Danish biopharma Lundbeck says it expects to launch the potential blockbuster migraine biologic eptinezumab early next year after agreeing to buy Alder BioPharmaceuticals.
The cash deal, expected to close in Q4 2019, is worth $1.95 billion (€1.78 billion) and falls into Lundbeck’s “expand and invest growth strategy” announced by the Danish biopharma firm in February 2019, aimed at expnding its breadth in brain disease therapies and rebuilding its pipeline.
Since then the firm acquired Abide Therapeutics, adding a serine hydrolases enzyme discovery platform and a Phase II Tourette’s candidate in a deal worth up to $400 million.
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“Today’s announcement for the agreement to acquire Alder is a further very exciting leap forward on our path to deliver long-term sustainable growth and value to our shareholders,” Lundbeck CEO Deborah Dunsire told stakeholders on a call discussing the Alder buy.
“We expand our reach in therapies for brain disease bringing the opportunity to build a migraine franchise and addressing a large market with substantially unmet medical needs.”
Alder’s lead asset is eptinezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody administered as a quarterly 30-minute IV infusion filed with the US Food and Drug Administration (FDA) as a potential migraine treatment. The Agency has set a PDUFA action date of 21 February 2020, something Lundbeck is hoping will end with an approval.
“We believe [eptinezumab] will launch in early 2020,” said Dunsire, adding this will “provide near-term growth with potential blockbuster over time.”
She added: “Additionally, Alder’s strong antibody capability accelerates Lundbeck’s ability to develop future biologics in brain diseases.”
Manufacturing
If approved, Lundbeck and Alder say the potential market will be 30 million patients in the US alone.
Alder has a long-standing relationship with Novartis subsidiary Sandoz and inked a supply agreement for eptinezumab back in 2015. But in preparation of commercialization, Alder extended the supply agreement in February 2019 ensuring Sandoz will manufacture quantities of eptinezumab drug substance until 2023.
But the firm also uses other contract manufacturing organizations (CMOs) and in an SEC filing last January said other third-party manufacturers could be used.
“We expect to enter into additional CMO relationships for our eptinezumab commercial supply needs as well as for our other product candidates,” the Form 10-K stated.
Lundbeck itself boasts small molecule active pharmaceutical ingredient (API) and fill/finish manufacturing capabilities but no biologics production facilities of its own.