Biotechnology Focus May 2011 by Promotive Communications

MAY 2011

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

VOLUME 14, NUMBER 5

Biosimilars When is the same not the same?

INSIDE:

Publication Mail Registration Number: 40052410

LEVERAGING THE $7 MILLION FUND DESIGNATED FOR ONTARIO BIOSCIENCE COMPANIES ANNOUNCED IN MAY 2010

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contents 15

MAY 2011 – VOLUME 14 – NUMBER 5

FEATURES BIOSIMILARS

he most common manufacturing process can be summarized in 7 carefully controlled stages: host cell development, master cell bank establishment, protein productions, purification, analysis, formulation and storage and handling. Subsequent Entry Biologics: How are they different from generics? In recent times, the term biologic has been used to define a new class of protein-based therapeutics that are produced using living organisms, including plants, animals and microorganism such as yeast and bacteria. Compared to conventional small molecule drugs such as Asprin, biologics are a newer class of protein-based pharmaceuticals that are significantly larger, inherently more complex, heterogeneous and thus much more difficult to characterize. It comes as no surprise then that the manufacturing of these glycoprotein molecules such as monoclonal antibodies (mAbs) is intricate in nature. The most common manufacturing process can be summarized in 7 carefully controlled stages: host cell development, master cell bank establishment, protein productions, purification, analysis, formulation and storage and handling.1 It has been demonstrated that even slight alterations in any stage can lead to significant changes in protein structure and lead to clinically relevant implications for safety, immunogenicity and potency.2-3 Governmental regulatory bodies agree that the current approval process of generic versions of small molecular drugs are not suitable for SEB approval and have taken steps to develop a separate pathway for SEBs to safeguard patent safety. To aid in decision-making regarding SEB submissions, on March 5th 2010 Health Canada published its finalized guidance document titled “Information and Submissions Requirements for Subsequent Entry Biologics and related documents”. 4 The first SEB (Omnitrope ®) was approved in Canada on April 22, 2009.

Regulatory approval: Ongoing developments and controversies Generic drugs receive marketing approval under the abbreviated new drug submission (ANDS) pathway. Through this pathway the generic manufacture need only dem-

onstrate pharmaceutical equivalence and bioequivalence between the generic and innovator products 5. Since generic drugs are considered therapeutically equivalent to the reference product they are often substituted for economic reasons. This differs with SEB’s. Health Canada emphasizes that SEBs are not generic biologics, and the authorization of a SEB is not a declaration of pharmaceutical or therapeutic equivalence to the reference biologic drug. 4 To this end, the SEB manufacture needs to invest in additional clinical trials as a part of the submission. According to the recently published guidance document, the SEB manufacturer is required to provide a reduced nonclinical and clinical package including comparability data (analytical comparison with reference product) and stringent post-marketing pharmacovigilance plans demonstrating similar safety and efficacy in larger populations4. On a global scale, Health Canada and the Food and Drug Administration (FDA) are moving in the right direction with ongoing developments that will provide more certainty in the legal and regulatory framework for SEBs. The European Medicines Agency (EMEA) a leader in biosimilar regulation. In 2005, the EMEA released its first guidelines on similar biological medicinal products 7 (in Europe referred to as biosimilars) and since then the agency has granted marketing approval for more than 12 different biosimilars competing with 4 innovator biologics: somatropin (Genotropin, Humatrope), epoetin (Eprex) and filgrastim (Neupogen) 6.

unique system, informally called the NOC Regulations, requires biosimilar companies to establish patent freedom-to-operate as a precondition to issuance of the NOC. This is in sharp contrast to conventional patent enforcement that begins only after issuance of an NOC. Under the NOC Regulations, the pioneering company that first develops a biologic drug has the opportunity to list its relevant patents on the Health Canada Patent Register. The patents may cover the biologic compound, formulations, dosage forms or uses. There are strict time limits for listing patents and the patents must be directly pertinent to the approved Canadian product. If a biosimilar company files a drug submission that references the pioneer’s data, the biosimilar company must also address freedom to operate with respect to patents on the Health Canada Patent Register. The biosimilar company must ultimately justify that all the patents are invalid, non-infringed or expired. If this is not done, then the biosimilar will not receive an NOC until the patents expire.

Biologic Patents A biologic that meets Health Canada’s safety and efficacy standards is eligible to receive a marketing authorization called an NOC. Canada created specialized rules to proactively prevent patent infringement during the Health Canada approval process. This

BY NOEL COURAGE AND EVA FURCZON

ACROSS CANADA

References:

Designated for Ontario Bioscience Companies Announced in May 2010

During the fall of 2009, with Ontario’s bioscience industry fighting for survival due to an inability to raise capital in the midst of a world-wide economic crisis, OBIO mobilized industry CEOs to take action. With a sense of urgency derived from the need for a plan to ensure the survival of the industry, OBIO organized its first provincewide consultation process ultimately generating a set of recommendations for industry survival and growth.1,2 These recommendations were provided to the Ontario provincial government and detailed changes to existing provincial capital and tax programs which when implemented would have a positive impact on biotech companies. The ensuing engagement and dialogue between industry and government on the nature of the challenges facing the industry as a whole resulted in the formation of a special fund – a one-time allocation of $7 million in special financing to Ontario bioscience companies announced as part of the Ministry of Research and Innovation (MRI) commercialization strategy in May 2010. For an industry where many companies are operating with less than a year’s cash – Ontario’s bioscience industry saw the $7 million fund as an important step particularly during a period of provincial fiscal restraint. Working collectively industry achieved recognition by government that existing programs are often inaccessible to bioscience companies whose capital requirements and long development time lines put them at a disadvantage when multi-industry programs force them to compete with less complex business models such as IT or clean-tech. OBIO’s Access to Capital Committee developed recommended guidelines for investment framework, eligibility criteria and timelines which were vetted by industry and presented by OBIO at an industry

1. Industry Generated Recommendations for Sustainability and Growth of Ontario’s Bioscience Industry in 2010 and Beyond (www.obio.ca) 2. Industry Generated Recommendations for Sustainability and Growth of Ontario’s Bioscience Industry in 2011 and Beyond (www.obio.ca)

The relationship between programs as proposed by OBIO

be considered ‘listed privates’. Denied access to this fund, public companies will have to wait for the markets to improve or for government programs which establish other thresholds such as whether a company is pre-revenue or cash flow positive. Almost a year post-announcement, an effective delivery program is in place and roughly half the fund has been committed. Intended as ‘one-time’, the $7 million fund uniquely addresses needs articulated by industry. Successful recipient companies will advance development programs closer to commercialization and enhance their ability

Ontario Bioscience Industry Organization: OBIO works on behalf of both public and private bioscience companies developing and commercializing therapies, diagnostics and devices. OBIO’s mandate is to encourage growth of the sector through advocacy and policy and program proposals. OBIO works to improve the operating climate so companies can access capital, create jobs and contribute to Ontario’s economic growth.

BY CHRIS GILLES

24 Reply Card #4891

R & D NEWS

The Canadian Renewable Fuels Association (CRFA) is applauding a new roadmap from the International Energy Agency (IEA) that reaffirms the critical role of biofuels in the future of global energy supplies. Biofuels, according to the roadmap, can account for over 25 per cent of transportation fuels by 2050 and “can play an important role in reducing CO2 emissions in the transport sector, and enhancing energy security.” “The CRFA agrees that stable long-term policies for biofuels are critical to increase investor confidence,” said Gordon Quaiattini, president of the CRFA. “We also agree that sustained funding and support mechanisms are required to enable promising advanced biofuel technologies to reach commercial production.” The IEA prepared its report titled: “Technology Roadmap: Biofuels for Transport,”

in consultation with representatives of government, industry, academia and nongovernmental organizations. The IEA stated in the report that “global biofuel consumption can increase in a sustainable way - one in which production of biofuels brings significant life cycle environmental benefits and does not compromise food security, from 55 million tonnes of oil equivalent (Mtoe) today to 750 Mtoe in 2050; this would mean that the global share of biofuel in total transport fuel would grow from two per cent today to 27 per cent in 2050.” “The IEA’s biofuels roadmap is sustainable and achievable. It reaffirms the tangible benefits of biofuels to our economy, our environment, and our energy supply,” added Quaiattini. “Canada as an energy superpower, with a national renewable fuels

Restructuring could render existing Angiotech shares worthless Angiotech Pharmaceuticals, Inc. has applied to the securities regulatory authorities in Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, Prince Edward Island, Saskatchewan and Québec for a decision that it be deemed to have ceased to be a reporting issuer in such jurisdictions. As a reporting issuer under applicable Canadian securities laws, the company is subject to Canadian filing and disclosure requirements in addition to those applicable under the laws of the U.S. If the decision is made, the company will no longer be a reporting issuer in any jurisdiction in Canada. Additionally, long-time Angiotech Phar-

mandate, is ideally positioned to be part of this biofuel growth opportunity.”

maceuticals Inc. shareholders will be left with nothing, if the British Columbia Supreme Court upholds a creditor-approved refinancing plan. That plan would cancel about $250 million in senior subordinated notes and give affected creditors who hold those notes roughly $250 million in a new kind of Angiotech share. Alternatively, each creditor could opt to receive up to a maximum of $150,000 in cash. Court sanctioning of the plan would render existing Angiotech shares worthless. The upshot of the proposal is that most Angiotech employees would be able to keep their jobs, although the company’s

