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FEATURES

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All Canadians Deserve Care

Canadian Biotechnology Leaders Championing Treatments For Rare Diseases

Rare Disease Day - February 29, 2012

Building a sustainable future for Canada’s bio-economy includes ensuring the collective health of all Canadians while supporting made in Canada solutions for novel therapies. As a recognized global leader in biotechnology, Canada must enable access for all to safe and effective treatments.

Canada is the only developed country in the world without a federal healthcare policy for persons with rare disorders. The United States created a policy 27 years ago. It is time to even the imbalance, with one in 12 Canadians suffering from rare diseases, Canada is being urged to create a policy encouraging research, and providing funding for existing therapies. This policy could be incorporated into the updated Food and Drugs Act to include an internationally recognized definition of orphan diseases and specific market incentives for companies in this space.

Montreal’s Enobia Pharma is one such company, which recently announced an agreement to collaborate with Alexion Pharmaceuticals on the development of therapies to treat patients with ultra-rare and life-threatening genetic metabolic disorders. Enobia’s lead product candidate is an enzyme-replacement therapy for patients suffering with hypophosphatasia, for which there are no approved treatment options.

“Enobia and our scientific collaborators have developed an elegant compound showing very promising clinical results to date,” said Dr. Robert Heft, President and Chief Executive Officer of Enobia.

BIOTECanada has been working in partnership with the Canadian Organization for Rare Disorders to establish a coalition of patients, industry, and researchers, in order to execute a multi-faceted advocacy campaign supporting the creation of an orphan drug policy.

BIOTECanada proposes the policy establishing a definition for rare disorders; granting orphan product designations; creating market incentives – expedited review of marketing application, clinical protocol assistance, regulatory fee waivers, market exclusivity/data protection, and development grants; and, establishing a Canadian office of Orphan Products.

Diane Bigras, Genzyme is organizing an upcoming meeting for those interested in the development of Orphan Product Policy. Please contact Cate McCready for more information.     

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BIOTECanada 25-year celebration kicks off with new members

Continuing our yearlong celebration of Canadian leadership and innovation, we are proud to welcome new members who are harnessing the excitement, which abounds from the industry. These four new members, spanning the country represent the determination of excellent science. We are looking forward to these new members being involved in our events and committee work.

DiagnoCure (TSX: CUR) is a life sciences company that develops and commercializes high‐value cancer diagnostic tests that increase clinician and patient confidence in making critical treatment decisions. In 2008, the Company launched the PrevistageTM GCC Colorectal Cancer Staging Test through its U.S. CLIA laboratory, and granted the worldwide exclusive rights to this test to Signal Genetics in June 2011. The Company also has a strategic alliance with Gen‐Probe (NASDAQ: GPRO) for the development and commercialization of a second‐generation prostate cancer test using PCA3, DiagnoCure’s proprietary molecular biomarker. The PROGENSA® PCA3 test is commercialized in Europe under CE mark and was recently approved in Canada; in the United States, the test is commercialized through clinical laboratories using PCA3 analyte specific reagents from Gen‐Probe; a PMA application was filed with the FDA. For more information, visit www.diagnocure.com.

Essa Pharmaceuticals Inc. located in Vancouver, British Columbia is focused on the development of small molecule drugs for the treatment of prostate cancer. Essa operates virtually with preclinical studies done in the laboratories of the company’s scientific founders and by contract research organizations. For more information visit www.essapharmaceuticals.com.

