NEWS RELEASE: BioVectra Inc. announces a $144.6 million expansion project, including a $37.5 million contribution through the Government of Canada’s Strategic Innovation Fund

BioVectra Inc. announces a $144.6 million expansion project, including a $37.5 million contribution through the Government of Canada’s Strategic Innovation Fund — Prime Minister Justin Trudeau visits BioVectra to announce Government of Canada investment in Atlantic Canadian CDMO and high-skilled jobs creation in the region — Charlottetown, Prince Edward Island, Canada (March 4, 2019) – Today, BioVectra Inc., an Atlantic Canadian Contract Development and Manufacturing Organization (CDMO), announced a five-year, $144.6 million (CAD) expansion project to enhance its Biopharmaceutical capabilities in both Charlottetown, Prince Edward Island and Windsor, Nova Scotia. Prime Minister, Justin Trudeau, visited BioVectra in Charlottetown to announce a $37.5 million contribution from the Government of Canada through the Strategic Innovation Fund (SIF). The $37.5 million contribution represents the single largest SIF Project ever awarded in Atlantic Canada. “Thanks to innovations in life sciences, Canadians are living longer, healthier lives than ever before. Canadian companies like BioVectra are creating new jobs and establishing themselves as global leaders in producing lifesaving treatments for serious illnesses that affect millions of people around the world. Today, we are not only investing in an innovative Canadian business, but also in Canadians and the future prosperity of our country.” – The Rt. Hon. Justin Trudeau, Prime Minister of Canada More specifically, the project is intended to support BioVectra’s on-going Active Pharmaceutical Ingredients (APIs) production capacity expansion in Charlottetown, as well as an expansion of its Biologics capabilities in Windsor, including a mammalian cell culture facility. Over the project’s five-year lifespan, 150 high-skilled, full-time jobs are expected to be created on Prince Edward Island and in Nova Scotia. “We are pleased to announce plans to create 150 additional jobs, 110 to be located at our Windsor site and 40 in Charlottetown,” said BioVectra President, Oliver Technow. “This is an extremely proud day for BioVectra, and we are deeply appreciative of the government’s support. Since 2015, we have invested approximately $25 million per year in expansions and technologies that have vastly enhanced our capabilities. Today’s announcement is a continuation of our commitment to growth right here in Atlantic Canada!” As a trusted and innovative partner, BioVectra’s global client base includes most of the top 20 biopharmaceutical companies in the world. “Our clients develop important, life-saving medicines for people all around the globe,” said BioVectra’s Windsor General Manager, Heather Delage. “This exciting expansion project is designed to help propel us toward being a top-tier player in the biologics field, where many therapies are advancing rapidly, and changing the way healthcare is delivered.” Beyond these expansion plans, BioVectra intends to complement its existing academic partnerships by forming additional collaborations with Canadian academic institutions. This investment includes reinforcing its future talent base by providing over 25 students with on-the-job training and internship opportunities on an annual basis. About BioVectra BioVectra is a CDMO that serves global pharmaceutical and biotech companies with full-service cGMP outsourcing solutions for intermediates and active pharmaceutical ingredients. An innovative and reliable service partner with a strong regulatory history, BioVectra has over 45 years of experience specializing in:

  • cGMP Microbial Fermentation
  • Complex Chemistry – High Potency APIs
  • Biologics
  • Formulation Development
For more information about BioVectra, please visit www.biovectra.com. Media Contact Jordan MacGregor Communications and Marketing Manager BioVectra Inc. Phone: 902-566-9116 ext. 6376 E-Mail: jmacgregor@biovectra.com Statements in this document that are not strictly historical, including statements regarding future business prospects, use of capital or the impact of any such events or developments, and any other statements regarding events or developments the company believes or anticipates will or may occur in the future, may be “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties. There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. The forward-looking statements made herein speak only as of the date hereof and the company does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.]]>

Most are small- to medium-sized firms whose offerings vary as widely as do their cultures. CDMOs can be found in out-of-the-way places such as foothill villages in the Swiss Alps and the cornfields of Iowa. They pop up on the outskirts of major European travel destinations like Lisbon and Paris. They cluster around Milan and can be found in the hinterlands of China.

