|Teva to Acquire Labrys Biologics, Inc.: Novel Migraine Prophylaxis Treatment Adds Significant New Dimension to Teva’s Growing Pain Care Franchise|
Teva will acquire Labrys for
With the goal of becoming a global leader in pain by 2020, the Labrys acquisition adds a significant migraine prophylaxis dimension to Teva’s extensive pain care franchise, which includes a range of investigational, approved and marketed treatments for migraine, cancer pain and chronic pain.
Labrys is developing LBR-101, a fully humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) currently in Phase IIb clinical trials for prevention of chronic and episodic migraine. Teva’s acquisition of the LBR-101 program targeting high frequency episodic and chronic migraine clearly complements the recent addition of Zecuity, an innovative therapy for the acute treatment of migraine, obtained through the acquisition of NuPathe. This ability to treat both acute and chronic migraine builds on Teva’s broader pain portfolio, which was recently further strengthened by positive pivotal Phase III results achieved by Teva’s potential abuse-deterrent extended release hydrocodone. The results gave a clear indication, in a clinical setting, of the promise of Teva’s proprietary technology with potential abuse-deterrent properties in a range of opioid medications.
“More than 8.5 million people in the US, EU and
“Teva is the ideal company to continue Labrys’ efforts to rapidly
advance the LBR-101 program and bring a much needed product to market,”
The closing of this transaction is subject to antitrust clearance and satisfaction of other conditions.
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
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.
About Labrys Biologics
Labrys Biologics is a private, venture-financed development stage
biotechnology company focused on the preventive treatment of migraine.
Labrys' lead candidate, LBR-101 (formerly RN-307), is an anti-CGRP
monoclonal antibody for the prevention of chronic and high frequency
migraine currently in Phase 2b clinical development. In
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, (including competition from
orally-administered alternatives, as well as from potential purported
generic equivalents); the possibility of material fines, penalties and
other sanctions and other adverse consequences arising out of our
ongoing FCPA investigations and related matters; our ability to achieve
expected results from the research and development efforts invested in
LBR -101; the size of the potential market for LBR-101; our ability to
consummate and integrate the proposed acquisition; the extent to which
any manufacturing or quality control problems damage our reputation for
quality production and require costly remediation; our potential
exposure to product liability claims that are not covered by insurance;
increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.