Nordic Life Science 1
TOP STORIES BUSINESS PHARMA ASTRAZENECA’S CALQUEN
CE GRANTED BREAKTHROUGH THERAPY DESIGNATION THE FDA HAS GRANTED THE DESIGNATION AS A MONOTHERAPY TREATMENT FOR ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL). THIS IS AN important regulatory milestone for our work in The UmanDiagnostics team BUSINE S S D E A L haematology and for patients living with chronic lymphocytic leukaemia, a life-threatening disease, states José Baselga, Executive Vice President, Oncology R&D, AstraZeneca. ”The Breakthrough Therapy Designation (BTD) acknowledges the growing body of evidence that supports Calquence as a highly-selective Bruton tyrosine kinase inhibitor with the potential to offer patients a new, differentiated, chemotherapy-free treatment option with a favourable safety profile,” says Baselga. QUANTERIX CORPORATION WILL ACQUIRE PRIVATELY HELD UMANDIAGNOSTICS FOR $22.5 MILLION, COMPRISED OF $16 MILLION IN CASH PLUS $6.5 MILLION IN QUANTERIX COMMON STOCK. HE MERGER BETWEEN the companies holds great promise for unlocking the value of Neurofilament Light, says Niklas Norgren, CEO of UmanDiagnostics. UmanDiagnostics, based in Umeå, Sweden, supplies Neurofilament Light (Nf-L) antibodies and ELISA kits, widely recognized by researchers and biopharmaceutical and diagnostics companies worldwide as the premier solution for the detection of Nf-L to advance the development of therapeutics and diagnostics for neurodegenerative 12 conditions. Nf-L has seen a dramatic growth in the last three years since Quanterix developed the first assay using Uman’s antibodies that could reliably measure Nf-L in blood. Nf-L has demonstrated utility in the diagnosis, prognosis, and monitoring of a wide range of conditions including Alzheimer’s Disease, Multiple Sclerosis, Parkinson’s Disease, traumatic brain injury (TBI), ALS, Huntington’s Disease. “We believe that the ability to measure Nf-L in blood is one of the most significant advances in diagnosis and monitoring of a wide range of neurodegenerative conditions and has the potential to dramatically improve the NORDICLIFESCIENCE.ORG lives of people suffering from some of the most debilitating diseases impacting society,” says Kevin Hrusovsky, CEO of Quanterix. ”The acquisition will allow us to better support growing research with Nf-L and ultimately has the potential to accelerate the availability of diagnostic tests.” “We greatly look forward to further advancing the field as part of Quanterix. We are compelled by Quanterix’ vision, mission, and strategy for disrupting the field of neurodegeneration research and diagnostics and are confident in the management team’s ability to continue its superb execution against this substantial opportunity,” says Niklas Norgren. The FDA granted the BTD based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials. Together the trials showed that Calquence alone or in combination significantly increased the time patients lived without disease progression or death, with safety and tolerability that was consistent with its established profile. This is the 10th BTD that AstraZeneca has received from the FDA since 2014. José Baselga