The Cross-Border Biotech Blog

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

Tag Archives: Health Canada

Monday Biotech Deal Review: May 16, 2011

Welcome to your Monday Biotech Deal Review for May 16, 2011. Angiotech has completed its second amended and restated plan of compromise or arrangement, cleaning up USD$250M in debt in respect of 7.75% senior subordinated notes, which are now cancelled, and has also resulted in the restructuring of $325M of existing floating rate notes through an exchange transaction.  There was also interesting licensing activity, notably involving Paladin Labs.  Lastly, Arch Biopartners announced their development achievement of a “bio-steel” material that is approximately 40% harder and 50% less corrosive than regular stainless steel.  Read on to learn more.   Read more of this post

Monday Biotech Deal Review: January 31, 2011

Welcome to your Monday Biotech Deal Review for January 31, 2011.  Angiotech has voluntarily entered into CCAA proceedings and will continue its restructuring efforts there.  There was also some investment activity involving government agencies in Ontario, Quebec and Prince Edward Island.  Read on to learn more, as well as the usual assortment of biotech news reviews from the past week.  Read more of this post

Monday Biotech Deal Review: January 24, 2010

Welcome to your Monday Biotech Deal Review for January 24, 2010.  Despite a slow financing week, there were a few operational announcements as well as awards granted to Canadian biotech companies by the NIH and the UK’s Medical Research Council.  Read on to learn more.  Read more of this post

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.

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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Health Canada’s Statistics on Patent Listings and Generics Litigation

In Canada, Under the PM(NOC) Regulations, the Minister of Health maintains a Patent Register (the analog to the U.S. Orange Book).  Health Canada collects statistics on patent listings and litigation, and Ogilvy Renault’s Life Sciences team recently put out a bulletin summarizing some of the data.  A few highlights:

  • Out of 248 applicable generic drug submissions, the generic manufacturer obtained the consent of the patent owner to market its product in Canada prior to patent expiry in only 1% of cases; and in 47% of cases the generic manufacturer intended to challenge the listed patent(s).
  • In litigated cases, generic manufacturers were successful in 67% of all decided cases, and the brand manufacturer / patent owner was successful in the remaining 33% of cases.
  • 495 different medicines are currently listed on the Patent Register.  49% of these products have one patent listed on the Register (by DIN).  23% have two patents on the Register.  43% of products have three or more patents on the Register.  One product has 22 patents listed on the Register.

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Health Canada Calibrates Caffeine Consumption — Energy Drinks May Get New Labels

Two recent bulletins from Health Canada‘s caffeine directorate provide updates for the sleep-impaired. 

The first update reminds us of recommended limits: 400mg/day for healthy adults.  Health Canada describes this as “about three 8oz cups of coffee.” Pay attention though, because a “medium” at Tim’s is 10oz (14oz in the U.S.) and only the rarely ordered “short” at Starbucks fits the 8oz bill (Starbucks’ “tall” is 14oz). 

They also suggest limits for pregnant women (300mg) and for children (45-85mg based on age from 4(!)-12).  Yes, there is a recommended maximum caffeine intake for 4-year-olds, and it isn’t “zero”.  Actually, noting that symptoms of too much caffeine include “insomnia, headaches, irritability, dehydration and nervousness,” it’s possible more 4-year-olds than you might expect are drinking coffee, since most of them I meet have at least three of those symptoms.

Health Canada is also “developing a new labelling standard for all energy drinks sold in Canada,” presumably so as not to accidentally over-caffeinate so many 4-year-olds.

On the other hand, if you are a sleep-deprived and responsible adult, Health Canada would like to offer you some new options.  As they put it:  “Health Canada has authorized broader use of caffeine as a food additive from cola-type beverages to all carbonated soft drinks,” which is already the case in the U.S. and the EU. However, to help you keep your intake moderate, they are also “urging manufacturers to voluntarily identify on product labels the total caffeine contained in a product.” … because with that information in hand, everyone will gravitate to the drinks that disclose low amounts of caffeine. Right? Don’t blow your 400mg all at once, people.

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Image from Wikimedia Commons from user Can’t sleep, clown will eat me, under the Creative Commons Attribution ShareAlike 3.0 License.

Subsequent Entry Biologics (aka Biosimilars) get Final Health Canada Guidance, 6 Years of Data Exclusivity

Health Canada released the finalized version of its Guidance Document for “Subsequent Entry Biologics” (SEBs).  The final version is mostly the same as the draft guidance released last March, and actually comes after the approval of Canada’s first SEB last April.

SEBs are a class of drugs that the EU calls “biosimilars” and the U.S. calls “a class of biologics we may recognize one day if health reform passes”“follow-on biologics,” but the gist is that they are copycat versions of existing large-molecule drugs.  Because of their complexity, different versions of the same biologic cannot be characterized as identical.  Hence “similar”.

