Migraine competition intensified! Lingbei completed the $1.95 billion acquisition of alder and obtained the CGRP antibody drug eptinezumab once in March!

October 28, 2019 / BIOON / -- lundbeck, a Danish pharmaceutical company, recently announced that it has completed the acquisition of alder biopharmaceuticals The acquisition was announced on September 16 with a total cash value of $1.95 billion Alder is a biopharmaceutical company based in Bossel, Washington, focusing on migraine The acquisition will greatly speed up and strengthen the pipeline construction in Lingbei Dr Deborah dunfire, Lingbei president and CEO, commented: "we are very pleased to welcome alder to Lingbei The acquisition of eptinezumab, an exciting migraine drug, will expand our portfolio to migraine, which is an important step in our expansion and investment growth strategy Lingbei can now participate in helping migraine communities, where there are many unmet medical needs " Alder is developing the drug eptinezumab, a research monoclonal antibody (mAb) that is administered intravenously for 30 minutes once a quarter (three months) to prevent migraine in adults Eptinezumab has rapid and complete bioavailability, high specificity and strong binding to the inhibition of calcitonin gene-related peptide (CGRP), which is considered to play a key role in mediating and inducing migraine Alder submitted a biological product license application (BLA) for eptinezumab to the US Food and Drug Administration (FDA) in February 2019 The FDA has set the action date of PDUFA as February 21, 2020 If approved by FDA, this will be the first treatment for migraine prevention with intravenous CGRP Lingbei is expected to submit eptinezumab to EU regulators for approval in 2020, and then to other parts of the world such as China and Japan for approval In addition to eptinezumab, alder has developed ald1910, a monoclonal antibody designed to inhibit pituitary adenylate cyclase activating peptide (PACAP) to prevent migraine Eptinezumab and ald1910 will help to establish Lingbei as a new leader in migraine and other pain syndromes The acquisition of alder will support Lingbei to achieve the goal of long-term sustainable growth and meet the priority of capital allocation The acquisition is expected to accelerate and diversify Lingbei's revenue growth as eptinezumab expects to launch prophylactic treatment of paroxysmal and chronic migraines in the United States in 2020 and the expansion of the product's indications Migraine: CGRP target competition pattern CGRP is a neuropeptide, which has been proved to be released during migraine attack, and is considered as the inducement of migraine attack At present, CGRP and its receptor have become the hot target of migraine drug development So far, in the United States and the European Union, three anti CGRP therapies have been approved for migraine treatment, including Novartis / ammovig (erenumab), alcanezumab (galcanezumab), ajovy (fremanezumab) In terms of medication, aimovig and emgality are injected subcutaneously once a month, ajovy can be injected subcutaneously once a month or once every three months, which is more convenient in terms of medication and will provide patients with a differentiated treatment option In addition to the three antibody drugs mentioned above, the single antibody drug eptinezumab (intravenous infusion once every three months) of alder company has been reviewed in the United States and is expected to be approved in early 2020, with a high response rate of 100% in some patients In June this year, Lilly emgality was approved by the US FDA as a new indication for the treatment of adult onset cluster migraine (ECH) This approval makes emgality the first and only drug to treat ECH It is also the first and only CGRP targeted antibody approved by FDA to treat two different headache diseases On Tyva's side, based on the ineffectiveness analysis, the company announced in April this year to terminate the phase III clinical project of ajov in the treatment of cluster headache At present, some companies are developing oral CGRP inhibitors In early March this year, Elgin submitted an application for marketing the oral drug ubrogepant in the United States for acute treatment of migraine (with or without aura), and the FDA will make a final review decision in the fourth quarter of 2019 If approved, ubrogepant will be the first oral CGRP receptor antagonist in the US market for acute migraine (with or without aura) treatment in the past 25 years However, biohaven invested $105 million in mid March to buy a PRV from GW and sent it to FDA in the second quarter of this year The application for marketing of zydis (rimegepant) orally disintegrating tablet, an oral CGRP receptor antagonist, was submitted This PRV will be used for NDA review of the drug, which can shorten the review period from 10 months to 4 months and complete the review within 6 months This means that Elgin and biohaven have launched a direct confrontation in competing for "the first oral CGRP receptor antagonist" It is worth mentioning that in the middle of this month, another oral migraine drug of Lilly, reyvow (lashiditan), was approved by the US FDA for acute treatment of migraine in adults with or without aura symptoms The approval is significant because reyvow represents the first new class of acute migraine drugs approved by FDA in more than 20 years It should be noted that reyvow is not suitable for the prophylactic treatment of migraine The dosage specifications of the drug are 50mg, 100mg and 200mg, which can be selected according to the needs The active component of reyvow is lasmiditan, which is an oral, central nervous system permeable, selective, 5-hydroxytryptamine 1F (5-HT1F) agonist It is different from the currently approved migraine drug in structure and mechanism, and has no vasoconstrictive activity It is worth mentioning that lasmiditan is the first and only drug molecule approved for acute treatment of migraine in adults This approval represents the first major innovation in the treatment of acute migraine in more than 20 years Lundbeck completes the acquisition of alder biopharmaceuticals – a company committed to transforming migration treatment and Prevention