Cangene Corporation announces that it is making organizational changes in its Canadian operations to reflect decreased U.S. government contract-manufacturing activity. The company intends to align its workforce focusing on its commercial products. These factors have driven a workforce reduction, announcing the termination of 40

Canada Council awards five prominent scholars $100,000 Killam Prizes

employees. This brings the total number of positions eliminated in the current fiscal year to approximately 100, representing 12 per cent of the company’s total workforce. The company says it will concentrate resources on pipeline development through product acquisition, partnering arrangements and internal R&D. In addition, as it

Dr. Keren Rice

Dr. Lotfollah Shafai

science, genetics, Aboriginal languages, antenna research, and social psychology highlights Canadian success in global issues. The Canada Council for the Arts, which administers the Killam Program, announced the winners were professor Gilles Bras-

Prof. Mark Zanna

The European Patent Office has granted patent protection for Microbix Biosystems Inc. proprietary VIRUSMAX™ technology, which is designed to increase influenza vaccine yields. The newly granted European Patent No. EP 1636352 entitled “Improvement in Virus Production,” covers the material, process and use of the VIRUSMAX technology that is the basis for the Microbix/ Hunan joint venture which is underway

sard of Université de Montréal, Dr. Michael Hayden of University of British Columbia, Dr. Keren Rice of University of Toronto, Dr. Lotfollah Shafai of University of Manitoba, and professor Mark Zanna of University of Waterloo.

his project “Mechanisms of p53 and ATF4 induced neuronal apoptosis”; James Hammond received $251,055 (3 years) for his project “Role of Nucleoside/Nucleobase Transporters in the Regulation of the Vascular Effects of Adenosine and its Metabolites”; David Hess received $139,904 (2 years) for his project “Progenitor cell regulation of the vascular regenerative niche”; Morris Karmazyn received $167,750 (2 years) for his project “Sodium-regulatory transporter in myocardial remodelling and heart failure”; Stephen Lownie received $170,306 (2 years) for his project “Selec-

tive Brain Cooling”; Kibret Mequanint received $234,495 (3 years) for the project “Smooth muscle cell phenotype regulation in 3D fibrous biodegradable scaffolds for vascular tissue engineering”; David Spence received $161,016 (2 years) for his project “Effect of aldosterone antagonism on carotid atherosclerosis”; Hao Wang received $142,742 (2 years) for his project “Prevention of antibody-mediated rejection by soluble CD83 in presensitized cardiac allograft recipients”; and Kaiping Yang received $140,330 (2 years) for his project “Early-life Origins of Visceral Adiposity”.

Photo: James Gathany

$1.7M supports heart and stroke research Researchers at the University of Western Ontario and Lawson Health Research Institute Health have received a $1.7 million boost from the Heart and Stroke Foundation of Ontario. In total, 10 scientists from London received funding for projects aimed at reducing the risk of heart disease and stroke, and improving the quality of life for Canadians. The complete list of recipients includes: Subrata Chakrabarti received $142,960 (2 years) for the project “Vasoactive and cardioactive factors in diabetic heart disease”; Sean Cregan received $181,468 (2 years) for

board of directors will be replaced. Angiotech is under court protection from creditors stemming from the Companies’ Creditors Arrangement Act.

to build Asia’s largest influenza vaccine production facility and the third largest vaccine plant in the world. The first phase of the facility is expected to be fully operational in 2013. Crucible International Biotechnologies Corp., a majority-owned subsidiary of Microbix, is facilitating the start-up and operation of this joint venture and will advance the commercialization of its VIRUSMAX™ technology in other markets, which are protected by patents that run well beyond the next decade. The new facility in China will ultimately have the capacity to produce more than 100 million doses of seasonal influenza vaccine annually, and up to 300 million doses of a pandemic influenza vaccine in the event of an outbreak to immunize against a single strain of influenza.

The Last Word Faltering in the critical step in converting opportunities into projects far enough along the value chain for Big Pharma to take over

Protox Therapeutics Inc. has opened a new office in San Diego, CA, and expects to complete the transition of operations to the new office sometime this year. To lead this transition, Protox Chairman Dr. Lars Ekman has accepted the role of executive chairman and president of Protox, and Dr. Allison J. Hulme has joined the company as chief operating officer and head of Research & Development. Both Drs. Ekman and Hulme will be based in San Diego. In connection with this move, president and chief executive officer Fahar Merchant, Ph.D. and senior vice president, Development and Regulatory Affairs Nina Merchant have resigned their positions and have agreed to serve as consultants to the company to assist in the orderly transition of operations to San Diego. Two drug candidates derived from the company’s INxin™ and PORxin™ platforms are in clinical development. Protox’s lead program, PRX302 (PORxin), achieved positive results from its Phase 2b placebo controlled trial called TRIUMPH, to treat benign prostatic hyperplasia (BPH or enlarged prostate).

BY PETER PEKOS

MAY 2011 BIOTECHNOLOGY FOCUS 11

10 BIOTECHNOLOGY FOCUS MAY 2011

DEPARTMENTS

NEW PRODUCTS Detector The new Metrohm 887 UV/VIS detector is paired with an 881 Ion Chromatograph and Dosino® PCR delivery system for ultra-low determination of hexavalent chromium. In fact, calibration levels down to 12.5 ppt have been achieved. Key features of the 887 UV/VIS detector include a diode array with 512 diodes, and the ability to select up to 8 variable wavelengths from 190 – 900 nm. The system is capable of recording the spectrum any time during the run, and up to 10 absorption maxima of any spectrum may be obtained to optimize the wavelength for a particular application. As is customary with all instruments available through Metrohm, 887 is backed by expert application and service support.

Tubes Kimble Chase Kontes brand NMR tubes are available in 3mm, 5mm and 10mm diameters, round or flat bottomed tubes, and specialty tubes equipped with valves or threaded openings. All Kontes brand NMR tubes are constructed using KIMAX® borosilicate glass with two grades available to meet every scientist’s needs; KG-33 glass is the lowest thermal expansion glass tubing offering the highest degree of thermal shock resistance for high temperature applications; and, N-51A is low thermal expansion glass tubing to accommodate ambient temperature applications. Available NMR tube closures include pressure caps comprised of polyethylene or PTFE, and red or white rubber septa. Polyethylene pressure caps are supplied with tubes ordered with caps included.

Reply Card #4892 Transfection Kit EMD Millipore launches its new NovaCHOice™ Transfection Kit that accelerates protein production from the suspension Chinese hamster ovary (CHO) cell line. This new reagent is the first kit optimized specifically for this popular cell line, which produces active, soluble forms of recombinant proteins used in research, drug discovery, preclinical studies, or patients. Suspension CHO cells are widely used for recombinant protein production because they are easy to scale-up for cell culture and protein purification. However, suspension CHO cell transfection has been challenging because few optimized transfection reagents were available. EMD Millipore’s NovaCHOice transfection kit overcomes this challenge by enabling efficient delivery of DNA into the cells, resulting in high levels of gene expression and superior protein yields. The NovaCHOice transfection kit can also improve the large-scale production of therapeutic recombinant proteins, such as therapeutic monoclonal antibodies, of which kilogram-scale yields are required per batch.

Reply Card #4893

Reply Card #4894 Cyclone Mill The Retsch cyclone mill TWISTER is specially designed for the processing of foods and feeds for subsequent NIR analysis. The optimized form of rotor and grinding chamber generates an air jet which carries the ground sample through the integrated cyclone into the sample bottle. The air jet prevents the material from heating up, thus preserving the moisture content. The provided sieves guarantee an optimum particle size distribution so that it is not necessary to recalibrate the NIR spectrometer. The rotor speed can be adjusted in three steps allowing for perfect adaptation to the sample requirements. Cleaning the mill is quick and easy as the air jet affects a complete discharge of the material from the grinding chamber. Reply Card #4895 Moisture Analyzer Shimadzu Scientific Instruments announces the availability of the MOC63u moisture analyzer with UniBloc sensor technology for reliable

continues to complete the remaining activities under the existing U.S. government contracts, the company will evaluate any new opportunities that fall within the scope of its reduced contract-manufacturing operations. The company’s U.S. based contract-manufacturing operations, Cangene bioPharma, Inc., are unaffected by this reorganization.

