• Marianne Berrens-Peijnenburg joins as Global Head of Medical Affairs

• Nadia Georges joins as Global Head of Market Access & Pricing

• Peter Verwaijen joins as Global Head of Marketing & Brand Strategy

Stockholm, Sweden, May 05, 2022. Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) today announced three key appointments to medical affairs and the commercial team to deliver on activities to ensure successful launches after anticipated approvals of Emcitate in USA and Europe in 2024. Marianne Berrens-Peijnenburg joins as Global Head of Medical Affairs, Nadia Georges joins as Global Head of Market Access & Pricing, and Peter Verwaijen joins as Global Head of Marketing & Brand Strategy.

Nicklas Westerholm, CEO of Egetis, commented: “Through the announced recruitments we bring additional industry leading rare disease expertise and experience in medical affairs and commercialization to the Company. The timing is right for Egetis to start stepwise building our international teams ahead of the expected Emcitate submissions for market approval in Europe and US next year to ensure a successful launch. We plan to commercialize Emcitate on our own in Europe and North America, with combined teams of around 50 FTEs at launch.”

Henrik Krook, VP Commercial Operations of Egetis, continued: “I am very pleased to welcome Marianne, Nadia and Peter to the Egetis team for the important work of ensuring successful preparations for the anticipated launch of Emcitate. There has been great interest among senior pharma leaders to join Egetis. Our selected leaders bring successful track records in orphan diseases with specific skills in areas such as enhancing disease awareness and demonstrating product value to secure funding/reimbursement of treatment.”

Marianne Berrens-Peijnenburg is a Medical Doctor who, in the role as Global Head of Medical Affairs, will be responsible for establishing small medical affairs teams in North America and Europe to drive activities such as health care professional education on MCT8 deficiency and stimulating increased diagnosis of patients. She has previously had international and senior roles at companies such as Santhera, Sanofi Genzyme and J&J. Marianne will be based in The Netherlands.

Nadia Georges will, in the role as Global Head of Market Access & Pricing, lead the development of the Emcitate pricing strategy and ensure that national payers recognize the full value of Emcitate treatment and thereby support funding/reimbursement. She brings experience from global and international roles at companies such as Ferring, Takeda and Sanofi. Nadia will be based in Switzerland.

Peter Verwaijen will, in the role as Global Head of Marketing & Brand Strategy, lead the development and execution of the Emcitate launch plan, including market preparations through executing initiatives such as disease awareness campaigns through the web, social media and at congresses for neurologists and endocrinologists. He has previously had international and senior positions at companies such as Santhera, Roche and Actelion. Peter will be based in The Netherlands.

For further information, please contact:

Nicklas Westerholm, CEO
+46 (0) 733 542 062
nicklas.westerholm@egetis.com

Karl Hård, Head of Investor Relations and Communications
+46 (0) 733 011 944
karl.hard@egetis.com

About Egetis Therapeutics AB
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 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 of 16 patients was reached in the beginning of April 2022. Results are expected in the first quarter of 2024 and are expected to be submitted post-approval to regulatory authorities shortly thereafter.
Emcitate holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone type beta (RTH- β) in the US and the EU. Emcitate has been granted Rare Pediatric Disease Designation (RPD) 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) poisoning. 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. Aladote has been granted ODD in the US and an application for ODD was submitted in the EU in the first quarter of 2021. There is an ongoing dialogue with EMA on the appropriate scope of the indication for an ODD in the EU.
Egetis Therapeutics (STO: EGTX) is listed on the Nasdaq Stockholm main market.
For more information, see www.egetis.com