-- XEN45 Approved in Global Markets; In Late-Stage Development in the U.S. --
-- Adds to Allergan's Leading Development and Commercialization Position in Glaucoma --
DUBLIN, Oct. 19, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that it has successfully completed the acquisition of AqueSys, Inc. a clinical-stage medical device company focused on developing ocular implants that reduce intraocular pressure (IOP) associated with glaucoma.
Logo - http://photos.prnewswire.com/prnh/20150612/222796LOGO
Allergan acquired AqueSys in an all-cash transaction, including a $300 million up-front payment and potential regulatory approval and commercialization milestone payments related to AqueSys' lead development product, XEN45.
The AqueSys acquisition adds XEN45, a soft shunt used in minimally invasive glaucoma surgeries (MIGs). XEN45 is implanted by ophthalmologists in the anterior chamber of the eye through a minimally invasive procedure with a single-use, pre-loaded injector. The proprietary XEN45 technology facilitates aqueous fluid flow to lower IOP while protecting against the potential for hypotony (IOP that is too low) that is associated with current subconjunctival procedures.
"The acquisition of AqueSys and XEN45 is highly complementary to our leadership position in eye care and underscores our commitment to develop and commercialize treatments that advance care and add value for ophthalmologists and their patients," said Brent Saunders, CEO and President of Allergan. "The treatment of glaucoma is increasingly shifting to dropless therapies given the challenges of patient compliance. The XEN45 device provides a minimally invasive approach to lowering IOP for physicians and their patients seeking new ways to treat glaucoma that go beyond conventional eye drop treatments."
XEN45 has received a CE mark in the European Union where it is indicated for the reduction of intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed. The CE mark allows treatment in conjunction with a cataract procedure or as a standalone procedure. XEN45 is also approved for use in Turkey, Canada and Switzerland. In the United States, XEN45 is in late-stage development, with the final U.S. Investigational Device Exemption (IDE) clinical trial fully enrolled as of the second quarter of 2015. Final approval by the U.S. Food and Drug Administration is expected by late 2016 or early 2017 via the 510K device pathway.
"In my glaucoma patients, I see a tremendous need for products that can help improve the process and compliance of treatment, in a minimally invasive way," said Ike Ahmed, MD, University of Toronto. "XEN45 provides just that – a minimally invasive procedure that helps to lower IOP effectively while minimizing the need for patients to remember, and be compliant with, their treatment. It's an important innovation for the glaucoma treatment community. "
XEN45 adds to Allergan's strong late-stage eye care pipeline, with therapies in development to treat glaucoma, dry eye disease, age-related macular degeneration (AMD) and diabetic macular edema (DME).
About Glaucoma
Glaucoma is a group of diseases that damage the eye's optic nerve and can result in vision loss and blindness.i Several large studies have shown that eye pressure is a major risk factor for optic nerve damage.i In open-angle glaucoma, even though an ocular fluid drainage angle is "open", the fluid passes too slowly through a meshwork drain.i When the fluid builds up, the pressure inside the eye rises to a level that may damage the optic nerve.i When the optic nerve is damaged from increased pressure, open-angle glaucoma-and vision loss may result.i In 2010, 60.5 million people globally were living with glaucoma.ii Given the aging of the world's population, the number of people living with glaucoma may increase to nearly 80 million by 2020.ii
About Allergan
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.
Forward-Looking Statement
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 ended June 30, 2015 (such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
i National Eye Institute – Glaucoma Facts: https://nei.nih.gov/health/glaucoma/glaucoma_facts
ii Bright Focus Foundation – Glaucoma Facts & Figures: http://www.brightfocus.org/glaucoma/article/glaucoma-facts-figures
| CONTACTS: |
Allergan: |
| Investors: |
|
| Lisa DeFrancesco |
|
| (862) 261-7152 |
|
| Media: |
|
| Mark Marmur |
|
| (862) 261-7558 |
SOURCE Allergan plc
Share this article