DUBLIN and ANN ARBOR, Mich., Sept. 6, 2016,– Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and RetroSense Therapeutics LLC, a Michigan Angel-backed, clinical-stage biotechnology company focused on novel gene therapy approaches to restore vision in patients suffering from blindness, today announced that Allergan has acquired substantially all of the assets of RetroSense in an all-cash transaction. Under the terms of the transaction, Allergan has paid RetroSense a $60 million upfront payment and has agreed to potential regulatory and commercialization milestone payments related to its lead development program, RST-001, a novel gene therapy for the potential treatment of Retinitis Pigmentosa (RP).
“The acquisition of RetroSense and its RST-001 program builds on Allergan’s deep commitment to eye care, and our focus on investing in game-changing innovation for retinal conditions, including Retinitis Pigmentosa, where patients desperately need treatment options,” said Brent Saunders, CEO and President of Allergan.
Retinitis Pigmentosa (RP) is a group of rare, inherited genetic disorders characterized by progressive peripheral vision loss and night vision difficulties followed by eventual central vision loss and blindness in many cases. Approximately 100,000 people living in the USi and 14 to 33 per 100,000 people worldwide have the disorder.ii
RST-001 is first-in-class gene therapy application of optogenetics, a therapeutic approach that confers light sensitivity to cells that were not previously, or natively, light sensitive. By applying optogenetics to retinas in which rod and cone photoreceptors have degenerated, the technology introduces additional light sensitivity to the retina. In 2014, RST-001 received an Orphan Drug Designation by the US FDA for the treatment of Retinitis Pigmentosa.
The RST-001 optogenetic approach employs a photosensitivity gene, channelrhodopsin-2, to create new photosensors in retinal ganglion cells to potentially restore vision in retinal degenerative conditions. In August 2015, RetroSense’s Investigational New Drug (IND) application for RST-001 received clearance from the United States Food and Drug Administration (FDA). In March 2016, RetroSense initiated a Phase I/IIa clinical trial to evaluate the safety of RST-001 in patients being dosed, and in August 2016, the low dose cohort of patients had been safely dosed.
“The RST-001 program and its optogenetic gene therapy approach could be a real breakthrough in the treatment of unmet needs across a host of retinal conditions, including RP,” said David Nicholson, Chief Research and Development Officer, Allergan. “The team at Allergan is excited by the prospect of advancing an entirely new approach in the treatment of retinal diseases, and this technology is highly complementary to our ongoing development programs in this critical treatment area.”
“With its deep commitment to eye care, strong eye care professional community network, and its commitment to advancing innovation across retinal conditions, Allergan was the most compelling partner and the best strategic fit to advance the development of RST-001 and maximize the potential for this technology platform,” said Sean Ainsworth, former CEO of RetroSense Therapeutics. “The addition of RST-001 to Allergan’s world-class eye care development and commercialization organization will position this potentially revolutionary technology to be used by ophthalmology professionals to improve the treatment of patients with retinal diseases around the world.”
“Retinitis Pigmentosa patients from around the world are closely following the RST-001 study,” stated David G. Birch, Ph.D., chief scientist and executive officer of the Retina Foundation of the Southwest and principal investigator of the Phase I/IIa clinical trial. “Today, the treatment options are so limited, physicians are excited about the potential to restore or improve vision for their patients.”
About Retinitis Pigmentosa
Retinitis pigmentosa (RP) is a group of inherited genetic disorders characterized by progressive peripheral vision loss and night vision difficulties followed by eventual central vision loss and blindness in many cases. RP is typically diagnosed in adolescents and young adults. The rate of progression and degree of visual loss varies from person to person.
Approximately 100,000 people living in the USi and 14 to 33 per 100,000 people worldwide have the disorder.ii Currently, there are no FDA or EMA approved therapies for the prevention or treatment of RP. RST-001 has received Orphan Drug Designation by the US FDA for the treatment of Retinitis Pigmentosa.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company’s R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 65+ mid-to-late stage pipeline programs in development.
Our Company’s success is powered by our more than 15,000 global colleagues’ commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
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.
RetroSense Therapeutics is a privately-held biotechnology company developing life-enhancing gene therapies designed to restore vision in patients suffering from blindness due to retinitis pigmentosa and advanced dry age-related macular degeneration. There are currently no FDA-approved drugs to improve or restore vision in patients with these retinal degenerative conditions. The Company’s approach to using optogenetics in vision restoration is based on pioneering, proprietary research conducted at Wayne State University and Massachusetts General Hospital. RetroSense has worldwide exclusive rights to the relevant intellectual property from both institutions. RetroSense is led by a team of seasoned veterans with deep experience in taking products from the discovery stage through to the clinic. RetroSense’s key investors include BlueWater Angels, Nerveda, Mesa Verde Ventures, Santen Pharmaceuticals, and RBV Capital.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’scurrent 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; 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 Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (such periodic public filings having been filed under the “Actavis plc” name). Except as expressly required by law, Allergandisclaims any intent or obligation to update these forward-looking statements.
i Foundation Fighting Blindness. Retinitis Pigmentosa: http://www.blindness.org/retinitis-pigmentosa
ii NCBI – Gene Reviews: http://www.ncbi.nlm.nih.gov/books/NBK1417/
SOURCE Allergan plc