Biotechnology Focus December 2014/January 2015

INSIGHTS FOR THE LIFE SCIENCE INDUSTRY

DECEMBER 2014/JANUARY 2015 VOLUME 17, NUMBER 6

CANADA’S HEALTHCARE TECHNOLOGY SECTOR WHAT’S HOT & WHAT’S NOT

INSIDE:

ERROR OR FOLLY?

The sorry state of basic research development in Canada

Publication Mail Registration Number: 40052410

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contents DECEMBER 2014/JANUARY 2015 – VOLUME 17 – NUMBER 6

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Canadian Healthcare Technologies: What’s Hot & What’s Not

Error or Folly? The sorry state of basic research development in Canada

FEATURES CANADIAN HEALTHCARE TECHNOLOGIES: WHAT’S HOT & WHAT’S NOT Investor interest is increasing in the Canadian healthcare sector, Wayne Schnarr discusses what areas are seeing the most activity (By Wayne Schnarr)

Opinion

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FLIPPING THE SWITCH IN PARKINSON’S PATIENTS FROM “OFF” TO “ON” Company CEO Anthony Giovinazzo discusses Cynapsus Therapeutics and its lead product for the management of “OFF” motor symptoms of Parkinson’s disease (By Shawn Lawrence)

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PHARMACEUTICAL AND HEALTHCARE LOGISTICS For many biopharmaceutical and healthcare product manufacturers, the business of logistics can be a mine field.The Kuehne + Nagel Group have your needs covered (By Shawn Lawrence)

25 DEPARTMENTS 6 9 26 28

RESEARCH NEWS BUSINESS CORNER NEW PRODUCTS CALENDAR OF EVENTS

MISSISSAUGA: Where Life Sciences Wins the Human Race (Special Report)

IN EVERY ISSUE 22

6 RESEARCH NEWS

New antibody therapeutics company, Northern Biologics, launched www.biotechnologyfocus.ca

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ACROSS CANADA Error or Folly? Experienced biotech executive David Allan underlines the reasons basic research development in Canada is in a sorry state (By David Allan)

THE LAST WORD Canadian Biotech: Back to Business (By Albert Friesen)

December 2014/January 2015 BIOTECHNOLOGY FOCUS 3

PUBLISHER’S NOTE

PUBLISHER/ EDITOR-IN-CHIEF SENIOR WRITER CONTRIBUTING WRITERS

OHIC report a roadmap for action The Ontario Health Innovation Council (OHIC) released its landmark “The Catalyst” report on December 19. True to its name, the report suggests ways to improve conditions for the adoption of new technologie to enhance health care services, reduce costs, create value and support economic growth in Ontario.

The council was established by the Ontario government in 2013. It brought together a diverse group of experts with extensive experience in health care, community care, medical devices, non-profit, mental health, research, academic and health technology businesses.

The council found that small and medium-sized health technology and biotech enterprises face significant challenges connecting with clinicians, patients and buyers to develop new solutions.

“Innovation has the potential to transform health care by empowering people to better manage their wellness and interact with clinicians in more effective ways,” said Dr. Dave Williams, chair of the Ontario Health Innovation Council, and president and CEO of Southlake Regional Health Centre. “However, innovation cannot thrive unless there is a fertile ground to develop new ideas and clear pathways that lead to adoption.”

In all, the OHIC issued six recommendations to achieve these goals. These recommendations included the establishment of an Office of the Chief Health Innovation Strategist, the appointment of innovation brokers to connect health start-ups to resources, the creation of a $20 million pre-market fund to put Ontario’s health system to work in the evaluation of emerging “made in Ontario” health technologies, and strategies to improve and coordinate the procurement, adoption and diffusion of these technologies across the entire health sector.

Several Ontario industry associations including Life Sciences Ontario, the Ontario Bioscience Innovation Organization and MaRS Discovery district have already endorsed the report and its recommendations.

News of this new report ties in very nicely with one of our stories in this issue, specifically David Allan’s piece on the disconnect that exists between government policy and industry in the bioscience space.

While Mr. Allan’s piece focuses more so on the shortcomings of federal government policy in relation to growing the bioscience sector, he does underline the strength of Ontario’s research community, and its great potential as a driver of economic growth.

He also explains it would be “folly” to continue in the direction we are headed. In other words, it’s time for government to step up and recognize this potential. Perhaps acting on the recommendations made in “The Catalyst” report is that first step. We’ll know more in January, when the Government of Ontario will be making an announcement on how it will act upon the report’s recommendations.

Terri Pavelic Shawn Lawrence Albert Friesen

David Allan

Wayne Schnarr

ACCOUNT MANAGER GRAPHIC DESIGNER CONTROLLER MARKETING MANAGER

Laskey Hart Elena Pankova John R. Jones Mary Malofy

CIRCULATION DIRECTOR Mary Labao circulation@promotive.net Tel: 289-879-4272

EDITORIAL ADVISORY BOARD Celine Bak, Analytica Advisors; Rob Henderson, BioTalent Canada; Najla Guthrie, KGK Synergize; Pierre Bourassa, IRAP, Montréal; Murray McLaughlin, Sustainable Chemistry Alliance; Carol Reynolds, AdFarm; Ulli Krull, UTM; John Kelly, KeliRo Company Inc.; Peter Pekos, Dalton Pharma Services; Brad Thompson, Oncolytics; Darrell Ethell, CanReg; John Hylton, John H. Hylton & Associates; Robert Foldes, Viteava Pharmaceuticals Inc.; Randal R.Goodfellow, P.Ag., Senior Vice President, Corporate Relations, Ensyn; Bob H. Sotiriadis, Robic LLP; Dale Patterson, Genome Canada; Darcy Pawlik, Syngenta Seeds Canada Inc; Gail Garland, OBIO; Barry Gee, CDRD; Bonnie Kuehl, Scientific Insights Consulting Group Inc.; Raphael Hofstein, MaRS Innovation Biotechnology Focus is published 6 times per year by Promotive Communications Inc. 23-4 Vata Court, Aurora, Ontario L4G 4B6 Phone 905-727-3875 Fax 905-727-4428 www.biotechnologyfocus.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 – 23-4 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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twitter.com/biotechfocus linkedin.com/company/biotechnology-focus google.com/+biotechnologyfocuscanada facebook.com/biotechnologyfocus 4 BIOTECHNOLOGY FOCUS December 2014/January 2015

LIFE SCIENCE IS A HUMAN RACE 78% of global CEOs rank human capital as the #1 priority*

Making the next breakthrough isn’t about luck. It’s about talent, pure and simple. The brightest minds, specialized education, the insatiably curious – all blended in this unique sector of the knowledge economy. The race is always on in Life Sciences, and Mississauga, Ontario – Canada, is where great companies build winning teams. What else do you need to know?

VISIT WINTHEHUMANRACE.CA TO START NOW. *Source: PwC 15 th Annual Global CEO Survey 2012

R & D NEWS New antibody therapeutics company Northern Biologics launched

Clinical Trials & Patents Neovasc Inc. (Richmond, BC) reports it has enrolled the first patient in the European arm of its TIARA-I Early Feasibility Trial. The trial is being conducted at centers in the U.S., Europe and Canada to assess the safety and performance of Neovasc’s Tiara™ mitral valve system and implantation procedure in highrisk surgical patients suffering from severe mitral regurgitation (MR).Severe MR is a critical condition that affects millions of patients and, if left untreated, can lead to heart failure or death. The first patient was enrolled by Dr. Stefan Verheye, at the Antwerp Cardiovascular Center / ZNA Middelheim, Belgium. The Tiara valve implantation was completed via a minimally invasive, transapical, transcatheter approach, resulting in elimination of the patient’s MR without leaks or other complications. To date, recovery of the patient has been uneventful. TIARA-I has received institutional review board (IRB) approval from the first of the participating U.S. medical centers and anticipates U.S. implantations of Tiara to begin in the coming months. It is expected that additional European and Canadian sites will begin enrolling patients in early 2015. n

Blueline Bioscience (Blueline), a Canadian biotechnology incubator based in Toronto’s Discovery District and backed by venture capital firm Versant Ventures, has launched its first spin-out biotech company.

The new company, Northern Biologics, is one of the first investments from Versant’s newly closed Fund V, with a $10 million Series A financing committed earlier this year. Under an existing agreement with Blueline, Celgene Corporation has the right to negotiate an R&D collaboration with Northern Biologics, under which additional upfront capital and undisclosed future payments would be provided to the company.

Blueline got the ball rolling on the launch of Northern Biologics in partnership with the University of Toronto (U of T) and University Health Network’s Princess Margaret Cancer Centre (UHN) in June, 2014.

Northern Biologics has in-licensed intellectual property from both U of T and UHN, including drug leads and a novel antibody generation platform. The new company will focus on advancing a portfolio of antibody-based therapeutics for both oncology and fibrosis. Stefan Larson, entrepreneur-in-residence with Versant Ventures has been named the company’s CEO, and Jeanne Magram, former site head for Pfizer’s Center for Therapeutic Innovations in New York, has joined Northern Biologics as chief scientific officer.

“Northern Biologics is a great example

of the kind of exciting and innovative earlystage company we can build when worldclass science comes together with entrepreneurial and seasoned venture capital investors,” said Larson, who notes that close collaboration between venture capital and academic institutions is still rare in Canada.

“We are now in a position to rapidly advance several potential new antibody therapies toward the clinic.”

Antibodies are the fastest growing area of therapeutics and represent many of the biggest blockbuster drugs on the market today.

“Antibodies and other medical products from biological sources play an expanding, revolutionary role as alternatives to small molecule drugs by treating disease in a more targeted way and reducing side effects,” said Peter Lewis, interim vice president of research and innovation at U of T. “Northern Biologics is a prime example of the way in which cross-collaboration works to advance and ultimately commercialize the innovative science that is happening in Canadian laboratories.”

The two most significant priorities for Northern Biologics over the next one to two years will be recruitment of its scientific team and rapid advancement of its first drug candidates in preparation for human clinical trials. The company is already actively recruiting and expects to have a team of at least 20 people in place by the end of 2015.

To see this story online visit http://biotechnologyfocus.ca/?p=13324

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Aeterna Zentaris Inc. (Quebec, QC) reports it has opened a new clinical site at the Hollings Cancer Center of the Medical University of South Carolina in Charleston, SC for its ongoing multinational, pivotal ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer.

The Hollings Cancer center is the only National Cancer Institute designated cancer center in South Carolina and the state’s largest academic-based cancer program. In addition to adding a new clinical site, the company also says that patient recruitment for this trial now stands at over 320 patients out of a projected total of 500 patients. The ZoptEC Phase 3 trial is an open-label, randomized, multicenter trial. It will be conducted in North America, Europe and Israel, under a special protocol assessment, comparing zoptarelin doxorubicin with doxorubicin as second line therapy for locally-advanced, recurrent or metastatic endometrial cancer. Lead investigators are Dr. David Scott Miller from the University of Texas Southwestern Medical Center and Dr. Hani Gabra, MD, from the Imperial College London Hammersmith Campus in London, England.

