Nordic Life Science 1
Business deals – Acquisitions – Agreements – Coll
aborations T E X T B Y M AL IN O T M ANI Ulf Hannelius, former CEO, Diamyd Medical BIOTECH Disappointing news for BioArctic It is formally legal to prescribe the company’s Alzheimer's drug throughout the EU, but in April, the Swedish healthcare system advised against using it. UPDATE Diamyd Medical discontinues Phase 3 trial and initiates strategic review The company will, after an unexpected interim analysis outcome, discontinue the DIAGNODE-3 trial evaluating retogatein in Stage 3 type 1 diabetes. THE RESULTS of the interim analysis were based on 174 evaluable participants followed from baseline to month 15. The results showed no clinically meaningful effect on C-peptide, a marker for endogenous insulin secretion, neither in the overall population nor in pre-specified subgroups. Furthermore, the pre-specified criteria required to support continuation of the trial were not met. With respect to retogatein, the company does not intend to allocate further internal resources to future clinical development. Instead, efforts will be directed to organizing, packaging, and preparing the relevant data, documentation, and know-how to enable a potential out-licensing, partnership, or transfer to an external party. As part of the review, Diamyd is also evaluating strategic alternatives for its biomanufacturing facility in Umeå including potential stand-alone opportunities, or a divestment. The Board of Directors has also implemented governance changes. CEO Ulf Hannelius has decided to step down from his role and Chairman Anders Essen-Möller has been appointed CEO. Vice Chairman Erik Nerpin has been appointed Chairman of the Board. Following the discontinuation of DIAGNODE-3 and taking trial wind-down costs, restructuring measures, and operational expenses into account, Diamyd estimates that its cash position will correspond to approximately SEK 225 million by December 31, 2026. NLS THE EUROPEAN MEDICINES Agency and the European Commission have approved the Alzheimer’s drug Leqembi for sale in the EU. Despite EU approval, the NT Council (the Swedish regional cooperation body) has advised against using the drug in Sweden. The council does not believe that the high price is justified in relation to the effect, it states. BioArctic has expressed that the high requirements for price levels in Sweden make it difficult to launch the treatment there. In addition, a newly released Cochrane report has concluded that the clinical benefit of new Alzheimer's drugs consisting of antibodies that target amyloid-beta (for example BioArctic/Eisai’s Leqembi) is negligible. The company criticizes the new report, stating that the report is unscientific and misleading. ”It is based on selecting one study each for drugs that have shown efficacy, such as Leqembi, and comparing this to around 15 negative studies from other drug candidates that have not shown relevant efficacy. It is not a scientific approach for carrying out such an analysis,” Gunilla Osswald told Finwire. Leqembi has been approved by more than 50 regulatory authorities worldwide. NLS USD 20 MILLION … … has been raised by Moleculent. The financing round was led by Rubicon Healthcare Partners, with participation from ARCH Venture Partners, Eir Ventures, and other existing investors. Gunilla Osswald, CEO, BioArctic NORDICLIFESCIENCE.ORG | 7 PHOTO JIM HALLING PHOTO FREDRIK SEDERHOLM