Protox announces move to San Diego and senior management transition

Microbix wins European patent protection for Virusmax Dr. Michael Hayden

The 2011 Killam Prizes, Canada’s most distinguished annual awards, were revealed today for five outstanding Canadians for their career achievements in health sciences, engineering, humanities, natural sciences and social sciences. Their work in the fields of computer

BY GAIL GARLAND

Cangene reorganizes Canadian operations

Read the IEA’s Roadmap here: www.iea.org/ papers/2011/biofuels_roadmap.pdf

Across Canada Leveraging the $7 million fund designated for Ontario bioscience companies announced in May 2010

MAY 2011 BIOTECHNOLOGY FOCUS 25

BUSINESS CORNER

“Biofuels could sustainably account for 25 per cent of world transportation fuel by 2050,” says International Energy Agency

Simultaneous ESI/APCI Measurement with a Dual Ion Source For the researcher looking for ways to shorten the time required for analysis and method development

For more ACROSS CANADA information visit our COMMERCIALIZATION Web Portal at www.bioscienceworld.ca

consultation session conducted by MRI in May, 2010. Investment guidelines recommended financing of $500,000-$1,000,000 in the form of a grant which together with a matching term sheet would lead to a value creation milestone. In the fall of 2010, the Investment Accelerator Fund (IAF) announced eligibility requirements and investment criteria for the $7 million fund. The fund is managed by MaRS and delivered by the IAF as a ‘side car’ fund to the Investment Accelerator Fund (IAF). The IAF program provides seed-stage financing to start-up companies. With only one out of 32 existing IAF deals benefitting a bioscience company, the IAF program has not historically been able to meet the needs of Ontario bioscience seed-stage companies over the last three years. Establishing the $7 million fund required several months of preparation and the adoption of a different set of requirements for a program aimed at established commercial companies. Later-stage, investor-backed companies that qualify for financing receive between $500,000 and $1 million by way of convertible debenture or other equity-based instrument. Early-stage companies eligible for funding under the IAF and requiring more than the maximum of $500,000 are eligible for up to an additional $500,000 from the $7 million fund. This increased financing should provide more bioscience start-ups access to the IAF. There are approximately 23 public companies in Ontario which can be considered, ‘human health bioscience companies’. Of these, 14 have a market capitalization of less than $50 million; none of these are profitable and most have ongoing clinical trials. Despite having access to public sources of capital, these companies have the same challenges accessing capital as private companies – they can

24 BIOTECHNOLOGY FOCUS MAY 2011

Prof. Gilles Brassard

BY MICHELLE DELACROIX

By: Gail Garland, President & CEO OBIO

to attract additional investment. Replenishment of the fund is an important way to advance Ontario’s competiveness in the field of bioscience. Let’s not miss the opportunity.

Filing a Clinical Trial Application in Canada A quick primer on the do’s and don’ts of filing a clinical trial application

CONTINUED ON PAGE 22

ACROSS CANADA

LEVERAGING THE $7 MILLION FUND

Biosimilars: When is the same not the same? Subsequent entry biologics in Canada, competition vs. exclusivities

MAY 2011 BIOTECHNOLOGY FOCUS 15

laboratory testing. First introduced by Shimadzu for precision balances in 1989, UniBloc ensures stable temperature characteristics, excellent response time and stable corner-load performance during analyses. The MOC63u features a variety of measurement modes, including multiple ending and drying modes, to suit the sample characteristics. The easy-start mode allows for a fast response time during testing, and the simple keypad permits easy operation. The long-life halogen heater prepares samples efficiently for quick and accurate measurement. In addition, this compact analyzer has a built-in USB port, a large pan size and an illuminated easy-to-read display. Windows® Direct capability lets users integrate weighing results with laboratory software without a special application.

Reply Card #4896 Freezer SANYO biomedical solutions division introduces its new, larger 25.7-cubic foot Twin Guard Series -86°C Ultralow Temperature Freezer, the MDFU700VXC, featuring dual cool technology. Designed to preserve the most sensitive, high-value biological, the MDF-U700VXC serves as the ideal critical storage appliance in repositories and medical research facilities. The new freezer has more flexibility in storage space, storing up to 576 boxes (2-inch). The larger storage cabinet combines with dual refrigeration systems for maximum protection. Because of the two-in-one freezer design, no additional backup freezer or its additional footprint and energy use is necessary. The cool safe refrigeration compressors feature innovative refrigerant feedback processes to reduce compressor temperature, extending compressor life and minimizing heat output.

Research News

Business Corner

New Products

Calendar of Events

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26 BIOTECHNOLOGY FOCUS MAY 2011

www.bioscienceworld.ca

MAY 2011 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE

PUBLISHER/ EDITOR-IN-CHIEF STAFF WRITERS

Conservative majority and the future of biotech in Canada The Conservative party after five years of minority rule have won a majority in the Canadian election. So, what does it all mean for science policy in Canada, and for that matter, how will the results of this election impact the future of industries such as ours in this country? No one can really say for certain what it means, but certainly we can speculate on what might and could happen. Again to start with what we already know, the “Harper government” has always placed emphasis on applied/commercial science and this will likely continue to be the trend. Some on the industry side of biotech might ask what’s so bad about that? Well, as has been the case for the past five years, the focus on applied science will likely come at the expense of basic science researchers or those in the academic sector. Indeed, the Harper government has a bit of a bad rep with basic science researchers across the country. This stems from past funding decisions and cuts to granting agencies such as the Natural Sciences and Engineering Research Council. From a brief glance at the tabled budget, the new majority government seems intent on continuing down this road with its policy decisions. In fact, according to what has been released in budget documents, there are proposed plans to slash some $11 billion over the next four years in federal programs leading to speculation that researchers at the NRC and other government agencies shouldn’t feel too secure in their jobs. That’s the bad news. So what’s the good? As mentioned, we know this government will move forward in passing its federal budget and that means more money for such revolutionary science organizations like Genome Canada, along with increases in tri-council funding. Moreover, Canada’s R&D Review Panel will be allowed to table its report on government support for business R&D, and this should allow the first steps to be taken to act on this report’s recommendations. In a sense this might mean some progress will be made in helping an ailing biotechnology sector that continues to be caught in the riptide of financial burden. Is that enough though to change our view of this government, its track record in supporting science and biotechnology in this country? Is it enough to make us believe that they understand the needs of our industry? We are at a tipping point, we have some of the best facilities and brightest minds in the world, but we need those who dictate our science policy to forge a direction, to help best fulfill our potential. For the next four years, this is the challenge, but more so the opportunity that awaits our new majority government.

Terri Pavelic Shawn Lawrence Christopher Rogers

CONTRIBUTING WRITERS

Eva Furczon

Gail Garland

Michelle DeLaCroix

Noel Courage

Peter Pekos

National Account Manager GRAPHIC DESIGNER CONTROLLER

Chris Gilles Patricia Bush Elena Pankova John R. Jones

MARKETING MANAGER

Mary Malofy

CIRCULATION DIRECTOR

James Zammit

circulation@promotive.net

EDITORIAL ADVISORY BOARD Najla Guthrie, KGK Synergize; Pierre Bourassa, IRAP, Montréal; Brad Guthrie, Alberta Advanced Education and Technology; Carol Reynolds, Genome Prairie; Ulli Krull, UTM; John Kelly, Erie Innovation and Commercialization; Peter Pekos, Dalton Pharma Services; Brad Thompson, Oncolytics; Darrell Ethell, CanReg; John Hylton, John H. Hylton & Associates; Robert Foldes, Mentis Partners; Colette Rivet, BioTalent; Grant Tipler, RBC; Randal R.Goodfellow, P.Ag., Senior Vice President, Corporate Relations, Ensyn; Bob H. Sotiriadis, LLB,a partner with Leger Robic Richard; Dale Patterson, Genome Canada; Darcy Pawlik, Syngenta Seeds Canada Inc; Gail Garland, OBIO; Barry Gee, LifeSciences British Columbia Biotechnology Focus is published 10 times per year by Promotive Communications Inc. 24-4 Vata Court, Aurora, Ontario L4G 4B6 Phone 905-727-3875 Fax 905-727-4428 www.bioscienceworld.ca E-mail: biotechnology_focus@promotive.net Subscription rate in Canada $35/year; USA $60/year; other countries $100/year. All rights reserved. No part of this publication may be reproduced without written consent. Publications Mail Registration Number: 40052410 Return undeliverable Canadian addresses to: circulation dept – 24-4 Vata Court, Aurora, Ontario L4G 4B6 National Library of Canada ISSN 1486-3138 \ All opinions expressed herein are those of the contributors and do not necessarily reflect the views of the publisher or any person or organization associated with the magazine.

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Reply Card #4883

R & D NEWS

Dr. Bruce McManus

PROOF Centre turns it sights on a leading cause of hospital stays

The PROOF Centre of Excellence is working with GlaxoSmithKline Inc. on one of the world’s major killers and the leading cause of hospitalization in Canada – chronic obstructive pulmonary disease (COPD) exacerbations (i.e. “lung attacks”). Drs. Don Sin and Wan Tan of the University of British Columbia and St. Paul’s Hospital will be leading the PROOF Centre in a multi-million dollar program to discover and develop new tools and biomarker blood tests to help clinicians predict which COPD patients will experience life-threatening “lung attacks.” GSK is providing biological specimens and clinical information collected from a subset of the ECLIPSE Cohort, a three-year, global multi-center study involving over 2,000 COPD patients. COPD is a serious lung disease that makes it hard to breathe. It is estimated that 210 million people have COPD worldwide and over 1.4 million in Canada. The disease kills one person every 10 seconds. COPD

exacerbations, often referred to as “lung attacks,” are a leading cause of death for people with COPD. Similar to heart attacks in cardiovascular disease, lung attacks can permanently damage the lungs. In Canada alone, the direct costs related to COPD exacerbations are $736 million a year. Hospital admissions for serious COPD lung attacks in Canada average a 10-day length of stay at a cost of $10,000 per stay. “We are delighted to have GlaxoSmithKline and leading COPD research clinicians like Drs. Sin and Tan working with us in our COPD biomarkers program,” says Dr. Bruce McManus, director of the PROOF Centre. “Little progress has been made in battling this devastating disease and its impact on society and our health system continues to grow. The PROOF Centre aims to change that situation.” The discovery phase of the program is already underway, with researchers working to identify blood-based biomarkers – sets of expressed genes and proteins – that can be used to identify COPD patients at high risk of exacerbation. If successful, this information may help guide patient management and may be used to help facilitate the development of new therapies to better treat COPD. The PROOF Centre expects to have candidate biomarker sets identified by the end of 2011.

