02/15/2021 | Press release | Distributed by Public on 02/15/2021 01:38
February 15, 2021
Stockholm, Sweden, February 15, 2021. Egetis Therapeutics AB (publ) (ticker: EGTX) today announced that Kristina Sjöblom Nygren, MD, has been appointed Chief Medical Officer (CMO), effective May 1, and will be member of the company's leadership team. The recruitment extends the orphan drug experience and expertise also to the clinical and medical function, further strengthening the company's alignment and strategic focus on this segment.
Kristina Sjöblom Nygren is a MD with more than 20 years of experience in the pharmaceutical industry from both large pharmaceutical companies and smaller biotech companies with an extensive experience in late-stage development and regulatory interactions in the rare disease and orphan drug segment in particular.
Prior to joining Egetis Therapeutics, Kristina worked as CMO and Head of Development at Santhera, a Swiss pharmaceutical company focusing on developing therapies for rare diseases. In this capacity, Kristina oversaw Clinical Operations, Regulatory Affairs and Medical Affairs and led activities in most phases of development including early and late-stage clinical development programs, registration, post-approval commitments and managed access-programs within rare diseases in different therapeutic areas.
Previously, Kristina spent 18 years at SOBI, Wyeth and AstraZeneca, where she held a number of senior positions, including VP Head of Clinical Development and VP Head of Therapeutic Area. Over the years, she has been involved in many different interactions with regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency's (EMA) including scientific advice and orphan drug applications.
Before joining the industry, Kristina worked as a licensed physician in several clinical positions. She holds a Diploma in Pharmaceutical Medicine, and an MD from the Karolinska Institute, Stockholm.
'We are extremely pleased to welcome Kristina to Egetis Therapeutics. With her long experience and excellent track record within orphan drugs and clinical development, Kristina will be instrumental in the execution of our development programs and corporate strategy. I am excited to work with her to further strengthen the existing medical platform and network in the orphan drug segment to ensure the continued success of our late-stage development portfolio.' said Nicklas Westerholm, CEO of Egetis Therapeutics.
For further information, please contact:
Nicklas Westerholm, CEO, Egetis Therapeutics
Tel. +46 (0) 73 354 20 62
Email: [email protected]
About Egetis Therapeutics
Egetis is an innovative, unique, and integrated pharmaceutical drug development company, focusing on projects in late-stage development for treatment of serious rare/niche diseases with significant unmet medical needs in the orphan drug segment. The drug candidate Emcitate® is a first in class drug candidate developed for the treatment of MCT8 deficiency, a rare disease with high unmet medical need and no available treatment. A Phase IIb clinical trial was completed with significant and clinically relevant effects. A pivotal Phase IIb/III early intervention study has been initiated in December 2020 with the first patient dosed and interim results are expected in 2022. Emcitate holds Orphan Drug Designation in the US and EU and was granted Rare Pediatric Disease Designation by the US FDA in November 2020. The drug candidate Aladote® is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol poisoning. A proof of principle study has been successfully completed and the design of the upcoming pivotal Phase IIb/III study for Aladote has been finalized after completed interactions with FDA, EMA and MHRA. Aladote® has been granted Orphan Drug Designation in the US. Results from the prematurely closed PledOx POLAR program in December 2020 showed that Pledox did not meet the efficacy endpoint. Based on further evaluation of the results from the POLAR studies, the strategic next steps for PledOx® will be determined together with our partner Solasia.
Egetis Therapeutics (STO: EGTX) is listed on the Nasdaq Stockholm main market since October 31, 2019. For more information, see www.egetis.com