biotech sector,” and Cell Therapeutics thinks this is a great time to be in the market and is looking to sell $40 million or so of equity.

Share Button

Do the Q2 Venture Capital Numbers plus the HGS Success Indicate a Light at the End of the Tunnel for Biotech Funding?

light at the end of the tunnel smallMany of the articles and talks on biotech funding over the past year or so have lamented that public markets are closed to biotechs, and that the absence of a public exit, coupled with the preference for licensing over M&A by big pharma, would seriously dis-incentivize venture funding for biotech startups.  Two data points this week suggest the tide may be turning:

  1. Human Genome Sciences’ drug candidate for Lupus shocked analysts, showing positive results in its clinical trial, which sent HGS shares up almost 400% and boosted shares of two other companies working on products in the same pathway.  More importantly, it reminded risk-seeking investors of the outsize returns that make them love biotech stocks.  Remember last week’s NVCA study showing a 20% cost-of-capital for biotech?  Everyone (including me) focused on the take-away argument for biologics exclusivity, but now is a good time to remember that the cost-of-capital calculations are backed into from the historical (outsized) returns shown by biotech’s success stories.
  2. PwC-NVCA numbers released Monday showed biotech as the biggest recipient of funds in Q2, exceeding every other industry (thanks in part to the crappy numbers for other industries, but still…), and getting $3.67 billion for 612 companies January-June.

The change in mood has been immediate.  One obvious example is this piece in the WSJ’s Venture Capital blog that touts the value of biotech partnering deals as a boon to investors.  The same partnering deals that just a few weeks ago were described as barriers to VC exits are now a rationale for follow-on investment.

Not that there aren’t still challenges.  The Aveo Pharma deal in the WSJ post has two important features — they retained key assets for an M&A or public exit and their partner took equity in the licensing deal —  but a few more headlines like “Biotech Start-Ups Striking It Rich With Partnerships” and we could be on the road to a biotech recovery.

Share Button

Canada’s Data Protection Regulations Upheld Against Court Challenge

Scale_of_justiceJPEGLast Friday* the Federal Court of Canada upheld the constitutional validity of Canada’s Data Protection Regulations, dismissing the applications of the Canadian Generic Pharmaceutical Association and Apotex Inc.

Canada’s data protection regime provides innovative drugs with:

  • a six-year data exclusivity period;
  • an eight-year market exclusivity period; and
  • an additional six-month period of market exclusivity in some cases for pediatric applications.

The Data Protection Regulations were enacted in 2006 to bring Canada into compliance with its TRIPS and NAFTA obligations.  Here’s today’s press release from Rx&D.

*The decision has not yet been posted. The citation will be 2009 FC 725.

Share Button

Interesting Data on the Value of Patent Examiner Interviews

Dennis has a post up at PatentlyO this week that attempts to assess the benefit to patent applicants of “interviews” — when your patent attorney discusses a filing directly with the USPTO examiner to address the examiner’s rejections.  The study looks at over 17,000 applications between 2000 and 2005, 18% of which involved interviews. 

Dennis finds that “early” interviews (those taking place before any final office action) are not correlated with increased success (grant rate).  However, “late” interviews (those taking place after a final office action) do correlate with success:

“Applications in the late interview group had a much higher grant rate than did applications where a final action was mailed but the case was not subsequently interviewed.  Here, 74% of those in the late interview group were allowed as compared with only 60% other applications where a final action was mailed. (+/– 3% at 95% CI).”

However, I wonder if the control group can be further subdivided to exclude cases where the applicant gave up — e.g., took no further steps after the final office action.  Commenters on PatentlyO also ask about a distinction between examiner-initiated and applicant-initiated interviews, based on experience that examiner-initiated interviews have a very high success rate.

