The Cross-Border Biotech Blog

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

Monthly Archives: June 2009

Monday Deal Review: June 29, 2009

This week’s Monday Deal Review has a full set of equity deals from shelf to launch to close, one new U.S. registration and one deregistration to match, and some ideas for what to do with your debt (!), all

REMS and Generics — Like Oil and Water

A great post from Michael McCaughan at the In Vivo Blog walks through the very complicated interaction between the world of REMS — the FDA’s Risk Evaluation and Mitigation Strategies that impose tight controls on the distribution channels for certain drugs — and the world of generics. Under the FDA Amendments Act, which started the [...]

Promotion

Our esteemed CMO and Editor has agreed to contribute posts on case law relevant to the cross-border biotech community.  Oh look, there’s one now.

Brain Dump: Vacation Edition

A bit of catching up from the last few days: Sanofi makes a further move into generics, continuing the trend we’ve noted of big pharma moving in a big way into international small molecule generics and domestic biosimilars. A new tool from the NIH — RePORT, which replaces the CRISP system – is a powerful way to search for [...]

PhRMA and BIO in the U.S. Supreme Court: False Claims Act Whistleblowers Beware

As PhRMA and BIO hoped it would, the U.S. Supreme Court has agreed to hear the appeal of a False Claims Act (FCA) case that could determine how easy it is to bring a whistleblower suit under the statute.  Noting the prevalence of healthcare fraud cases brought under the FCA, PhRMA and BIO filed a brief [...]

SBIR Reauthorization Likely: Uncertain Improvements for VC-Backed Companies

The SBIR program in the U.S. looks to be heading toward reauthorization with increased funding amounts — up to $250,000 in Phase One (up from $100,000) and up to $2,000,000 in Phase Two (up from $750,000).  VC-backed companies are not eligible under the current program, but that should change.  The Senate version of the bill [...]

Gone Fishin’

I will have only occasional access to WordPress (which I use to publish the blog) over the next week.  I hope to keep up some posts, but full/regular posting will resume July 2.  The best way to know when I’m back (and to keep up with the blog in general) is to subscribe to the RSS feed. [...]

Ogilvy is #1

The Legal Post reports that Ogilvy Renault has won the Golden Law Award from the International Legal Alliance Summit, recognizing the firm as the best in Canada for the second year in a row.  Go team!

Monday Deal Review: June 22, 2009

A whole gaggle of securities deals, a cluster of licenses and a flock of M&A all migrate back to Canada for summer in this week’s Monday Deal Review.  Plus, a deal that may improve the medical isotope shortage.  

Weekend Science Review: Abba Edition

Take a Chance on Rats:  Fiona Zeeb in Catharine Winstanley’s lab at UBC has created a rat experimental model for gambling that attracted some news coverage.  Unlike previous rat gambling experiments, this model responds to human physiological moderators of gambling behaviour, like serotonergic and dopaminergic agents, suggesting that it will be a useful system for [...]

Trends Update — Comparative Effectiveness and Personalized Medicine: Patient-Centered Outcomes Research Act of 2009 Increases Personalized Medicine Focus

A story on GenomeWeb yesterday takes a close look at the Baucus-Conrad Comparative Effectiveness Bill and notes that the influence of personalized medicine that we’ve flagged as a trend in 2009 has shown up in this year’s verison of the bill as language specifying research approaches such as “molecularly informed trials” and “genetic and molecular sub-typing.” This year’s version of [...]

Ontario Emerging Technologies Fund: Q&A From MRI Briefing

The questions and answers from last Friday’s MRI information session have been posted on MERX.  Here’s the link to the whole thing (if you have MERX access), but I’ll save you some time: There are two parts to the bid — one for evaluating Qualified Investors and one for evaluating Qualified Investments.  The same bidder might [...]

Relocation, Relocation, Relocation: Biotech Incentives and Economic Development

Despite the skepticism expressed in the New York Times article last week, the efforts by various jurisdictions to attract biotech business continues apace. For one, the Mayor of Jerusalem announced a $25 million program to build infrastructure and human resources for a biomedical research park at Hebrew University School of Medicine.  Of course, they’ll have [...]

Ontario Venture Capital Fund Does Direct Investments Too, But Still No Biotech

A press release today about I Love Rewards’ $8.7 million B round serves to remind everyone that the Ontario Venture Capital Fund has 20% of its $205 million allocable to direct co-investments.  Well, it did, at least.  Now it has $1.8 million less. Other investors in ILR’s B round were GrandBanks Capital, out of Boston, and [...]

Jeremy Grushcow Quoted in Nature Biotechnology

Check out the quotes from our fearless leader in Brian Orelli’s piece on the tensions between investors and management at biotech companies.

Ontario Emerging Technologies Fund RFP: Excerpts from MRI Presentation

A couple of weeks ago, Ontario’s Ministry of Research and Innovation put out an RFP for the new $250 million Emerging Technologies Fund, looking for a third party to evaluate co-investor and investment applications, and to administer and monitor investments for the fund. Last Friday, they held a briefing for interested parties where they presented [...]

