- Two Lead Development Products Rapastinel (GLYX-13) and NRX-1074 Demonstrated Rapid Onset of Action and Robust Efficacy in Phase 2 Studies in Major Depressive Disorder -
- Adds Potential Breakthrough Treatments for Depression -
- Enhances Allergan's World-Class Position in Mental Health -
DUBLIN, Aug. 31, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that it has successfully completed the acquisition of Naurex Inc., a clinical-stage biopharmaceutical company developing transformative therapies for challenging disorders of the central nervous system, including depression. Allergan acquired Naurex for a $560 million upfront payment net of cash acquired, $460 million of which is payable upon the closing of the acquisition and $100 million of which is payable by January of 2016, as well as potential R&D success-based and sales-threshold milestone payments.
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"The acquisition of Naurex enhances our ability to be among the leaders in the development of novel, game-changing therapies in mental health. This is an area of medicine that requires new ways to tackle some of society's most challenging diseases and disorders," said Brent Saunders, CEO and President of Allergan. "Naurex's unique pipeline includes GLYX-13 and NRX-1074, two compounds that utilize NMDA modulation as a potential new approach to the treatment of Major Depressive Disorder (MDD), a disease that can lead to suicidality among the most severe patients. The growing number of unregulated clinics to treat severe depression with off-label medicines is indicative of the desperate need for new treatment options for patients with depression. We have geared up to advance the development of these compounds into the next phase of clinical trials."
The acquisition of Naurex strengthens Allergan's development pipeline in mental health with the addition of Naurex's lead development product rapastinel (GLYX-13), a once-weekly intravenous Phase 3-ready molecule that has demonstrated rapid, robust and sustained efficacy in multiple Phase 2 clinical studies in depression. The acquisition also adds Naurex's development product NRX-1074, a next-generation drug candidate, the intravenous form of which has shown rapid and robust antidepressant efficacy in an initial single-dose Phase 2 study. NRX-1074 is also an orally bioavailable drug candidate which is in Phase 1 studies. Rapastinel and NRX-1074 are both targeted modulators of the N-methyl-D-aspartate (NMDA) receptor. Both therapies have been found to be well-tolerated in all studies to date, with no drug-related serious adverse events.
These therapies add to Allergan's strong late-stage mental health research and development portfolio, with therapies in development to treat schizophrenia, bipolar disorder and chronic migraine.
Additional information about Naurex, rapastinel and NRX-1074, as well as the unmet medical need in the treatment of MDD is available as a slide presentation on the Allergan web site at http://ir.allergan.com.
About Major Depressive Disorder (MDD)
MDD is a serious medical condition often requiring treatment, affecting almost 16 million adults in the United States yearly or approximately 7% of the adult U.S. population. MDD, also known as depression, is a common debilitating disorder in which feelings of sadness and other symptoms occur nearly every day for at least two weeks and interfere with a person's ability to function. Depression costs the U.S. an estimated $83 billion each year. Among all medical illnesses, MDD is a leading cause of disability in the U.S. The World Health Organization predicts depression will become the second leading cause of disability by the year 2020.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
For more information, visit Allergan's website at www.allergan.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's' current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, whether clinical trials of rapastinel or NRX-1074 will be successful, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; risks associated with acquisitions, mergers and joint ventures; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Quarterly Report on Form 10-Q for the quarter ended June 30, 2015. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
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SOURCE Allergan plc