To date, more than 120 sites are in operation and more than 320 of the expected 500 patients have been entered into the trial. n

For more R&D news visit http://biotechnologyfocus.ca/ category/topics/science/

R & D NEWS Cracking the code of cellular reprogramming An international consortium, led by McEwen scientist Dr. Andras Nagy’s laboratory at Mount Sinai Hospital’s Lunenfeld-Tanenbaum Research Institute has conducted the first high resolution characterization of molecular events required for the formation of stem cells from specialized cells, a process called cellular reprogramming. By doing so, the team also identified a new type of stem cell called F-class.

According to the researchers, the new type of stem cell has unique properties compared to previously known stem cell types.

The discovery may open new avenues for generating useful “designer” cells, which might not necessarily exist in the body or during development but could be safer and more efficient when used for therapy.

The importance and anticipated impact of this research is supported by the unprecedented coordinated publication of five scientific articles in the highly respected journals, Nature and Nature Communications on December 11, 2014.

The extremely in-depth analysis of the process of reprogramming specialized cells to stem cells focused on learning how to control the path to either the new F-class stem cell versus “traditional”, embryoniclike stem cells. Comparing the two cell types revealed that the new class of stem cells is easier, less expensive and faster to grow compared with the embryonic-like stem cells. Because of these properties, the new F-class stem cells can be produced more economically in very large quantities, which

will speed up drug screening efforts, disease modeling and eventually the development of treatments for different illnesses.

The Nagy Laboratory at Mount Sinai Hospital’s Lunenfeld-Tanenbaum Research Institute is historically a stem cell laboratory.

The team joined research on reprogramming shortly after Dr. Shinya Yamanaka’s discovery of induced pluripotent stem (iPS) cells, for which he received the Nobel Prize in 2012.

Additionally, Dr. Andras Nagy’s laboratory was the first to report a method of producing stem cells without the need for viruses that could harm the genetic material. This work was published in 2009, also in the journal Nature. For this discovery Dr. Nagy was selected for the first annual Scientific American Top 10 Honor Roll in 2009, which he shared with U.S. President Barack Obama, Bill Gates, Michael Bloomberg and others.

In 2010, Dr. Nagy received financial support from the Ministry of Science and Innovation of Ontario, his industry partner Pfizer, the Canadian Institutes of Health Research and the McEwen Centre for Regenerative Medicine to carry out the research that

resulted in the current five publications.

This support allowed his group to engage with other stem cell research experts from laboratories in Australia, South Korea and The Netherlands. The resulting consortium generated and analyzed an unprecedented dataset, uncovering the molecular events underlying biological processes of cell fate change toward stem cells.

“It was an enormously enlightening feeling that a single scientific question was able to transcend geographical distances, time zones, international borders and cultural differences. Each of the close to 50 scientists with unique expertise contributed to a unified product which none of us as individuals could even get close to,” said Dr. Nagy.

The research project, spearheaded by Dr. Andras Nagy at Mount Sinai Hospital’s Lunenfeld-Tanenbaum Research Institute, involved close to 50 researchers in Canada, The Netherlands, South Korea, and Australia, over four years. The team has catalogued the major biological stages of the reprogramming process, identifying which combination of genes and proteins are associated with each step. The comprehensive dataset generated from this work acts as a detailed multi-dimensional map that will be used world-wide for even more discovery by hundreds of labs working on reprogramming, stem cells, cancer, fetal development and regenerative medicine.

To see this story online visit http://biotechnologyfocus.ca//?p=13336

Life Sciences Ontario Annual Awards Gala Dinner Recognizing 2015 Award Recipients Reserve your table or ticket today

February 25, 2015 at Liberty Grand, Exhibition Place, Toronto Lifetime Achievement Award: John Oliver, B.S.A., Chairman, Flax Canada 2015 Inc.; Advisory Board, Canadian Agri-Food Policy Institute and President, Maple Leaf Bio-Concepts & Lojon Associates International LSO Volunteer Award: Christine Beyaert, Counsellor, Cohn & Wolfe

Public Service Award: Dr. Deb Stark, MBA, Deputy Minister of the Ministry of Agriculture, Food and Rural Affairs

Community Service Award: Dr. Luis Barreto MBBS, MD, MHSc, President, Dr. Luis Barreto & Associates & Special Advisor, Vaccine Program, Human Health Therapeutics, Canada’s National Research Council (NRC).

Life Sciences Company of the Year: Xagenic Inc. Shana Kelley, Founder & Chief Technology Officer

For more information on registration and sponsorship phone: 416-426-7293 or email: admin@lifesciencesontario.ca.

More details will be posted on www.lifesciencesontario.ca December 2014/January 2015 BIOTECHNOLOGY FOCUS 7

R & D NEWS Oncolytics Biotech Inc. seeking orphan drug designation for REOLYSIN® Oncolytics Biotech Inc. reports it has submitted applications for orphan drug designation to the U.S. Food and Drug Administration (FDA) for REOLYSIN® as a treatment for pancreatic and ovarian cancers.

REOLYSIN® is Oncolytics’ proprietary isolate of the reovirus. Its primary mode of activity is to infect and selectively target tumours by activating Ras pathway mutations and/or over-expressions of Ras pathway elements including, amongst others, EGFR, BRAF, and KRAS. Up to 70 per cent of pancreatic cancers have activating Ras pathway mutations and/or over-expressions.

“Many patients with either pancreatic or ovarian cancer are not diagnosed until after their disease has progressed to its later stages, which reduces their survival outcomes,” said Dr. Brad Thompson, president and CEO of Oncolytics. “The development of more targeted treatment options, in this

case an agent targeting cancers with Ras pathway defects, will allow patients to access the most suitable treatment for their specific case.”

The FDA grants Orphan Drug Designation status to products that treat rare diseases. The designation provides incentives to sponsors developing drugs or biologics, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The FDA defines rare diseases as those affecting fewer than 200,000 people in the U.S. at any given time. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval..

To see this story online visit http://biotechnologyfocus.ca/?p=12494

Dr.Fang Liu

CAMH discovery of novel drug target may lead to better treatment for schizophrenia

Scientists at the Centre for Addiction and Mental Health (CAMH) have identified a novel drug target that could lead to the development of better antipsychotic medications.

Dr. Fang Liu, senior scientist in CAMH’s Campbell Family Mental Health Research

Institute and professor in the Department of Psychiatry, University of Toronto, and her team published their findings online in the journal Neuron. Current treatment for patients with schizophrenia involves taking medications that block or interfere with the action of the neurotransmitter dopamine, which acts on dopamine D2 receptors in the brain. However, because this D2-blocking action may cause unwanted side-effects, such as slow gait, stiffness and tremor, Dr. Liu and her team looked for new ways to interfere with the action of D2 receptors, without causing these side-effects.

Dr. Liu and colleagues showed that the D2 receptor could combine with a protein called the Disrupted-In-Schizophrenia (DISC1) protein. Then, they showed that levels of this combined protein were higher in post-mortem brain tissues of deceased patients with schizophrenia, suggesting it was associated with the illness. Delving even further, the researchers identified the regions where the two proteins bound together.

With this information, they were able to generate a peptide to disrupt the binding of the two proteins, speculating that it may reduce symptoms. In animal models of schizophrenia, they were able to demon-

8 BIOTECHNOLOGY FOCUS December 2014/January 2015

strate that this disruption led to antipsychotic effects, comparable to commonly used antipsychotic medications, but without their side-effects.

“The most exciting aspect of our finding is not the antipsychotic effect of this peptide, which all current antipsychotics have, but rather the possibility of a lack of the side-effects in humans compared to current medications”, says Dr. Liu. “We hope that it will lead to a better treatment for schizophrenia patients who experience side-effects from current medications.”

These side-effects discourage some patients from taking their medications, which impacts recovery. Schizophrenia is a chronic, often severe and disabling mental illness that affects one per cent of the general population.

“Our future steps are to determine how this discovery can be translated into a novel treatment for patients as soon as possible,” says Dr. Liu. “We are optimistic that our findings will lead to new and better options for treatment for schizophrenia.”

This study was funded by the Canadian Institutes of Health Research (CIHR).

To see this story online visit http://biotechnologyfocus.ca//?p=13320

BUSINESS CORNER Versant Ventures closes $305 million healthcare fund

Global healthcare investment firm Versant Ventures reports it has closed a new fund at $305 million US. Exceeding its target size of $250 million, the new ‘Versant Venture Capital V L.P. fund’ also included significant support from the Business Development Bank of Canada, the Fonds de solidarité FTQ, Northleaf Venture Catalyst Fund and Teralys Capital.

“We are grateful for the support of all our limited partners, who allow us to pursue the mission of helping exceptional entrepreneurs build the next generation of healthcare companies,” said Brad Bolzon, Versant’s managing director. “We are encouraged to see such strong support from Canadian investors who understand the value of supporting medical innovation occurring in institutions across the country.”

The Versant V portfolio will be diversified with investments made across the healthcare sector and at all stages of company development. Consistent with Versant’s recent strategy, a key focus will be the discovery and development of novel therapeutics. This includes de-

signing and building companies based on breakthrough discoveries, and financing them with venture syndicates or Pharmaceutical partners including “build-to-buy” collaborations. Many of these investments will be driven by Versant’s own company creation engines which have collectively spawned seven new companies and consummated almost as many strategic pharmaceutical partnerships.

Examples include: Quanticel, Inception 3, and Northern Biologics, a Toronto-based company just launched from the Blueline Bioscience engine. This new company is developing therapeutic antibodies in a strategic partnership with Celgene. The remainder of the fund will be devoted to high-potential companies across the healthcare sector that are in need of growth capital to develop or commercialize their products.

“We are witnessing significant changes in the way innovative products are developed and financed,” noted Bolzon. “Versant’s investment strategy in Canada will involve more collaborative models that unite entrepreneurs, investors and industry partners to advance important thera-

pies. As one of our first investments from the new fund, Northern Biologics exemplifies this approach.”

The new fund also gives Versant the ability to continue to act as a catalyst in the resurgence of the venture ecosystem across Canada. “We entered Canada with the idea that we could identify untapped healthcare investment opportunities,” says Versant partner Jerel Davis who oversees Canadian investment activities.

Over the last 18 months, Versant has launched multiple enterprises throughout Canada including Inception Sciences research sites in Vancouver and Montreal and formed Blueline Bioscience, a biotechnology incubator in Toronto. Versant will take a pan-Canadian outlook to identify breakthroughs from world class research centers, capitalize on available life sciences talent and deploy its unique investment model.

“Our vision is already becoming a reality based on the companies we have seen launch in Vancouver, Montreal and Toronto. We believe that this approach to incubating and supporting early stage companies fits the Canadian environment extremely well,” noted Davis.

Since its inception, Versant has raised $1.9 billion US to invest in innovative biopharmaceutical, medical device, and healthcare services/HCIT companies. The firm invests from offices in the United States, Canada, and Europe, and it has assembled a team with deep investment, operational, and scientific expertise that enables a hands-on approach to company building.

To see this story online visit http://biotechnologyfocus.ca/?p=13326

Immunovaccine graduates to Toronto Stock Exchange Shares for Immunovaccine Inc. are now trading on the Toronto Stock Exchange (TSX) following the company’s graduation to the exchange on Nov. 26. The shares are listed under the symbol “IMV’.