Trends Update — Nonprofits Funding Commercialization: TB Alliance Splits Development Costs With J&J Sub for TB Drug

One of the trends in 2009 we have been following is the increasing willingness of non-profits and disease advocacy groups to fund commercial product development by for-profit companies.  Today, the nonprofit Global Alliance for TB Drug Development announced that it will share the development costs for J&J subsidiary Tibotec’s drug TMC207, and that the TB [...]

New Funding for BDC Says Venture Capital in Canada “Tastes Great!”; Kedorsky Says “Less Filling!”

Yesterday Tony Clement announced an additional $450 million in funding to BDC:* $100 million in credit guarantees, $260 million for follow-on investments in companies where BDC is already a direct investor, and $90 million to invest in venture funds.  The follow-on money and the LP money will be spent over 3 years. (On purpose. (Ha.)) All [...]

Trends Update — Electronic Medical Records: GE’s First Healthymagination Project Aims to Speed EMR Adoption, May Also Help GE Sell Stuff

GE has put $100 million — the first installment of a promised $6 billion commitment to its “healthymagination” goals — into funding zero-interest loans to physicians’ offices, hospitals, clinics, etc. to support the purchase of (GE’s own) electronic medical records (EMR) systems. The program is called “Stimulus Simplicity” and it has a couple of very [...]

Monday Deal Review: June 15, 2009

Another active week for Canadian deals, headed by Merck’s new deal with Xenon, along with some new funding, some new collaborations, and some new products coming to, and going from, Canadian companies all for your easy-reading pleasure

Xenon In, Neuromed Out: Merck Nets Zero Canadian Collaborations This Week

Yesterday, Merck signed a deal with Vancouver-based Xenon Pharmaceuticals.  Merck will fund the R&D and in return gets an option on the output — small molecule cardiovascular drugs (if at first you don’t succeed…).  Xenon describes the deal as generating option exercise fees, research, development and regulatory milestone payments of up to US$94.5million for the [...]

Ontario H1N1 Swine Flu Update June 11: 1,562 Total Cases, 10 in Hospital. Oh, and It’s a Pandemic.

Ontario’s update yesterday brought the total number of cases in the province to 1,562 with two deaths, both fatalities having been people with underlying medical conditions.  The number of people hospitalized has increased from 6 to 10 since our last update (no word on the turn-over in that number), some of whom do and some of whom do not [...]

Health IT in Ontario: Electronic Medical Records, eHealth Procurement Need Help; Online Resources Make Progress

The Ontario Health Quality Council’s (OHQC) 2009 Annual Report On Ontario’s Health System was released earlier this week, and it notes that Ontario lags when it comes to EMR adoption: 25 percent of family-practice doctors in Ontario had electronic medical records, compared to 50 percent in Alberta, 98 percent in the Netherlands and 89 percent in [...]

FTC Weighs In: Favors Compromise on Biosimilars Exclusivity, Disfavors Pay-For-Delay

The FTC released a report today that explores the economics of biosimilars’ market entry and competition.  It predicts that biosimilars will be priced only 10 to 30% under their corresponding pioneer biologics; and that pioneer biologics will retain 70-90% of their market share subsequent to biosimilar market entry.  Based on these predictions, the FTC concludes that the proposed [...]

Totally Worth 3:57 of Your Time. Totally.

Making the rounds (har) with the HealthIT blogging crowd:

Monday Deal Review: June 8, 2009

Well, it’s a day late, but no dollars short.  Here is an action-packed Deal Review.  Read on for some debt settlement, some creditor un-settlment (a BIA filing), and all kinds of M&A related rejigging…

Chalk River Reactor Isotope Shortage Gets Timing Update, International Attention, Local Solution

The shut-down of Ontario’s Chalk River reactor, one of the few sources of medical isotopes for imaging in the world, is now predicted to last at least three months, and the resulting isotope shortage has been noted by the WSJ’s Health Blog as likely to get “a whole lot worse.” Meanwhile, in Quebec, Sherbrooke University [...]

Friday Science Review: Studying for the Bar Edition

While I am studying for the Ontario Bar exams over the next few weeks (a jurisdictional hat trick if I pull it off), I will try to keep up with the blog by cutting down on the analysis and commentary and putting you a bit closer to the primary source material than usual.  For the science review, [...]

The Economist on White Biotechnology (aka Green Chemistry, Industrial Biotechnology)

A good piece in The Economist sums up the science and policy of industrial biotechnology.  Among other kernels of information (har), they cite a McKinsey consultant for the proposition that “[s]ales of industrial-biotechnology products were about $140 billion in 2007, and 6% of all chemicals sales were generated with the help of biotechnology.” Interested? Montréal [...]

Novel Deal Structures Becoming More Common

At the RIC/OCETA talk I participated in last month, one of the trends in deal-making that I mentioned was novel structures.  At the time, examples included option deals and new ways to split rights and territories.  More recently, we’ve seen GSK and Pfizer form a joint venture to develop HIV treatments, and two more interesting ideas [...]

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