Centre for Regenerative Medicine opens at Toronto’s Mount Sinai biology of stem cells and the mechanisms The Samuel Lunenfeld Research Institute at Mount Sinai Hospital recently celebrated the official opening of a new Centre for Regenerative Medicine and Musculoskeletal Research. The new centre includes laboratory facilities and instruments to support the research of the hospital’s scientists, orthopaedic surgeons and pathologists in stem cell biology, arthritis, sarcoma, and osteoporosis, among other areas. The hospital said the initiative represents Canada’s first collaborative effort involving scientists and clinicians dedicated to discovering and applying new knowledge into bone and tissue regeneration, including the development of joint replacements. “Through their investigations into the

6 BIOTECHNOLOGY FOCUS MAY 2011

behind tissue regeneration, Lunenfeld scientists are leading research that will open the door to improved therapies and possible cures for spinal cord injury, damaged joints, arthritis, diabetes and Parkinson’s disease, among other illnesses,” said Dr. Jim Woodgett, director of research at the Lunenfeld Institute. “This centre will help Ontario build its reputation as an international centre of medical research,” added Glen Murray, the province’s Minister of Research and Innovation, at the opening. The centre includes 10,000 sq ft of research facilities, expanding on the Lunenfeld’s existing facilities at the same location, which include over 155,000 sq ft of laboratory space.

Clinical Trials & Patents n Stem Cell Therapeutics Corp. (Calgary, AB) announces the enrolment of the first patient in the SCT supported Open label Phase 2a traumatic brain injury trial entitled “A Phase IIa, Single Center, Open Label Study to Characterize the Safety of Human Chorionic Gonadotrophin (hCG) and Epoeitin Alpha (EPO) in Traumatic Brain Injury”. The principal investigator for this investigator-led clinical trial is Dr. David Zygun at the Foothills Hospital. The purpose of this trial is to characterize the safety profile of NTx®-428 when administered to patients who have sustained a TBI. Additionally, a number of secondary endpoints will be studied, these include preliminary characterization of magnetic resonance imaging, motor, cognitive and functional recovery. The trial is anticipated to complete the enrolment of 10 patients by year end 2011.

Osta Biotechnologies Inc. (Montréal, QC) releases the results of a pre-clinical study on its compound, OB-28 in an Alzheimer’s disease animal model. Data from this study showed statistically significant amelioration of behavioural deficits in a transgenic mouse model of Alzheimer’s disease treated with OB-28. The pre-clinical study was conducted in collaboration with Dr. Donald Ingram, Professor, Nutritional Neuroscience and Aging Laboratory and Director, Animal Metabolism and Behaviour Core, Pennington Biomedical Research Center, a research campus of the Lousiana State University. In this study, a total of 103 wild type (wt) and double transgenic three month old mice were treated with either saline, memantine (10 mg/kg/day) or OB-28 at doses of 15 mg/kg/day and 30 mg/kg/day via daily intra-peritoneal injections over a period of four months and the behavioural deficits in the wt and dTg mice were assayed using the Stone T-maze (STM) test as well as contextual and tone fear conditioning tests. The STM test measures learning to navigate through a series of 14 choice-points enroute from a start box to a goal box to escape from water. In this learning test, OB-28 was found to have a statistically significant and positive impact on amelioration of behavioural deficits in the dTg mice in terms of a significant reduction in mean acquisition errors in five trial blocks compared to those treated with saline control. Memantine was also found to have a positive and statically significant impact on amelioration of behavioural deficits in dTg mice compared to those treated with saline control. Trends for a positive impact of OB-28 at both dose levels in dTg mice were also observed in the fear conditioning tests compared to those treated with saline control but these effects did not reach statistical significance In addition, the three treatments appeared to have no significant impact on performance in any of the wt animals.

R & D NEWS CDRD-BC Cancer Agency Collaboration Leads to Licensing of Cancer-Fighting Drug The Centre for Drug Research and Development (CDRD) and the BC Cancer Agency (BCCA) announced that Champions Oncology, Inc., a public US company engaged in the development of advanced technology solutions to personalize the development and use of oncology drugs, has exercised an option to license Irinophore C™, a liposomal formulation of Irinotecan. This transaction represents the second successful licensing agreement of a technology jointly developed between a CDRD-affiliated institution and CDRD, and the first between BCCA and CDRD. Irinophore C™ is a lipid-based nanoparticle made by efficiently loading the irinotecan payload into its interior core using a novel and proprietary method developed by BCCA researchers. The compound is currently completing preclinical development and is due to enter phase I clinical study as a single agent in patients having advanced solid tumors in Q4 2011. The CDRD collaboration completed critical activities toward demonstrating the technology’s clinical benefit including demonstrating that Irinophore C™ can significantly reduce the clinical dose-limiting gastrointestinal toxicity

associated with Camptosar®. Champions has tested the activity of Irinophore C™ using its TumorgraftTM translational technology platform. The results confirmed significant efficacy and safety advantages for Irinophore C™ as compared to the approved drug Camptosar® on various tumor types. “The support provided by CDRD enabled important toxicology tests for this new formulation which have all gone very well to date. With this support we were able to bring Irinophore CTM to the point where it is today,” said Dr. Patrick Rebstein, associate director, Technology Development Office, Provincial Health Services Authority. “CDRD played a key role in taking this technology from our initial experiments through demonstration of efficacy, safety and amelioration of a critical side effect of the current standard-of-care treatment for colorectal cancer. This data was key to getting this to a state where it would give clinicians the confidence to move this into formal development,” said Dr. Marcel Bally, head, Department of Experimental Therapeutics, BCCA. “Furthermore, without the results of the CDRD project, it is uncertain if we would have found a com-

mercial pathway as quickly as we did through Champions,” added Dr. Bally. “This licensing agreement further validates the successful collaboration model at CDRD, where we can provide drug development knowledge, technical infrastructure, commercialization expertise, and funding for researchers across Canada so they can carry out critical experiments to further advance their discoveries into new therapeutics,” said Natalie Dakers, CEO, CDRD. “CDRD is delighted to have played an important part in enabling a commercialization pathway for this technology through a licensing agreement with Champions.” The project received funding support from CDRD through the “Pfizer-CDRD Innovation Fund,” which was created to fast-track the commercialization of academic research projects into high-value medicines.

Reply Card #4884 MAY 2011 BIOTECHNOLOGY FOCUS 7

R & D NEWS Xenon CSO, Dr. Michael Hayden receives Canada Gairdner Wightman Award

Dr. Michael Hayden (photo courtesy of Xenon Pharmaceuticals Inc.)

Chief scientific officer and co-founder of Xenon Pharma Dr. Michael Hayden has received the Canada Gairdner Wightman Award for leadership in medical science in Canada. The Wightman Award is another major honour for Dr. Hayden, having previously been awarded the Order of Canada and Order of British Columbia, the Canadian Institutes of Health Research’s Health Researcher of the Year Award, LifeSciences

BC’s Genome BC Award for Scientific Excellence and the Prix Galien Canada. “I am thrilled to receive this award,” said Dr. Hayden during the awards ceremony in Toronto. “As a physician scientist, to whom chance has given unusual opportunities, I am deeply aware of the degree to which my own success today is built upon the work, cooperation and struggles of others.” “This is a wonderful moment for Michael

and the Xenon team is extremely proud of Michael’s profound achievements. His scientific and entrepreneurial talents and the commitment he has made to finding novel cures for difficult to treat diseases have made us a better company and Canada a better scientific community,” said Dr. Simon Pimstone, a co-founder, president and chief executive officer at Xenon Pharmaceuticals Inc. An author of more than 600 publications, Dr. Hayden is the most cited author on Huntington’s disease in the world. He is well known for having developed a predictive genetic test for Huntington’s disease, which was the first ever predictive test for any genetic disorder. With Xenon he has also identified genes associated with rare disorders such as Tangier disease, juvenile hemochromatosis and congenital insensitivity to pain. These discoveries are leading to novel approaches for treating common diseases such as cardiovascular disease, anemia and pain. The Gairdner Awards are a highly respected international prize. Ten of the last 24 Nobel Prizes in medicine or physiology have been awarded to past Gairdner recipients. Prior to Dr. Hayden winning the Wightman Award, the last British Columbian to receive a Gairdner Award was the late UBC Chemistry Prof. Michael Smith, who won the 1986 Gairdner Foundation International Award and went on to win the 1993 Nobel Prize for Chemistry.

$400k fund launched to spark new genomics research ideas The Ontario Genomics Institute (OGI) has launched a new $400,000 fund for highimpact, high-risk technology development research projects in genomics. The SPARK program will provide four awards of up to $50,000 annually over the next two years to be used for short duration research projects of six to twelve months, with a focus on projects that are unique and result in transformative technology development. “With SPARK, we want to catalyze new research directions and increase the competitiveness of Ontario researchers,” commented Dr. Mark Poznansky, presi-

8 BIOTECHNOLOGY FOCUS MAY 2011

dent and CEO. “Our intention with the launch of this program is to fund projects that may not be readily funded by other mechanisms as they would be viewed as too risky or lacking in preliminary results. SPARK is another example of our drive to support new ideas, fresh approaches and pioneering thinking.” Available to researchers who will perform their research in Ontario, the program will target projects that focus on developing technologies such as instrumentation, software, experimental approaches or reagents, with potential for significant impact in the genomics sciences.

Applications are being accepted from till June 15, 2011. Results will be announced by Aug. 15, 2011. “Ontario is home to some of the smartest, brightest and most creative thinkers and doers, but all too often they face barriers to obtaining initial funds to help them develop new ideas into ones that are more solid and tangible,” commented Dr. Mark Poznansky. “There is an urgent need in our province and country to foster such talent, encourage it and cultivate it if we are to remain competitive in the life sciences and be a successful hub for research globally.”

