DUBLIN and SOUTH SAN FRANCISCO, Calif., July 6, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Oculeve, a development-stage medical device company focused on developing novel treatments for dry eye disease, today announced that they have entered into an agreement under which Allergan will acquire Oculeve in an all-cash transaction. Under the terms of the agreement, Allergan will acquire Oculeve for a $125 million upfront payment and commercialization milestone payments related to Oculeve's lead development program OD-01. The agreement also includes the acquisition of an additional earlier-stage dry eye device development program. Allergan's 2015 earnings-per-share forecast provided on May 11, 2015 is unchanged as a result of the acquisition. The Company remains committed to de-levering to below 3.5x debt to Adjusted EBITDA by the end of the first quarter of 2016.
The acquisition of Oculeve adds novel, complementary dry eye development programs to Allergan's current eye care research and development programs, including OD-01, a non-invasive nasal neurostimulation device that increases tear production in patients with dry eye disease. Oculeve has completed four clinical studies of OD-01 to date in more than 200 patients, showing positive safety and efficacy of the device. Allergan plans to conduct two additional pivotal trials prior to FDA submission, which is expected in 2016 with potential commercial launch in 2017.
"Allergan is committed to developing a broad range of innovations that help patients address dry eye," said David Nicholson, Executive Vice President, Global Brands Research and Development at Allergan. "The OD-01 program has been shown to provide a strong safety and efficacy profile, and if approved, would provide an exciting new treatment option for patients that is complementary to our existing product offerings in this important treatment area."
"Allergan's position and expertise in eye care will maximize the development and potential commercialization of the OD-01 technology," said Michael Ackermann, President and CEO of Oculeve. "I am extraordinarily appreciative and proud of the Oculeve team that has worked so hard to develop our exciting technology, and I am thrilled for us to partner with the Allergan team on the continued development, potential approval and availability of OD-01 to patients worldwide."
Chronic dry eye is a disease that can be caused by advanced age, contact lens wear, certain medications, eye diseases, other medical conditions or environmental factors. One type of chronic dry eye is caused by decreased tear production due to inflammation. Without enough tears, the film protecting the eye can break down, creating dry spots on the cornea. Chronic dry eye is estimated to affect 25 million patients in the U.S.i
The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Pending approvals, Allergan anticipates closing the transaction in the third quarter of 2015.
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.
Oculeve, Inc. is a medical device company located in South San Francisco, CA, focused on new technologies for dry eye disease. The company was founded out of a multi-disciplinary collaboration with the Stanford Biodesign Center and Department of Ophthalmology at Stanford University, spun-out by Michael Ackermann, CEO, Jim Loudin, VP of Research and Development, Professor Mark Blumenkranz, who serves on the Oculeve Board of Directors, and Professor Daniel Palanker, who serves on the Scientific Advisory Board. The company is backed by investors Kleiner Perkins Caufield and Byers (who also seeded the company), New Enterprise Associates and Versant Ventures, and is represented legally by Wilson, Sonsini, Goodrich & Rosati, and Morrison Forester.
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, 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 endedMarch 31, 2015. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.