Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced the successful completion of the acquisition of Labrys.
The acquisition of Labrys brings to Teva LBR-101, a fully humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), which is currently in Phase IIb clinical trials for prevention of chronic and episodic migraine. Teva’s acquisition of LBR-101 complements the recent acquisition of ZECUITY ®, a novel iontophoretic patch that delivers sumatriptan via the skin for the acute treatment of migraine, and positions Teva to compete for leadership in the treatment and prevention of migraine.
Additionally, the growing migraine franchise forms part of a strategic expansion of Teva’s overall CNS portfolio, in addition to a number of products in development for a broad range of pain states and in particular a large development program in the field of potential abuse deterrent opioids.
“We are pleased to finalize this acquisition. It’s an exciting opportunity to develop a much needed treatment option for people suffering from the impact of chronic and episodic migraine. The CGRP pathway is scientifically robust, the molecule has the right specifications to deliver on its clinical promise and the patient population is both large and underserved. This could make a real and meaningful difference to patients’ lives” said Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer.
LBR-101 (formerly RN-307) is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a well-validated target in migraine. It is currently in Phase IIb clinical trials for prevention of episodic and chronic migraine. LBR-101, originally discovered by Rinat Neuroscience (bought by Pfizer in 2006), was acquired by Labrys from Pfizer in 2012. LBR-101 has successfully completed five Phase I trials with 94 healthy volunteers dosed with active drug. Results were published in Cephalalgia, the official journal of the International Headache Society, in December 2013, and presented at the 2014 annual meeting of the American Academy of Neurology. A sixth Phase 1 study (bridging study) tested IV and subcutaneous doses (24 participants received active medication). Both intravenous and subcutaneous administrations were well tolerated. LBR-101 exhibited a long terminal half-life which supports once-monthly subcutaneous dosing. Most treatment-related adverse events were mild, transient and resolved spontaneously. The maximum tolerated dose has not been identified. LBR-101 was not associated with any clinically relevant patterns of change in vital signs, ECG parameters, or laboratory findings.
Proof of efficacy has been observed for several small-molecule CGRP antagonists in the symptomatic (acute) relief of migraine. However, liver toxicity or formulation difficulties have limited their use in migraine prophylaxis. Chronic migraine is characterized by headaches on at least 15 days per month and high frequency episodic migraine shares many similarities with chronic migraine. Patients with this condition are at a high risk of transformation to chronic migraine, and have similar unmet needs due to a paucity of currently approved preventive medications. These preventive medications require daily use, are not effective in a large percentage of patients, and are commonly associated with adverse events. Consequently, prophylactic treatment of episodic and chronic migraine continues to present considerable challenges, and there remains a significant medical need for new, safe and effective migraine prophylactic treatment options.