A Danish drugmaker is betting nearly $2 billion on a company based near Seattle that is awaiting a Food and Drug Administration decision on a drug for migraine prevention.
Valby, Denmark-based Lundbeck said Monday that it would acquire Alder BioPharmaceuticals – based in the Seattle suburb of Bothell, Washington – for up to $1.95 billion, in a deal that the Danish drugmaker said would enhance its monoclonal antibody process and development capabilities.
Alder’s lead drug candidate is eptinezumab, a monoclonal antibody for migraine prevention that targets the calcinonin gene-related peptide, or CGRP, and has been submitted to the FDA for approval, with the agency expected to rule on the drug by Feb. 21, 2020.
Shares of Alder were up 83 percent on the Nasdaq in mid-morning trading Monday. Shares of Lundbeck were down less than 1 percent on the Copenhagen Stock Exchange.
Lundbeck’s primary area of focus has been drugs to treat neurological disorders and mental illnesses. Rexulti (brexpiprazole), which it markets with Japanese drugmaker Otsuka Pharmaceutical as a treatment for major depressive disorder, is also in Phase III development for post-traumatic stress disorder and agitation in Alzheimer’s-type dementia, as well as Phase II development for borderline personality disorder. Other drugs in development include investigational treatments for Parkinson’s disease, schizophrenia and Tourette syndrome.
Alder is mainly focused on migraine, a condition that affects 36 million Americans, primarily women, according to its website. In addition to eptinezumab, it is also developing ALD1910, which targets PACAP-38, also as a treatment for prevention of migraine, though it is in preclinical development.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In July, Alder presented data from post-hoc analyses of two Phase III studies of eptinezumab at the American Headache Society’s annual meeting. In one study, 63.3 percent of patients receiving the drug at 100mg and 64.4 percent of those receiving 300mg had at least one month free of migraines, compared with 47.7 percent of those on placebo; in the other study, the rates were 34.6 percent and 39.7 percent of those receiving the drug at the respective doses, compared with 22.4 percent of those on placebo. Rates of patients who experienced no migraine days during at least half of the one-year study period were 18.1-25.2 percent and 14-19.1 percent among those receiving the drug at the two dose levels, compared with 4.9-12.6 percent among those receiving placebo.
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