“Over the past several quarters, Immunovaccine has made significant progress in advancing our broad pipeline of nextgeneration vaccine candidates in the areas of cancer and infectious diseases, and our graduation to the main board is an important step as we broaden our investor audiences both in Canada and abroad,” com-

mented company CEO Dr. Marc Mansour.

Immunovaccine Inc. develops cancer immunotherapies and infectious disease vaccines based on its DepoVax™ platform, a formulation that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and the company’s lead cancer vaccine therapy, DPX-Survivac, is expected to enter Phase 2 clinical studies in both ovarian cancer and glioblastoma (brain cancer),

with the company also exploring additional studies in other indications including lymphoma and recurrent ovarian cancer. The company also has vaccines in developmentfor respiratory syncytial virus (RSV), anthrax and Ebola virus.

To see this story online visit http://biotechnologyfocus.ca/??p=13187

December 2014/January 2015 BIOTECHNOLOGY FOCUS 9

BUSINESS CORNER Canadian Ebola vaccine licensed to Merck Global pharma giant Merck & Co Inc. has bought the worldwide commercial rights to NewLink Genetics Corp’s experimental Ebola virus vaccine rVSV-EBOV. The vaccine platform is based on an attenuated strain of vesicular stomatitis virus that has been modified to express an Ebola virus protein that plays an essential role in establishing virus infection. The rVSV-EBOV vaccine was created by scientists at the Public Health Agency of Canada’s National Microbiology Laboratory. A significant portion of the funding for the further development of the vaccine came from the CBRN Research and Technology Initiative, a federal program led by Defence Research and Development Canada.

NewLink, whose subsidiary licensed commercial rights to the rVSV-EBOV vaccine in 2010, said it would receive $50 million US plus royalties from Merck, including $30 million upfront. Additionally, the Public Health Agency of Canada will retain non-commercial rights Merck added in a news release that large late-stage trials of the product could begin early next year.

The Walter Reed Army Institute of Research and the U.S. National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health, are currently conducting early-stage trials of the NewLink vaccine. The trials involve healthy volunteers and are testing whether the vaccine is safe and provokes

a protective immune response.

The World Health Organization is also coordinating early-stage trials in Switzerland, Germany, Kenya and Gabon.

To see this story online visit http://biotechnologyfocus.ca/?p=13199

Dealmakers Bradmer Pharmaceuticals Inc. has entered into a letter of intent dated November 18, 2014 with XORTX Pharma Corp. to complete a going-public transaction for XORTX. XORTX is a privately held life science company based in Calgary. The development stage company focuses on proprietary repositioning existing drugs with known biological mechanism and safety for use as novel therapy in kidney disease and diabetes. Both Bradmer and XORTX intend to hold their respective shareholder meetings on or before March 15, 2015 to approve the proposed transaction. n

Cardiome Pharma Corp. through an affiliate has entered into an agreement with Pharmacare Limited, a member of the Aspen Group, to sell and distribute BRINAVESS® (vernakalant intravenous) exclusively in South Africa. Under the terms of the agreement, Aspen has agreed to specific annual commercial goals for BRINAVESS. Financial details of the agreement were not disclosed. BRINAVESS is used for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults for non-surgery patients with atrial fibrillation of seven days duration or n

less and for post-cardiac surgery patients with atrial fibrillation of three days duration or less.

Knight Therapeutics Inc. (Montreal, QC) has entered into a senior secured debt agreement with CRH Medical Corporation (Vancouver, BC), a North American medical company focused on providing physicians with innovative products and services for the treatment of gastrointestinal diseases. This secured loan will fund CRH’s acquisition of Gastroenterology Anesthesia Associates, LLC and GAA Management, LCC, collectively a Southeast US-based Anesthesia services provider. Knight’s secured loan of USD$30 million will be complemented by (i) a sub-secured loan of CAD$22.5 million from Crown Capital, (ii) an unsecured loan of USD$2 million from the Bloom Burton Healthcare Structured Lending Fund II, (iii) an equity financing of CRH common shares raising USD$5 million, (iv) and CRH cash on hand. The loan matures on December 1, 2016 and will be extended for one year should CRH meet profitability milestones. The loan is secured by a charge over the assets of CRH and GAA. In addition, Knight has been issued 3,000,000 common shares in the capital of CRH. n

10 BIOTECHNOLOGY FOCUS December 2014/January 2015

Aeterna Zentaris Inc. (Quebec City, QC) and Sinopharm A-Think Pharmaceuticals Co., Ltd. have signed an exclusive license and technology transfer agreement, for the Aeterna’s lead anti-cancer compound, zoptarelin doxorubicin, for the initial indication of endometrial cancer, for the Chinese, Hong Kong and Macau markets. Under the terms of the master collaboration agreement, Aeterna Zentaris will be entitled to receive a non‑refundable $1 million fee for the transfer of the company’s technology for zoptarelin doxorubicin to SinopharmA-Think.

SinopharmA-Think has also agreed to make additional payments to the company upon achieving certain pre-established regulatory and commercial milestones. Furthermore, the company will receive royalties on future net sales of zoptarelin doxorubicin in the territory. SinopharmA-Think will be responsible for the development, production, registration and commercialization of the product in the territory. n

For more Business Corner news visit http://biotechnologyfocus.ca/category/ topics/business/

BUSINESS CORNER Knight Therapeutics cashes in lottery ticket: sells priority review voucher to Gilead for $125 million Gilead Sciences is paying Montreal-based Knight Therapeutics $125 million in cash to buy the latter’s priority review voucher (PRV), a unique tool that can be used to speed up a future filing.

Developed by the U.S. Food and Drug Administration (FDA) in 2007 under the Food and Drug Administration Amendments Act (FDAAA), a PRV is an incentive for companies to invest in new drugs and vaccines for neglected tropical diseases. The PRV is a transferrable asset that entitles the holder to a priority review for a drug of its choice.

This means the priority review voucher entitles Gilead to move a drug of its choice through the FDA up to four months faster than the normal track. The catch is that it can only be sold once.

Gilead has not disclosed what it intends to use the PRV for yet. To use the voucher, the owner has to give the FDA at least a 365-day warning that it plans to use the voucher for a future marketing application.

The PRV was granted to Knight in March, 2014 with the approval of Impavido® (miltefosine) for treatment of patients with visceral, mucosal and cutaneous leishmaniasis. According to the World Health Ogranization, approximately 1.3 million people a year become sick with leishmaniasis. Knight chief executive Jonathan Goodman had said when the PRV was initially awarded that the company planned to “monetize the voucher for maximum value.”

The sale of the PRV to Gilead marks the second time a PRV has exchanged hands via a sale. Earlier this year, Regeneron Pharmaceuticals, Inc. purchased a rare pediatric disease priority review voucher from BioMarin Pharmaceutical Inc. Regeneron paid $67.5 million for that priority review voucher.

Knight Therapeutics was advised in the transaction by global investment banking firm, Jefferies LLC.

258 biotech graduates start Canadian biotech careers thanks to federal program

Thanks to the Career Focus program funded by the Youth Employment Strategy of the federal department of Employment and Social Development Canada, BioTalent Canada has successfully employed 258 new graduates with dozens of biotech businesses across Canada.

Career Focus is a wage subsidy program administered by BioTalent Canada that small and medium-size businesses across Canada can access and obtain up to $20,000 in federal subsidies for a new graduate’s first year of employment.

Since this version of the program began in April of 2013, BioTalent Canada has disbursed almost $2.5 Million in wage subsidies for new graduates to Canadian companies. The program matches dollar per dollar the employer’s contribution to the first year’s salary of the new graduate, up to a maximum of $20,000.

“The Career Focus Program is by far our most popular and successful program,” said Rob Henderson, BioTalent Canada’s president and CEO. “The program effectively addresses the two greatest challenges facing Bio-economy SMEs – access to capital and access to talent.”

While BioTalent Canada has been a participant in the Career Focus program for almost a decade, never have they had such a quick and overwhelming response from bio-economy businesses across Canada. The organization attributes the success to two things: the increased demand in Canada’s Bio-economy and BioTalent Canada’s corporate

partners, who spread news of the program widely to hundreds of businesses.

Charles River Laboratories, a contract research firm located on the island of Montreal, is one of the Canadian companies that benefited from the Career Focus Program. “With an international reputation, our technical expertise and science is recognized worldwide. Charles River is always willing to help new graduates start their professional career in an exciting environment like ours,” said Crystel Kiriakos, recruiter, Human Resources.

“The Career Focus Program helped us attract post-secondary graduates with the opportunity to gain experience in the industry and find permanent employment in their field of study,” she said.

Their newest employee agrees.

“Charles River gave me the perfect opportunity right after graduating, with its diversity of activities and important case load; I’m gaining incredible experience and learning new things every day,” said Charles River Laboratories’ clinical veterinarian and recent graduate MarieChristine Barma Hamel.

BioTalent Canada credits the need within the industry for the success of the program. “While the demand has never been greater for a program like this, BioTalent Canada’s national and provincial industry association and corporate partners were instrumental in getting the word out,” said Rob Henderson. “So much so that we exceeded our quota and disbursed all program funds quicker than ever before. This is a huge advantage of our corporate partnership program which is the largest and widest in Canada’s bioeconomy,” he said.

Currently 95 per cent of young people who are placed in the Career Focus Program retain employment in their host company, or return to school. BioTalent Canada plans to publish a research report outlining labour statistics of the program and placements of the Career Focus program in early 2015.

For more information about the program, please visit www.biotalent.ca/ wagesubsidies.

To see this story online visit http://biotechnologyfocus.ca//?p=13195

To see this story online visit http://biotechnologyfocus.ca//?p=13131 December 2014/January 2015 BIOTECHNOLOGY FOCUS 11

By: Wayne Schnarr

INDUSTRY INTEL

CANADA’S HEALTHCARE TECHNOLOGY SECTOR What’s Hot & What’s Not There has been a surge in activity and investor interest in the Canadian healthcare sector in 2014.The following factors, all originating outside Canada, substantially influenced this surge:

• Rationalization of the pharmaceutical and medical technology industries will probably be a continuous process. Large companies are disposing of non-core and underperforming assets which are being acquired by global and regional players, including some Canadian companies.

However, the larger companies are also licensing or acquiring the assets which they need now and over the next ten years to fill their pipelines.

• IPO windows for U.S. biotechnology companies have occurred in an unpredictable manner over the last two decades. The IPO window during the last two years has allowed senior private companies to complete IPOs, including those by two Vancouver companies, Aquinox Pharmaceuticals and Xenon Pharmaceuticals. The IPOs and other major financings completed during this window gave companies three to four years of cash to reach major clinical or commercial milestones.

• Moving head offices to lower tax jurisdictions triggered many headlines, action by U.S. regulators and substantial share price volatility for potential targets. Montréalbased Paladin Labs was acquired by Endo, following which Endo moved its global headquarters from the U.S. to Ireland for its lower tax rates. Auxilium planned to acquire Vancouver-based QLT for a similar reason but Endo will now acquire Auxilium, using its tax advantage to make the superior bid.

• The Ebola outbreak in several African countries became a factor when it was carried back to the U.S. and Spain, and the developed nations realized they needed therapeutics. Whereas the African countries and WHO could never pay market prices for a vaccine or therapeutic, U.S. biodefence programs, especially BARDA, would fund both development and stockpiling of Ebola therapeutics.

