Egetis Therapeutics gets Notice of Allowance for a new US patent for a combination therapy with Aladote

Egetis Therapeutics AB (publ) (ticker: EGTX) today announced that the US Patent Office (USPTO) has issued a Notice of Allowance for a new patent covering a combination treatment with the company’s clinical candidate drug Aladote® (calmangafodipir) and N-acetylcysteine (NAC). The new patent further improves the unique value proposition of the Aladote franchise and provides patent protection until year 2037 in the US, before a potential extension.

The new patent covers a combination treatment with NAC and Aladote for “late presenters”, i e patients that started treatment with NAC and calmangafodipir 8 hours or later after an overdose of paracetamol. A potential combination product is also covered by the patent.

“We are very pleased that the patent for this combination treatment of Aladote and NAC will be granted, which further strengthens our robust calmangafodipir patent portfolio that amongst others includes a composition of matter patent with protection until year 2032 in US and EU ”, said Nicklas Westerholm, CEO, Egetis Therapeutics.

Aladote has been granted Orphan Drug Designation in the US and an application for ODD was submitted in Europe in Q1 2021. There is an ongoing dialogue with EMA on the appropriate indication for an ODD in the EU.

About Egetis Therapeutics AB

Egetis Therapeutics is an innovative, unique, and integrated pharmaceutical drug development company, focusing on projects in late-stage development for treatment of serious diseases with significant unmet medical needs in the orphan drug segment. The drug candidate Emcitate is developed as the first potential treatment for patients with MCT8 deficiency, a rare disease with high unmet medical need and no available treatment. A Phase IIb clinical trial has been completed with significant and clinically relevant effects. A Phase IIb/III early intervention study has been initiated with the first patient dosed in Dec 2020. Emcitate holds Orphan Drug Designation (ODD) in the US and EU and has been granted Rare Pediatric Disease Designation and Fast Track Designation by the US FDA. 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 and an application for ODD was submitted in Europe in Q1 2021. There is an ongoing dialogue with EMA on the appropriate indication for an ODD in the EU.

Egetis Therapeutics (STO: EGTX) is listed on the Nasdaq Stockholm main market. For more information, see http:// www.egetis.com/