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

Category Archives: Trends in 2009

Science and Technology in India’s Election

Trends in 2009 post this week noted the increasing innovative activity in India and China.  Further evidence of that trend comes from a ScienceInsider report today that support for science and technology has taken a prominent place in the ruling Congress Party’s election manifesto.  The party notes that in the last two years it has opened:

eight new Indian Institutes of Technology, seven new Indian Institutes of Management, five new Indian Institutes of Science Education and Research, 30 new Central Universities, 20 new Indian Institutes of Information Technology, and 374 new colleges in educationally deprived districts.

Onward and upward in the IPRI Report

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Trends in 2009: Shifting IP Constituencies as Innovator Pharma Buys Generics and Asia Turns to Innovation

Growing industrial and geopolitical realignment of economic interests has the potential to re-define intellectual property constituencies in 2009.

1.  Industrial realignment: the entry of innovator pharma companies into the generics business.

This year has already seen Merck get into follow-on biologics by buying Insimed and Pfizer build its generics business with its Aurobindo deal.  As traditional innovator pharma companies become more invested in follow-on biologics and small molecule generics, they will have a greater (self-)interest in a functioning subsequent entry pathway. 

Watch how this is playing out in the follow-on biologics arena as two competing FOB bills make their way through Congress.  Right now, the 12-year exclusivity period in the Eshoo-Barton FOB bill and the 5-year exclusivity period in Waxman’s FOB bill are duking it out, and we’re already seeing increased industry flexibility.  Innovator pharma has historically insisted on a 14-year exclusivity period to accompany follow-on biologics legislation, but BIO has already indicated some willingness to support Eshoo-Barton, as has PhRMA

Dani’s the expert, but my layman’s guess is that we get a FOB pathway this time around, and that the exclusivity number lands somewhere in the 8-10 year range.  This is consistent with a Teva-promoted analysis and it’s easy to see that it covers the arithmetic middle ground.

2.  Geopolitical realignment: increasing innovative activity in Asia, which has historically focused more on generics.

In China, a recent deal between Lotus Pharmaceuticals, Inc. (OTCBB: LTUS) and Beijing Yipuan Bio-Medical Technology Co., Ltd. (“Yipuan”) to acquire the drug Yipubishan points to China’s interest in promoting innovation.  Yipubishan, which is used to treat the symptoms of gastric ulcers and hemorrhages of the upper digestive tract, was partly funded through the use of grants from the Innovation Fund for Small – Medium Technology Based Firms of the Ministry of Science and Technology of the PRC.  Yipubishan became the first prescription drug of its kind developed in China to be included in the National Torch Project, which recognizes and promotes commercialization of high-tech discoveries and encourages companies to use high technology.  The Torch Project is one of a series of PRC Science and Technology initiatives.

In India, Wockhardt’s pioneering efforts in biotechnology are among many signs of increasing innovative activity, and have attracted interest from Pfizer and Sanofi.  Wockhardt has set up a global-scale biopharmaceuticals manufacturing powerhouse, the Wockhardt Biotech Park, in Aurangabad, India. This state-of-the-art complex comprises six dedicated, manufacturing facilities, and is designed according to US FDA and EMEA standards. It will also house new biotechnology products that are currently in various stages of development. The complex has the capacity to cater to 10-15% of global demand for major biopharmaceuticals.

India and China are in the 3rd quintile of countries in the 2009 IPRI Report, with India ranking 46/115 and China ranking 68/115 but they are steadily increasing their innovative activity. 

Within a short span, I would expect them to rank more like Israel, which has a world-class innovative industry as well as a strong generics industry (Teva), or Taiwan, which recently announced an initiative to boost cleantech and biotech.  Both Israel and Taiwan are ranked 29/115 in the 2009 IPRI Report. 

Electronic Medical Records Update: Walmart Solution, Google Problem

When we identified electronic medical records as a trend in 2009, it was before $19 billion of the stimulus was allocated to implementing EMR.  With that money on the table, the movement toward wide scale implementation has only accelerated:

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Waxman Drives Hard Bargain on FOBs Market Exclusivity

Representatives Waxman (D-CA), Pallone (D-NJ) and Deal (R-GA) released the Promoting Innovation and Access to Life Saving Medicine Act today, a.k.a. Follow-On Biologics legislation. The legislation provides a five-year initial exclusivity for products with a unique molecular structure. The Biotechnology Industry Organization is not too happy. In the past BIO has called for a 14-year data exclusivity

Perhaps actions South of the Border will move the ball forward at Health Canada on its regulatory pathway for biosimilars? It has been almost exactly a year since Health Canada’s draft guidance on biosimilars was published. Health Canada subsequently published a summary of its Consultation on the Regulatory Framework for Subsequent Entry Biologics following a stakeholder meeting in June.

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Patent Reform Live (Updated): Senate Judiciary Committee Hearings

You can watch the Senate Judiciary Committee hearings live here starting at 10 am.