R & D NEWS

Photo: Stephen Ausmus

Animal vaccine manufacturing centre opens Bioniche Life Sciences Inc. has officially opened its new Animal Health and Food Safety Vaccine Manufacturing Centre at its corporate headquarters in Belleville, ON. According to Bioniche, the facility represents the largest livestock vaccine manufacturing facility in Canada and will have both the capacity to supply Canadian animal vaccine requirements and meet international regulatory standards (Good Manufacturing Practice - GMP). Once fully commissioned, the first product to be manufactured in the Centre will be the Company’s E. coli O157 cattle vaccine EconicheTM - directed to reducing the level of this deadly pathogen in water, food and the environment and, in turn, help minimize the potential for infection of humans. According to Mohamed Elrafih, vice president of Manufacturing Operations at Bioniche Life Sciences Inc., 19 employees have been hired for the Vaccine Manufacturing Centre to date, with a further seven employees recently hired in other areas of the

facility in indirect support positions. An additional 15 to 20 employees are expected to be hired over the next 18 months. Construction of the manufacturing centre was made possible through financial support from the Ontario Ministry of Economic Development & Trade (Advanced

Manufacturing Investment Strategy Program) - $10 million repayable contribution; Agriculture & Agri-Food Canada (Agri-Opportunities Program) - $5 million repayable contribution; the Business Development Bank of Canada - $5 million repayable contribution; and Industry Canada (Industrial Technologies Office) - $5 million repayable contribution. “This government funding was critical to achieve our vision for a state-of-the-art Canadian vaccine manufacturing facility to produce a range of vaccines to prevent illnesses in animals and to reduce the likelihood of human illness from animal diseases,” said Graeme McRae, chairman, president and CEO of Bioniche Life Sciences Inc. “We are proud of our internal Manufacturing Operations team that worked with a Montreal-based engineering firm and a Belleville-based general construction contractor to complete the project. Approximately 90 per cent of the equipment purchased for the facility was made in Canada.”

May 31 and June 1, 2011 F U N D I N G I N N O V A T I V E C O M PA N I E S

St. Andrew’s Club & Conference Centre 150 King Street West, 27th Floor, Toronto

BioFinance 2011

is the leading investor conference in Canada for the lifescience industries. This two day event brings together key industry players and companies interested in investment opportunities and issues affecting companies in the life science sectors. Over 60 presenting companies will span a range of industries including biologics, medical devices, drug delivery, vaccines, diagnostics, bio-energy, green technologies, bio materials, industrial biotech, and research services. Reply Card #4885

www.biofinance.ca

U Contact mstinson@biofinance.ca U Tel 1-866-342-4933 MAY 2011 BIOTECHNOLOGY FOCUS 9

R & D NEWS “Biofuels could sustainably account for 25 per cent of world transportation fuel by 2050,” says International Energy Agency The Canadian Renewable Fuels Association (CRFA) is applauding a new roadmap from the International Energy Agency (IEA) that reaffirms the critical role of biofuels in the future of global energy supplies. Biofuels, according to the roadmap, can account for over 25 per cent of transportation fuels by 2050 and “can play an important role in reducing CO2 emissions in the transport sector, and enhancing energy security.” “The CRFA agrees that stable long-term policies for biofuels are critical to increase investor confidence,” said Gordon Quaiattini, president of the CRFA. “We also agree that sustained funding and support mechanisms are required to enable promising advanced biofuel technologies to reach commercial production.” The IEA prepared its report titled: “Technology Roadmap: Biofuels for Transport,”

mandate, is ideally positioned to be part of this biofuel growth opportunity.” Read the IEA’s Roadmap here: www.iea.org/ papers/2011/biofuels_roadmap.pdf

Canada Council awards ﬁve prominent scholars $100,000 Killam Prizes

Prof. Gilles Brassard

Dr. Michael Hayden

Dr. Keren Rice

Dr. Lotfollah Shafai

Prof. Mark Zanna

BUSINESS CORNER Restructuring could render existing Angiotech shares worthless Angiotech Pharmaceuticals, Inc. has applied to the securities regulatory authorities in Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, Prince Edward Island, Saskatchewan and Québec for a decision that it be deemed to have ceased to be a reporting issuer in such jurisdictions. As a reporting issuer under applicable Canadian securities laws, the company is subject to Canadian filing and disclosure requirements in addition to those applicable under the laws of the U.S. If the decision is made, the company will no longer be a reporting issuer in any jurisdiction in Canada. Additionally, long-time Angiotech Phar-

Angiotech is under court protection from creditors stemming from the Companies’ Creditors Arrangement Act.

Cangene reorganizes Canadian operations Cangene Corporation announces that it is making organizational changes in its Canadian operations to reflect decreased U.S. government contract-manufacturing activity. The company intends to align its workforce focusing on its commercial products. These factors have driven a workforce reduction, announcing the termination of 40

Microbix wins European patent protection for Virusmax

Photo: James Gathany

Protox announces move to San Diego and senior management transition Protox Therapeutics Inc. has opened a new office in San Diego, CA, and expects to complete the transition of operations to the new office sometime this year. To lead this transition, Protox Chairman Dr. Lars Ekman has accepted the role of executive chairman and president of Protox, and Dr. Allison J. Hulme has joined the company as chief operating officer and head of Research & Development. Both Drs. Ekman and Hulme will be based in San Diego. In connection with this move, president and chief executive officer Fahar Merchant, Ph.D. and senior vice president, Development and Regulatory Affairs Nina Merchant have resigned their positions and have agreed to serve as consultants to the company to assist in the orderly transition of operations to San Diego. Two drug candidates derived from the company’s INxin™ and PORxin™ platforms are in clinical development. Protox’s lead program, PRX302 (PORxin), achieved positive results from its Phase 2b placebo controlled trial called TRIUMPH, to treat benign prostatic hyperplasia (BPH or enlarged prostate). MAY 2011 BIOTECHNOLOGY FOCUS 11

BUSINESS CORNER Stellar Pharmaceuticals Inc. and Watson Pharmaceuticals, Inc. terminate Uracyst supply and licensing agreements Stellar Pharmaceuticals Inc. and Watson Pharmaceuticals, Inc. have terminated their supply and licensing agreements related to Uracyst® for the treatment of interstitial cystitis. Watson acquired the rights to develop and commercialize Uracyst® in the U.S. in December 2006. In November 2010, Wat-

son issued a statement that based on the results of a pilot test study evaluating Uracyst®, Watson did not plan to allocate any additional resources to further pursue the product development program. In connection with the termination of the agreements, Stellar will pay a royalty on net

Blue Gold Canada Signs Contract in Mexico to Treat Wastewater Blue Gold Canada, a company developing nano and bio technology products to clean water, have signed a memorandum of understanding with Hasar’s Grupo Ecologico that outlines plans to install a wastewater treatment plant at the Hasar’s landfill in Guadalajara Mexico. The Blue Gold Dove Biotech wastewater treatment plant will have the capacity to treat 50,000 litres of water per hour and will use a proprietary line of Organic/Natural products to remove the contamination from the leachate pools. The treated effluent will then be clean for agriculture use. “CWP-121 is an organic/natural solution to remove all contamination from wastewater without any harm to hu-

mans, the environment or animals. It is a completely safe and natural product,” said Justin Singh, Blue Gold co-founder. The project is scheduled to be installed later this year and to be used as a showcase to expand the Blue Gold Biotech brand in Mexico.

sales of Uracyst® in the U.S. over the life of certain Uracyst® patents. Notwithstanding the termination of the agreements, Stellar continues to believe that Uracyst® will become a commercially viable product in the United States market. Stellar intends to aggressively seek a new product sponsor for the product in the U.S.

Paladin Labs Inc. product now available in Canada Canadian specialty pharmaceutical company Paladin Labs Inc has announced the Canadian launch of Seasonique™. Seasonique is a new approach in birth control pills for the prevention of pregnancy designed to provide only four menstrual periods per year. It is designed to reduce the number of periods a women experiences from 13 to four per year and is the first 91-day combination oral contraceptive regimen approved in Canada which is placebo free. This represents a new approach to the extended-cycle oral contraceptive category which began with the launch of Seasonale® in 2008. Seasonique™ was manufactured by Teva Pharmaceutical Industries Ltd. Paladin licensed the Canadian rights to SEASONIQUE™ in 2005 from Teva.