MoenGlobal Advisors Inc. based in Ottawa specializes in business development, government affairs and market access. They provide strategic advice on opportunities for corporate partnering and on challenges arising from regulatory, market access and political risks. Practice areas include biotechnology and life sciences, clean technology, natural resources, international trade, and emerging markets. For more information visit www.moenglobal.com

Parvus Therapeutics Inc. in Calgary is developing and commercializing a nanotechnology-based therapeutic platform for the treatment of autoimmunity. For more information visit www.parvustherapeutics.com

SignalChem in Richmond British Columbia has established itself as a leader in the development of innovative cell signaling products to meet the needs of scientist in basic research and drug discovery. The company has utilized its core capabilities of cellular signaling, molecular biology and protein biochemistry to generate more than 500 products as part of its current and continuously expanding product portfolio. For more information visit www.signalchem.com

ViroPharma is improving the lives of patients and delivering medicines which address serious unmet medical needs. ViroPharma is dedicated to developing and marketing products that help address dangerous, potentially life-threatening conditions including diseases such as hereditary angioedema (HAE) that are caused by C1 esterase inhibitor deficiency, and C. difficile. ViroPharma is focusing efforts on providing these medicines to physicians that treat and/or prevent serious diseases, and will expand on those franchises by capitalizing on business development. For more information visit www.viropharma.com

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POLICY & COMMITTEE WATCH - Building the Bio-economy

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SEB Leadership

The SEB Task Force continues to educate and raise awareness to patients, their families, doctors, nurses and pharmacists. Having recently held a successful gathering in Toronto with the nephrologist community the committee is now turning attention towards an SEB Summit, tentatively scheduled for May 2012. This summit will provide a forum for dialogue between Health Canada, Health Technology Assessment agencies, payers and experts on SEBs. By convening a panel of scientists, clinicians, regulatory, and payer experts to focus on issues to be considered in the evaluation of SEBs. This opportunity will allow the task force to reinforce the strengths of the Health Canada draft guidance from March 2011, ensuring safe and effective biologic drugs for Canadians. For further information contact Cate McCready.

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Personalized Medicine Conference

On behalf of Members, BIOTECanada was invited to attend a multi-stakeholder workshop on Personalized Medicine in Canada January 12-13, 2012 hosted by Health Canada and the Canadian Institutes of Health Research in Ottawa. The Workshop defined Personalized Medicine as the tailoring of preventative, diagnostic or therapeutic interventions to the characteristics of an individual or population. Attendance was well represented by government, university and hospital professionals.

The organizers stated the purpose was to initiate a Canadian dialogue on personalized medicine issues, to begin building a broad understanding of the challenges, identify stakeholder interests and explore possible synergies and cooperation for a Canadian approach. A report should be available in the near future that BIOTECanada will make available. For more information please contact Ron Boch

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Vaccine Industry Committee members present at Canadian Association for Immunization Research and Evaluation Workshop

The Canadian Association for Immunization Research and Evaluation (CAIRE) Workshop on Enhancing Partnerships in Vaccine-based Disease Prevention was held on January 18, 2012. 

Log into the Members' Only Section of our website to read more.

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Registration Update: 2012 CADTH Symposium

The early-bird registration period for the 2012 CADTH Symposium is now open and runs until February 12. CADTH has recently implemented new registration rules for industry representatives. Each company will be limited to two (2) individual registrations during the early-bird period and subsequently, registration will be open on a first-come, first-serve basis until the attendance limit is reached.

Historically, the CADTH Symposium draws 500-550 participants and this year, it will be held in Ottawa, Ontario. If you are interested in attending the Symposium, click here and complete the 'Request to Attend' form. If you have any questions about CADTH’s new registration rules for the 2012 Symposium, please contact Hani Ammache.

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PUBLIC AFFAIRS

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Federal Government Budget Watch 2012

Prime Minister signals major transformations coming for Canadian research

Ever since the Research and Development Expert Panel Report presented by Tom Jenkins and colleagues in late 2011, the Prime Minister Stephen Harper and Gary Goodyear, Minister of State for Science and Technology have been keen to implement the recommendations from the Report. The Report outlined the need for a simpler more streamlined program, aimed at lessening the level of abuse from perceived applicants or their agents. The panel suggested limiting the criteria to labour related costs while raising limits to help address any value gaps. The SR&ED tax credit program costs the federal government 3.5 billion annually, with another 1.5 billion from provincial programs. The program is accessed by almost 25,000 companies.

