The Cross-Border Biotech Blog

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

Category Archives: Biotech Trends in 2011

Biotech Trends Update — IP Constituencies: Innovator-Generic Mixing Continues in Canada

As traditional pharma companies continue to diversify their revenue sources in the face of their pending patent cliffs, we have followed their entry into and expansion of their generics business lines. We have also noted activity in the reverse – generics companies developing novel products to build their margins and take advantage of their production capacity and expertise.

This week saw a Canadian example of the latter trend in Pharmascience’s purchase of Aegera for undisclosed terms. Pharmascience is a Montreal-based generics company and Aegera is a cancer-focused clinical stage company that has been backed by a raft of mostly Canadian venture capital outfits.

Canada’s domestic “generics” companies are now almost uniformly mixed generic / innovator businesses. Apotex carries out R&D through its ApoPharma subsidiary and has at least one novel product on the market. Valeant (nee Biovail) has a number of novel products in its pipeline as well. This should be particularly noteworthy in the innovation and economic development communities given recent decreases in Canadian R&D activity by global innovator pharma companies.

Biotech Trends in 2011: Biosimilars

In our original post on biosimilars, Lumira Capital’s Beni Rovinski set out the business opportunities, the technical challenges and the regulatory hurdles facing follow-on biologics in 2009. Since then, as Beni predicted, a series of pharma deals have followed Merck’s Insimed acquisition, and the regulatory framework in North America has been clarified substantially, with final Health Canada guidance having been issued and the the U.S. BCPI Act working its way through the FDA’s rule-making process.

The biosimilars market has also evolved in a couple of unexpected ways: 

  1. Teva decided not to wait for a distinct U.S. biosimilars pathway, and instead submitted a full BLA for Neupoval (which was accepted). Although Neupoval’s approval is now delayed, with the 12-year exclusivity period in the BCPI Act far exceeding similar periods in the EU and Canada, more companies may follow Teva’s approach instead of navigating the U.S. biosimilar regime.
  2. At the JP Morgan conference last week, the CEO’s of Amgen and Biogen Idec, two companies that have been built on innovator biologics, both openly discussed their own plans to produce biosimilars. Although Amgen’s Sharer said the company “should participate in an intelligent way without disturbing the core business,” and was looking to Asian and Latin American markets, Biogen Idec’s Scangos said flatly that “[t]he next decade will be about access and cost as much as it is about innovation,” and that biosimilars are “a low risk way to generate substantial revenue.”

As the regulatory and business environments continue to evolve, we’ll continue to keep an eye on the latest developments.

This post is the fourth in a series briefly outlining the biotech industry trends we’ve been following on the blog and noting some recent developments, plus directions for 2011.

Biotech Trends in 2011: Transgenics

As our ability to manipulate the genomes of plants and animals grows, we can increase crop yields, reduce environmental impact, improve nutrition and turn barren land arable.  Canada, in particular, has been at the forefront of much of this technology:

  • The Enviropig, developed in Guelph, Ontario, in 1999, produces phytase, an enzyme regular pigs lack, which helps it digest naturally occurring plant phosphorous in its feed more efficiently, which reduces feed costs and decreases the amount of phosphorus that winds up in pigs’ waste – making it less polluting. Recent coverage, from specialty (GenOmics video) to national to international (BBC video) highlights the animals’ great potential.
  • AquaBounty’s AcqAdvantage salmon, developed in Prince Edward Island, is even closer to approval. Although the FDA panel assigned to review the fish decided not to reach a conclusion this past Fall, they are still likely to be the first GM animal to be widely consumed by humans.  The AcqAdvantage salmon grow much more quickly than their non-GM peers and are farmed under close scrutiny, thereby improving environmental impact and reducing costs and overfishing.

Nevertheless, much of Europe continues to resist growing or importing GM strains, and the U.S., traditionally a strong supported of GM crops, seems to be wavering:

We will continue to follow these important legal, regulatory and scientific developments.

This post is the third in a series briefly outlining the biotech industry trends we’ve been following on the blog and noting some recent developments, plus directions for 2011.

Biotech Trends in 2011: Commercialization by Non-Profit Foundations

Financing for biotech companies is a major part of my work at my real job, and the horrible financing environment in the wake of 2008′s financial crisis was one of the motivators for starting this blog. So, when nonprofit foundations started financing commercialization and product development in addition to their traditional role in financing research, it was a trend this blog was quick to note.

In the years since, a steady stream of new entrants have financed a wide variety of companies and projects, and the trend has appeared in the last year as a panel and the BIO convention and in E&Y’s annual biotech industry report.

Most recently, the Canadian Cystic Fibrosis Foundation gave a $750,000 grant to a new Cystic Fibrosis Technology Initiative (CFTI) which was launched in partnership with the University of British Columbia and the Centre for Drug Research and Development (CDRD). The CFTI will “assemble researchers and identify promising discoveries from across Canada to create new medicines” for CF. Selected promising new drug candidates will be developed with CDRD. The initial application deadline is January 28th and details are available here.

With MJFF and Gates leading the way and with a continued shortage of traditional development and commercialization funding for the industry, expect to see lots more of these deals in Canada and internationally in the coming year.

This post is the third in a series briefly outlining the biotech industry trends we’ve been following on the blog and noting some recent developments, plus directions for 2011.

Biotech Trends in 2011: Comparative Effectiveness and Personalized Medicine

When this blog was launched in 2009, comparative effectiveness and personalized medicine were fairly new features in the North American landscape. Our initial argument that they were related topics — determining which treatment is best depends on which patient is being treated – was soon bolstered by the comparative effectiveness provisions in the U.S. stimulus bill and new personalized medicine data via the FDA.

The proposition has since become common knowledge, culminating in statements by Francis Collins and at BIO 2010 and discussed in the New York Times. Personalized medicine is now a key strategy for 12-50% of current drug pipelines, according to a recent Tufts study, and is a significant driver for DNA sequencing technology companies. If anything, the pendulum has swung a bit too far towards ‘hype,’ and as Matthew Herper reminds us, there are still non-personalized potential blockbusters in the pipeline.

The two concepts have even merged in a motto:

“the right drug to the right patient at the right time,”

which I still don’t like as much as “Personalized Effectiveness” (my neologized mash-up), but seems to be sticking. We’re just going to call it “Personalized Medicine” for now and will continue to follow major developments. You can too, on this page.

This post is the second in a series briefly outlining the biotech industry trends we’ve been following on the blog and noting some recent developments, plus directions for 2011.

Biotech Trends in 2011: Social Media in Biotech and Healthcare

Use of social media by pharmaceutical companies, biotechs, and industry observers will continue to grow in scale, value and importance this year. The emergence of Twitter as a public health surveillance tool and the pending (still pending…) release of the FDA’s social media guidelines will contribute to this growth in the short term, and we’ll continue to keep an eye on novel developments.

This post is the first in a series briefly outlining the biotech industry trends we’ve been following on the blog and noting some recent developments, plus directions for 2011.

Follow

Get every new post delivered to your Inbox.

Join 130 other followers