Dealmakers n Medicago Inc. (Québec, QC) has entered into a research collaboration agreement for the development of a non-influenza vaccine candidate with a top 10 global pharmaceutical company. Under the terms of the research collaboration, Medicago will apply its transient expression system to develop a vaccine candidate for a non-disclosed target. Medicago is eligible to receive payments on achievement of specified milestones stipulated in the contract. “We believe this collaboration represents an important validation of our scientific leadership in vaccines,” said Andy Sheldon, president and CEO of Medicago. “The combination of our rapid, efficacious and cost-effective VLP vaccine technology with such an accomplished partner allows us to further demonstrate the capability of our vaccine platform and has the potential to lead to further collaborations.” n VWR International (Radnor, PA), a distributor of laboratory supplies and services, says it is acquiring the business of Anachemia Canada and its affiliates, pending customary closing

conditions. Based in Montreal, Anachemia sells and distributes chemicals, laboratory supplies and equipment in the US, Canada, Latin America and Mexico. In addition, Anachemia exports certain products around the world. Anachemia has provided products and services to the research, environmental, industrial and mining industries since 1942. Warnex Inc. (Laval, QC) has entered into a credit support agreement (CSA) with Persistence Capital Partners (PCP), a leading Canadian healthcare private equity firm and Warnex’s largest shareholder, pursuant to which PCP has agreed to guarantee Warnex’s obligations under its existing banking facilities. On the basis of the guarantee provided by PCP to Warnex’s current bankers, the authorized amount of Warnex’s operating line of credit will be increased from $1 million to $1.25 million, effective until March 31, 2012, and Warnex’s existing term loans will remain in place until their maturity. Under the terms of the CSA, Warnex has agreed to pay to PCP, in consideration for the credit support n

consented, certain guarantee and standby fees. Additionally, for so long as the banking facilities and the debentures issued by Warnex to various holders remain outstanding, Warnex has undertaken certain covenants in favour of PCP relating to reporting, corporate governance, operations and financial matters. ProMetic Life Sciences Inc. (Laval, QC) has entered into an agreement with Celgene Corporation (Summit, NJ) for the worldwide rights to a commercial application of ProMetic’s Protein Technologies. Under the terms of this agreement, Abraxis BioScience, Inc., a wholly owned subsidiary of Celgene will forgive a $10 million long-term debt entered into with ProMetic on February 9, 2010, effectively terminating said loan agreement four years prior to its original term in return for intellectual property rights for specific commercial application of its Protein Technologies within restricted fields of use. The Agreement is subject to certain conditions relating to the completion of relevant intellectual property transfer documentation.

12 BIOTECHNOLOGY FOCUS MAY 2011

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Reply Card #4886 CA_Add Bioechnology Focus.indd 2

3/21/2011 10:26:47 AM

BIOSIMILARS

By: Eva Furczon, Honours B.Sc., M.Biotech

SUBSEQUENT ENTRY BIOLOGICS IN CANADA:

Noel Courage, B.Sc. (Biochem), LL.B

Introduction:

Canada has approved its first subsequent entry biologic (SEB), Omnitrope® (somatropin). More approvals are expected because many well known biologics are facing patent expiry in the coming years. This short article will provide an overview of biologics, highlight the ongoing developments in the approval pathway of SEBs, as well as explain the patent and regulatory exclusivities available to innovator biologic manufacturers.

14 BIOTECHNOLOGY FOCUS MAY 2011

Competition vs. Exclusivities

BIOSIMILARS

he most common manufacturing process can be summarized in 7 carefully controlled stages: host cell development, master cell bank establishment, protein production, purification, analysis, formulation and storage and handling. Subsequent Entry Biologics: How are they different from generics? In recent times, the term biologic has been used to define a new class of protein-based therapeutics that are produced using living organisms, including plants, animals and microorganism such as yeast and bacteria. Compared to conventional small molecule drugs such as Asprin, biologics are a newer class of protein-based pharmaceuticals that are significantly larger, inherently more complex, heterogeneous and thus much more difficult to characterize. It comes as no surprise then that the manufacturing of these glycoprotein molecules such as monoclonal antibodies (mAbs) is intricate in nature. The most common manufacturing process can be summarized in seven carefully controlled stages: host cell development, master cell bank establishment, protein productions, purification, analysis, formulation and storage and handling.1 It has been demonstrated that even slight alterations in any stage can lead to significant changes in protein structure and lead to clinically relevant implications for safety, immunogenicity and potency.2-3 Governmental regulatory bodies agree that the current approval process of generic versions of small molecular drugs are not suitable for SEB approval and have taken steps to develop a separate pathway for SEBs to safeguard patent safety. To aid in decision-making regarding SEB submissions, on March 5th 2010 Health Canada published its finalized guidance document titled “Information and Submissions Requirements for Subsequent Entry Biologics and related documents”. 4 The first SEB (Omnitrope ®) was approved in Canada on April 22, 2009.

onstrate pharmaceutical equivalence and bioequivalence between the generic and innovator products.5 Since generic drugs are considered therapeutically equivalent to the reference product they are often substituted for economic reasons. This differs with SEB’s. Health Canada emphasizes that SEBs are not generic biologics, and the authorization of a SEB is not a declaration of pharmaceutical or therapeutic equivalence to the reference biologic drug.4 To this end, the SEB manufacture needs to invest in additional clinical trials as a part of the submission. According to the recently published guidance document, the SEB manufacturer is required to provide a reduced nonclinical and clinical package including comparability data (analytical comparison with reference product) and stringent post-marketing pharmacovigilance plans demonstrating similar safety and efficacy in larger populations4. On a global scale, Health Canada and the Food and Drug Administration (FDA) are moving in the right direction with ongoing developments that will provide more certainty in the legal and regulatory framework for SEBs. The European Medicines Agency (EMEA) is a leader in biosimilar regulation. In 2005, the EMEA released its first guidelines on similar biological medicinal products7 (in Europe referred to as biosimilars) and since then the agency has granted marketing approval for more than 12 different biosimilars competing with four innovator biologics: somatropin (Genotropin, Humatrope), epoetin (Eprex) and filgrastim (Neupogen).6

regulatory

A Quick Primer for Filing a

Clinical Trial Application in Canada Michelle DeLaCroix, RAC, Director, CTA Group, CanReg Inc.

Before a clinical trial can begin in Canada, it must receive approval from Health Canada. The submission of a Clinical Trial Application (CTA) is a pivotal step in this process and all clinical trials are subject to regulations defined in Division 5 of the Food and Drug Regulations, which apply equally to Sponsor/Manufacturer as to Investigators. Pre-CTA meetings are recommended if the trial is for a New Chemical Entity or if the sponsor has not filed a CTA in Canada before. There is a default 30 day review period for a CTA submission. Although clinical trials are permitted to begin after 30 days from the filing of the CTA, it is always recommended that the Sponsor wait for the No Objection Letter (NOL) to be issued before beginning the trial. The Organization of a CTA The Common Technical Document (CTD) format is utilized for the organization of a CTA in a modified form to include only modules 1, 2 and 3. CTAs are submitted as paper submission with the submission duplicated electonrically in a unique folder system. In addition to the GCP guidelines, there is a Clinical Trials guidance document and a online manual available, which provides general guidance about CTAs. Unlike the U.S. Investigational New Drug Applications (INDs), clinical trial applications in Canada require a CTA submission to be filed for each study to be conducted in Canada. Preclinical and clinical experiences are summarized and provided in an Investigator’s Brochure. Complete chemistry and manufacturing (CMC) data are required as part of the filing, but in the case of pharmaceuticals, the amount and level of information is determined by the phase of study. As sponsors advance in phases of development, it is required that new CMC information is submitted with the new CTAs for each phase. In the case of investigator-initiated studies (external to the pharmaceutical manufacturer), the CMC information is usually either cross-referenced to a previous Health Canada approved application for an investigational product, or cross-referenced to an active Canadian Drug Identification Number (DIN). The content of the Investigator’s Brochure and Protocol is expected to comply with International Conference on Harmonization guidelines. Since many Investigator CTAs involve marketed products that are being used outside their approved indication(s), a copy of the current Canadian product monograph may be supplied in lieu of an Investigator’s Brochure. Each CTA must include an attestation by a Senior Medical or Scientific Officer in Canada who has reviewed the protocol and certifies that the trial will be conducted according to GCP guidelines, Division 5 of the Food and Drug Regulations and all information contained with the CTA is accurate. In addition to Health Canada approval, a research ethics board must approve the protocol and consent form(s) before the study begins. The Qualified Investigator must be a medical doctor who is licensed and in good standing within the jurisdiction where the research will occur. If the product is being imported from a non-Canadian supplier, the lots of drug must be released for use in Canada by a Quality Representative in Canada. About the Author: Michelle DeLaCroix leads the CTA Group at the CanReg Inc., one of the largest regulatory consulting firms in the world. She can be reached at mdelacroix@canreginc.com or 1 866 722-6734 ext.1256

Biotechnology Focus MAY 2011

During the Trial Administrative changes to the protocol, consent form or issues related to GCP standards can be made by Notification to Health Canada within 15 days of the change. Significant protocol changes affecting the selection and monitoring or the patients or endpoints of the study or CMC changes warrant the submission of an amendment, which is subject to another 30 day review period. If the clinical trial or the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person, the sponsor may immediately make the amendment without prior review by Health Canada, but must submit a Notification within 15 days of making the change and following in 15 days by the filing of a CTA-Amendment for review by Health Canada. Safety concerns that arise during a clinical trial are often related to adverse drug reactions. Adverse drug reactions are defined as any noxious and unintended response to a drug that is caused by the administration of any dose of the drug. If the adverse drug reaction is unexpected, life-threatening or fatal, it must be reported to Health Canada within 7 days, with additional information provided within another 8 days or 15 days for reports considered unexpected and serious in nature. If at any time during a trial, Health Canada decides that the safety of subjects is at risk, the trial may be suspended or cancelled. The Investigator’s Brochures are to be reviewed and updated at a minimum of once each year and submitted to Health Canada as an update to the CTA. Canadian Regulations require sponsors to maintain all records for a minimum period of 25 years. The Inspectorate has the authority to inspect any site involved in a clinical trial, and inspects up to 2% of clinical trial sites each year. If any deviations from the regulations or GCP are noted, the site is expected to improve in these areas to assure proper conduct of the clinical trial. In conclusion, the success of any clinical development program relies upon the quality and accuracy of information provided in a clinical trial application and the compliance of all individuals involved in the studies. The authorization of clinical trials in Canada is straightforward, ensuring that Canada remains competitive with the U.S. and other countries.

