BerGenBio Receives FDA Approval of Fast Track Designation for Bemcentinib
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
BERGEN, Norway,?Oct. 22, 2019?/PRNewswire/ --? BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, today announces that the U.S. Food and Drug Administration (FDA) has approved Fast Track Designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed. There are currently no marketed drugs specifically approved for all relapsed AML patients, representing a significant unmet medical need. BerGenBio has ongoing phase 2 trials in this indication and plans to seek regulatory advice from the FDA and European Medicines Agency (EMA) to determine the optimal regulatory path for bemcentinib in relapsed AML.
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.?A drug that receives?Fast Track?designation is eligible for the following:
+47 917 86 304 Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513 International Media Relations Mary-Jane Elliott,?Chris Welsh,?
Nicholas Brown,?Carina Jurs,?
Consilium Strategic Communications?
bergenbio@consilium-comms.com?
+44 20 3709 5700 Media Relations in?Norway Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891 Forward looking statements This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This information was brought to you by Cision?http://news.cision.com The following files are available for download: SOURCE BerGenBio ASA
- More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
- More frequent communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
- Eligibility for?Accelerated Approval and Priority Review, if relevant criteria are met
- Rolling Review,?which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
+47 917 86 304 Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513 International Media Relations Mary-Jane Elliott,?Chris Welsh,?
Nicholas Brown,?Carina Jurs,?
Consilium Strategic Communications?
bergenbio@consilium-comms.com?
+44 20 3709 5700 Media Relations in?Norway Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891 Forward looking statements This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This information was brought to you by Cision?http://news.cision.com The following files are available for download: SOURCE BerGenBio ASA