12 BIOTECHNOLOGY FOCUS December 2014/January 2015

While biotechnology was very hot in U.S. markets during 2013 with an open IPO window, numerous follow on financings and rapidly climbing valuations, the activity in Canada was strong but not hot. There were no institutionally-backed IPOs – the last one in Canada was IMRIS in late 2007. Investors profited when several senior Canadian companies were acquired or taken private, among them: Atrium Innovations, Cangene, CML HealthCare, Medicago, OPMEDIC Group, Paladin Labs and Patheon. While the NASDAQ Biotechnology Index doubled in 2013, a group of 19 Canadian therapeutics companies had an average share price increase of 41 per cent (see quarterly blogs at http://www.bloomburton.com/blog/).

A single event in 2013 may have triggered the surge and defined the focus of Canadian investor interest for 2014. Endo Health Solutions announced on November 5 that it would acquire Paladin Labs in a stock and cash transaction which valued Paladin Labs shares at C$77 and the transaction at about US$1.6 billion. Under the terms of the transaction, Paladin Labs shareholders received for each Paladin share: C$1.16 in cash, 1 share of Knight Therapeutics and 1.6331 shares of Endo, the latter valued at US$104.05 based on the closing price on February 28, 2014 when the acquisition was completed.

For public companies, share price increases determine which companies and sectors are hot. The hottest Canadian healthcare group throughout 2014 has been the Therapeutics – Commercial group, where companies have revenues from approved drugs, many of which were acquired. Canadian investors are still generally risk averse, preferring to accept the commercial risk of this sector rather than the scientific and clinical risk of early stage companies.

INDUSTRY INTEL

Some investors were looking for the next Paladin Labs, where the patient accumulation of late-stage and commercial products and the subsequent acquisition by Endo was an enormous success for Paladin shareholders.

Some investors may have picked companies which had the best potential to be tax-inversion targets. However, the share prices in this group have not dropped after recent U.S. regulatory action to discourage tax-inversion transactions.

For seven of the larger companies in this group (excludes Nordion, which was acquired, and Valeant), the average share price change for the first nine-months of 2014 was +115 per cent, with the best performers being Concordia Healthcare (+362 per cent), BioSyent (+154 per cent) and Nuvo Research (+123 per cent).

Former Paladin CEO Jonathan Goodman also liked his business model, started Knight Therapeutics as Paladin 2.0 and raised over $250 million to start executing that business strategy. Knight Therapeutics recently sold its U.S. FDA Priority Review Voucher to Gilead Sciences, for which it will receive US$125 million in cash upon closing the transaction.

While BELLUS Health (+238 per cent) is not part of this group, it probably benefited from the commercial focus of investors. Although its lead product is still in a Phase 3 trial, BELLUS Health and its partner in KIACTA are looking to monetize their investment. The Microbix Biosystems (+264 per cent) share price rose twice based on patent litigation against Novartis, initially in the U.S. and then in the E.U., alleging infringement of its VIRUSMAX patent.

Ebola-based share price volatility impacted many companies with antiviral or vaccine products or technologies. One of the few companies with an Ebola product in a hu-

man trial before the outbreak was Tekmira Pharmaceuticals (+181 per cent). The share price volatility was probably due to both Ebola and news on other RNAi products in both its own and its partners pipelines. ImmunoVaccine (+105 per cent) announced positive results for an Ebola vaccine using its DepoVax technology which was tested in a primate study performed by the U.S. NIAID. More than 30 other Canadian healthcare companies had nine-month share price changes of more than 40 per cent, both positive and negative. Some share price movements were not clearly related to a significant event but may have been bounces from share price lows or relief bounces on completion of a survival financing. Typical of early stage companies, share price movements of several companies were related to clinical and regulatory progress, delays or disappointments.

Looking deeper at these 30 other companies: • ProMetic Life Sciences (+85 per cent) has a revenue-generating bioseparations business and announced progress in developing both a plasma-derived product (plasminogen) and a small molecule (PBI-4050).

• TSO3 (+76 per cent) announced progress in the U.S. FDA review of its STERIZONE VP4 sterilizer.

• Neovasc (+55 per cent) announced the first human implants of its Tiara mitral valve.

• Spectral Diagnostics (-45 per cent) expanded the number of patients in its pivotal trial of the PMX device for treating sepsis, which will result in a delay in final clinical data.

• Oncolytics Biotech (-61 per cent) announced Phase 2 clinical trial data using REOLYSIN to treat pancreatic cancer which was positive for the KRAS mutated group

MORE THAN 30 OTHER CANADIAN HEALTHCARE COMPANIES HAD NINE-MONTH SHARE PRICE CHANGES OF MORE THAN 40 PER CENT, BOTH POSITIVE AND NEGATIVE. SOME SHARE PRICE MOVEMENTS WERE NOT CLEARLY RELATED TO A SIGNIFICANT EVENT BUT MAY HAVE BEEN BOUNCES FROM SHARE PRICE LOWS OR RELIEF BOUNCES ON COMPLETION OF A SURVIVAL FINANCING.

but did not meet market expectations.

• iCo Therapeutics (-86 per cent) announced data from a Phase 2 clinical trial treating diabetic macular edema patients which did not show a clear benefit from the use of iCo-007.

For private companies, the indicator for hot areas is the completion of major financings, such as the following two completed in Canada in 2014.

Antibodies remain a hot area, especially antibody-drug conjugates. Vancouverbased Zymeworks is developing bi-specific antibodies and antibody drug conjugates for the treatment of oncology, autoimmunity and inflammatory diseases. They

December 2014/January 2015 BIOTECHNOLOGY FOCUS 13

INDUSTRY INTEL GOOD CLINICAL DATA CAN TURN INVESTOR ATTENTION TO A PREVIOUSLY IGNORED CLASS OF DRUGS.

A FIVE PER CENT OR MORE DISTRIBUTION AND A SLOWLY GROWING SHARE PRICE BY A HEALTH SERVICES COMPANY MAY BE A HOT INVESTMENT FOR AN INCOME INVESTOR WHEREAS THE INVESTOR IN EARLY STAGE COMPANIES IS LOOKING FOR THE HOT COMPANIES FOR WHICH ANNOUNCEMENTS CAN DOUBLE THEIR SHARE PRICE.

recently completed a $17.3 million financing and an expanded licensing and collaboration agreement with Eli Lilly.

Certain drug targets continue to attract investments. Amgen’s cholesterol-lowering drug evolocumab targeting PCSK9 is under review at the U.S. FDA. Montreal-based Liphorus Pharmaceuticals has just raised $6.4 million from Sanderling Ventures to develop small molecules that address PCSK9 at the intracellular level.

One of the common stock market disclaimers ‘past share price performance may not be an indicator of future share price performance’ is applicable and can also be morphed into ‘hot areas in 2014 may not be hot in 2015 or subsequent years.’ Below I’ve compiled a list of what factors should be considered and what questions should be asked when determining what will be hot in the next few months or years: • Commercial progress is not always immediately reflected in the share price. The long-term share price chart for Paladin Labs shows periods where the share price was stagnant.

• Hot can turn into cold for an entire class of drugs if one drug shows an unacceptable side effect profile.

• Good clinical data can turn investor attention to a previously ignored class of drugs.

• Just as the acquisition of Paladin Labs may have defined the investor focus for 2014, a single event could define the investor focus for 2015. It might be the IPO announced for Profound Medical, which is developing a treatment for prostate cancer which combines MRI guidance and ultrasound energy to deliver thermal ablative therapy. The IPO is structured as a $30 million private placement and an RTO of a capital pool company.

14 BIOTECHNOLOGY FOCUS December 2014/January 2015

• A five per cent or more distribution and a slowly growing share price by a health services company may be a hot investment for an income investor whereas the investor in early stage companies is looking for the hot companies for which announcements can double their share price.

• An investor could take a top-down approach to this analysis – look at what the large companies need to license or acquire and invest in those areas.

• Should short-term trading be a focus since more than 1/3 of the companies in the Canadian healthcare sector had share price changes of +/- 40 per centor more in the first nine months of 2014?

Wayne Schnarr is a mostly-retired healthcare consultant with over 30 years of experience in the biotech and financial industries. He is currently an advisor to Bloom Burton & Co. and TMX Equicom. The opinions expressed in this article are strictly personal and do not reflect the opinions of any current or past employers or consulting clients. Past share price performance may not be an indicator of future share price performance. The author and his immediate family members may have long or short positions in the shares of some companies mentioned in or assessed during the preparation of this article. Investors should obtain professional advice based on their own individual circumstances before making an investment decision.

To see this story online visit www.biotechnologyfocus.ca/ industry-report-whats-hot-whatscanadian-healthcare-sector

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INNOVATOR

Flipping the switch in Parkinson’s patients

FROM “OFF” TO “ON”

P

Anthony Giovinazzo, CEO and President of Cynapsus Therapeutics Inc.

arkinson’s disease, it affects more than one million people in the U.S. and approximately six million globally, with both figures expected to double in the next 15 years due to the effect of the aging Baby Boomer Generation. And for many sufferers of this chronic and progressive neurodegenerative disease, the loss of motor activity is just half of the struggle that they are burdened with. It’s estimated that one quarter to one half of all people with Parkinson’s disease also experience what are called “freezing” or “off” episodes.

These episodes can occur between one and several times a day and last anywhere between 30 and 120 minutes per episode.

What is an “off” episode? It’s a period of time during which Parkinson’s symptoms reemerge despite taking standard-of-care Parkinson’s drugs. These episodes are relatively

16 BIOTECHNOLOGY FOCUS December 2014/January 2015

common in patients who use Levodopa (L-dopa), the gold standard-of-care for the disease. The episodes begin when during treatment L-dopa enters the bloodstream too slowly, or the dose is insufficient. While there is a rescue therapy available to patients via a drug called apomorphine, it too has its own set of complications. Specifically, its mode of delivery, injection, is both inconvenient and painful. It also can produce negative reactions, including irritation at the injection site.

Enter Canadian biotech company Cynapsus Therapeutics Inc., whose lead product APL-130277 may soon prove a viable alternative for the delivery of apomorphine.

Cynapsus CEO and President Anthony Giovinazzo explains, “What we are developing is an under-the-tongue thin-film strip system, similar to a Listerine® Breath strip, that a Parkinson’s patient can easily retrieve, place under their tongue and is fast acting when an ‘off’ episode is starting, thus eliminating the requirement for injections.”

With the administration of injectable apomorphine being cumbersome and painful, Giovinazzo believes his strip will allow for more widespread adoption of this effective

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INNOVATOR drug. The drug, apomorphine (which is not a narcotic or scheduled drug) has been approved in the U.S. for 10 years and in Europe for 20 years. Its rapid and unique efficacy has been known for a long time.

The strip, which dissolves in about one to two minutes, delivers the drug into the bloodstream in a similar time interval and concentration as an injectable dose, making it a more convenient and tolerable alternative.

Moreover, as a sublingually delivered drug, Giovinazzo says it has the potential of treating a much larger group of Parkinson’s patients.

“Essentially, we’re delivering the same drug unaltered but through an improved mode of delivery.”

He adds that over the last 15 years, some 10 or more companies have tried to reformulate apomorphine in other ways, such as drops inside the nasal cavity, pumps, patches, pulmonary inhalers and suppositories, but all failed for two reasons.

