Allergan PLC, which had a rough year following its controversial patent transfer deal with a Native American tribe, said it will cut over 1,000 jobs in preparation for losing patent exclusivity for blockbuster dry-eye drug Restasis. Reductions will primarily focus on positions related to “commercial and other functions,” according to filings with the Securities and Exchange Commission. The company estimates overall operating expense savings from the internal restructuring to be $300 million to $400 million.
Allergan declined to provide details on what the job cut would mean for employees at its Irvine campus, which is home to the U.S. Specialized Therapeutics unit that includes medical aesthetics, eye drugs and therapeutic Botox. Allergan currently employs about 18,000 globally, 1,400 in Irvine as of September, per the Business Journal’s list of drugmakers.
It took the unusual route in transferring the rights of Restasis to the Saint Regis Mohawk Tribe in New York in order to avoid fighting patent dispute challenges from generic drugmakers in both federal court and through the inter partes review at the U.S. Patent and Trademark Office. The tribe can protect the patents on grounds of sovereign immunity under the IPR system. An unfavorable federal district court ruling in October—a judge invalidated exclusive protections for Restasis—means Allergan could face generic Restasis brands as early as this year.
Restasis generated $1.4 billion in sales in 2016, second to Botox’ nearly $2 billion.
Separately, Allergan shareholders reached a settlement with Pershing Square Holdings and Valeant Pharmaceuticals International whereby the two companies agreed to pay $290 million to settle investor claims they engaged in insider trading in an unsuccessful 2014 takeover bid for Allergan.
Fresh Eyes
San Clemente-based eye stent developer Glaukos Corp. is well on its way to fulfilling a goal in its transition into a “hybrid pharma and device” player with both drug delivery and biosensor platforms, according to Chief Executive Thomas Burns.
The company filed for Food and Drug Administration approval for its iStent inject Trabecular Micro-Bypass Stent late last year. The device is designed to reduce intraocular pressure in mild to moderate open-angle glaucoma patients undergoing cataract surgery by facilitating eye fluid drainage.
Shares of the company trade at $26 for a nearly $880 million market cap.
Burns said the product is “the first in a series of five new products we are expecting to introduce over the next five years, culminating in what we believe will be the industry’s broadest portfolio of technologies designed to address the full range of glaucoma disease state and progression.”
The original iStent received FDA approval in 2012, and is approved for use in Europe, Australia, Brazil and Canada. Glaukos reported $40 million in sales in the third quarter, up from $30 million from the same period a year ago. Growth primarily came from expansion of the company’s direct sales operations into new international markets.
It plans to further expand its portfolio developing additional iStent products to address open-angle glaucoma throughout the disease’s progression, starting with ocular hypertension and ending with advanced to refractory open-angle glaucoma that results in severe optic nerve damage and vision loss. Its product offerings will also include iDose and the IOP sensor system.
The Dose sensory system, which Glaukos paid up to $15 million for, including $5.5 million in cash and additional performance-based payments, is a microinvasive ocular implant designed to monitor glaucoma patients’ intraocular pressure measurements over extended periods of time. It bought intraocular pressure sensor system from Dose Medical in Los Angeles in April as part of the strategy. The wireless system includes a rechargeable battery meant to function for multiple years. iDose is an injectable drug delivery implant for improvement of patient medication compliance and adherence in glaucoma management.
Sensor OK
Irvine-based patient monitoring device maker Masimo Corp. announced it secured approval to market its RD Rainbow Lite SET Sensors in Europe. The device, which uses twice as many wavelengths of light as the company’s SET sensors, is designed to measure oxygen reserve index and fluid volume changes.
The sensor allows clinicians to augment patient monitoring, Masimo Chief Executive Joe Kiani said in a statement.
The oxygen reserve index is a new continuous, noninvasive variable that can help provide an early alarm when oxygen levels deteriorate, and prevent hyperoxia, or oxygen toxicity that occurs when cells, tissues and organs are exposed to an excess supply of oxygen.