Share Button

Trends Update — Comparative Effectiveness and Personalized Medicine: Genetic Test Identifies Patient Subpopulation for Benefit, Avoids Wasted Money and Time for Others on Erbitux, Vectibix

B&W_DNA_sequenceThis is exactly how personalized medicine and comparative effectiveness can interact to benefit patients, pharma companies and payors:

  • data shows that patients with KRAS mutations don’t benefit from anti-EGFR antibody meds Erbitux or Vectibix;
  • the FDA approves a labeling change identifying the patients who won’t benefit;
  • payors see costs savings from eliminating pointless prescriptions;
  • patients without the KRAS mutations have added incentive to take the drugs, benefiting themselves and the pharma companies who make the drugs.

As the WSJ Health Blog says:

“Erbitux and other expensive cancer medicines have faced repeated questions about whether drugs that prolong life for short periods of time are worth the high costs… Not using Erbitux as a first-line treatment for [KRAS-variant] patients could save about $600 million a year.”

The manufacturers Bloomberg’s reporter spoke to are fully supportive:

“‘The inclusion of KRAS as a biomarker in the Erbitux labeling helps physicians to better understand the most appropriate use of the drug in the management of patients with metastatic colorectal cancer,’ said Fouad Namouni, an oncology executive for Bristol-Myers …

Physicians can eliminate Vectibix and Erbitux for colon cancer patients with the KRAS mutation and ‘redirect those patients to alternative therapies, avoiding unnecessary treatments in patients who are unlikely to benefit,’ said Sean Harper, Amgen’s chief medical officer.”

Share Button

Monday Deal Review: July 20, 2009

B&W_BigNickelThis week’s deal review has some more info about Ambrilia’s deal with Kotinos that I tweeted about at the time (my Twitter stream shows up in the sidebar on the right here), as well as an update on JLL-Patheon and a raft of securities deals, including an issuer bid after the jump…

New Tennessee State Tax Credits Incentivize Venture Fund Investments

Tennessee_state_flagThe Tennessee legislature passed a bill earlier this month that indirectly creates $120 million of venture funding.  It gives tax deductions to insurance companies that invest in qualified entities called “TN Investcos” which are in turn instructed to make “focused investments of capital in early or seed stage companies with high growth potential.”  Firms that meet the requirements and are interested in being one of the six Investcos apply to the Tennessee Department of Economic and Community Development.  The companies receiving TN Investco funds must:

  • be independently owned and operated and headquartered in Tennessee,
  • conduct its principal business operations in Tennessee, and
  • have at least 60% of its employees located within Tennessee. 

Restrictions include:

  • no more than 100 employees, and 
  • not principally engaged in professional accounting, medical, or legal services; banking or lending; real estate development; insurance; oil and gas exploration; or direct gambling services. 

According to a memo on the legislation by Tennessee law firm Waller Lansden, a similar $100 million tax credit program started in 2004 in Alabama has “created 781 jobs bearing an average annual wage of $40,628″ and “generated more than $32 million in new annual payroll for the state.”

Share Button

White House Weekly Address: The Pitch for Health Reform

With the critical Senate Finance bill still pending, here’s the pitch from the White House:

The only two things I heard Obama describe as requirements for a bill he would sign:

  • No addition to the deficit over 10 years; and
  • Insurance exchange: one-stop shop to compare prices, coverage and, interestingly, track record.

He definitely advocated a public plan option, but it wasn’t clear whether that was inside or outside the list of requirements.

Share Button

No Company is an Island: More Pharma and Biotech Collaboration

Island Nihoa_aerialTwo deals this week showcase collaborative efforts between major pharma players:

 

 

These follow last month’s earlier-stage collaborations between GSK and Pfizer for HIV treatments and betwen AstraZeneca and Merck for cancer treatments.

Why are we seeing these collaborations?  I have a couple of thoughts:

  1. This is a tough regulatory environment and companies are going to reach for every advantage they can get … maybe putting more effort into initial approvals that they might otherwise dole out over time.
  2. I think it’s notable that these projects are all aimed at HIV and cancer, two complex and incredibly tenacious diseases.  The low hanging fruit is (a) gone, and (b) not finishing the jobs. 

