Teva Pharmaceutical Industries will acquire Labrys Biologics for up-to-$825 million, the companies said today, in a deal the buyer hopes will help it achieve its goal of becoming a global leader in pain drugs by 2020.
Labrys’ lead candidate, LBR-101, is a fully humanized monoclonal antibody now in Phase IIb clinical trials for prevention of chronic and high frequency episodic migraine.
That would add a prophylactic dimension to a Teva pain drug franchise that includes a mix of marketed, approved, and investigational treatments for migraine, as well as chronic pain and cancer pain. Teva added Zecuity® (sumatriptan iontophoretic transdermal system), approved by FDA last year as the first patch to treat migraine, when it bested what is now Endo to acquire NuPathe in January for $144 million plus milestone payments.
Zecuity joined a portfolio that includes marketed branded drugs Fentora and Actiq, both for management of breakthrough cancer pain; and Amrix, indicated for muscle spasm associated with acute, painful musculoskeletal conditions. Teva’s hopes of adding to that portfolio were raised earlier this year when it trumpeted positive pivotal Phase III results of its potential abuse-deterrent extended release hydrocodone
LBR-101 is designed to target high frequency episodic and chronic migraine by binding to calcitonin gene-related peptide (CGRP). Labrys acquired LBR-101, then called RN-307, from Pfizer when it closed in December 2012 on a $31 million Series A financing round backed by venBio, Canaan Partners, InterWest Partners, and Sofinnova Ventures. RN-307 was originally discovered and developed by Rinat Pharmaceuticals, which Pfizer bought in 2006.
Labrys launched two Phase IIb studies of the migraine candidate in January. The first study is designed to assess LBR-101 in patients with chronic migraine, who experience at least 15 headache days per month; the second, in patients with high frequency episodic migraine, who experience headaches eight to 14 days per month.
“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,” Michael Hayden, Teva’s president of global R&D and CSO, said in a statement.
Teva is counting on LBR-101 to fulfill rosy annual sales forecasts peaking at a range of $2 billion to $3 billion—which would go a long way toward recouping the sales it stands to lose once a generic version of its blockbuster Copaxone reaches the market.
Last year, Teva racked up $4.328 billion in sales on Copaxone, placing the multiple sclerosis drug No. 15 on GEN’s List of Top 25 Best Selling Drugs of 2013.
Teva agreed to pay Labrys $200 million cash upfront at the closing of the deal, plus up to $625 million in payments tied to achieving undisclosed prelaunch milestones. The companies said the closing of the deal is subject to antitrust clearance and satisfaction of other conditions.