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AFT builds North American momentum

Director Appointment22 December 2020AFTHealthcare

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.