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The Danish biopharmaceutical company Lundbeck has announced its intention to launch eptinezumab, a potentially dangerous biological agent for migraine, early next year after agreeing to buy Alder BioPharmaceuticals.
The cash transaction, which is expected to be finalized in the fourth quarter of 2019, stands at $ 1.95 billion (1.78 billion euros) and fits into the strategy of development and investment of Lundbeck announced by the Danish biopharmaceutical company in February 2019, which aimed to extend its scope in the treatment of brain diseases. and rebuilding his pipeline.
Since then, the company has acquired Abide Therapeutics, adding a platform for the discovery of serine hydrolase enzymes and a Phase II Tourette candidate under a contract worth up to $ 400 million.
Image: iStock / brijith vijayan
"The announcement of the Alder Acquisition Agreement announced today is another exciting step on our path to generate long-term, sustainable growth and added value for our shareholders," said the CEO's CEO. Lundbeck, Deborah Dunsire, a call regarding the purchase of Alder.
"We are expanding our field of action in the treatment of brain diseases by providing the opportunity to create a franchise for migraine and treat a large market whose medical needs are largely unmet."
Alder's main active ingredient is eptinezumab, a monoclonal anti-calcitonin gene-related antibody (anti-CGRP) administered as a 30-minute intravenous intravenous infusion filed with the FDA (Food and Drug Administration). ) as a potential treatment for migraine. The Agency has set February 21, 2020 as the date for implementation of PDUFA, which Lundbeck hopes to end with approval.
"We believe [eptinezumab] will launch in early 2020, "said Dunsire, adding that this" will provide short-term growth with considerable production potential over time. "
She added, "In addition, Alder's high antibody capacity accelerates Lundbeck's ability to develop future biologics for brain diseases."
Manufacturing
If approved, Lundbeck and Alder estimate that the potential market will be 30 million patients in the United States alone.
Alder has long-standing relationships with Sandoz, a Novartis subsidiary, and has signed a contract to supply eptinezumab in 2015. However, in anticipation of commercialization, Alder extended the supply agreement in February 2019, ensuring that Sandoz will manufacture amounts of pharmaceutical substance eptinezumab until 2023.
But the company also uses other contract manufacturing organizations (CMOs) and, in a document filed by the SEC last January, indicated that other third-party manufacturers could be used.
"We expect to establish further relationships with the collecting society for our commercial procurement needs in eptinezumab as well as for our other product candidates," says Form 10-K.
Lundbeck itself has Active Pharmaceutical Ingredients (APIs) and small molecule filling / finishing capabilities, but no organic production facilities per se.
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