Here’s a letter sent yesterday (pdf) by Sens. Feingold, Wyden, Bond, Brownback, Grassley, Kyl and Coburn to Sens. Leahy and Hatch expressing the writers’ concerns.

Witness list and links to the witness statements after the jump…

Trends in 2009: Personalized Medicine and Cancer Update

The Boston Globe reported this week on current trends in genetic testing of tumors:

  • Massachusetts General Hospital will be adding $2,000 per patient worth of genetic testing as part of its standard of care for cancer.
  • Dana-Farber tests selected patients, including patients with certain melanomas, where doctors know those malignancies can carry abnormalities that are susceptible to certain drugs.
  • Memorial Sloan-Kettering Cancer Center in New York, will start screening most patients with lung cancer within weeks.

This week has seen some scientific developments reported in tumor screening as well:

  • A study in PNAS reports on an analysis of genome-wide expression and copy-number data in endometrial cancers and finds a couple of prognostically-relevant results.
  • A study in the Journal of Clinical Oncology reports on the use of a 50 gene array to successfully identify four breast cancer tumor types that have been previously defined: luminal A, luminal B, HER2-enriched and basal-like.

We’ll see if the accumulation of data is sufficient to make a case for insurance coverage.

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The Patent Reform Act of 2009: Absent Inequitable Conduct Provisions Help Biotech

The Patent Reform Act of 2009 was introduced by Senator Patrick Leahy (D-VT) Chairman of the Senate Judiciary Committee. The bill includes Senator Orrin Hatch (R-UT) as a co-sponsor. Notably missing from the list of co-sponsors is Senator Arlen Specter (R-PA), Ranking Republican on the Judiciary Committee.

Provisions relating to inequitable conduct have been removed from the previous version introduced last year. Inequitable conduct is a critical provision for the larger pharmaceutical companies. Provisions relating to apportionment of damages are of secondary importance to large pharma, but critical to biotech. The biotech industry does not favor the current damages language. The fact that inequitable conduct provisions are missing means that large pharma will focus its opposition to the patent reform bill on damages provisions.

The text of the Senate bill is not up on Thomas yet, but you can find the full text as introduced here (pdf).  See also Dennis’ Patently-O post with summary and commentary.

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GTC Biotherapeutics goes for a Regulatory Double Combo Shot

GTC Biotherapeutics, which recently saw ATryn approved, announced a collaboration agreement with AgResearch Limited, a New Zealand Crown Research Institute. 

AgResearch will develop genetically modified animals capable of producing the building blocks for “biosimilar” versions of existing products that will begin coming off U.S. patent in 2014.

The double combo shot:  the success of the collaboration depends on

  1. a continuing trend of GE animal approvals, as well as
  2. the successful introduction of a biosimilars pathway in the U.S., (which is called for in Obama’s budget).

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Warfarin and Personalized Medicine

dna_sequenceThe optimal dose of Warfarin for an individual can vary across a 10-fold range, and depends in part on genetic variation in two genes, CYP2C9 and VKORC1.  In 2007, the FDA required a labelling change to warn of patients with increased risk of bleeding due to these variations.  However, population-wide assessments of outcomes based on genetic testing were not definitive.

A paper in the current issue of the New England Journal of Medicine uses retrospective data to build a new dosing algorithm and predicts significant benefit from the use of the algorithm for the 46% of patients who require lower- or higher-than-normal doses.  The algorithm and data used to derive it will be made available via PharmGKB, a database managed by researchers at Stanford, and the research has prompted a full-scale prospective study of the personalized approach.

Frank M. Torti, M.D., acting commissioner of Food and Drugs said that the prospective study

is precisely what is needed to advance the promise of personalized medicine, ensuring that patients receive the safest and most effective drug dose.

Read our other posts on personalized medicine.
 

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Teva Decides Not to Wait for U.S. Biosimilars Legislation

In Beni’s post earlier this week on Biosimilars, he identified two major challenges to introducing follow-on biologics into the North American market: technical proficiency, and the absence of a regulatory regime.

Based on the approval of Teva’s biosimilar version of Neupogen in the EU last September, Teva has evidently cleared the first hurdle (and their joint venture with Lonza means their technical capabilities will only increase).

Yesterday, Teva announced that they were not waiting for a Biosimilars regime to be enacted before entering the U.S. market, and instead will take on the extra cost of filing a full BLA for their version of the biologic.

Does this mean we don’t need a biosimilars regime to get biosimilars to market?  Teva itself takes a different position.

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Trends in 2009: Facing the Challenges of Introducing Biosimilars or Follow-on Biologics in the North American Market

The so-called biotechnology drugs or biologics (large, complex protein molecules derived from living cells, usually by use of recombinant DNA technology) are among the fastest-growing class of pharmaceuticals. Within the next two years, some market forecasts predict that biopharmaceuticals will amount to more than 50% of newly approved medicines. In addition to a growing market share, a substantial number of major biotechnology-based drugs will come off patent and enable the development of new biologics. The race by pharmaceutical companies to get into biologics, or further support their existing biologics capacities in order to start developing biosimilars or follow-on biologics (FOBs), is illustrated by the rapid pace of recent deals in this sector. The latest of these deals is the acquisition of Insmed by Merck, which was announced last Thursday; however I believe this deal was more about expanding state-of-the-art manufacturing facilities rather than acquiring extremely valuable FOBs.

