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History

2022

Agreement with TFS Trial Form Support AB regarding pharmacovigilance and Adhex Pharma regarding commercial production of ISICORT® in large-scale volume. AcuCort becomes exempt from the application fee by the FDA. An application for ethical review of the questionnaire survey on allergy treatment is submitted.

2021

Stability studies show at least 36 months shelf life. A second patent for ISICORT® is granted in the United States. Patent protection in Japan. The application for market approval in the Nordic countries is submitted. A rights issue and a directed issue will provide a total of approximately SEK 31 million before issue costs. The Swedish Medical Products Agency approves ISICORT® for the treatment of patients with COVID-19 with breathing difficulties and need for oxygen therapy.

2020

ISICORT® an approved drug in Sweden. Patent protection for ISICORT® by the patent office of China.

2019

The application for market approval in Sweden is submitted to the Medical Products Agency. A new share issue with preferential rights for the shareholders will provide AcuCort with approximately SEK 41.2 million before issue costs.

2018

Production at the lab scale level is scaled up to commercial size, and production according to GMP begins. An agreement is signed with the CRO company Quinta-Analytica to conduct bioequivalence studies for the application for market approval of the drug in the EU and the US. Approved patent in the US for “Acute Glucocorticoid therapy” which describes medical self-treatment with glucocorticoids in emergency situations when there is no access to medical personnel. A rights issue raises almost SEK 11 million after financing costs.

2017

An agreement is signed with the contract manufacturer Adhex Pharma regarding the development of production. AcuCort AB (publ) is listed in April on AktieTorget (now Spotlight Stock Market). The distribution issue raises SEK 14 million after financing costs.

2016

SEK 6 million is provided through a rights issue. Resolution on distribution issue and listing on AktieTorget.

2015

A new patent application is submitted that protects the specific and unique formulation of the product. A rights issue of SEK 1 million.

2014

Market research is carried out. The mouth film manufacturer tesa Labtec replaces LTS as development and manufacturing partner. The first pilot scale batches are successfully manufactured for 4 mg and 8 mg strength respectively. SEK 7.3 million is provided through an issue.

2013

The Swedish Medical Products Agency confirms that only a repetition of a previous clinical study is needed to apply for registration in the EU. SEK 2.5 million is provided through an issue.

2012

The Swedish Medical Products Agency confirms the development plan for EU registration. An animal study of local tolerance shows favorable results. SEK 8.5 million will be provided through an issue.

2011

A fresh start for AcuCort and the project when the PULS group acquires the project from DuoCort AB. AcuCort receives approximately SEK 9 million through issues for development and clinical trials.

2007

The oral film manufacturer LTS Lohmann is contracted to help with the development of the product.

2006

AcuCort AB is formed as a subsidiary of DuoCort AB.

2005

The first patent application is filed.

2004

DuoCort, a project in the PULS group, now Aqilion, discovers the possibility of developing a product with simple administration of a glucocorticoid via the oral cavity.