Press release

Egetis recruits Anny Bedard as President of Egetis North America

Stockholm, Sweden, December 20, 2022. Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) today announced the recruitment of Anny Bedard as President of Egetis North America and as a member of the Company’s leadership team.
Ms. Bedard has over 25 years of international experience in both established and entrepreneurial biopharmaceutical companies, across a broad set of strategic and operating functions in diverse business environments. Her key expertise lies in new market entry, strategic planning, alliance management, country and regional management, product launch, sales and business development. She has 15 years of experience in the Rare Disease space. Ms. Bedard will be responsible for establishing and maintaining a successful presence of Egetis and its products in the United States and Canada, including establishing the infrastructure for Egetis North America, developing relationships with key national stakeholders, and recruiting a highly effective team to support all initiatives necessary for the successful launch of Emcitate in 2024.
Sara Melton, former President of Egetis North America, will leave the Company to pursue other opportunities.

Nicklas Westerholm, CEO of Egetis, commented: “Anny Bedard is a successful industry veteran who has delivered outstanding results across many commercial leadership areas, and I’m delighted to welcome her to Egetis. During the last 15 years she has focused on devising and executing market entry strategies for rare diseases and establishing new entities, which is a perfect fit with Egetis’ objectives. Anny will be responsible for continuing the establishment of a commercial infrastructure in the US for Emcitate and driving our pre-launch activities ahead of the planned New Drug Application for Emcitate to the FDA in 2023 and launch in 2024. We are also thankful to Sara Melton for her dedicated work to initiate Egetis presence in North America and wish her success in her future endeavors.”

Anny Bedard, President Egetis North America, said: “I am delighted to join Egetis at this important strategic time to establish itself in North America. I admire Egetis for its determination and courage for developing new therapeutics for rare diseases with significant unmet medical needs. I am inspired by Egetis’ vision and its collaborative culture and look forward to work with this team to build a strong company in North America for the benefit of patients, stakeholders and investors.”

Prior to joining Egetis Ms. Bedard served as President of ABio Consulting, where she focused on rare diseases. Anny advised and supported strategic decision making for multiple US and EU biopharma companies across diverse therapeutic areas, technologies and markets to deliver growth at the product, franchise and corporate level. Before that she was Vice President, Head of International Business, at Sarepta Therapeutics where she designed and executed Sarepta’s entry into Latin America and Asia Pacific. At Shire, she established and led the company’s successful growth in multiple geographies and launched the company’s leading brands in Fabry, Gaucher, Hunter Syndrome and hereditary angioedema. Ms. Bedard started her career at Fournier Pharma and worked at Serono US before joining Shire and Sarepta. She has a Masters degree in cellular and molecular biology from Laval University in Quebec, Canada.

About Egetis Therapeutics

Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.
The Company’s lead candidate Emcitate is under development for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In previous studies (Triac Trial I and a long-term real-life study) Emcitate has shown highly significant and clinically relevant results on serum T3 levels and secondary clinical endpoints. As a result of fruitful regulatory interaction Egetis intends to submit a marketing authorisation application (MAA) for Emcitate to the European Medicines Agency (EMA) in the first half of 2023 based on existing clinical data.
In the US, after discussions with the FDA, Egetis will conduct a small randomized, placebo-controlled study in 16 patients to verify the results on T3 levels seen in previous clinical trials and publications. Egetis intends to submit a new drug application (NDA) in the US for Emcitate in mid-2023 under the Fast-Track Designation granted by FDA.
Emcitate is currently being investigated in the Triac Trial II, a Phase II/III study in very young MCT8 deficiency patients (<30 months of age) exploring potential disease modifying effects of early intervention from a neurocognitive and neurodevelopmental perspective. The recruitment target was achieved in the second quarter 2022 and 22 patients have been included in the study. Results are expected mid 2024 and are expected to be submitted post-approval to regulatory authorities.
Emcitate holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone type beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Emcitate has been granted Rare Pediatric Disease Designation (RPDD) which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval.
The drug candidate Aladote is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed and the design of the upcoming pivotal Phase IIb/III study with the purpose of applying for market approval in the US and Europe for Aladote has been finalized after completed interactions with FDA, EMA and MHRA and study start is planned for early 2023. Aladote has been granted ODD in the US and in the EU.
Egetis Therapeutics (STO: EGTX) is listed on the Nasdaq Stockholm main market. For more information, see www.egetis.com