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Comparative Effectiveness Stimulus Stimulates Reactions

The $1.1 billion in the stimulus bill for comparative effectiveness research has, not surprisingly, generated a good deal of public attention.  Friday’s Washington Post and the front page of today’s New York Times both have stories covering the political jockeying.

Although both pieces focus on potential problems from the lack of individualization, either from libertarian or advocacy perspectives, neither has picked up our strain that personalized medicine, also favored by the Obama administration, will change the shape of the entire comparative effectiveness debate.
More on a recent example after the jump…

More Info on Canadian Electronic Medical Records Implementation

In our Trends in 2009 series, we noted that Electronic Medical Records are poised to make significant inroads this year in Canada and the U.S. Yesterday, Leona Aglukkaq, Canada’s Minister of Health, confirmed that:

Funding of $500 million announced today is in addition to $400 million in support provided to Canada Health Infoway in Budget 2007. This brings the Government of Canada’s total commitment to this initiative to $2.1 billion.

Canada Health Infoway in turn announced today the availability of a new certification service that will enable

Health information technology vendors entering
the Canadian consumer health solution market [to] apply for
pre-implementation certification for their consumer health platforms.

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Trends in 2009: Genetically Engineered Animal Approvals

The past few weeks have seen at least three conspicuous developments towards a functional regulatory regime that will lead to increasing numbers of FDA approvals for Genetically Engineered (GE) animals:

  1. The FDA released their final Guidance on Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (pdf), as well as a FAQ and comment responses.
  2. The FDA approved ATryn, a drug produced in the milk of GE goats.  Consistent with the Guidance, CBER approved the human biologic based on its safety and efficacy, and CVM approved the rDNA construct in the goats that produce ATryn.  In keeping with the comment responses, the FDA took steps to increase the transparency of the process by holding a public hearing prior to approval.
  3. Yesterday, a report surfaced (so to speak) about the FDA’s visit to Aqua Bounty Farms, in Prince Edward Island, Canada for an inspection in connection with Aqua Bounty’s application for approval of GE salmon, and the FDA spokesperson reached by CBC said approval could come “soon.”

All in all, it looks like the FDA is not wasting any time trying out its shiny new guidance.  Other Canadian products noted in the FAQ are “pigs with smaller environmental footprints, as well as GE animals intended to produce human pharmaceuticals.”

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Electronic Medical Records and Public Health

Here’s one electronic records initiative that looks good as cost-savings and doesn’t seem too controversial from a privacy perspective:

…as the province moves toward electronic health records, Dr. Barbara Yaffe,  Toronto’s associate medical officer of health, said she wants children’s immunization charts to be included.

…By law children in Ontario must be vaccinated against measles, mumps, rubella, diphtheria, tetanus and polio.

But in 2008 the city witnessed the largest outbreak of measles since the mid-1990s, as well as cases of mumps…

“[W]e would always be up-to-date on what every child has. We wouldn’t have to go through all this inefficient process of sending letters and bugging parents and even suspending some children, if we had that information.”

As a parent who is a recipient of those (many, many!) letters, I’m 100% in favour.

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Trends in 2009: Electronic Medical Records

EMR got a boost in Canada’s budget, and is getting traction in the U.S. as well.  In Canada, EMR initiatives are likely to be implemented by the Provincial health plans directly, with back-end services from a variety of vendors.  In the U.S., the ultimate structure is less clear.  Google has tried to get ahead of the trend (as has Microsoft), and the WSJ Health Blog had an interesting post last week:

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Personalized Medicine: Local to Global

Two local developments in personalized medicine in Canada, one at the forefront of global efforts, one making recommendations on how to play catch-up:

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Trends, Trends Everywhere: Random Gloating II

Trends in 2009: Personalized Medicine … Just Down the Street

Trends in 2009: You’ve Got a Friend In…

story yesterday reminded me about a movement I think we’ll start seeing a lot more of — funding to commercial entities by disease advocacy foundations.  This will be fueled in 2009 by two factors:

  • a self-perpetuating availability heuristic that will encourage foundations to seek commercialization opportunities; and
  • an economic environment that will have companies looking harder than ever for non-dilutive financing.

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Trends in 2009: Random Gloating

Remember way back Monday when we identified Comparative Effectiveness as a trend to watch in 2009? Well, here it is, showing up as part of the bailout bill. More on the bailout bill’s Bio provisions to come. AAAS is running continually updated coverage of the bill and its R&D provisions here.

Trends in 2009: Comparative Effectiveness and Personalized Medicine

Two potentially conflicting trends may see a dramatically increased profile in 2009: Government Bailouts and Free-Market Capitalism Comparative Effectiveness and Personalized Medicine. Both have been highlighted by the incoming Obama administration.  Details and analysis after the jump…

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