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Statement
| 1.Date of occurrence of the event:2022/04/27
2.Company name:TaiMed Biologics Inc.
3.Relationship to the Company (please enter "head office" or
"subsidiaries"):Head Office
4.Reciprocal shareholding ratios:N/A
5.Cause of occurrence:
In March 2016, TaiMed and Theratechnologies Inc. signed a 12-year exclusive
distribution and marketing agreement for the new AIDS drug Trogarzo in the
United States and Canada (hereinafter referred to as North American
Territory). The Agreement covers the intravenous injection of Trogarzo and
new dosage forms developed in the future. In March 2017, TaiMed and
Theratechnologies revised and amended the Agreement and added the exclusive
rights to commercialize Trogarzo in Europe, including the European Union
and its neighboring countries such as the United Kingdom, Israel, Norway,
Russia and Switzerland (hereinafter referred to as the European Territory),
totaling more than 30 countries.
The administration of Trogarzo by intravenous injection was approved by the
European Medicines Agency (EMA) in September 2019, and was launched in
Germany as the first country in Europe in September 2020. Later,
Theratechnologies reached a public reimbursement agreement with the Italian
Medicines Agency in the fourth quarter of 2021, and also successively
negotiated the pricing and reimbursement with several other European
countries.
Recent price negotiations with key European countries were not satisfactory
to Theratechnologies and the proposed reimbursed prices fall well below the
floor price set by TaiMed, making it unfeasible to continue selling the
drug in those countries. (Note: TaiMed, per the license agreement, has the
right to set a floor price to ensure a reasonable profit after its
manufacturing and supply chain costs are covered.)
Accordingly, Theratechnologies has sent a notice of termination to TaiMed
that they will cease commercialization of Trogarzo in Europe 180 days from
April 27, 2022 and will return to TaiMed the European commercialization
rights. During this period, both parties will work together to ensure a
smooth transition in accordance with the license agreement and relevant
laws and regulations.
TaiMed is determined to continue to market Trogarzo and provide the drug
to MDR AIDS patients who need it and has already begun searching for a new
commercial partner for the European region through both internal and
external efforts. It will be announced by a company press release once the
partner has been confirmed. At present, since the sales of Trogarzo in the
European market have just started, the net sales account for less than 10%
of the sales in the US market and has little impact on the company
financials.
Theratechnologies continues to have the exclusive rights to commercialize
Trogarzo in North American Territory.
According to the exclusive marketing agreement in European Territory,
TaiMed received an initial upfront payment of 906,077 Theratechnologies'
common shares equivalent to US$3 million and an European launch milestone
payment of US$5 million in cash. Those payments are non-refundable.
6.Countermeasures:None
7.Any other matters that need to be specified:
New drug development requires a long process and sizeable investments with
no guarantee of success, which therefore may pose substantial investment
risks. Investors are advised to exercise caution and conduct thorough
evaluation.
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