Lundbeck announced the acquisition aimed at eptinezumab, Alder’s investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide that has been submitted to the U.S. Food and Drug Administration for potential approval.
Shares of Alder BioPharmaceuticals have shot up more than 83% in premarket trading after Denmark-based H. Lundbeck A/S announced it was acquiring the company for $2 billion as it eyes a potential blockbuster treatment for migraine prevention.
This morning, Lundbeck announced the acquisition aimed at eptinezumab, Alder’s investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide that has been submitted to the U.S. Food and Drug Administration for potential approval. The FDA set a PDUFA date of Feb. 21, 2020 for eptinezumab. If approved, eptinezumab will be the first-to-market IV CGRP therapy for migraine prevention in the U.S., giving it some distinct advantages over other anti-CGRP drugs in the market and under development.
For Lundbeck, the acquisition of Alder follows its May deal for San Diego-based Abide Therapeutics. That deal, which included a $250 million down payment, provided Lundbeck with a novel discovery platform and a U.S.-based research hub. Abide’s lead product ABX-1431 is believed to have potential to address multiple indications in psychiatry and neurology.
In its announcement, Lundbeck said eptinezumab will accelerate and diversify Lundbeck’s revenue growth and will also enhance Lundbeck’s antibody process and development capabilities. Deborah Dunsire, president and chief executive officer of Lundbeck, called Alder an “excellent strategic fit” for her company’s focus on treatments of the brain.
“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,” Dunsire said in a statement.
Clinical data has shown that following the 30-minute infusion time of eptinezumab, there is a 100 percent bioavailability of the medication in a patient. In April, Alder CEO Robert Azelby told BioSpace that data is important because that means that 100 percent of the medicine is available to block CGRP and migraine prevention begins in 24 hours. Phase III data showed that eptinezumab was effective in significantly reducing the average number of migraine days in patients with both episodic migraine, 14 migraines or less per month, and chronic migraine, 15 migraines or more per month. During that interview, Azelby said in both late-stage clinical trials, there was a “strong depth of response” from patients.
Alder is also developing ALD1910, a mAb designed to inhibit pituitary adenylate cyclase-activating polypeptide (PACAP) for migraine prevention. Eptinezumab, together with ALD1910, will help establish Lundbeck as an emerging leader in migraine and other pain syndromes, the company said in its announcement.
This morning, Azelby called Lundbeck the “ideal partner” to advance Alder’s migraine treatments and positions eptinezumab for a successful launch in and outside of the United States. The Alder Board of Directors unanimously supported the acquisition.
Under the terms of the agreement, Lundbeck will commence a tender offer for all outstanding shares of Alder, whereby Alder stockholders will be offered an upfront payment for $18 per share in cash, along with one non-tradeable Contingent Value Right of $2 per share. The upfront cash consideration represents a 79% premium to Alder’s shareholders based on the closing price on Sept. 13. Lundbeck expects to fund the acquisition through existing cash resources and bank financing.