“Firstly, they could not get enough of the drug into the bloodstream fast enough, and secondly they did not deal with the irritating nature of the drug,” says Giovinazzo. “The choice to use a sublingual strip allows us to address both challenges.”

Cynapsus acquired the rights to APL-130277 when it purchased Adagio Pharmaceuticals in 2011, but Giovinazzo’s ties to the technology stretch further than that. He was a co-inventor of the original intellectual property.

For Giovinazzo and his two other initial coinventors (they had worked for him in two other CNS companies, Cervelo Pharmaceuticals Inc. and Cita NeuroPharma Inc.) who each had had several years of experience in Parkinson’s related drug development, the unmet medical need was obvious. Together, they had met several neurologist experts over the past five years, all of whom said that if a more practical solution to the delivery of apomorphine could be found, many hundreds of thousands and possibly millions of patients would benefit.

The drug APL-130277

One of the co-inventors was an MD from Europe who had worked in Parkinson’s for several years at Novartis, the other was an American Ph.D. in formulation chemistry with 25 years of pharma experience. The three of them spent some 18 months together (with the costs borne by Giovinazzo’s lines of credit and mortgages on his home) looking at everything the other companies and researchers had tried.

The invention team compiled a list of chemistry and delivery issues that would need to be overcome. The result was a complex multivariate set of problems that if the result was going to be protectable by patents (which today it is) would require a unique solution.

“The three of us all came to the same conclusion, that a sublingual thin film strip system just might do the trick,” Giovinazzo recalls.

“That led to the filing of the initial broad patents which were held by our private holding company Adagio Pharmaceuticals Ltd.” The decision to bring the technology to Cynapsus was personal, but it was also business driven in that it was urged by the company’s investors.

“They essentially said if we’re going to fund your company, we want the company to own all the rights going forward, so bringing the product in house was necessary,” says Giovinazzo. “In doing so we substantially strengthened our hold on the product; we went from broad patents that claimed a whole area or field, to additional families of patents that are very specific to the formulations that we were developing.”

It was a decision he hasn’t regretted. The company has since examined APL-130277 in a number of prototypes, animal models and five clinical studies to date, with 110 subjects.

Earlier studies confirmed its mechanical properties, dose proportionality and consistency of pharmacokinetics profile. The latest of which, CTH-105, is a Phase 2 trial (CTH-105) in Parkinson’s patients that indicates the company is on the right track in achieving the goals of the technology.

Specifically, the multicenter open-label study assessed the drug in 16 patients with Parkinson’s disease, and it was able to provide patients with a rapid improvement in motor function in as little as 10 minutes, lasting up to 90 minutes. In all, 14 of the 16 patients converted from “off” to “on” through the use of several different doses of APL-130277.

“I think this trial reinforced the market opportunity and our clinical and regulatory pathway for APL-130277,” says Giovinazzo.

Likewise, the significant scientific milestone for the company was matched by an equally successful accomplishment on the financial

18 BIOTECHNOLOGY FOCUS December 2014/January 2015

side of the ledger in 2014. Namely, the company was successful with an oversubscribed financing of $25 million. Giovinazzo believes the successful financing is directly related to the interest shown by the clinical community in the merits of the technology and the small but highly effective team he has built.

That team is made up of an experienced Chief Medical Officer, Dr. Albert Agro, who Giovinazzo repatriated to Canada after several years of being in large pharma in the US and Europe; a Chief Scientific Officer & EVP Manufacturing, Dr. Thierry Bilbault, who left large pharma after 20 years of expertise in thin film development, manufacturing and some 50 + product launches; a Chief Financial Officer, Mr. Andrew Williams, with extensive experience in technology companies and capital management; a Senior Director, Clinical Development and Medical Affairs, Dr. Jordan Dubow, a US based movement disorder specialist neurologist who was at Abbvie helping develop Parkinson’s related drug candidates; and a Director of Business Development, Mr. Nigel de Gruyther who is former pharmacist and sell side investment banking analyst.

In terms of the merits of the technology, APL-130277 was recognized as one of the “Top 10 Neurology Projects to Watch” by a joint selection committee. This award was based on an independent validation of the potential of APL-130277 by a group of independent U.S. CNS experts.

“They evaluated a number of companies in North America and determined that we were one of the top 10 that should be looked at by large pharma from a partnering or asset development perspective,” Giovinazzo says.

“Some of the rationale behind that was, there have been some validating transactions in the marketplace which have begun to corroborate the size of the potential market of ‘off’ episode [treatments] specifically.”

In fact, the potential size of the worldwide market is likely in the range of $ 1 billion or more according to studies by the company, the Michael J. Fox Foundation for Parkinson’s Research, investment banking analysts and others.

Moreover, it means a lot to have the largest not-for-profit foundation devoted to Parkinson’s disease research in your corner. The Michael J. Fox Foundation for Parkinson’s Research has expressed its faith in technology by providing two separate research grants to advance APL-130277 in clinical trials, one for USD$947,925 in 2012 and another for $500,000 awarded this past June. The process to apply for these grants included due diligence undertaken by scientists and medical

INNOVATOR

The Cynapsus Therapeutics Inc. team practitioners who work inside the Michael J. Fox Foundation as well as an external review committee of world experts. In both instances, APL-130277 was deemed worthy.

In addition to the grants, the Foundation has also opened up its clinical trial database to Cynapsus, driving patients to the company’s clinical sites—which was very helpful from a patient recruitment timeline point of view, says Giovinazzo.

“It’s really a great partnership in that they’ve made a number of suggestions on what we do and how we do it, and they have been catalysts in helping us raise the money,” he says. “As a funding mechanism, it’s a great example of how not-for-profit organizations can effectively help industry move innovation forward. I think that having The Michael J. Fox Foundation Stamp of Approval was also significant in helping us leverage funds from the investor community.”

Looking ahead, 2015 is a seminal year for the company as it embarks on completing its registration studies to enable a New Drug Application to the FDA in late 2016. The company believes that at a minimum the FDA (whom they will meet with in February) will require a bioavailability study in healthy volunteers, and efficacy and safety studies in Parkinson’s patients. These studies are already in the works and are expected to be completed in 2015 through mid 2016.

“The bioavailability study will demonstrate that our strip is equivalent to a certain dose of the injection,” he says. He adds that the company will also do an efficacy study of approximately 100 Parkinson’s patients for somewhere between two and three months in active observation, and then we will do a safety study of about six to twelve months in length with about 100 to 150 Parkinson’s patients.

“The purpose of that safety study is to demonstrate to the FDA that our film strip won’t cause any greater irritation than the injection does and we’re encouraged that it might in fact have lower irritation, because of the technical engineering that was built in to the strip to eliminate irritation—which is the real crux of [our] intellectual property per se.”

Between the bioavailability study and the combined efficacy and safety study, Giovinazzo thinks Cynapsus is on the path for filing a new drug application sometime in late-2016.

“The money we’ve raised from large sophisticated U.S. institutional investors in April of 2014, will provide the majority of the capital to reach that point.”

He adds that the company has also already spoken with the FDA, having done so three years ago, and is meeting them again this year in anticipation of filing an NDA by late 2016.

That said, Giovinazzo says the company may still explore the option of an exit via a licensing deal or sale to an interested third party. On that front, he is encouraged by the recent string of lucrative deals related to Parkinson’s disease products. He cites two transactions in particular that bear watching as comparable for Cynapus: the purchase of Civitas Therapeutics and the worldwide rights to CVT-301, a Phase 3 treatment candidate for “off” episodes of Parkinson’s disease by Acorda Therapeutics, Inc. for $525 million in cash; and Lundbeck’s $658 million acquisition of Chelsea Therapeutics International, Ltd. and its Parkinson’s disease-related blood pressure drop product, Northera.

“Both transactions set very serious comparable values. Like us, Civitas Therapeutics completed its Phase 2b study, issued their data and Acorda decided to pay $525 million cash up front to purchase them. In their case, they deliver levodopa and not apomorphine, and they deliver it through the lungs. They hope to deal with at least two of the four different types of ‘off’ episodes, whereas apomorphine deals with all four of them. On that basis, that $525 million implies a two-times value for Cynapsus. We believe that sets the floor and the global value of our company should be closer to a billion if APL130277 obtains FDA approval.”

The other transaction saw Lundbeck, a very large specialty pharmaceutical company focused in CNS, acquiring American public company Chelsea for $530 million cash up front, and another $128 million in what’s called contingent value rights for the company.

“They’re also in the Parkinson’s field in that their drug Northera deals with what’s called blood pressure drop,” says Giovinazzo. “This condition affects 10 to 15 per cent of all Parkinson’s patients. This is significant in that the number of Parkinson’s patients that drug helps, is about half the number of Parkinson’s patients that apomorphine addresses. So again I believe we’re looking at a two-time value proposition. Of course they had FDA

approval for Northera, so the comparable would be in two to three years time.”

In preparation for just such a scenario, Giovinazzo has already done his own due diligence to assess whether APL-130227, once approved, can gain a foothold in the market.

“We have been somewhat of an unusual small biopharma company in that over the last five years, regarding the APL project, we have undertaken a number of surveys by consultants of 775 neurologists in North America, Europe and several other major countries in the world. We’ve also interviewed and surveyed 14 of the largest payors in the U.S. and likewise we’ve had direct surveys and interviews of 37 Parkinson’s patients in the U.S. The purpose of these surveys and interviews with the neurologists was to determine what they saw was the opportunity with APL130277, and would they favour a sublingual strip of apomorphine over the injection. The payors we surveyed because we wanted to understand what the reimbursement issues might be, if any, and what their price elasticity relative to the injection would be. Lastly, our survey of patients was critical because we wanted to get firsthand knowledge of what their experiences had been with these off episodes. We wanted to know if they were important enough to treat, and would the availability of a strip as opposed to an injection make a difference to them.”

As Giovinazzo explains, the business of biotech should go beyond just developing a drug. It’s about gaining market intelligence and thinking bigger and beyond development.

“Through these surveys, we have to have raw data that is credible, that supports how we would penetrate the market; how we would approach doctors and payors and make sure we understand how to articulate that not just for our own purposes, but also to potential partners such that they understand the market.”

In essence, he’s already answered the question of who’s going to pay how much for the drug, and has a firm grasp on the clinical value of the drug to the patient and the physician.

It’s all shaping up for what could be a milestone year for Cynapsus in 2015 as the company embarks towards continued success in Phase 3 trials.

To see this story online visit www.biotechnologyfocus.ca/ flipping-switch-parkinsonspatients

December 2014/January 2015 BIOTECHNOLOGY FOCUS 19

By Shawn Lawrence

OUTSOURCING

THE RIGHT REMEDY FOR YOUR PHARMACEUTICAL AND HEALTHCARE

LOGISTICS NEEDS

F

or many pharmaceutical and healthcare product manufacturers, the business of logistics can be a mine field filled with its own set of challenges. After all, when it comes to healthcare products, logistics goes beyond just storing and shipping the product. It can include everything from temperature control management, keeping the product secure in terms of the chain of custody, and most importantly, it comes with its own set of regulatory compliance guidelines.

Thus, not every logistics company is capable of providing the right type of services to meet pharmaceutical and healthcare logistics needs. Enter the Kuehne + Nagel Group.

