The Cross-Border Biotech Blog

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

Tag Archives: J&J

Biotech Trends Update — Commercialization by Foundations: JDRF, J&J and DexCom Collaborate on Artificial Pancreas

One of the industry trends we’re following in 2010 is the increasing commercialization activity by non-profit foundations. The Juvenile Diabetes Research Foundation has been taking active and creative approaches to funding treatments for their constituents.  Last month, JDRF in Canada partnered with a government funding agency to create a clinical trials network in Ontario; and today, an AP story at PharmPro reports that JDRF in the U.S. is bringing together two corporate partners to develop an artificial pancreas.

JDRF has been funding work on an artifical pancreas since about 2006; but this latest initiative moves the focus over to commercialization

Johnson & Johnson’s Animas Corp. unit (responsible for insulin pumps), and glucose monitor maker DexCom will work together on a device about the size of a cell phone that would be worn outside the body, with initial patient testing potentially beginning in less than a year.

JDRF is putting $8 million towards the project over the next three years, but they did not disclose either the amounts of the corporate commitments or the allocation of revenues from the project.

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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.

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Post-Vacation Brain Dump: Deal Developments

Some exciting deal news from the week:

And some interesting company news:

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

Mycobacterium_tuberculosisOne 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 Alliance and Tibotec will collaborate on future pipeline products.

This is not the TB Alliance’s first foray into commercial development.  In May, they announced four other drug development collaborations, including 3 with academic institutions, and one with Anacor Pharmaceuticals.  Under the Anacor collaboration, Anacor gets unspecified “support” from the TB Alliance, and the TB Alliance gets a non-exclusive, royalty-free worldwide license for TB.

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Wednesday Brain Dump: Two of Everything! Edition

Two Camels!  Dolly the cloned sheep, meet Injaz the cloned camel.

Two R&D Heads!  The combined Pfizer-Wyeth will have Mikael Dolsten heading up the newly created BioTherapeutics Research Group and Martin Mackay heading up the small molecule PharmaTherapeutics Research Group.  (Two CapitalLetters!)  The In Vivo Blog has a podcast interviewing both.

Two VA Initiatives!  In addition to the electronic medical records initiative we mentioned earlier this week, the Department of Veterans Affairs is also setting up a large cohort genetic study that will establish a database of genetic information from patients that will be linked to the participants’ electronic health records.  This is great news for personalized medicine because it will ensure that the EHR standard that comes out of the VA project will accomodate and utilize individualized genotypic data.

Two R’s, Two L’s, Two B’s!  G. Steven Burrill (two r’s, two l’s, one b) says he’s confident he can raise $1 billion (there it is!) to develop the Pine Island biotechnology project and a private equity/venture capital fund, which will support development of new technologies out of the Mayo Clinic and the University of Minnesota, among others.

Two Guidance…s!  Health Canada issued a finalized version of a Guidance Document on data protection (only applicable to qualifying innovative drugs that received an NOC on or after June 17, 2006) AND a revised version of the draft Guidance Document on Subsequent Entry Biologics, (which includes a 6-year data protection period).  More to come on this.

Two Border Crossings!  Simponi, a biologic developed by Johnson & Johnson and Schering-Plough, crossed the border Northbound — gaining approval from Health Canada before the FDA; and Molecular Templates Inc. crossed the border Southbound — leaving Ontario for the Texas Life-Sciences Collaboration Center.

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There’s No Bailout Like a Good Exit

A Bloomberg article this morning takes a look at the recent boom in Israel’s biotech and device stocks, and credits the government cash infusion (which we noted at the time) for some of the buoyancy; but also attributes much of the gain to speculation that the J&J-Omrix deal is the beginning, not the end, of acquisitions in the well-priced sector.  According to Bloomberg data, bargains still abound in Israel:

Most of the stocks still trade below their initial public offering prices and are valued at less than half of their global competitors relative to cash, according to data compiled by Bloomberg.

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J&J and Basilea to Arbitrate

In case you hadn’t heard, Basilea filed a claim for arbitration under their license agreement with J&J for the antibiotic ceftobiprole, based on the anticipated news, confirmed today, that the the EMEA has halted the EU Commission decision process on ceftobiprole pending EU led GCP inspections.

Brian Orelli has a nice post up on the wider ramifications of the mess that the industry will be in if the FDA has to scrutinize the reliability of every filing.

Wider ramifications aside, it is unusual to see a license and development agreement go to arbitration (as the WSJ Post points out, quoting Credit Suisse analyst Catherine Arnold). 

Based on the description in Basliea’s 2005 annual report (pdf), the agreement with J&J appears to have contained the usual joint committee structure for managing the development process; so it will be interesting to follow the story and see if we can learn any drafting lessons.

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