Is this the end of magic bullets and the beginning of biotech patent pools?  Too soon to say.

Share Button

New Data Shows 70% of Canada’s Biotech Companies Have Under 12 Months’ Cash. BIOTECanada’s New Ask: Government Loans.

Canadian moneyA Canwest story today highlights new BIOTECanada data showing 70% of survey respondents have under 1 year of cash, up from 50% in January.  FierceBiotech picked it up as well, guaranteeing a full dose of international attention.  

Even though the remaining 30% of respondents likely include some with big recent successes — Bioniche, Allostera and Zymeworks — and some with creative approaches — ConjuChem, Neuromed, etc. — the top-line number is grim indeed.  Plus, as Kasia Majewski points out:

“Most firms have found away to extend their cash, but they’ve done that by massive layoffs, by shutting done operations to the bare bones. So essentially the lights are on but there’s one guy home.”

Given that there has been no systemic cash infusion, it’s not surprising that the number of firms in trouble has gone up since January. 

On the other hand:

There is a bolus of fund-of-funds and direct capital waiting to be deployed, including:

Plus, Lumira Capital’s Q2 newsletter (pdf) points to the new BDC money, Alberta Investment Management Corp’s PE plans and the new Alberta Enterprise Corporation as potential additional sources of funding in the medium term.

BIOTECanada bottom line:

In the winter, the organization was focused on tax initiatives.  Yesterday, though, the focus was entirely on

“negotiations with Industry Canada to obtain a loan program for Canada’s biotech sector that can hold the industry over until capital markets rebound. … [Specifically,] government loans to be repaid after a two- year period at six per cent interest.”

Maybe it’s the new money looming on the horizon, or the seeming lack of traction for the tax policy asks, but the focus has definitely shifted.

My bottom line:

Even the new loan program advocated by BIOTECanada will not help if the other government funding doesn’t make it to biotech companies and VCs. We’ve been keeping an OVCF scoreboard that still shows a goose-egg for biotech investments.  It may be early days for these new capital sources, but the hour is late for Canadian biotech companies.

Bookmark and Share

Pfizer and Ontario BIP Program Funding New $6.9 million “POP-CURE” Project for Colorectal Cancer Genomics

B&W_DNA_sequence Pfizer Global Research and Development is contributing $6 million and the Ontario government is contributing $900,000, through the Biopharmaceutical Investment Program (BIP), for a new project “to discover and validate new targets for the diagnosis, prognosis and treatment of colorectal cancer.”  Brad Wouters, a Senior Scientist with the Ontario Cancer Institute (OCI) and a Senior Investigator at the Ontario Institute for Cancer Research (OICR), will lead the project.

Here’s the scoop from the OICR press release:

“Dr. Wouters and a team of scientists at OCI and OICR will use genomic and molecular pathology approaches and develop a large clinical biobank to identify molecular signatures in colorectal cancer. These molecular signatures will be used to accelerate the development of biomarkers for early detection, monitoring and treatment of cancer.”

The Canadian Press article includes some additional background info on the project, which Paul Lévesque, president of Pfizer Canada, says began with a trip by Ontario researchers to meet Pfizer scientists in San Diego almost two years ago.

Bookmark and Share

Bailout Update: New UK Life Sciences Blueprint Aims to Promote Innovation

world_map_2002The UK has a new Life Sciences Blueprint that sets as a goal the creation of an internationally-recognized life sciences cluster.  Here’s the press release and here’s the full report (pdf). 

Innovation Pass and Changes at NICE:

The Blueprint kicks off an “Innovation Pass” program under which certain novel medicines (criteria TBD) will be available for a 3-year period without the otherwise mandatory predicate of review by the National Institute for Health and Clinical Excellence (NICE).  A further report is due from Sir Ian Kennedy next week (July 22) that aims “to identify the aspects of value and innovation which NICE should take into account in its work.”  If innovation stimulus is considered a part of the comparative effectiveness analysis, who knows how widely the door may open even after the Innovation Pass. 

