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.”
The Weight-Loss Gold Rush: Legal and Regulatory Implications
July 11th 2024Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses how the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 drugs, what needs to be done for GLP-1s to be covered, advice for investors and financiers considering entering the weight-loss medication market and more.
Healthcare Marketing Strategies for Reaching Diverse Audiences
May 14th 2024Amanda Powers-Han, Chief Marketing Officer, Greater Than One, and Pharmaceutical Executive Editorial Advisory Board member, discusses how improved DE&I in healthcare marketing strategies can not only reach diverse audiences more effectively but also contribute to improved patient care outcomes, challenges faced in crafting culturally sensitive messages, and much more.