Regulators are seeking a balance with respect to how much biosimilars can rely on data from the original (“reference”) drug in applying for their own approval, and with respect to how long to protect the reference drug’s data.  Here are some highlights of Health Canada’s approach:

  • A full New Drug Submission required for SEBs, (not an abbreviated submission, as for small-moelcule generics).
  • The data exclusivity period — the time that must elapse before an SEB can use the data from the reference biologic’s application — is 6 years.
  • Studies comparing the reference biologic to the SEB must be conducted in a side-by-side format.

For more information, check out the Ogilvy Renault Pharma in Brief publication, or read the whole Guidance Document.

The Long Arm of Canada’s Patented Medicine Prices Review Board (PMPRB)

In Canada, the Patented Medicine Prices Review Board (PMPRB)’s mandate is to (1) “ensure that prices charged by patentees for patented medicines sold in Canada are not excessive,” and (2) “report on pharmaceutical trends of all medicines, and on the R&D spending by pharmaceutical patentees. ” It has jurisdiction over any patented medicine “sold in any market in Canada.”

In a recent case, Canada (Attorney General) v. Celgene Corporation (A-177-09), the Federal Court of Appeal restored the PMPRB’s order that  a patented medicine sold by a U.S. company and shipped F.O.B. the U.S.A. to physicians in Canada was nevertheless “sold in any market in Canada” and subject to the jurisdiction of the Board, despite shipment, invoicing and payment all occuring directly to the U.S. in U.S. currency.  In this case, Celgene was shipping THALOMID to Canadians under Health Canada’s Special Access Programme (“SAP”).

This decision means that SAP drugs will be subject to the PMPRB’s jurisdiction whether they’re manufactured in Canada or not.

For the full story, check out the Ogilvy Renault bulletin on the case.

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I-131! Getchyer Rrrred Hot I-131 Here! Health Canada Approves Alternate Source for Thryoid Cancer Treatment

683px-Schematicky_atomDraximage has been approved by Health Canada to supply I-131 from South Africa’s Safari reactor to treat Canadian thyroid cancer patients. As the Health Canada press release points out, “[p]roduction of I-131 in Canada was interrupted by the unplanned shutdown of the Chalk River National Research Universal reactor (NRU) in May 2009.” Draximage is a division of DRAXIS Specialty Pharmaceuticals, which was bought by Jubliant Organosys in May 2008.

Update: Good thing too, because the Chalk River reactor may be out of commission through the Fall or even into 2010.

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Swine Flu, Snake Oil

antigenicshift_hirescrop1A warning from Health Canada about various products you should not buy or take that claim to “to fight or prevent H1N1 flu virus.”  Basically, there is no such thing as generic Tamiflu or Relenza approved in Canada.  Don’t get swine-dled.

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Canada’s First Subsequent Entry Biologic!

Guest post from Jill Daley, part of our all-star life sciences team at Ogilvy:

Today, Sandoz Canada announced that Health Canada has granted it a market authorization for Omnitrope™.

This announcement marks the approval of the first subsequent entry biologic (SEB, also known as a “follow-on biologic” (FOB) in the U.S. or a “biosimilar” in the EU) of a previously approved recombinant biotechnology drug by Health Canada.

Omnitrope™ has received similar treatment in the United States and in Europe where it has been approved as a “follow-on protein” and a “biosimilar”  respectively.

Interestingly, today’s announcement came less than one month following Health Canada’s issuance of the Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics.  The Ogilvy Renault bulletin analyzing the draft guidance is here.

The draft guidance is open to consultation until May 26, 2009. Interested stakeholders are invited to submit written coments via email (BGTD_PPD_DPP@HC-SC.GC.CA), mail or fax (613-952-5364).

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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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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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Wednesday Brain Dump: March 11, 2009

Regulatory Brain Dump…

Regulating Nanotech:  The FDA is collaborating with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to expand knowledge of how nanoparticles behave and affect biologic systems.  Results will be placed in the public domain.

Regulating Natural Health Products: Health Canada launched the first phase of Online Solution, a secure online system for regulating natural health products in Canada.

Not Waiting for Regulation: Like Teva’s decision in February, Momenta Pharmaceuticals doesn’t think it needs to wait for a follow-on biologics pathway.  It’s proceeding with its application (presumably still a BLA) for a generic version of Lovenox, and unlike Teva, Momenta doesn’t think the FDA will require human trials for its product.

Commissioning Regulation:  A number of reports, including the In Vivo Blog and the WSJ Health Blog have been pointing to the nomination of Margaret Hamburg as FDA Commissioner, with Joshua Sharfstein as deputy.

Self-Regulation:

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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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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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