Britannia Pharmaceuticals Ltd.

STOCKHOLM, April 9, 2024 /PRNewswire/ -- Tridentify are delighted to announce that Intrance Medical Systems Inc. now have signed a LOI purchase commitment of $ 300 000. Their Tridentify safeguarding solution will be used for the 'logistic journey' of the drug component for clinical trials in at least Europe and the US for patients with Parkinson diseases in advanced stage. The clinical development program for US registration has recently been initiated, with a larger more extensive study planned for late 2024. "Intrance Medical Systems is focused on the development and commercialization of its lead clinical product for the treatment of advanced Parkinson's disease. The product, Lecigon, is successfully marketed and available across Europe (by Britannia Pharmaceuticals). Intrance Medical plans to bring this innovative system to the US, Canada, Japan, Taiwan and LATAM. The US clinical development program includes key studies where accurate data to the FDA is paramount. Since Lecigon requires an unbroken cold supply chain and whose properties can change if improperly handled, we have found that Tridentify has a unique solution with monitoring and continuous calculation of remaining shelf life. We're excited about our collaboration and anticipate extending our partnership in the future," says Patrick Shea, CEO at Intrance Medical Systems Inc. " Tridentify is excited about the next steps with Intrance Medical Inc. Together with Intrance we want to ensure high quality standards in their important development of a new Parkinson treatment. We are proud to be able to safeguard the shipments for the clinical trials in Europe and in the US, as well as to support the important safety for patients with severe diseases," says Ann-Christine Jungmar, CEO at Tridentify. For further information, kindly contact: Ann-Christine Jungmar, CEO Tridentify +46 708 71 46 76 [email protected] This information was brought to you by Cision The following files are available for download:

Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization. Kinpeygo is an orphan medicinal product and the first and only treatment approved in the UK for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need. Kinpeygo is currently approved under conditional approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. STADA, which holds the commercial rights in the European Economic Area (EEA) member states, Switzerland and the UK, has already launched the IgAN medicine in Germany in September 2022 and is working to extend patient access to other countries. The submission to the MHRA for full approval, made by STADA's affiliate Britannia Pharmaceuticals Ltd., is based on the full two-year data set from the Phase 3 NefIgArd clinical trial, as recently published in leading medical journal The Lancet [1]. The trial met its primary endpoint, with Kinpeygo demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of nine months of treatment with Kinpeygo or placebo and 15 months of follow-up off drug. [1] Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomised phase 3 trial - The Lancet For further information, please contact: Åsa Hillsten, Head of Investor Relations & Sustainability, Calliditas Tel.: +46 76 403 35 43, email: asa.hillsten@calliditas.com The information was sent for publication, through the agency of the contact persons set out above, on October 3, 2023 at 09:20 a.m. CET. The following files are available for download: SOURCE Calliditas Therapeutics