The idea of a CDMO on Prince Edward Island—the tiny Maritime Province best known as the setting for Lucy Maud Montgomery’s novel “Anne of Green Gables”—may seem one step beyond the pale. BioVectra, however, has grown in the 18 years since it began producing active pharmaceutical ingredients (APIs) to become a world-class player.
Most recently, BioVectra ventured across the Northumberland Strait to Nova Scotia, where, after a major setback, it is preparing to open a commercial-scale facility for microbe-derived biologic drugs.
The foray began in 2014 when a customer required microbial fermentation beyond what BioVectra could supply from its Charlottetown headquarters. BioVectra responded by acquiring a factory in Windsor, Nova Scotia, at which the drugmaker Sepracor once manufactured the API for its insomnia therapy Lunesta. But just as a major renovation got under way to convert the facility from small-molecule chemical to biologics production, BioVectra’s contract hit the shoals.
“Unfortunately, our partner’s market demand did not come through to reality,” recalls Heather Delage, BioVectra’s vice president of business development. “They did not end up needing the extra capacity, and our relationship became much less significant.” In essence, the deal was off. “We ended up with the facility and some very large bioreactors on order that we were obligated to purchase.”
Given little choice, BioVectra proceeded with its plan to become a commercial-scale biologics CDMO. Now, with the first phase of reactor installations complete and the Windsor site nearing final validation, BioVectra has three contracts nailed down. Small-scale fermentation is already under way for these projects at its headquarters in Charlottetown. Work will be transferred to Windsor when the site is fully operational by the end of this year.
BioVectra’s aggressive push into large-scale fermentation, despite the loss of a key contract, reflects a recurrent theme of opportunism for a company started in 1970 as Diagnostic Chemicals by J. Regis Duffy, a professor at the University of Prince Edward Island, to make clinical reagents with the intent of creating jobs on the island for chemistry graduates. In the ensuing years, customer requests for fine chemicals, drug intermediates, products derived from microbial fermentation, APIs, and biologics have been met with partnerships, investments, and risky new ventures. The company now operates three facilities, including an R&D building offering analytical and process development down the road from headquarters.
Construction is also under way at the main plant in Charlottetown to accommodate a recent contract with Keryx Biopharmaceuticals to manufacture ferric citrate, the API in the kidney disease therapy Auryxia.
Matt Frizzle, director of business development, says contract development and manufacturing accounts for 70% of BioVectra’s business; long-term partnerships, some in generic drug development done at the R&D center, make up the remainder.
Synthetic chemistry accounts for 50% of revenue; the balance is a mix including R&D, reagent and peptide manufacturing, fermentation, and generics development. The company hopes to grow its fledgling biologics operation to between 25 and 30% of sales over five years. All commercial-scale biologics production will be done in Windsor, where the company has spent $60 million in the past three years building the plant.
BioVectra has funded its expansion over the years largely through risk-sharing arrangements with partners. The company’s pursuit of partnerships also led to its current corporate ownership. BioVectra was the key supplier of the API in Questcor’s H.P. Acthar Gel, a topical hormone treatment for autoimmune disease. Questcor wanted to secure ownership of the manufacturing process, so it bought BioVectra in 2013 for $50 million. Mallinckrodt acquired Questcor the following year. Life under big-company ownership has not significantly impacted BioVectra, employees say. The main change is a Mallinckrodt-appointed CEO, Oliver Technow, who started in 2015. Technow, a German, began his career in pharmaceuticals working for Fresenius Medical Care. Most recently he headed the Canadian business of the Japanese drugmaker Eisai.
Moving into the CDMO business, Technow says, was a refreshing change from the big-pharma world. And coming to BioVectra, where nearly half the 320 employees are lifelong residents of Prince Edward Island, made for a feeling, in the Maritime vernacular, of having “come from away.”
But BioVectra is far from insular in its pursuit of business, Technow maintains, which is impressive. “The whole idea of locating biosciences in an area like this takes guts,” he says. “Who would think of it? You think of potatoes, lobsters, mussels, and oysters. ‘Anne of Green Gables.’ Cruise ships.”
Technow notes, though, that BioVectra is not alone—the Prince Edward Island BioAlliance has nearly 60 members, most much smaller than BioVectra, making the island a mini biotech hub.
“I am actually at the point,” he says, “where when people ask me why I would operate a business on Prince Edward Island, I say, why not? Prince Edward Island is punching above its weight.”
Still, BioVectra has reached a turning point where its business model needs to evolve, Technow acknowledges. “The company has had a very typical CDMO model,” he says. “You have a client, they want something and you build something, and hopefully over time you become their manufacturer of choice.” But a CDMO can do everything right and the customer’s project can still fail, he points out. “We want to move away from this very fragile, dangerous, one-dimensional business model.”
As BioVectra matures as a contract services firm, CEO Oliver Technow says it needs to take a less opportunistic approach to business development.
Technow says the firm has a three-pronged strategy now: Maintain the CDMO business, develop a stronger fermentation offering, and invest more heavily in R&D. “We are diversifying and spreading the risk and by doing so creating a more stable business model.”
Part of the R&D prong is APIs for generic drugs. Marc Sauer, vice president of R&D, says BioVectra began working to develop generics in 2007.
“The focus was on difficult-to-make generics,” he says. “Something that presents a challenge. Given our size, we aren’t going to work on commodities, like generic pain medication. There are companies out there that can do that faster, better, and cheaper than we can.”
And BioVectra harbors some stretch goals, including moving into mammalian-cell biologics in Windsor and developing compounds that can be used as “warheads” in antibody-drug conjugates.
James Bruno, president of the consulting firm Chemical & Pharmaceutical Solutions, is impressed with how BioVectra has evolved. “They have some good ideas, blending a lot of technologies,” he says. The question is whether the firm will be able to capitalize on its growth in an increasingly competitive market.
The key, Bruno says, may be patience in pursuing contracts, making sure the firm is a suitable fit for prospective customers. One good sign, he adds, is that BioVectra recently demurred on a contract with one of his clients.
“They came up front and said, ‘We don’t think we can do a good job with this.’ They handled it correctly,” Bruno says. “I think they have good people in position now. I think they are more focused than they have ever been.”
One thing the company does not have to worry about, Bruno says, is location. It is much easier for U.S. and European clients to do business with a CDMO in eastern Canada than one in China, he points out. Prince Edward Island is hardly thought of as exotic by potential U.S. clients.
Nonetheless, BioVectra has carefully included a picture of Confederation Bridge, which connects Prince Edward Island with New Brunswick, on its logo, emphasizing accessibility to an island that until 20 years ago could be reached only by ferry and small aircraft. Charlottetown Airport, across the street from BioVectra’s headquarters, is smaller than many strip malls.
Technow sees a solid metaphor in the bridge. “It’s truly what we represent—innovation from North America to the world,” he says. “This is an organization awakening from a rather remote part of the world to be a truly global player. And we are ready for the challenge.”
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News Release ACOA: Windsor Expansion Helps BioVectra Meet Global Market Demand