Recently, when speaking at the World Economic Forum in Davos, Switzerland Prime Minister Harper again signalled his plans to change the existing SR&ED Tax Credit program. Harper: "We will continue to make the investments in science and technology necessary to sustain a modern competitive economy. But we believe that Canada's less than optimal results for those investments is a significant problem for our country. We have recently received a report on this, the Jenkins report, and we will soon act on the problems the report identifies." The government has repeatedly said there's plenty of government money for research and innovation in Canada, they would like to see the private sector contributing more.

In subsequent meetings with senior government officials and members of the Research and Development Review Panel, BIOTECanada has been told the federal government wants to end misuse of the tax credit system and look towards re-investing the savings into more direct forms of support to research-intensive companies.

BIOTECanada will continues to present the point of view of our industry to federal officials wherever possible.  For member companies who are concerned about the impact of the changes we encourage you to contact your Member of Parliament.  Who is your member of Parliament--find out here:  www.parl.gc.ca

Recent media coverage on this issue includes the following:

CBC story

Globe & Mail article

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MEMBER OPPORTUNITIES

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Investor Networking in Whistler Kicks off BioPartnering North America

Heading into the BioPartnering North America conference held at the Vancouver Convention Centre at the end of this month, BIOTECanada will be holding our annual CEO Summit networking reception at the home of Paul Hastings in Whistler.  This annual event brings together our emerging biotech company CEOs, representatives from our multi-national member companies, and investors from the US and Canada.

Attendees to this year’s event include CTI Life Sciences Fund, Frazier Healthcare Ventures, InterWest Partners, Kearny Venture Partners, MedImmune Ventures, MPM Capital, Sofinnova Ventures, TPG Capital, Bayer Healthcare LLC, Genentech, NovoNordisk, Merck Research Laboratories, Lumira Capital , BDC Venture Capital, BC Renaissance, GrowthWorks, and Biogen Idec. Thank you to our Premier Leaders BiogenIdec, Gowlings, Sanofi Pasteur, and VWR for their support of this networking event. 

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Mark your calendars. BIO International Convention Session

Monday June 18, 2012 in Boston

Smart & Biggar have led an initiative and secured a session at the BIO International Convention in Boston coming up in June. This session will discuss the cross-border Intellectual Property challenges, issues and model developed by Canada and California (two well-established trade partners), using Cancer Stem Cell research as an example of such strategic collaborative initiative.

Knowing Canada considers innovation as a key economic driver, it is strategically important to commercialize publicly funded research in order to generate both economic and social benefits. In today’s globally competitive and open innovation environment, there is a need to connect government, academia / research and industry (private sector partners and investors) more closely. This will increase the probability of successfully commercializing such cross-border collaborative research.

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Is your Canadian Life Sciences public profile up to date?

Networking and connecting is a critical element for business development. How can interested parties locate your information? The Canadian Life Sciences database is the place to search for Canadian companies working within the biotechnology industry. To ensure we provide a comprehensive overview and up to date company directory we would encourage you to review your Company’s current profile. Whether listing your own company, updating contact information, or recommending a company which should be considered for inclusion you will find all you need at www.canadianlifesciences.com

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Bringing Clean Technologies to Market 

SDTC is accepting Statements of Interest from February 22nd to April 18th, 2012
 
SDTC invests in late-stage development and pre-commercial demonstration of clean technologies by Canadian companies in a range of innovative solutions across all industries that address Climate Change, Clean Air, Water and Soil
 
CONNECT with SDTC Applications
Applications@sdtc.ca
www.sdtc.ca/applications

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MEMBER RECOGNITION

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Leadership Change at Pfizer 

We congratulate John Helou, Pfizer and Member of the BIOTECanada Board of Directors who was recently appointed to the position of Country Lead for the Canadian business. John takes on this responsibility in addition to his current role of General Manager, Specialty Care - Canada and Puerto Rico, Pfizer. John’s demonstrated leadership abilities as a General Manager in Specialty Care as well as his previous experience successfully leading Pfizer Canada’s Public Affairs & Stakeholder Relations Division make him a clear choice for this expanded role.