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Reply Card #4887



By Chris Gilles

Bioanalytical Techniques

Simultaneous ESI/APCI Measurement with a Dual Ion Source

Every day, researchers synthesize and test large amounts of compounds in the chemistry laboratories of pharmaceutical and chemical manufacturing companies. In these labs, many LCMS instruments run simultaneously. Although software improvements can enhance the efficiency of analytical throughput, software alone can not improve the analysis.

he question concerning researchers is whether the LCMS really detects synthesized compounds. Addressing this issue requires the application of new technology linked to the LCMS hardware. In LCMS measurement, the polarity of the target compounds determines the selection of the ionization mode. For example, electrospray ionization (ESI) generally is selected for analyzing high-polarity compounds typically found in drugs and pesticides. Atmospheric pressure chemical ionization (APCI) is selected for compounds having lower polarity. (Figure 1.) When analysts know the properties of a substance, selecting the appropriate ionization mode is relatively easy. However, for synthesis researchers who handle a wide variety of compounds, the time required for selecting the best ionization mode for each compound can have a negative impact on research and development efficiency be-

cause it may be difficult to predict the best ionization method for a variety of samples. Additionally, because each ionization approach can produce a variety of background and adduct ions, the question remains as to whether the synthesized compound is actually detected. For many analysts, the primary goal is to achieve detection of the target compounds as quickly as possible. However, acquiring data using both ESI and APCI ionization modes generally requires the use of an ion source (probe) specific to each of the modes. For a researcher looking for any way possible to shorten analysis time, installing a second probe and re-running an analysis seems like a waste of time.

A Single Analysis for ESI and APCI Acquisition For the researcher looking for ways to shorten the time required for analysis and

Figure 1: Selection of Ionization Mode with Respect to Analyte Polarity and Molecular Weight

method development, a technique combining two different ionization modes would significantly improve laboratory efficiency and confidence in results. How might sample analysis be conducted using both ESI and APCI ionization concurrently without severely compromising either technique? Due to the substantial differences in the ionization mechanisms of ESI and APCI, achieving this goal requires significant development. Ionization is produced in ESI by applying a high voltage to the capillary through which a stream of ionized analyte molecules exits in nebulized droplet form. In APCI, reaction ions are formed by the electrical discharge around a high voltage corona needle. These ions react in the gas phase with neutral analyte molecules to produce ionization. Because ESI and APCI probes are each designed to optimize their respective technique, a new technology would be required to integrate both of these probes to achieve simultaneous measurement of ESI and APCI data. The DUIS-2020 is a dual ion source (DUIS) consisting of an integrated probe for analysis using both ESI and APCI techniques. The ionization flow using the DUIS is as follows: a) Sample (including mobile phase) is introduced into the probe. b) In the ESI probe, the liquid is nebulized into a fine spray. c) As a drying gas is used to evaporate the nebulized spray, ionization by APCI is produced by the corona needle. d) The sample ionized by the ESI and APCI techniques passes through the desolvation line to enter the vacuum region. ESI and APCI ionization are executed concurrently and continuously with the DUIS without relying on switching between modes. Software control of the individual continued on page 20

18 BIOTECHNOLOGY FOCUS MAY 2011

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Bioanalytical Techniques Figure 2: Number of Acquired Points Affects Peak Shape

data points across even the narrowest peaks. Whereas polarity switching was previously accomplished by switching positive and negative high-voltage power sources arranged in parallel, the Shimadzu LCMS-2020 adopts a new technology (patent pending) in which polarity switching is conducted using serially arranged positive and negative high-voltage power sources. This ultra-fast switching technology achieves 15 ms polarity switching.

Improved Throughput No. Of acquired points: 20 points

continued from page 18 ESI and APCI voltages allows the chemist to easily select ESI, APCI or DUIS ionization without changing hardware. Furthermore, the standard ESI probe is used in the DUIS interface, permitting analysts to achieve uncompromised ESI performance.

Optimizing for Ultra-High Speed Analysis The introduction of ultra-high speed analysis has proven effective for improving research and development efficiency. However, along with the benefits of greater efficiency comes the importance of minimizing the

No. Of acquired points: 4-5 points

loss of data points (digital points acquired during analysis) due to the narrow peak widths associated with fast LC. Polarity switching between negative ion detection and positive ion detection is commonly necessary for unknown or complex samples. Modern improvements in chromatography demand that polarity switching times be only a few milliseconds because even a slight reduction in the number of acquired points can result in reduced sensitivity and distorted peak shapes. (Figure 2.) The DUIS interface combines rapid polarity switching with continuous ESI and APCI ionization, allowing sufficient acquisition of

Figure 3: Analysis of Water Soluble and Fat Soluble Vitamins (3-Vitamin Mixture)

Figure 3 shows the MS chromatograms obtained from the analysis of a sample consisting of water-soluble vitamins, thiamine and riboflavin, and the fat-soluble vitamin calciferol. Analysis was first conducted by ESI and by APCI individually, and then by the DUIS in dual mode. The results show that good sensitivity is obtained for thiamine and riboflavin using ESI, but that they are scarcely detected using APCI. Additionally, calciferol is detected using APCI, but ionization is insufficient using ESI. When DUIS is employed, however, well-balanced MS spectra are obtained. In conventional systems, the same analysis must be repeated after exchanging the probe, but by using DUIS, the analysis is completed in a single run. This demonstrates the power of DUIS in providing laboratories with a tool for faster method development and higher sample throughput.

Conclusion To achieve a rapid and thorough mass spectral analysis of complex or unknown samples, it is imperative to develop a system that results in a high probability of detection. Because compounds preferentially ionize based on both polarity and ionization methods, it is critical to develop techniques that support multiple methods. Traditional dedicated ionization sources can hinder high-throughput analysis such as metabolic screening by limiting the number of samples that can be examined within a set timeframe. By combining ESI and APCI into a single run, researchers can reduce instrument time by half, allowing a greater number of samples to be analyzed. Chris Gilles is the LCMS Product Manager at Shimadzu Scientific Instruments

Water Soluble and Fat Soluble Vitamins (3-Vitamin Mixture) 1. Thiamine: m/z 265, Cation, generated through ionization, water soluble vitamin 2. Riboflavin: m/z 377, Protonated molecular ion, water soluble vitamin 3. Calciferol: m/z 397, Protonated molecular ion, fat soluble vitamin

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Biosimilars

The biosimilar company must ultimately justify that all the patents are invalid, non-infringed or expired. If this is not done, then the biosimilar will not receive an NOC until the patents expire. continued from page 15 Europe does not have patent regulations linked as a precondition to a marketing authorization. Biosimilar manufacturers can get their marketing approval without addressing patents. In the US, a complex patent clearance system has been implemented as a precondition to biosimilar approval. The biosimilar manufacturer must disclose its regulatory submission to the reference product sponsor. The reference product sponsor then provides a list of patents it believes could be infringed. There are opportunities during the process for settlement negotiations and a patent infringement lawsuit.

Regulatory Exclusivities

If the patent owner and biosimilar manufacturer disagree about freedom to operate, a court case known as an NOC Proceeding will assess evidence about patent infringement and validity. The court will then decide whether to prohibit Health Canada from issuing the biosimilar a NOC because of the risk of patent infringement. No NOC can be issued while the court is considering the issues, which can take up to 24 months. If the biosimilar company wins, it gets its marketing authorization. If the biosimilar company loses, it has to wait until patent expiry to get its NOC. The biosimilar litigation landscape is complex because a conventional patent infringement or invalidity lawsuit may be initiated concurrently with, or after, a NOC Proceeding. The NOC Regulations have been extensively litigated in the context of conventional, small molecule pharmaceuticals. No NOC Proceeding has been completed for a biosimilar yet. However, the NOC Regulations will be an important biosimilar patent protection tool once biosimilar development increases. 22 BIOTECHNOLOGY FOCUS MAY 2011

Canada, the US and Europe all have data exclusivity. During the exclusivity period, the pioneer biologic data cannot be relied on by a biosimilar company seeking approval of its own drug. In Canada, innovative biologic drugs may be eligible to receive an 8 year period of data exclusivity. Slightly modified versions of previously-approved biologics will not be eligible. An additional six months of data exclusivity is available for biologics that have been the subject of pediatric studies. The intent is to allow the brand name company a period of exclusivity to recoup its R&D investments in the biologic. A biosimilar manufacturer cannot even have Health Canada review its drug submission during the first six years of the data exclusivity period.

pioneer companies and SEB manufacturers. Lastly, it is important to ensure that all stakeholders are educated to make well-informed decisions with the goal of patient safety as the top priority.

