AFT builds North American momentum
AFT Pharmaceuticals Limited, Level 1, 1 2 9 H u r s t m e r e R o a d , T a k a p u n a , A u c k l a n d 0622, N e w Z e a l a n d
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com
MARKET AND MEDIA RELEASE 23 DECEMBER 2020
AFT builds North American momentum
Diversified pharmaceutical company appoints new north American-based director
and launches Maxigesic® in Canada
AFT Pharmaceuticals’ (NZX; AFT, ASX; AFP) today announces it is building momentum
in the pivotal North American market with the appointment of Toronto-based Dr Ted
Witek to the board and the launch of its Maxigesic pain relief medicine in Canada.
Dr Witek, an American professional director, healthcare advisor and academic, joins
the board on 1 January 2021 as an independent non-executive director. He
strengthens the board’s experience with North American pharmaceutical regulators
and markets. His appointment is a recognition of the importance AFT attaches to its
success in the North American market.
The launch of Maxigesic in Canada, under AFT’s Combogesic® brand, represents the
company’s first foray into North America and opens the door to a Canadian
analgesic market worth CAD$813 million
1
.
Director appointment
Dr Witek brings to AFT more than three decades of international clinical development
and leadership experience. He will be replacing independent non-executive director
Jim Burns who has indicated his wish to step down from the AFT board at the next
annual meeting in August 2021.
AFT Chair David Flacks said: “We are delighted Ted has agreed to join the board. We
expect his in-depth understanding of North American pharmaceutical regulators and
markets to be of great value as we move to expand our presence in the US and
Canada.”
Between 2014 and 2018 Dr Witek served as Senior Vice President, Corporate
Partnerships, and Chief Scientific Officer at Innoviva in San Francisco. Prior to that he
spent more than two decades, mainly in the US, with Boehringer Ingelheim where he
1
IQVIA CDH June 2019. Total analgesic market in the year to the end of June 2019.
AFT Pharmaceuticals Limited, Level 1, 1 2 9 H u r s t m e r e R o a d , T a k a p u n a , A u c k l a n d 0622, N e w Z e a l a n d
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com
rose to the role of President and CEO of the multi-national’s Canadian and Portuguese
operations.
He has served on the boards of numerous professional societies including the Board
of Directors of Canada’s Research-Based Pharmaceutical Companies (Rx&D) and
the Drug/Device Discovery and Development Committee of the American Thoracic
Society.
He has also served on the boards of numerous advisory organisations and companies
including the Government of Ontario Health Innovation Council, Columbia University
Health and Innovation Technology Lab, Lumira Ventures and Trudell Medical
International.
Dr Witek holds a Doctor of Public Health from Columbia University, a Master of Public
Health from Yale University, and a Master of Business Administration from Henley
Management College in the UK. He has also authored more than 100 scientific
publications in the fields of respiratory health, public health, airway disease, and drug
development and is a reviewer for numerous scientific journals.
The board has determined that Dr Witek is an Independent Director (within the
meaning of the NZX Listing Rules).
Mr Flacks also thanked Mr Burns for his contribution to the company
“Jim joined the board in September of 2015 and has provided guidance to AFT
through its initial public offer, its listing on the NZX and ASX and recent international
expansion. We are grateful for his ongoing support for the company,” Mr Flacks said.
Canadian launch
Canadian distribution partner BioSyent Pharma Inc. has begun shipping Maxigesic
pain relief tablets, branded Combogesic® in that country, to local wholesalers.
The move, which BioSyent’s parent has announced to the Toronto Stock Exchange
(TSX) Venture Exchange, represents AFT’s first foray into the North American market.
AFT Pharmaceuticals Chief Executive Dr Hartley Atkinson said: “The launch of
Maxigesic under our Combogesic® brand in Canada is an exciting opportunity for
AFT. This launch and Dr Witek’s appointment to the board put AFT in a strong position
to take advantage of the significant opportunities we see in North America.”
BioSyent also has distribution rights to additional forms of Maxigesic®/Combogesic®
in Canada, including an oral liquid for paediatric use and an intravenous formulation
for hospital use, both of which will require regulatory approval before launching.
AFT is meanwhile in the final stages of obtaining regulatory approval for Maxigesic in
the US. In November, the US Food and Drug Administration (FDA) said an FDA Good
Manufacturing Practice inspection of the tablet production facilities for Maxigesic was
the “only deficiency” with AFT’s application for regulatory approval. The inspection
has not yet taken place due to COVID-19 related travel disruptions.
BioSyent’s release to the TSX Venture Exchange is attached.
AFT Pharmaceuticals Limited, Level 1, 1 2 9 H u r s t m e r e R o a d , T a k a p u n a , A u c k l a n d 0622, N e w Z e a l a n d
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com
For and on behalf of AFT Pharmaceuticals Limited by Malcolm Tubby, Chief Financial
Officer.