Founded as a family-owned enterprise in 1890, the Kuehne + Nagel Group is one of the world’s leading logistics companies across all industries. With approximately 65,000 employees working at more than 1,000 locations in over 100 countries, the Group covers every aspect of international logistics – on land, at sea and in the air. It also has a significant footprint in Canada, its first Canadian location established in 1953 (the very first that the German/Swiss company expanded to outside of Germany).

Part of this Canadian footprint is a special 380,000 square foot facility located in Mississauga, ON. What makes this facility special is that is home to the company’s Canadian Pharmaceutical and Healthcare logistics center. The building, which officially opened in March 2012 is truly unique says Darrell Skelly, director, Strategic Customer Development Pharmaceutical & Healthcare for Kuehne + Nagel Ltd. “We offer warehousing of human and animal pharmaceuticals, medical devices and other consumer healthcare products. It is fully Pharma Healthcare GMP compliant, with Health Canada drug establishment and medical device licenses in place.”

He explains what makes the building

unique is both the intricate details of its physical design as well as the people who work within it.

In terms of the design, 100,000 sq.ft. is for consumer healthcare products with a further 80,000 sq.ft. that is both temperature and humidity- controlled.

The additional 80,000 sq.ft. of Pharmaceutical Healthcare 15°C to 25°C space is temperature mapped and validated with white scrubable surfaces and GMP complaint sealed flooring. Temperature and humidity set points by zone are maintained by seven roof mounted HVAC units controlled electronically by a building computer system.

Segregated receiving and shipping bay doors are accordion style to eliminate dust and prevent rodent entrance. Multiple Cool Zone areas are also available to meet clients’ specific needs in keeping with the demands of the highly regulated pharmaceutical sector.

“We have multiple coolers and freezers built that range from 2ºC to 8ºC all the way down to -30ºC because we are client driven.

We actually build to the exact requirements

for their products and in most cases we’re the ones investing our capital to meet our clients design needs.”

Whatever the requirements, freezers, coolers or narcotics vaults all are customizable.

He adds that there are redundancy measures in place for everything in the facility; including a diesel generator to support full operations should power go down, coupled with enough fuel on site for three days plus fuel replenishment agreements to ensure power is never lost.

“So we never have to stop working and there are monitors everywhere for temperature and humidity environment measurement, transmitting data to a server, accessible by internet to our employees and securely to the quality control staff of our clients.”

As alluded to, within the facility everything is monitored for both temperature and humidity. This is important due to the

The Global Logistics Network  Worldwide network – more than 1000 locations in over 100 countries  Integrated service portfolio – approximately 63,000 employees  Turnover of CHF 20,930 million in 2013

20 BIOTECHNOLOGY FOCUS December 2014/January 2015

p. 3

OUTSOURCING

nature of the products, and not many logistics facilities today are able to meet both these needs. Another aspect of the facility’s uniqueness is that clients are also given the ability through secured internet-based EDx System access to both track and look at the real-time temperature and humidity readings in their zone of storage and also to print this data for immediate reporting. Combined with further online access to the KN Login system, clients retain strong working control as they may further see specific order status as well as overall inventory status right down to the item level.

“In a way, we’re adding to their capabilities by providing full supply chain visibility from source right through to end-customer. It helps our clients be in control and also helps them to prepare for any audits or studies they wish to do. They gain more capability through outsourcing, and they give nothing up. ” The staff on the site for the Pharma Healthcare centre is equally unique. Again, due to the specialized nature of the products they are handling, the staff are GMP and client specific trained with a focus to ensure quality performance and safety in the patient care supply chain.

He explains, many drugs are highly sensitive to temperature; some are extremely valuable; and all are subject to a complex array of government regulations. In the Pharma Healthcare supply chain, every detail counts.

“Our staff, both here and globally are the ones ensuring that every single process, order and aspect of what they do meets global and local regulatory guidelines and the standard operating procedures as well as each client’s requirements for the storage, warehousing and transportation of their goods. So we have a very high skill level that aligns with the Pharma Healthcare product storage and distribution.”

In fact, the company is an award winning company in terms of both its GMP training and its cold chain management, winning the “Eye for Transport” 3PL award best 3PL for pharma/life science/healthcare supply chains in 2013 and “IQPC” Cool Chain Excellence Awards in 2012 in Europe.

Skelly says it’s important to note that the

service they provide goes beyond just storing and shipping the product. It’s about meeting the needs of the client/customer and ultimately the patient.

“We sell integrated logistics solutions. It’s not just about storing your products; it’s about what is your market strategy, how can we help you reach your end customer and how can we do that from your source, wherever in the world you’re bringing the products from to wherever in the world you need them to be.”

Skelly adds that is what makes the facility so attractive to potential clients, is that it can be tailored to meet the requirements of the client source to end-customer.

“We realize that one size does not fill all so, we’re willing to make strategic investments to ensure our customers are happy. We’re very focused on continuous improvement both here in Canada and worldwide. We have engineers on site who are continuously looking to see how processes can be improved, by changing the way we do things, or adding technology to make things simpler, more effective and accurate. It’s all about being more efficient to create savings for our customers.”

On a global scale the company ranks as one of the top exporters/importers of drugs.

Being global, the company has strived to standardize its pharma and healthcare logistics operations with all the necessary regulating government bodies including the World Health Organization, the U.S. FDA and with Health Canada as applicable.

“Whatever the regulating body is, we do that on one common system worldwide.

Once clients set up on our systems once, it’s just about retesting in other markets. With this capability, we offer them a chance to get a footprint in other markets to expand simply through our reach.”

Likewise, Kuehne + Nagel’s clients also benefit from the company’s international standing.

“On a larger scale we build pharma healthcare solutions that are designed to take products from the source or manufacturing right through to the end customer, or in this case the patient. For Pharma Healthcare, we have 53 centers in 30 countries. So, for a lot of the companies or clients that come to us, we’re not just able to serve them here in Canada, but we can do so also in other countries. We give them the list and they are astounded by our presence,” says Skelly.

Taking it step-by-step, Skelly says the company can arrange the pickup anywhere in the world at the manufacturing plants, provide the containers whether for sea or air, arrange for them to clear customs on an export basis, travel and being monitored at

multiple temperature environments, come to a port or airport, in this case Canada, where they arrange for the proper transport pickup to come right to the facilities too.

“We receive it and enter it into our warehouse management system, put the product away in barcoded specific locations unique to that product, lot number, expiry date and if a medical device, its serial number. That’s all managed on a system that meets Health Canada’s expectations for a Pharma Healthcare validated system.”

Returning to what they do here in the Mississauga facility, he says they deal with all kinds of local and international companies.

“In this facility, we have a full suite of pharma and healthcare products including nutritional products, brand and generic pharmaceutical products, biologics, vaccines, animal drugs and medical devices. We have about a dozen clients in the healthcare industry in this facility currently, as we speak, with two more new clients coming. We also have space to welcome the biotechnology community further starting with 40,000 sq. ft. in the current building still to fill.”

But the company’s logistics footprint in the healthcare and pharmaceutical space goes beyond what they do in the facility he says.

“For example, there are approximately 100 Pharma Healthcare companies that use our sea and air freight services for importing and exporting, and we’re the top air freight mover of drugs in this country,” says Skelly.

The facilities location in the heart of Mississauga’s life science cluster was not accidental says Skelly.

“There are many reasons why Mr. Keuhne negotiated buying this land. This is an industry that’s important to our business. Not only does Mississauga sit at the gateway to the Golden Horseshoe, 45 minutes from CN and CP rail hubs and 20 minutes from Pearson International Airport, but we want to be in the heart of Mississauga’s biotech, pharma and medical device communities. There are about 200 healthcare companies within about 20km of this site, we are in the heart of “Pill Hill”, and we want their business.”

For these reasons, Skelly says the company intends to build a third facility approximately 300,000 sq. ft. on the campus in the near future. The end goal, he says, is to further expand Kuehne + Nagel’s pharmaceutical & healthcare and logistics services.

To see this story online visit http://biotechnologyfocus.ca/ right-remedy-pharmaceuticalhealthcare-logistics-needs-2

December 2014/January 2015 BIOTECHNOLOGY FOCUS 21

By David Allan

ACROSS CANADA

ERROR OR FOLLY?

THE SORRY STATE OF BASIC RESEARCH DEVELOPMENT IN CANADA

P

ublic policy in Canada in respect of the commercialization of our basic life-sciences research has been a costly folly. Only a government sufficiently enlightened to reverse this folly will stand head and shoulders above its predecessors. The absence of constructive policies for commercialization of basic medical research and the presence of impediments in the form of tax policies that specifically discourage capital formation for that activity have resulted in a monumental economic cost to the country and, in particular, to Ontario. Why particularly Ontario and just how much of an economic cost?

As a recent report (http://www. tradecommissioner.gc.ca/eng/science/ document.jsp?did=131981)\) from the Department of Foreign Affairs (DFAIT) states: “Toronto has the largest faculty of medicine in North America, producing more

peer-reviewed publications than any other medical centre in the world. Canada’s health sciences research community includes over 30,000 investigators in 16 medical schools and over 100 teaching hospitals and research Institutes.”

Pretty impressive figures and those “peerreviewed papers” – what I would call a “national resource” – are as precise an equivalent for the life sciences as the rocks, biogenic pools, and trees are the raw materials for our natural resources industries. The publications describe discoveries, innovations or processes of sufficient novelty and interest to merit peer review and thus are the raw material that should be exploited by the “biotech” industry. I use “biotech” rather than “life-sciences” because biotech is where the exploration and development companies work and lifesciences goes beyond to embrace the multinational pharmaceutical companies.

22 BIOTECHNOLOGY FOCUS December 2014/January 2015

A national resource that has produced “more peer-reviewed publications than any other medical centre in the world” is the scientific equivalent of Canada’s happy geographic accident that has provided this nation with its competitive advantage from its natural resources that has given rise to thousands of Canadian companies exploiting them.

A “national resource” of the magnitude we enjoy is significantly superior in quantity to anything available to any of the hundreds of “biotech development companies” that exist in our neighbor to the south – none of them had access at their creation to anything that even approaches the magnitude of Canada’s medical science output.

Of those hundreds we shall focus on just a handful to demonstrate the colossal economic impact in which the development of “biological discovery” can result and that measures what we have foregone.

The largest of the U.S. biotechs by market cap - Gilead Sciences – was valued 20 years ago at $400 million. The third largest, Celgene, was valued at $130 million at the same time. The sixth largest, Alexion, was valued at $15 million. These three companies today – just 20 years on – have a combined market capitalization of ~$290 billion.

Market cap is a fair, evidential proxy for the present value of a company’s ultimate economic contribution. The market cap of those three exceeds the combined market capitalization of all 1,513 listed mining companies on the Toronto Stock Exchange, and to further understand the magnitude also that of Toyota (the world’s largest automotive manufacturer), plus GM and Ford. Just four of the largest U.S. biotechs alone – Gilead, Amgen, Celgene and BiogenIdec – exceed the total value of the entire 340 listed oil and gas companies in Canada. To ensure that our thesis is not dismissed by comparison those four also exceed the market capitalizations of Canada’s “Big Six” banks plus its two largest insurance companies, Sun Life and Manulife.

