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AcuCort AB (Spotlight Stock Market: ACUC) has noted an updated status regarding its second patent family application for its drug candidate ISICORT® in the US. The information from the US Patent and Trademark Office, USPTO, on this updated status has not yet been received by the company.
The US Patent and Trademark Office has made an update on its website regarding AcuCort's second patent application for ISICORT®. The application has been granted the status of "Final Rejection Counted, Not Yet Mailed". This means that the application in its current form is not approved and that the company has not yet been informed.
US patent applications typically proceed in a number of steps. A so-called final rejection does not close the prosecution of the application. AcuCort has the possibility of responding thereto and may also file a divisional application to maintain the application. This work cannot take place until the patent authority has shared its comments.
"We will continue our work with the company's second patent application in the US to further strengthen the patent protection for ISICORT®. We respect and follow the application process that applies in the United States and look forward to the next step," says Ann Gidner, CEO of AcuCort AB.
Active patent strategy
AcuCort has an active patent strategy covering important drug markets. The company's drug candidate ISICORT® is already protected by the patent "Acute Glucocorticoid Therapy". This patent describes medical self-treatment with glucocorticoids in emergency situations without access to medical personnel. The patent is granted in 31 countries, including 21 European countries and the United States. The patent is valid until 2025, except in the United States where the patent is valid until the end of 2028.
In 2017, the company filed a second patent application, co-owned with former manufacturing partner LTS Lohmann, in 44 countries to further strengthen the patent protection for ISICORT® and extend market exclusivity. The patent mainly describes the formulation, the manufacturing process and the intended use of ISICORT®. The European Patent Office, EPO, has previously granted the said patent application and the company has validated the application in 16 EU countries including Turkey which provides protection until November 2035.
For more information, please contact
Ann Gidner, interim CEO, AcuCort AB
Phone: +46 (0)72 315 1414
Email: ann.gidner@acucort.se
About AcuCort AB (publ)
AcuCort develops and commercializes ISICORT®, a new fast-dissolving oral film to put on the tongue, based on a well-known cortisone substance - dexamethasone. ISICORT® is a smart product in a new, innovative, patented and user-friendly dosage form primarily for the treatment of severe and acute allergic reactions, croup in children and chemotherapy-induced nausea and vomiting (CINV). The bioequivalence study that forms the basis of the application for marketing approval in Europe was carried out with positive results and a national hybrid application has been submitted to the Swedish Medical Products Agency. Altogether, this strengthens the company's assessment that the time to commercialization of ISICORT® may be relatively short. AcuCort (ticker: ACUC) is listed on the Spotlight Stock Market in Sweden. Please visit www.acucort.com.