JERUSALEM & SAN MATEO, Calif.—Teva Pharmaceutical Industries Ltd. and Labrys Biologics, Inc. have announced the establishment of a definitive agreement under which Teva will acquire Labrys, a development-stage biotechnology company with a focus on treatments for chronic and episodic migraine.
Per the terms of the agreement, Teva will acquire Labrys for $200 million up front in cash at closing, with the potential for an additional up to $625 million in contingent payments if certain pre-launch milestones are met. The closing of the transaction is subject to antitrust clearance and other customary closing conditions.
Labrys’ lead drug candidate is LBR-101, a fully humanized monoclonal antibody currently in Phase 2b clinical trials for the prevention of chronic and episodic migraine. The compound binds to calcitonin gene-related peptide (CGRP), which is a validated target in migraine. Several small-molecule CGRP antagonists in the symptomatic relief of migraine have demonstrated proof of efficacy.
“More than 8.5 million people in the U.S., EU and Japan (G7) suffer from episodic or chronic migraine requiring preventative treatment, a condition that can destroy their quality of life,” Michael Hayden, president of Global R&D and chief scientific officer at Teva, said in a press release. “CGRP is a well-validated target in migraine, and Labrys has progressed the development of LBR-101 with scientific rigor and excellence. With its long half-life, target specificity and favorable pharmacokinetic profile allowing for infrequent and convenient, subcutaneous administration, LBR-101 represents a very exciting biologic product candidate and much-needed option for the management of this truly debilitating condition.”
Labrys acquired LBR-101 (formerly RN-307) from Pfizer in 2012, which purchased the compound when it acquired Rinat Neuroscience in 2006. LBR-101 has completed five Phase 1 trials with healthy volunteers dosed with active drug. In a sixth Phase 1 study, both intravenous and subcutaneous administrations were found to be well tolerated. The drug also demonstrated a long terminal half-life, supporting a once-monthly subcutaneous dosing regimen. A maximum tolerated dose has not been identified, and most treatment-related adverse events were mild, transient and resolved spontaneously. Sales of LBR-101 are forecast to reach between $2 billion and $3 billion.
“Teva is the ideal company to continue Labrys’ efforts to rapidly advance the LBR-101 program and bring a much-needed product to market,” Steven P. James, president and CEO of Labrys, commented in a statement. “Since closing a Series A investment round in 2013, Labrys has made remarkable strides advancing LBR-101 in a robust Phase 2 development program and attracting a high-caliber company in Teva to complete clinical development.”
This is the second acquisition for Teva so far this year, as the company announced a definitive agreement to acquire NuPathe Inc. in January, a transaction that also gained Teva a migraine treatment product. NuPathe’s migraine treatment ZECUITY is the first and only prescription migraine patch approved by the U.S. Food and Drug Administration for the treatment of migraine with or without aura in adults. It is a disposable, single-use iontophoretic transdermal patch that delivers sumatriptan, the most widely prescribed migraine medication, through the skin. Teva completed its tender offer for NuPathe in February.