References: 1. Schachter H. The ‘yellow brick road’ to branched complex N-glycans. Glycobiology 1991;1(5):453-61. 2. Impact of manufacturing changes. Biotechnology Advances 2007;3(25):325-31 3. Schellekens H. Biosimilar epoetins: how similar are they? Eur J Hosp Pharma Sci 2004;3:43-47 4. Health Canada. Information and submission requirements for subsequent entry biologics (SEBs) and related documents, 2010. Available at: http://www.hc-sc. gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/notice-avis_sebpbu_2010-eng.php (accessed May 10, 2011). 5. Health Canada. Fact sheet: Subsequent entry biologics. Available at: http://www. hc-sc.gc.ca/dhp-mps/brgtherap/activit/ fs-fi/fs-fi_seb-pbu_07-2006-eng.php (accessed May 10, 2011). 6. BIOTECanada. SEBs, Biosimilars, FOBs: Understanding the clinical implications and international experience. Available at: http://www.biotech.ca/uploads/ sebs/belin-110909.pdf (accessed May 10, 2011). 7. European Medicines Agency. Guideline on similar biological medicinal products, 2005. Noel Courage is a partner in the intellectual property law firm, Bereskin & Parr LLP. Eva Furczon is freelance consultant specialized in biotechnology, D5Pharma Consulting and oncology specialist at Roche Canada.

Conclusions

Acknowledgements:

With the arrival of the first SEB in Canada, SEBs are undoubtedly here to stay. Health Canada has created guidance documents to facilitate approval of SEBs, which will increase competition in the biologic marketplace. The extent to which a SEB will be allowed to rely on the pioneer biologic data will vary considerably depending on the nature of the product. Awareness of patent and regulatory exclusivity strategy will become increasingly important for both

The scientific content of this paper has benefited from the input and support provided by Dr. Leigh Revers, University of Toronto.

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By: Gail Garland, President & CEO OBIO

across canada

LEVERAGING THE $7 MILLION FUND

Designated for Ontario Bioscience Companies announced in May 2010

Across Canada

to attract additional investment. Replenishment of the fund is an important way to advance Ontario’s competiveness in the field of bioscience. Let’s not miss the opportunity.

References: 1. Industry Generated Recommendations for Sustainability and Growth of Ontario’s Bioscience Industry in 2010 and Beyond (www.obio.ca) 2. Industry Generated Recommendations for Sustainability and Growth of Ontario’s Bioscience Industry in 2011 and Beyond (www.obio.ca)

The relationship between programs as proposed by OBIO

Reply Card #4891

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MAY 2011 BIOTECHNOLOGY FOCUS 25

Reply Card #4895 Moisture Analyzer Shimadzu Scientific Instruments announces the availability of the MOC63u moisture analyzer with UniBloc sensor technology for reliable 26 BIOTECHNOLOGY FOCUS MAY 2011

NEW PRODUCTS Spectrometer Ocean Optics has launched a family of aberration-corrected holographic concave diffraction grating spectrometers that delivers low stray light, high throughput and excellent thermal stability for applications ranging from absorbance measurements of optically dense solutions to fluorescence measurements in solutions and powders. Torus is a compact visible spectrometer (360-825 nm) with greater throughput and less stray light (~0.015% at 400 nm) than planar-grating and other miniature spectrometers. A flat field optical design and a reflective holographic concave grating disperses light; the concavity of the Torus’ grating reflects and focuses the light and the grating groove pattern disperses the light. The toroidal nature of the grating further enhances the aberration correction and efficiency. For convenient experiment setups, the Torus Spectrometer interfaces to a computer via its USB port and couples to Ocean Optics accessories. The Torus model is available with a variety of slits, filters and other optical bench accessories for optimizing configurations. Free-space optical coupling is accommodated with standard C-mount adapter.

tal analysis solution. The iCAP 6200 ICPOES now incorporates a wider wavelength range of 175-847nm. This enables users to measure a broader range of analytes during multi-element analyses and access more sensitive wavelengths for improved analyte detection capability. The instrument is a simple, multi-element analysis solution for laboratories that perform routine analyses of up to 100 samples per day. With its enhanced specifications, the iCAP 6200 can now measure sulfur as part

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Company & Advertiser Index COMPANY

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Angiotech Pharmaceuticals Inc............... 11................................. BC Cancer Agency.................................... 7.................................. Biofinance..................................................... 9.............................4885

June 27-30

Bioniche Life Sciences Inc........................ 9..................................

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BioTalent Canada..................................... 19, 31.............. 4888, 4889

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Celgene Corporation.............................. 12................................. Centre for Drug Research............................................................ and Development.................................... 7.................................. Children’s Miracle Network...................... 25............................ 4891 Dalton Pharma Services............................. 5.............................4883 Eppendorf..................................................21,32............... 4900, 4901 Fisher Scientific............................................ 2.............................4882

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Kimble Chase Kontes.............................. 26........................ 4894

August 8-9

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Lawson Health Research Institute........... 10................................. Medicago Inc........................................... 12................................. Metrohm................................................. 26........................ 4892 Microbix Biosystems Inc......................... 11................................. Millipore.................................................. 26........................ 4893

Osta Biotechnologies Inc......................... 6.................................. Paladin Labs Inc. ..................................... 12................................. ProMetic Life Sciences Inc....................... 12................................. Protox Therapeutics Inc.......................... 11................................. Retsch..................................................... 26........................ 4895

Stellar Pharmaceuticals Inc..................... 12................................. Stem Cell Therapeutics Corp................... 6.................................. Thermo Scientific.................................... 27........................ 4899

VWR International................................... 12, 13.........................4886 Warnex Inc.............................................. 12................................. Watson Pharmaceuticals......................... 12................................. Xenon Pharmaceuticals............................. 8......................................

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THE LAST WORD

Faltering in

the Critical Step

n the part of Canada where I live, you can always count on the apple blossoms blooming in the first week Peter Pekos, of May. I look forward to it not only CEO, Dalton Pharma because of the freshness of their beauty Services but also because of the promise of harvest that they bring. A few years ago, I asked a friend who is an apple grower and has good reason to be concerned about his harvest, what he worries about most in the cycle from blossom to picking. “The weather after the blossoms appear is the critical step,” he said. “If it is too cold or rainy the insects won’t be out and the conversion from blossom to tiny fruit will be way down. Once the little apples get started, I can manage everything else until the picking starts”. Our industry is similar in many ways. The blossoms still come out year after year. As the CEO of a drug development and manufacturing services provider for the global industry, as the chair of one of Ontario’s newest Research and Innovation Centres (Venture Lab, York Region’s Regional Innovation Centre), and as an angel investor (who has won, lost and broke even), I have the privilege of seeing a wide variety of extremely promising opportunities in their early stages. Tragically, we are faltering in the critical step of converting these opportunities into projects far advanced enough for Big Pharma to take over. I don’t know who first called this step the “Valley of Death”, but the term is very appropriate. At present, Biotech is not able to attract the venture capital on the scale needed to refill the pipeline emptied by the continuing exit of Big Pharma from early stage R&D. Governments have been taking measures to fill the gap, and I applaud these initiatives. A high profile example is British Columbia’s Centre for Drug Research and Development (CDRD), a national Centre of Excellence for Commercialization and Research. CDRD has been able to attract $3 million in funding from Pfizer for an innovation fund to fast-track the commercialization of promising projects. Because organizations of this type are so important in sustaining our industry, I believe that we should do everything possible to maximize their efficiency and their return on public investment. Toward this end, I have put forward four suggestions below:

1. We must look for best practices by studying other countries and global regions. 2. Government support must be non-partisan. 3. Government support should be “non-egalitarian” (focused, not evenly spread). 4. We must encourage early stage funding for new ventures. 30 BIOTECHNOLOGY FOCUS MAY 2011

I have advocated studies of models in other jurisdictions on many occasions in the past. This should not only be done before a new centre or tech transfer body is created, but also an ongoing exercise of benchmarking and review after it is well established. Models should include both newer initiatives, such as the one in the Australian province of Victoria, and older ones such as Max Planck Innovation, which since 1979 has overseen a total of about 3,300 inventions from various Max Planck Institutes. In 1990, Max Planck Innovation began its professional support of spin-offs, and since then has been involved in 92 spin-offs. Almost half of these have been in the life sciences, including Sugen Inc. (acquired by Pfizer) and U3 Pharma AG (acquired by Daiichi Sankyo). Removal of partisan politics and egalitarian principles from government involvement is as difficult as it is necessary. The two are of course intertwined and in many ways part of our Canadian culture. Using funding as a political tool is not only a temptation, it is a tradition. How can we develop aligned federal, provincial, and local programs in a system governed by partisan thinking? When political priorities favour the short term, how can we move to the longer time horizons that we need? Of course spreading public money more or less evenly across federal and provincial regions seems like the fair thing to do. But we want our centres of excellence and bioscience industry clusters to be world class, and this will not happen if government investment is spread too thinly. The practical approach is to focus on the leverage of existing strengths where they are already located, rather than try to develop similar levels of high expertise in areas sprinkled across the country. To prevent early stage ventures from disappearing forever in the Valley of Death, we must do everything possible to encourage investment by angel investors or mezzanine venture capitalists. In addition to compelling tax incentives, we should create matched equity investment programs that are managed by industry professionals. In public/private investment intended to fill the early stage gap that we face, choosing winners is an uncertain undertaking at best. My experience is that we need to look at the big picture over the long term, and celebrate and publicize the success of the harvest. This is what encourages new investment. The failures can help us learn, if we let them, by guiding the refinement of government programs. Michael Jordan is one of the most celebrated basketball players of all time. Did he have failures? He once said that in his career he missed more than 9000 shots, lost almost 300 games, and on 26 occasions missed the game winning shot he was trusted to make. “I’ve failed over and over and over again in my life”, he said. “And that is why I succeed.”

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Biotechnology Focus May 2011

Articles inside

New Products

Biosimilars: When is the same not the same?

The Last Word

Simultaneous ESI/APCI Measurement with a Dual Ion Source

Across Canada

Filing a Clinical Trial Application in Canada