"The acquisition of AqueSys and its XEN45 program builds on Allergan's deep and long-standing commitment to innovation in eye care," said Brent Saunders, CEO and President of Allergan. "Our eye care team has a strong track record of introducing novel treatments for patients with glaucoma. The acquisition of the XEN45 device demonstrates our commitment to alternative next-generation glaucoma treatments which are appealing to both patients and physicians and extend beyond conventional medication eyedrops."
The acquisition of AqueSys adds XEN45, a soft shunt that is implanted in the subconjunctival space in the eye through a minimally invasive procedure with a single use, pre-loaded proprietary injector. The proprietary XEN45 technology facilitates aqueous fluid flow to lower Intra-Ocular Pressure (IOP) while protecting against the potential for hypotony (IOP that is too low) that is associated with current subconjunctival procedures. The minimally invasive procedure is performed by ophthalmologists.
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. AqueSys is pursuing reimbursement in these countries. In the United States, XEN45 is in late-stage development, with the final US Investigational Device Exemption (IDE) clinical trial fully enrolled in 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.
"The XEN45 program has been shown to provide a robust efficacy profile with minimal side effects, and if approved in the U.S., would provide an exciting new treatment option for patients, and one that is highly complementary to our ongoing portfolio and development programs in this critical treatment area," said David Nicholson, EVP and President, Global Brands Research and Development at Allergan.
"With its pedigree in the eye care space, its deep commercial network in eye care professional communities, and its commitment to being a leading provider of treatments for glaucoma, Allergan was a natural fit and a compelling partner for us to maximize the potential for the XEN45 technology platform," said Ron Bache, CEO of AqueSys. "The addition of the XEN45 technology to Allergan's world-class eye care development and commercialization organization will propel the potential use of this best-in-class technology by global ophthalmologists and the patients that they treat."
"The XEN45 platform is a minimally invasive reinvention of the sub-conjunctival outflow approach to the treatment of glaucoma, one used for many years by surgeons," said Robert N. Weinreb, M.D., Distinguished Professor of Ophthalmology and Director of the Shiley Eye Institute at the University of California San Diego. "XEN45 provides the advantage of a simpler and less invasive way of conducting a well-established procedure to treat our glaucoma patients, and if approved in the U.S., would provide an exciting new option for ophthalmologists."
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]
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 fourth quarter of 2015.
Allergan plc AGN, -0.45% 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.
About AqueSys, Inc.
AqueSys, Inc. is the first ophthalmic device company to focus exclusively on the treatment of glaucoma by re-envisioning sub-conjunctival outflow with a minimally invasive stent for the reduction of intraocular pressure. Backed by more than a decade of research and recent commercialization in European and Canadian markets, the safety and efficacy of the company's proprietary technology supports glaucoma surgeons and patients in the management of intraocular pressure to arrest the progression of vision loss associated with glaucoma. Privately held and headquartered in Southern California, AqueSys is working to change the treatment of glaucoma to benefit patients, physicians and payors around the world through the research, development, manufacturing and commercialization of its minimally invasive glaucoma stents. Additional information about the XEN Gel Stent can be found at www.aquesys.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, 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.