Between these changes and the recent report on genomic medicine from the House of Lords Science and Technology Committee, which recommends that the purview of NICE be extended to “include a programme for evaluating the validity, utility and cost-benefits of all new genomic tests for common diseases, including pharmacogenetic tests,” big changes may be heading NICE’s way.

Also notable:

  • The Government will invest £150 million alongside private sector investment, with the aim of leveraging enough private investment to build a £1bn, 10-year Venture Capital Fund.  This is Lord Drayson’s idea that we held up at the time as a model for technology-agnostic lobbying;
  • Along with a variety of educational initiatives and programs, the Society of Biology will begin to accredit undergraduate bioscience degrees to help ensure that graduates leave with the core skills and competencies required by employers;
  • A reassessment of the UK’s various R&D tax incentive programs (A little tax joke for you there as a prize for making it this far down the post.);
  • An £18 million program for regenerative medicine R&D; and of course
  • A marketing initiative to make sure everyone knows all the great stuff they’re doing.

Share Button

Corporate Liability Journal Article on Wyeth v. Levine, Reigel v. Medtronic and Medtronic v. Lohr

Check out Jeremy’s latest article, published in the current issue of Corporate Liability Journal.

In The Changing Landscape of U.S. State Tort Liability for FDA-Approved Drugs and Medical Devices (pdf), Jeremy and his co-author, Alison Varga, take a more detailed look at this year’s U.S. Supreme Court decisions in Wyeth v. Levine and Reigel v. Medtronic, which Jeremy has been following on the blog.

Share Button

Toronto International Film Festival (TIFF) 2009 to Open with “Creation,” a Darwin Biography

TIFF LogoJust announced (thanks @ABWeir!) — the opening night film for TIFF 2009 will be “Creation.” Here’s the film’s blurb:

“Randal Hume Keynes OBE is a British conservationist and author and a great-great-grandson of Charles Darwin. He is the author of the intimate exploration of his famous ancestry, Annie’s Box, subtitled Darwin, His Daughter, and Human Evolution a book about the relationship between Darwin and his daughter Annie whose early death deeply affected him and his views on religion. CREATION is the screen adaption of Annie’s Box by John Collee.”

You know it’s going to be a good year when it starts with evolutionary biology!

Bookmark and Share

Trends Update — Biosimilars: Sen. Kennedy, Gov. Dean and NVCA Study all Support 12+ Years of Exclusivity

The debate over the proper data exclusivity period for innovator biologics (as protection against biosimilars/follow-on biologics/subsequent-entry biologics) had a busy week last week.

A couple of thoughts:

  1. The exclusivity period in the EU is 8 years (data) +2 years (marketing) +1 year (for new indications), and the current proposal in Canada is 6 years, so a baseline of 12-14 years’ protection would leave the U.S. system paying for exclusive pricing longer than other major markets.  I’m fine if the U.S. decides to further subsidize pharma innovation, but I’d prefer a more transparent approach with less market distortion; and
  2. It’s hard to balance rationally between data exclusivity and patent exclusivity when the patent system is in significant flux.  Having patent reform as a moving piece (or as part of biosimilars legislation) only muddies the debate.

Update: The WSJ picks these up this morning too.  Here’s the NVCA story, and here’s the one on Kennedy’s efforts and the debate it’s generating in committee.

Share Button

Senate Action on Small Business Innovation This Week?

SBIR bannerThe Senate schedule for today does not include consideration of The Small Business Innovation and Research Act of 2009. Late last week there were rumors the House version of legislation, passed by the U.S. House of Representatives on July 8, would receive expedited consideration on the Senate floor as early as today, using the unanimous consent Senate measure. The Congressional Budget Office estimates the cost of implementing the House legislation would be $272 million 2010-2014. The legislation increases funding amounts and eases eligibility for SBIR grants to companies backed by venture capital investors. SBIR grants are available in all U.S. federal agencies, including NIH, Dept. Defense, Dept. Energy and NASA.

