In light of impending generic competition, Allergan PLC recently made the point that its eye care business is more than dry-eye drug Restasis. The pharmaceutical company recently announced positive phase III clinical data on Bimatoprost SR, “the first-in-class sustained-release biodegradable implant for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension,” it said in a press release. Allergan estimates that as many as 80% of glaucoma patients fail to administer their drops regularly.
The device is designed to release daily drops over the course of at least four months.
The first phase III study involved 594 subjects with open-angle glaucoma or ocular hypertension. The company plans to file for Food and Drug Administration approval next year.
Allergan’s controversial Restasis licensing deal last year with the Saint Regis Mohawk Tribe was poorly received, and the company said it anticipates generic competition for its top-selling eye drug this year.
Allergan shares recently traded at nearly $172 each for about a $59 billion market cap.
The company recently responded to an activist letter calling for management and board changes, naming Thomas Freyman to its board, the fourth new director appointment in 16 months. He’s a former Abbott Laboratories executive vice president of finance and administration and replaces Patrick O’Sullivan, who will retire from the board in July. Sullivan joined the board in 2013 following Allergan’s acquisition of Warner Chilcott PLC.
Following the retirement of O’Sullivan and the addition of Freyman, Allergan’s board will continue to have 12 members, 10 of whom are independent.
The other board adds over the past 16 months were John Davidson, former senior vice president, controller and chief accounting officer of security company Tyco International; Joseph Boccuzi, previously a partner of Global Life Sciences and chief executive officer at executive research and leadership consulting firm Spencer Stuart; and Adriane Brown, president and chief operating officer of private global invention company Intellectual Ventures Management LLC. Brown replaced Michael Gallagher, who’s a former chief executive and a director at Playtex Products LLC.
Lead Independent Director Chris Coughlin said Allergan has been actively involved in updating board membership with appropriate experience as it transitions from a generics drugmaker to a branded pharmaceutical company. Coughlin joined Allergan’s board in 2014 after serving on the board of Forest Laboratories.
The Business Journal reported last week that Allergan’s evergreen top seller, Botox, will soon add two oral calcitonin gene-related peptide therapies to its therapeutics portfolio. The drugs, ubrogepant and atogepant, target migraines, the former for treatment, the latter for prevention. The company plans to submit a new-drug application to the FDA for ubrogepant next year.
Its antidepressant, Rapastinel, is pending FDA approval.
Rehabilitation Care
Newport Beach-based Hoag Memorial Hospital Presbyterian has opened the Fudge Family Acute Rehabilitation Center to provide a comprehensive continuum of care to patients being treated for neurological and orthopedic issues, traumatic brain injury and stroke.
The care provider said that hospital co-located acute rehabilitation centers are rare in Orange County and that patients have had to leave Hoag for private post-acute rehabilitation centers to help them regain motor, cognitive and functional skills.
The 18-bed center stemmed from a $4 million gift from former Hoag stroke patient Gary Fudge.
“Because we built this facility from the ground up, the entire center is designed to maximize rehabilitation and improve functional outcomes,” said Hoag Director of Rehabilitation Mark Glavinic.
The center provides physical, occupational and speech therapy in a home-like environment. Patients also have access to services, such as respiratory therapy, dietary consultations, laboratory services, pharmacy and radiology.
It’s part of Hoag’s Pickup Family Neurosciences Institute, which was renamed following a $15 million gift in November.
Bits & Pieces
San Clemente-based device maker Glaukos Corp. reported positive results from a two-year trial of its “iStent inject” Trabecular Micro-Bypass System in reducing intraocular pressure in patients undergoing cataract surgery. The 505-subject study is being conducted at 41 sites. The device hasn’t been approved for use in the U.S.; Glaukos submitted an application in December. The company said iStent inject is about a third the size of iStent, which received FDA approval in 2012. … MemorialCare Saddleback Medical Center received a Thrombectomy-Capable Stroke Center certification from the joint commission of the American Heart Association and American Stroke Association. Stroke is the fifth-leading cause of death in the U.S.