Extensive facility renovation, new equipment, assists life sciences firm in creating jobs, growing regional economy April 12, 2018 – Windsor, NS – Atlantic Canada Opportunities Agency Canada is a country of innovators. Curiosity, creativity and a collaborative spirit are what lead to the kinds of innovations and technologies that improve our daily lives and drive our economy, and our country, forward. That is why the Government of Canada is investing $5,000,000 in BioVectra Inc. to help the Charlottetown-based biotechnology and pharmaceutical ingredient manufacturing company expand its operations to Nova Scotia. This will enable the firm to grow, create additional highly skilled positions and help build sustained economic prosperity in Atlantic Canada. The funding was announced today by the Honourable Scott Brison, Secretary of the Treasury Board and Member of Parliament for Kings-Hants, on behalf of the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for the Atlantic Canada Opportunities Agency(ACOA). The repayable contribution is being made through ACOA’s Business Development Program, which helps small and medium-sized enterprises expand and modernize to improve competitiveness. BioVectra will use the assistance to complete major renovations at its Windsor facility and to purchase new equipment. This will allow the company to increase its capacity to develop and manufacture biologic drug substances for global pharmaceutical and biotechnology companies. These materials are used in the creation of products to treat cancer, autoimmune disorders, diabetes, arthritis, and many other serious illnesses. The project will create 28 full-time positions, and by 2020, when the plant is fully operational, it is expected that more than double that number of people will be employed there. This investment builds on commitments made by the Government of Canada and the four Atlantic Provinces to drive economic growth in the region through the Atlantic Growth Strategy, which supports strategic investments in initiatives that build on the region’s competitive advantages, such as its strong export potential, growing innovation network, and skilled workforce.

