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Danish drugmaker Lundbeck is to acquire the US migraine treatment company Alder BioPharmaceuticals (Bothell, WA) in a transaction valued at up to $1.95 billion.
Alder is developing eptinezumab-an investigational monoclonal antibody (mAb) that is administered as a quarterly 30-minute IV infusion-for the preventive treatment of migraine in adults. If approved by FDA, it will be the first IV CGRP therapy for migraine prevention. Alder submitted a Biologics License Application (BLA) to FDA for eptinezumab in February 2019; FDA has set a Prescription Drug User Fee Act (PDUFA) action date of February 21, 2020. Lundbeck expects to submit eptinezumab for approval to regulatory authorities in the European Union during 2020, followed by submissions for approval in other regions around the world, including China and Japan.
The proposed transaction is anticipated to significantly strengthen Lundbeck’s business as early as 2020, accelerating the build of Lundbeck’s late-stage pipeline and providing access to new capabilities in the monoclonal antibody field. The addition of eptinezumab will expand Lundbeck’s leading global brain disease franchise.
“Alder is an excellent strategic fit for Lundbeck’s focused expertise in brain diseases and organizational capabilities," said Dr. Deborah Dunsire, Lundbeck's President and CEO. "Migraine prevention is an attractive indication for us that leverages our specialized commercial expertise in delivering medicines for brain diseases. We expect the global launch of eptinezumab for the preventive treatment of migraine, as well as the further potential development of the product in additional indications, to accelerate Lundbeck’s growth in the coming years.”