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The acquisition will enhance Lundbeck’s brain disease therapy portfolio as well as its antibody process and development capabilities.
On Sept. 16, 2019, H. Lundbeck and Alder BioPharmaceuticals, a Bothell, WA-based clinical-stage biopharmaceutical company, announced a definitive agreement for Lundbeck to acquire Alder in a transaction valued at up to $1.95 billion.
Under the agreement, Lundbeck will commence a tender offer for all outstanding shares of Alder, whereby Alder stockholders will be offered an upfront payment of $18 per share in cash. Alder shareholders will also receive one non-tradeable contingent value right (CVR) that entitles them to an additional $2 per share upon approval of Alder’s lead candidate by the European Medicines Agency (EMA), representing a total potential consideration of $20 per share or a transaction value of up to $1.95 billion, net of cash and on a fully diluted basis.
Alder’s focus is on developing antibody therapeutics to treat migraine, and through its acquisition, it will expand Lundbeck’s range of therapeutics for brain diseases. In addition, by acquiring Alder, Lundbeck will further enhance its capabilities to deliver future biological innovations in brain diseases.
Lead mAb for migraine
Alder is developing its lead candidate, eptinezumab, for the preventive treatment of migraine in adults. Eptinezumab is an investigational monoclonal antibody (mAb) that is administered as a quarterly 30-minute intravenous (IV) infusion. The mAb was designed for immediate and complete bioavailability with high specificity and strong binding for suppression of calcitonin gene-related peptide (CGRP), a neuropeptide believed to play a key role in mediating and initiating migraines, according to Alder.
If approved by FDA, eptinezumab will be the first IV CGRP therapy for migraine prevention, Alder reports. The company is also developing ALD1910, a mAb designed to inhibit pituitary adenylate cyclase-activating polypeptide (PACAP) for migraine prevention. Eptinezumab, together with ALD1910, will help boost Lundbeck’s position in migraine and other pain syndromes.
Alder submitted a biologics license application (BLA) to FDA for eptinezumab in February 2019, and the agency has set a Prescription Drug User Fee Act (PDUFA) action date of Feb. 21, 2020. In addition, 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.
“Alder is an excellent strategic fit for Lundbeck’s focused expertise in brain diseases and organizational capabilities. This transaction flows from our strategic intent to [e]xpand and [i]nvest to [g]row. 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,” said Dr. Deborah Dunsire, president and CEO of Lundbeck, in a company press release.
“As a global leader in neuroscience research with products registered in more than 100 countries and a strong network of neurology specialists, Lundbeck is the ideal partner to advance Alder’s mission of changing the treatment paradigm for migraine prevention. We believe this positions eptinezumab for a successful launch both in and outside of the United States,” said Bob Azelby, Alder’s president and CEO, in the press release. “Importantly, today's news provides Alder shareholders with significant and immediate cash value, as well as the ability to benefit further once eptinezumab is approved by the EMA. Looking ahead, we expect Lundbeck will leverage Alder’s expertise in antibody development to explore additional indications for eptinezumab and continue the development of ALD1910.”
Source: H. Lundbeck