Bookmark and Share

Monday Deal Review: July 12, 2009

B&W_BigNickelThe highlights of this week were definitely the Bioniche-Endo deal and Allostera’s $17 million raise, but that was just the tip of the iceberg as Canadian deal activity heated up along with the weather.  A novel deal with an income trust swapping cash for a biotech’s public shell starts things off after the jump…

Bioniche Signs Urocidin Deal with Endo Pharmaceuticals: $20 Million Up Front, $110 Million plus Supply to Follow

Exciting deal! Since Rick and I worked on this one, let me just turn it over to the press release:

Bioniche Life Sciences Inc. (TSX: BNC) and Endo Pharmaceuticals (Nasdaq: ENDP) jointly announced today that Endo has licensed from Bioniche the exclusive rights to develop and market Urocidin™ in the U.S. with an option for global rights. Urocidin is a patented formulation of Mycobacterial Cell Wall-DNA Complex (MCC) developed by Bioniche for the treatment of non-muscle-invasive bladder cancer that is currently undergoing Phase III clinical testing. Under the agreement signed by both companies, Endo will pay Bioniche an up-front cash payment of $20M USD and the potential for up to $110M USD in additional payments linked to the achievement of future clinical, regulatory, and commercial milestones. In addition, Bioniche will manufacture the product and receive a transfer price for supply.

Update: Here it is on FierceBiotech.

Update 2: Here’s the BIO SmartBrief post.

Share Button

Trends Update — Electronic Medical Records: Ottawa Telehealth Success, Privacy Fiasco in Alberta, Beta Test in Montreal

floppy-disk1New data yesterday from a home telehealth monitoring program developed by the University of Ottawa Heart Institute claims a whopping 54% cut in hospital readmission for heart failure patients.  Readmission rates dropped to under 15% for patients on the program, which includes daily vitals monitoring and immediate contact if anything seems amiss. UOHI says they realize up to $20,000 in savings for each patient safely diverted.

Of course, any time you create electronic medical records, you create privacy risks, as this week’s fiasco in Alberta shows.  Over 11,000 patients were notified of a privacy breach after a virus infected over 100 Alberta Health Service computers.  A follow-up CBC story quotes a computer security expert who is appalled (the virus is 7 years old).

If you still want to hop on the electronic medical record bandwagon, McGill University Health Centre is collaborating with Medical.MD to promote a 300-subscriber beta test (first-come, first served) for Medical.MD’s web-based personal health records management tool — MedforYou.  Medical.MD says the service will be very user-friendly and will include information on allergies, procedures, providers and medications as well as a journaling function.

Share Button

$700 Million Close Opens the Doors at Teralys Capital

Teralys Capital, the fund-of-funds announced in Quebec’s budget in March, actually closed on its $700 million today and “is now ready to move ahead with its mandate to finance private venture capital funds that invest in technology companies in the life sciences, information technology and clean technology sectors.”  (I guess the extra $125 million they were planning to raise from the private sector went to Excel’s new fund instead!)

I’m still not sure Teralys has a website, and today’s press release ends with “For further information: The telephone number provided below is for the exclusive use of journalists and other media representatives: Josée Lagacé, (514) 850-4835.”  But not if you’re a journalist running a VC fund.  Or a VC.  In other words, don’t call them, they’ll call you.

Share Button

Two Initiatives in Canada Aim to Grow Fresh Crops of Entrepreneurs

Chris Arsenault at iNovia has had an interesting series of tweets recently — two noting Canadian programs for young entrepreneurs:

He’s also in the middle of an interesting (and necessarily pithy) debate with Craig Netterfeld at Wellington about entrepreneurship nature vs nurture. 

twitter_logo_headerI had a convoluted parenthetical here about how I wasn’t actually “following” them because I’m not on Twitter, but it seemed easier just to be on Twitter than to explain why I wasn’t.

Bookmark and Share

Follow

Get every new post delivered to your Inbox.

Join 129 other followers