Quotes

“Science and technology – along with stronger international trade – are rapidly changing the way Canadians live and work, bringing new challenges and more opportunities. Investing in BioVectra Inc., an industry-leading biotechnology and pharmaceutical ingredient manufacturing firm, will help strengthen and grow the middle class, and lay a more solid foundation for the next generations of Canadians.” – The Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for ACOA  “The jobs of the future depend on Canadians’ ability to continue to adapt, innovate, and maintain our competitive edge in the fast-paced and increasingly global economy. BioVectra is already known worldwide for its expertise in developing and producing active pharmaceutical ingredients used in products that treat life-threatening diseases. This modern, 50,000 square-foot facility will increase the company’s manufacturing capacity by 40 per cent and allow BioVectra to become a rare one-stop shop for its global biotech and pharmaceutical customers.” – The Honourable Scott Brison, President of the Treasury Board and Member of Parliament for Kings-Hants “As an integral part and leader within the vibrant Atlantic Canadian BioScience cluster, we consider ourselves fortunate to operate in a supportive ecosystem where substantial emphasis is placed on talent, skills and innovation. The contribution from ACOA’s Business Development program will enable BioVectra to continue to thrive, create highly skilled jobs in Atlantic Canada, and help solidify Canadian leadership within the very competitive global markets we participate in.” – Oliver Technow, President, BioVectra Inc.

Quick facts

  • BioVectra Inc., headquartered in Charlottetown, P.E.I., has more than 300 employees, and will initially add another 28 jobs in Windsor. The company’s four locations – three in Charlottetown and one in Windsor – total approximately 110,000 square feet.
  • BioVectra’s predecessor, Diagnostic Chemicals Ltd. (DCL), was founded in 1970 by Dr. Regis Duffy, then a UPEI chemistry professor, who began producing small amounts of a specialty chemical under contract to a U.S. firm.
  • Since its inception, BioVectra, which is part of the active pharmaceutical ingredient life cycle from early clinical development to commercial supply, has created hundreds of products used on the market today.

Contacts

Alex Smith Director of Communications and Outreach Atlantic Canada Opportunities Agency Phone: 902-426-9417 / 902-830-3839 (cell) E-mail: alex.smith@canada.ca Jordan MacGregor Communications and Marketing Manager BioVectra Inc. Phone: 902-566-9116 ext 6376 E-Mail: jmacgregor@biovectra.com]]>

BioVectra and Keryx Biopharmaceuticals Enter Agreement for Ferric Citrate Production Expansion

About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts, is focused on the development and commercialization of innovative medicines that provide unique and meaningful advantages to people with kidney disease. The Keryx team consists of approximately 200 committed people working with passion to advance the care of people with this complex disease. This dedication has resulted in two FDA-approved indications for Keryx’s first medicine, Auryxia® (ferric citrate) tablets. For more information about Keryx, please visit www.keryx.com. About BioVectra BioVectra is a CDMO that serves pharmaceutical and biotech companies with full-service cGMP outsourcing solutions for intermediates and active pharmaceutical ingredients. An innovative and reliable service partner with a strong regulatory history, BioVectra has over 45 years of experience specializing in:  GMP Microbial Fermentation & Purification  Complex Chemistry  Process & Analytical Development For more information about BioVectra, please visit www.biovectra.com. Media Contact Jordan MacGregor Marketing and Communications Manager jmacgregor@biovectra.com 902-566-9116 ext. 6376 www.biovectra.com]]>