A curmudgeon would say that apples-toapples would compare biotech to Apple, or Exxon, or even Alibaba rather than to Canada’s natural resource companies. That is completely missing the point. The point is that we have an established competitive advantage in terms of our basic science community and, to our great discredit, we have not only ignored the conversion of this national resource into economic value for this nation but we have created impediments, that we will not disassemble, to its commercialization.

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ACROSS CANADA “ERROR” IS A DECISION THAT TURNS OUT TO HAVE BEEN WRONG, AS THINGS DO. “FOLLY” IS A DECISION THAT TURNS OUT TO HAVE BEEN WRONG BUT MADE DESPITE THE AVAILABILITY OF EVIDENT, READILY-AVAILABLE AND FEASIBLE ALTERNATIVES. Biological exploration and development is undertaken very much as is geological exploration – predominantly by small and mediumsized enterprises. Public policy’s best results are often through tax inducement, positive or negative and, in the case of geological exploration, one of the world’s most admired subsidies, the flow-through-share scheme, has been demonstrably valuable in its 50-year life.

That encouragement to geological exploration is achieved by allocating to the providers of capital the write-offs from losses that are not currently useful to the exploration company thereby decreasing the capital provider’s cost by ~50 per cent. No better description of the utility of this scheme is available than the one posted by the Canada Revenue Agency in its own description.1 Failure in geological exploration is likely to occur rapidly – months but not numerous years – and exploratory success results in a world-market commodity that requires only transportation to secure its price. Conversely, in biological exploration, failure occurs with measurable frequency after many years of development and time-to-failure can exceed 15 years. The “likelihood-of-approval” of an oncology drug in the first stages of development (after “exploration” has identified the asset) is a mere six to seven per cent2 – a number unheard of in geological exploration – and even post-approval there is no certainty regarding the price that a therapeutic might command or that the drug would achieve uptake by physicians. Price and volume can be unknown until after marketing approval.

Capital formation in Canada for this sector has not been well served either by leadership through a broad-spectrum public policy embracing the economic impact of the sector nor by inspiring leadership encouraging capital formation for it. Nor has capital formation been encouraged or promulgated by the national stock exchange as its interest in SMEs has declined markedly over the years. Certain federal and provincial programs have provided capital to the sector for both exploration as well as development with the Scientific Research and Experimental Development Tax Incentive Program (SR&ED) being a coveted exemplar for the rest of the world. However the magnitude of the amounts of capital that are required for development of even a single

drug for a single company in the sector has evidentially not been addressed by any federal or provincial government program because, I submit, it must somehow not be understood that the cost of development for a drug in Canada is largely the same as it is in Japan, Europe or the United States.

Canadian VCs are every bit as sophisticated, professional and well-managed as their peers internationally but the funding available to them pales in comparison to that available in the public markets. One Ontario company, YM BioSciences, raised $80 million in a single equity issue in 2012, approximately the same amount that was provided by all venture capital sources across all investees across the entire province of Ontario that year. The fact is that the public markets in the U.S. provide greater amounts of capital to the life-sciences than venture capital does, whereas in Canada public markets are an oily eddy, a backwater for capital for biotechnology. Incredibly, what is entirely overlooked is that Canada has an enormous population of highly risktolerant investors – those who have poured billions and billions of dollars into the flowthrough-share programs over the past 50 years. The impediment that the federal tax policy creates to these risk-tolerant investors to provide capital, in both the public and private markets, for commercialization of basic life science research, is the monumental folly that has led to our international humiliation and embarrassment that our national resource has been left to decay giving birth to no full-grown, productive development companies because of perverse neglect.

Public policy in Canada ignores the development sector of medical basic research at its economic peril and concentration on basic industries’ maintenance of employment, whilst necessary and socially and economically critical, will never take this province or this country “From Recovery to Growth”.

The hard evidence in this paper shows that biotech is by far and away the nag to bet on for this race.

Where biotech has long been considered an exotic economic appendix, policymakers have been oblivious to its economic and job-creation impact - employment of architects and engineers designing and building

24 BIOTECHNOLOGY FOCUS December 2014/January 2015

factories, construction crews, scientists and workers engaged in manufacturing, managers managing, capital market intermediaries raising capital, high-earning graduates, and Canadian-manufactured medicines reducing costs by replacing imports. The natural resource industry, whose exploration and development is so vigorously supported by Canadian tax policy, in large measure ships our raw materials abroad for processing before Canada re-imports the value-added products. By comparison this is folly.

There are solutions. The initial financial burden on the system can be benign, the raw materials are at our feet and the economic impact of making this sector a priority of government will be rapid and substantial.

The only requirement is comprehension, vision and execution.

References 1. Canada Revenue Agency http://www. cra-arc.gc.ca/tx/bsnss/tpcs/fts-paa/ menu-eng.html Flow-through shares (FTSs) Certain corporations in the mining, oil and gas, and renewable energy and energy conservation sectors may issue FTSs to help finance their exploration and project development activities. The FTSs must be newly issued shares that have the attributes generally attached to common shares. Junior resource corporations often have difficulty raising capital to finance their exploration and development activities. Moreover, many are in a non-taxable position and do not need to deduct their resource expenses. The FTS mechanism allows the issuer corporation to transfer the resource expenses to the investor. A junior resource corporation, in particular, benefits greatly from FTS financing.

2. Clinical Development Success Rates for Investigational Drugs. Michael Hay, David W Thomas, John L Craighead, Celia Economides & Jesse Rosenthal. Nature Biotechnology volume 32 Number 1 January 2014

To see this story online visit www.biotechnologyfocus.ca/ error-folly-sorry-state-basicresearch-development-canada

SPECIAL REPORT

MISSISSAUGA:

Where Life Sciences Wins the Human Race clinical experiences in a wide range of health-care settings.

Continued Growth and investment

Accelerating Innovation Exceptional talent, innovative companies and the convergence of the supports for the life sciences industry are propelling this leading economic cluster forward. For Mississauga, Ontario Canada this is a multidimensional, key sector employing thousands of knowledge workers. The work of our life sciences companies benefit the world with new scientific discoveries, new processes and new drugs and inventions helping people live longer, better lives.

Tried Trained and Talented Mississauga values a strong global business future, fostering a prosperous and sustainable economy that attracts and grows talent. Our City provides firms with access to a skilled talent force with 66 per cent of resident workers having post-secondary education, higher than the national average.

The City is surrounded by 21 of Ontario’s finest, post-secondary institutions, most notably, the University of Toronto Missis-

sauga (UTM) campus that offers one of the few Master of Biotechnology and Master of Management of Innovation programs in Canada.

The University of Toronto Mississauga’s four-storey Terrence Donnelly Health Sciences Complex houses the Mississauga Academy of Medicine, one of the most advanced sites for training family medicine and community-based primary care physicians in Canada. The complex includes laboratory space for life sciences research and expanded facilities for the Biomedical Communications Program.

The Mississauga Academy of Medicine links Mississauga’s vibrant community health-care network with excellence in teaching and research. The Academy partners with Mississauga’s Trillium Health Partners and has access to more than 12 hospitals that are within a 30-minute drive of Mississauga that engage in research and development activities and offer students

Future growth of Mississauga’s Life Sciences Sector is gaining strength and global exposure as leading international companies such as Baxter and Eisai Ltd. continue to re-invest and expand operations in Mississauga.

Baxter recently announced a $10 million investment to build a new facility in Mississauga, Ontario for its Centralized Intravenous Admixing Pharmacy Service (CIVA). The new investment will triple the size of the current facility and will expand Baxter’s ability to meet the needs of Canadian hospitals, clinics and other care facilities for ready-to-administer intravenous (IV) admixtures including chemotherapy, high alert medications and anti-infectives, enabling pharmacists to focus on more direct patient care and clinical activities.

Eisai Limited, the Canadian pharmaceutical sales subsidiary of Eisai Inc., the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. has also expanded into a permanent head office location in Mississauga after four years of tremendous success in the Canadian market.

Today Mississauga is Canada’s sixth largest city with a population of 752,000 and is one of Canada’s leading life sciences clusters with over 280 companies employing over 25,000 knowledge workers. Companies like AstraZeneca, GlaxoSmithKline, Baxter, Bayer and Amgen are just a few of the world renowned companies that call Mississauga home. This sector is strong, vibrant and a leading business component in the City that attracts highly-skilled scientific, technical and management personnel with post-secondary education from in and around Mississauga.

To learn more about Mississauga’s life sciences sector, visit www.winthehumanrace.ca.

December 2014/January 2015 BIOTECHNOLOGY FOCUS 25

NEW PRODUCTS Data logger Omega has launched its new wireless data logger, the OM-CP-RFPRHTEMP2000A . With an LCD screen and keyboard, users can input measurements and records of pressure, humidity and temperature. Results can be recorded in a variety of units and displayed in graphic or tabular formats. Configurable alarms, a battery life indicator, and wall mounting options make the device adaptable to user needs. Additionally, it can be used as a standalone device or it can be paired with

Sample Preparation Torrey Pines Scientific® announces the release of its EchoTherm™ MIC20 Remote Terminal, a device made to facilitate the configuration

Web: www.torreypinesscientific.com

Web: www.omega.ca Sequencing Kit The latest in the line of Illumina’s library prep kits is the 18S ITS Amplicon-Seq kit, designed to simplify metagenomic analysis. The kit aids in the

Web: www.torreypinesscientific.com Peristaltic Pump Harvard Apparatus has released a new peristaltic pump, now complete with weight integration in order to dispense reproductive biotechnology

and monitoring of samples. Without an external computer, the MIC20 controls the RIC20 and RHB20 – two units designed for controlling sample temperatures on robotic decks. Once the remote is connected, it displays temperatures and timers and is able to calibrate the units. The MIC20 itself measures 4.0” (102mm) x 5.0” (127mm) x 2.5” (63.5 mm) and weighs less than a pound, making it a compact and convenient choice. Battery life is estimated to be 230 continuous hours, with an external battery supply sold separately. a wireless transceiver to transmit data back to a central PC. Other extensions can be used as repeaters to transmit data over a greater distance.

possible fit. Labs with specific plumbing and electrical needs may wish to purchase additional fixtures, sold separately.

Fume Hoods After undergoing new innovations and reconfigurations, Flow Sciences’ new hoods, the Saf T Flow™ Chemical Fume Hood Series boasts enticing energy savings of up to 60 per cent. The hoods have been configured to remove fumes while in use at a face velocity of 60 fpm, protecting users without sacrificing efficiency. Available from 3” to 8” wide, in 1” increments, the hoods ensure the best

preparation of multiplexed amplicon libraries – which are compatible with regular Illumina sequencing primers - in order to identify uncultured fungal and microeukaryotic organisms. Included within the kit are up to 384 multiplexing barcodes to reduce the cost of 18S NGS studies on the Illumina® MiSeq platform.

Web: www.illumina.com 26 BIOTECHNOLOGY FOCUS December 2014/January 2015

samples, organic solvents, or food samples based on units of weight. The controller simultaneously allows communication between the pump and scale while displaying data on an interface compatible with Mettler Toledo XS series, Ohaus Defender 5000 series, and Ohaus Ranger series scales.

Anti-Drip, Auto-Tare and Slow-Down features increase efficiency and accuracy while reducing chances of error.

