The Cross-Border Biotech Blog

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

Monthly Archives: June 2010

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.

Read more of this post

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:

Friday Science Review: June 11, 2010

Catch up on these genetics stories between World Cup soccer games…

Genetic Links to Autism: Phase 2 results of the Autism Genome Project mapping the genetics of autism is reported this week in Nature. Researchers used the latest microarray technology to identify a trend that autism patients carry more insertion and deletion mutations affecting their genes.  Several genes were also labelled as potential autism risk factor genes and could be very useful for diagnostic purposes. “Guided by these massive genomic data sets, we can start to see the forest through the trees, offering answers and hope for families with autism,” says Dr. Stephen Scherer at The Hospital for Sick Children who led the consortium along with Dr. Peter Szatmari at McMaster University.  You can read about it here or sit back and watch this interview with Dr. Scherer.

Note that this study contrasts the controversial 1998 Lancet paper by Dr. Andrew Wakefield who suggested a strong link between the MMR (measles, mumps, rubella) vaccine and autism, leading to many parents withdrawing their children from the effective vaccine program.  The Lancet journal retracted the paper in February 2010.

Nature versus Nurture: Epigenetics is at the crossroads of genetics and environmental factors – the science of how the environment affects gene regulation at the molecular level that leads to a disease pathway.  “With the concepts of epigenetics we can start to understand how a disease risk factor is alternately switched on and off,” Dr. Arturas Petronis at the Centre for Addiction and Mental Health (CAMH) explains in this new perspective article published in Nature.

Epigenetics provides a new theoretical framework that addresses the vast complexities, irregularities, and controversies detected in common human diseases. For instance, epigenetics explains why one identical twin may be affected with cancer or diabetes although the co-twin is perfectly healthy. “In a case like this, the inherited genes are identical and the environment is similar. But one twin’s risk factor has been triggered, while the other twin’s risk factor has not been triggered,” says Dr. Petronis.

For personalized medicine to move forward, it is imperative to understand the mechanism of how environmental cues lead to genetic changes and how this process can be controlled.

Biotech’s Murky IPO Window Increases M&A Attractiveness

A recent press release from Burrill & Company points out that only 1 of 8 U.S. biotech IPOs in 2010 is currently trading above its IPO price. IMRIS was the last Canadian biotech IPO, completed in November 2007 at $6.00, and it is currently trading at $5.50 after dipping under $2 in late 2008. Facing these difficult public markets and limited treasuries, it is not surprising to see Canadian VCs opting to sell companies in their portfolios, including the recent sales of two companies with revenues. Toronto’s Visualsonics was sold to U.S.-based SonoSite for about 2.4 times Visualsonics’ trailing 12-month sales of $30 M. Montreal’s Resonant Medical was sold to Swedish company Elekta for about 3 times expected 2010/2011 revenue of $10 M.

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:

Friday Science Review: June 4, 2010

New fixes for spinal injury, Staph infection and cancers…

Spinal Cord Self-Repair: A natural repair mechanism in our bodies may be the key to treating spinal-cord injuries.  Following a spinal cord injury, there is an increase in expression of serotonin receptors and the receptors are spontaneously active even in the absence of serotonin.  This autoactivation is thought to be a response or repair mechanism that is initiated as a result of the injury.  Pharmacological agents may be used to try to enhance this receptor activity to promote recovery.  The caveat, however, is that the receptors remain “on” and may explain the spasms experienced by spinal injury patients.  In this case, inhibitory drugs may be beneficial to preventing these muscle spasms.  Dr. Karim Fouad and his team conducted the research at the University of Alberta (Edmonton) and present their work in Nature Medicine.

Super Bug’s Magic Revealed:  MRSA, or methicillin-resistant Staphylococcus aureus, is a strain of Staph that has become resistant to most types of antibiotics.  Scientists now know why and what makes a harmless bacteria become pathogenic Super Bugs.  A small chemical (aureusimines) made by MRSA bugs is the key factor that determines their virulence and ability to cause severe disease.  The researchers discovered how these chemicals are made in the bacterium and then tried to shut off the different pathways involved in the synthesis of these chemicals.   Blocking aureusimine production resulted in a much weaker and less virulent bug, which allowed the mouse model patients to recover from S. aureus infections.  This information comes at a crucial time when drug resistance is on the rise and new anti-bacterial targets are desperately needed.  McMaster University scientists led by Dr. Nathan Magarvey describe their breakthrough discovery in the latest Science magazine.

Controlling Cell Growth: The research of Dr. Nahaum Sonenberg and his McGill University team on the mechanisms controlling cell growth and proliferation have had significant impact in advancing the field.  They continue their key discoveries with the delineation of mTORC1 and the 4E-BP proteins.  Although mTORC1 is known to be involved in connecting growth and nutrient signals to control cell size and cell division, 4E-BPs are only involved in mediating the cell proliferation pathway and not cell growth.  This distinction is important because mTORC1 is implicated in a variety of diseases and these related pathways are targets for therapeutic drugs, so further refinements can be made accordingly.  The report is published here in Science magazine.

A Cancer Cure in Sponge? A peptide found in sea sponge can inhibit tumour cell metastasis.  The Neopetrosiamide A (NeoA) peptide prevents tumour cells from sticking to surfaces by decreasing cell surface proteins such as integrins and inducing the disassembly of structural complexes called focal adhesions.  Its mechanism of action is unknown but it somehow causes important “sticky” proteins to be kicked out of the cell rather than trafficking to their proper locations.  This is a developing story to keep an eye on.  The study is published in PLoS One by Dr. Calvin Roskelley’s team at the University of British Columbia.

Biotech IPOs Past — 10 Years After the Biotech Venture Capital Boom of 1999-2001

You often hear people in this industry reminiscing about biotech booms and praying for another IPO window to open. The three most recent boom/windows were in 1995-1996, 1999-2001 and 2003-2005, each of which was impacted by both positive external market forces and a driving factor within biotech. The most spectacular boom/window was in 1999-2001, with the external trigger being the dotcom bubble and the internal trigger was two emerging technologies, genomics and proteomics, which had potential game-changing attributes that appealed to many dotcom investors. Co-authored with James Smith, Vice President Healthcare at The Equicom Group, this report looks back at the 1999-2001 boom/window, the IPOs and their subsequent performance.

Welcome to New Cross-Border Biotech Blog Contributor Wayne Schnarr

I am very excited to introduce Wayne Schnarr as a contributor to the Cross-Border Biotech Blog. Wayne has a ton of industry experience and always has smart things to say, as you will see for yourselves in a minute. Welcome!

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