For more information:
Investors Media
Dr Hartley Atkinson Richard Inder
Managing Director The Project
AFT Pharmaceuticals Tel: +64 21 645 643
Tel: +64 9488 0232
About AFT Pharmaceuticals
AFT is a growing multinational pharmaceutical company that develops, markets and
distributes a broad portfolio of pharmaceutical products across a wide range of
therapeutic categories which are distributed across all major pharmaceutical
distribution channels: over the counter (OTC), prescription and hospital. Our product
portfolio comprises both proprietary and in-licensed products, and includes patented,
branded and generic drugs. Our business model is to develop and in-license products
for sale by our own dedicated sales teams in our home markets of Australia and New
Zealand and in certain Southeast Asian markets, and to out-license our products to
local licensees and distributors to over 125 countries around the world. For more
information about the company, visit our website www.aftpharm.com.
---
This press release may contain information or statements that are forward-looking. The contents herein represent our judgment, as at the release
date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking
information or statements. Potential risks may include, but are not limited to, those associated with clinical trials, product development, future
revenue, operations, profitability and obtaining regulatory approvals.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange)
accepts responsibility for the adequacy or accuracy of this press release.
......... .........
NEWS RELEASE
BIOSYENT LAUNCHES COMBOGESIC
®
, FIRST-EVER ACETAMINOPHEN +
IBUPROFEN COMBINATION TABLET IN
CANADA NOW AVAILABLE
CANADIANS HAVE A NEW PAIN RELIEF OPTION
FOR IMMEDIATE RELEASE DECEMBER 16, 2020
MISSISSAUGA, ONTARIO (December 16, 2020) BioSyent Inc. (“BioSyent”, “the Company”, TSX Venture: RX) is pleased
to announce that its subsidiary, BioSyent Pharma Inc., has commenced the first shipments of Combogesic
®
to Canadian
wholesalers. Combogesic
®
is the first fixed-dose combination of acetaminophen and ibuprofen in a single tablet in
Canada and is indicated for the short-term management of mild to moderate acute pain and the reduction of fever in
adults.
Combining two trusted, familiar, and effective active ingredients, acetaminophen and ibuprofen, in a new patented
formulation, Combogesic
®
brings together two different modes of action into one effective pain reliever. Though the two
active ingredients have been available in Canada for decades, Combogesic
®
represents the first Health Canada
approved combination of these proven pain relievers in a single tablet.
“A novel combination of two popular non-prescription analgesics – ibuprofen and acetaminophen – Combogesic
®
provides clinicians with an additional therapeutic option for achieving multimodal analgesia for mild to moderate pain
management in adults without compromising the well-established safety profile of either active constituent,” said Dr.
Nardine Nakhla, a community pharmacist and clinical lecturer at the University of Waterloo School of Pharmacy.
BioSyent Pharma Inc. in-licensed Combogesic
®
for Canada from AFT Pharmaceuticals Ltd. who market the product,
either directly or through partners, to 44 other countries under various brand names including Maxigesic
®
. In other
markets it comes in different dosage forms and strengths. The efficacy of Combogesic
®
is based on its clinically proven
unique ratio – one tablet contains 325 mg of acetaminophen and 97.5 mg of ibuprofen, a 3.3:1 ratio.
Combogesic
®
has a well-established safety and tolerability profile and is opioid-free. The safety of Combogesic
®
is
comparable to similar doses of either acetaminophen or ibuprofen alone. Examples of acute pain include headaches,
menstrual cramps, sprains, and strains. Acute pain can also occur from tissue injuries and after surgical operations.
“We are pleased to make Combogesic
®
available to Canadians as a new option for the management of acute pain and
reduction of fever,” said René Goehrum, President and CEO of BioSyent. “Canadians consume over 2.7 billion doses
of analgesics annually to treat acute pain or fever and our research tells us that a portion of this market is not satisfied.
We are excited to achieve this milestone of bringing Combogesic
®
to the market and to have it contribute to the long-
term growth and diversification of our Canadian pharmaceutical business.”
Combogesic
®
is available without a prescription by simply asking at the pharmacy counter or by ordering on-line.
You can find more information about Combogesic
®
at www.Combogesic.ca
This press release may contain information or statements that are forward-looking. The contents herein represent our judgment, as at the release
date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking
information or statements. Potential risks may include, but are not limited to, those associated with clinical trials, product development, future
revenue, operations, profitability and obtaining regulatory approvals.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange)
accepts responsibility for the adequacy or accuracy of this press release.
About BioSyent Inc.
Listed on the TSX Venture Exchange under the trading symbol “RX”, BioSyent is a profitable growth-oriented specialty
pharmaceutical company focused on in-licensing or acquiring innovative pharmaceutical and other healthcare products
that have been successfully developed, are safe and effective, and have a proven track record of improving the lives of
patients. BioSyent supports the healthcare professionals that treat these patients by marketing its products through its
community, specialty/hospital and international business units.
As of the time of this press release, the Company has 12,805,200 common shares outstanding.
For a direct market quote for the TSX Venture Exchange and other Company financial information please visit
www.tmxmoney.com
.
For further information please contact:
Mr. René C. Goehrum
President and CEO
BioSyent Inc.
E-Mail: investors@biosyent.com
Phone: 905-206-0013
Web: www.biosyent.com
Data sourced from publicly available filings. Our datasets may not be complete. Automated analysis can produce errors. If you believe any data on this page is incorrect, please contact us at hello@nzxplorer.co.nz. For informational purposes only. Not investment advice.