Web: www.harvardbioscience.ca Liquid Handling Poulten & Graf is now offering its volumetric glassware lines to North American customers. The VOLAC Glassware and FORTUNA® liquid handling line abides by the statements of accuracy

issued by the US Pharmacopoeia, and each piece is individually tested with its own individual number in order to ensure full traceability and accuracy. Their products range from dispensers to pipettors, and cover most laboratory applications, as well as many chemical and pharmaceutical manufacturing uses.

Web: www.poulten-graf.de/

NEW PRODUCTS Cell Imaging Vermont company BioTek has introduced its new Cell Imaging Multi-mode reader, the Cytation™ 5. As a second generation product, the Cytation™ 5 comes equipped with microscopy and multi-mode modules able to control tem-

body fragments. With better selectivity and resolution, the CaPure-HA is able to function in dimer and higher order aggregates that accompany upstream feedstock titers. Efficient binding capacities mean that the resin can be used from capture to final polishing, eliminating additional applications and thus new card:Layout 1 1/31/2013 9:09 AM Page 1 reducing costs.

Web: www.tosohbioscience.com Pumps and Dispensers Fluid Metering, Inc. has released its new catalog of OEM metering pumps and dispensers that eliminate valves and sapphire-hard ceram-

Web: www.fluidmetering.com

SRC101

peratures, detect samples, capture images and facilitate analysis. Imaging modules provide 60 x magnifications in fluorescence, brightfield, H&E and phase contrast modes in order to present phenotypic cellular information and quantitative data.

Web: www.biotek.com

ics, resulting in pumps that are more precise and efficient. OEM applications are suitable applications for medical, analytical and industrial markets, and the latest pumps are no exception. They deliver the same performance as standard valveless pumps, but in a much more compact application, and with additional installations like the “Intelligent Stepper Pump”.

Driven by compact stepper or brushless DC drive motors, they feature only one moving part and unique valveless piston pumping technology.

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Flow Cytometry OMEGA announces

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the release of its line of FMG980 Series insertion electromagnetic flowmeters, crafted from stainless steel, brass, and PVC in order to increase adaptability in the lab.

Designed to withstand changing viscosities and inconsistent flows with no moving parts, the FMG980 is suitable for air-driven diaphragm pumps or messy applications where most mechanical meters would be dirtied. The meters can be combined with transmitters, indicators, or displays from the same line. The meters measure 25 to

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305 mm (1 to 12”), although fixed depth insertion meters necessitate special installation.

Web: www.omega.ca Chromatography Available from Tosoh Bioscience, the Hydroxyapatite chromatography resin CaPure-HA has been developed for the purification and separation of monoclonal and polyclonal antibodies and their isoforms, isozymes and anti-

Academic Biotech Organization Clean Tech organization Contract Research / Manufacturing Organization 50d Diagnostics Organization 50f Food processing / manufacturing 50g Instrument Manufacturer / Distributor

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Analysis Instruments Basic Lab Equipment Chemicals/Biochemicals Chromatography – Gas Chromatography – Liquid Filtration, Water Purification LIMS

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CALENDAR JANUARY 2015

Web: www.biocontact.qc.ca/

January 12-14

February 27-March 1

Biotech Showcase 2015/ J.P. Morgan Healthcare Investor Conference Venue: San Francisco, CA Tel: 760 692 5917 Email: krogers@ebdgroup.com Web: www.ebdgroup.com/bts/index.php

BIOTECanada Investor Summit Venue: Whistler, BC Email: julie.mair@biotech.ca Web: www.biotech.ca

FEBRUARY 2015 February 7-11 SLAS2015 Venue: Washington, DC Tel: 630-256-7527 Fax: 630-741-7527 Email: slas@slas.org Web: www.slas2015.org

MARCH 2015 March 8-12

Email: bbloom@bloomburton.com Web: www.bloomburton.com/conference

May 22-24 Labcon 2015 Venue: Montreal, QC Tel: 905-667-8688 Email: labcon@csmls.org Web: www.csmls.org

JUNE 2015

PITTCON 2015 Venue: New Orleans, LS Twitter: @Pittcon Tel: 412-825-3220 Fax: 412-825-3224 Email: info@pittcon.org Web: www.pittcon.org

June 13-17 Canadian Chemistry Conference and Exhibition Venue: Ottawa, ON Tel: 613-232-6252 Email: acampbell@cheminst.ca Web: www.csc2015.ca

March 24-27

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Bio CEO & Investor Conference Venue: New York, NY Twitter: @bio1x1 and #BIOCEO15 Web: www.bio.org/events/conferences/

PharmaLink 2015 Venue: Cincinnati, OH Tel: 513-745-3020 Email: toombm@xavier.edu Web: www.pharmalink2015.com

Bio International Convention Venue: Philadelphia, PA Tel: +1.202.962.6655 Email: convention@bio.org Web: http://convention.bio.org/2015/

February 25

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BioContactQuebec 2015 Venue: Quebec City, QC Tel: 418 694-8778 Fax: 418 694-0614 Email : mgodbout@hodran.com

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Canadian Laboratory Medicine Congress Venue: Montreal, QC Tel: 613-531-9210 Email: info@clmc.ca Web: www.clmc.ca/2015/

COMPANY & ADVERTISER INDEX COMPANY

PAGE

WEBSITE

Aeterna Zentaris Inc.................................................................................... 6,10......................................................................................www.aezsinc.com The Albert at Bay................................................................................................15..................................................................................... www.albertatbay.com Best Western Victoria Park Suites...................................................................15....................................................................................www.victoriapark.com Biotalent Canada.......................................................................................... 11.........................................................................................www.biotalent.ca Brady Canada.....................................................................................................17.............................................................................. www.BradyCanada.ca/lab Cardiome Pharma Corp............................................................................... 10.....................................................................................www.cardiome.com Centre for Addiction and Mental Health....................................................... 8............................................................................................... www.camh.ca Childrens Miracle Network..............................................................................23................................................................www.ChildrensMiracleNetwork.ca City of Mississauga.............................................................................................5............................................................................. www.winthehumanrace.ca Eppendorf...........................................................................................................32.........................................................................................www.epMotion.com Fluid Metering Inc........................................................................................ 27..............................................................................www.fluidmetering.com Illumina Inc.................................................................................................. 26.......................................................................................www.illumina.com Knight Therapeutics Inc............................................................................. 10,11...............................................................................www.gud-knight.com Life Sciences Ontario..........................................................................................7............................................................................ www.lifesciencesontario.ca Merck & Co. Inc............................................................................................ 10............................................................................................. www.merck.ca Neovasc Inc................................................................................................... 6........................................................................................www.neovasc.com Omega...................................................................................................... 26, 27......................................................................................... www.omega.ca Oncolytics Biotech Inc.................................................................................. 8........................................................................ www.oncolyticsbiotech.com POI........................................................................................................................31........................................................................................................ www.poi.ca Poulten & Graf.............................................................................................. 26.................................................................................. www.poulten-graf.de Versant Ventures........................................................................................ 6, 9.........................................................................www.versantventures.com VWR.......................................................................................................................2............................................................................................... www.ca.vwr.com 28 BIOTECHNOLOGY FOCUS December 2014/January 2015

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THE LAST WORD

By Albert Friesen

CANADIAN BIOTECH: Back to Business The following article first appeared on the Bloom Burton & Co. Cross-Border Biotech Blog at www.bloomburton.com/blog, and is republished with permission.

“Canada is a world leader in science, technology and innovation, and is recognized as one of the most innovative and competitive economies in the world.” A quotation from the Government of Canada web site which I believe is fairly close to reality.

The Council of Canadian Academies prepared a report entitled “Paradox Lost: Explaining Canada’s Research Strength and Innovation Weakness” which addressed two questions; 1. Why has Canada’s research excellence not translated into more business innovation?

2. How has Canada’s economy sustained relative prosperity despite weak innovation and correspondingly feeble productivity growth?

Dr. Albert Friesen

is a founder of the Industrial Biotechnology Association of Canada (now BIOTECanada).

He is currently President and CEO of Medicure Inc., and President of Genesys Venture Inc. (GVI).

This commentary only addresses the first question, that is, how can we be more productive in translating research into business innovation?

Canada does have success stories so what are we to learn from these?

We are the inventors of insulin, the electron microscope, the pace maker, instant food and numerous other products. Did you know that Henry Woodward, a Canadian, holds the original patent for the light bulb, subsequently purchased by the Edison Company? But, where were these inventions commercialized?

Biotechnology and the life sciences industry in general, is critical for Canada’s future economic, cultural and social well being. We need continued strong support for basic research and development and increased focus and energy on the commercialization of Canada’s world class research.

I was fortunate to start my biotech career with the development of WinRho at the Winnipeg Rh Institute. I believe this is a success story. WinRho, is manufactured in Canada at the Winnipeg plant which is now part of the operations of Emergent Biosolutions. WinRho, saves lives and contributes to the economic well being of Manitoba and Canada.

There are many other research successes in Canada but too few Canadian commercialization successes.

Canada’s bio-economy is significant (about 7 per cent of Canada’s GDP), but we are presently losing ground to the growth and commitment being shown in other countries.

China is investing huge amounts into biotechnology as part of their five-year plan. Germany, India, Brazil and others are also investing. The U.S. is stepping up its focus on an innovation strategy. Nations aren’t standing still and are making serious investments because they want these jobs.

What do we need to do to improve the translation of

30 BIOTECHNOLOGY FOCUS December 2014/January 2015

research into successful economic outcomes? I suggest two things: 1. A greater emphasis on teaching and celebrating a strong entrepreneurial spirit in Canada 2. Increasing our innovation efficiency by a market or business pull of the technology.

An Entrepreneur is defined “as a person who organizes and operates a business or businesses, taking on greater than normal financial risks in order to do so.” So our biotech companies need to operate more like a business, which means developing and following a business plan which has a realistic and timely path forward to profitability. There was an era in Canadian biotech when the business plans of most companies involved raising risk capital and hoping for a buy out. Today, the Canadian biotech industry needs to focus on timely developments leading to earnings generation. Secondly, there should be a greater focus on having the business pull the technology to commercialization rather than the technology pushing the commercialization.

Innovation is hard work and persistence. The notion that innovation is mere chance is incorrect. Thomas Edison put it succinctly, “Genius (or Innovation) is one per cent inspiration and 99 per cent perspiration.”

The innovator’s job is not to deliver a proven result but to discover and implement what seems to be impossible.

This will, by its nature, be risky and involve failures. This is necessary and should be celebrated, not criticized.

We must train and celebrate entrepreneurs. Innovation is converting assumptions into products and services as quickly and inexpensively as possible. This takes discipline, determination, persistence and even perspiration.

I believe Canadian biotech companies are making the transition to a more earnings based model. Medicure Inc., one of the companies I co-founded, began as a research company focused on the development and commercialization of a cardiology technology from the University of Manitoba. During the development process, Medicure acquired the U.S. commercial rights for the cardiovascular drug, Aggrastat, originally developed by Merck. The revenue from sales of Aggrastat in the U.S. sustained Medicure through some difficult times and has now positioned the company for sustained growth and profitability.

Using this model as our guide, I am as optimistic as ever about the Canadian biotech industry.

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