A Food and Drug Administration regulatory process that could lead to potential generic competition to Irvine-based Allergan Inc.’s Restasis dry-eye drug, among others, was recently discussed at the Generic Pharmaceutical Association’s Fall Technical Conference and highlighted by Boston-based investment bank Leerink Swann LLC.
“Over the past 12 months, the FDA has made progress addressing bioequivalence guidance for a number of complex products … including [Allergan’s] Restasis,” analysts Jason Gerberry and Christopher Kuehnle wrote in a report issued Oct. 31, a day after GPhA finished its conference.
The FDA said in June that a generic version of Restasis could be approved without requiring human testing if its composition was similar to the branded drug.
Allergan has vowed to make a vehement case in calling on the FDA to reverse its opinion.
The company is “encouraged that 22 medical societies, patient groups and consumer groups submitted comments, all raising concerns about public health and patient safety if generics were to be approved of Allergan’s complex oil and water emulsion,” Chief Executive David Pyott said on the company’s third-quarter earnings call.
“It is noteworthy that not one single submission was made in favor of the draft guidance,” Pyott said.
The drug maker has submitted studies of several test emulsions “showing that these emulsions that meet the draft guidelines nonetheless significantly differ from Restasis,” Pyott said. “Based on our investigations, FDA has never, in the past, approved an ophthalmic emulsion solely on in vitro data.”
The FDA’s draft guidance for a potential generic of Restasis will have the “highest management attention” in the coming months, according to Pyott.
“We will take every appropriate legal and regulatory action to uphold sound science and patient safety,” he added.
Meeting Focuses on Chronic Diseases
Chronic diseases are the subject of the upcoming MassDevice Big 100 West gathering in Irvine.
The event is scheduled for Dec. 10 at the Hyatt Regency Irvine.
It’s regularly organized by the Massachusetts Medical Device Journal, a Boston-based industry news website.
A statement on MassDevice notes that chronic diseases and conditions account for 70% of all U.S. deaths, according to the Centers for Disease Control and Prevention.
“The prevalence of conditions such as diabetes and cardiovascular disorders have tremendous societal costs but also represent the single largest business opportunity for the medical technology industry today and in the future,” MassDevice said.
“However, with this opportunity comes new challenges of patient engagement, new methods of reimbursement and the onset of the Affordable Care Act, which will change the business model of the medical device industry.”
Big 100 speakers include Michael Farrell, chief executive of San Diego-based ResMed Inc., which makes devices to treat disorders such as sleep apnea; Dr. Mark Carlson, chief medical officer for Minnesota-based St. Jude Medical Inc., a diversified cardiovascular device maker that employs more than 330 people in Orange County; and Rick Altinger, chief executive of Palo Alto-based Glooko Inc., which makes a mobile diabetes monitor.
Company Shares Trial Results
Direct Flow Medical Inc., a Northern California device maker that manufactures in Lake Forest, said an ongoing clinical study of its less-invasive heart valve demonstrated that 96% of the subjects were free of all causes of death and that there was no incidence of moderate or severe aortic regurgitation, which can cause complications after implantation.
Direct Flow’s valves are used to treat patients with severe aortic stenosis, or a narrowing of the arteries. Company executives have said they chose OC for manufacturing because of the breadth of medical device talent here.
Bits and Pieces
Irvine-based Biolase Inc. said it signed a deal with Redwood City-based Auris Surgical Robotics Inc. to co-develop an ophthalmologic robot for removing cataracts. Biolase, which makes dental and other types of medical lasers, said the product will feature its WaterLase cutting device mounted on a robotic operating system made by Auris. … Fountain Valley-based Edinger Medical Group said it received a platinum award from the California Department of Managed Health Care’s Right Care initiative. The initiative is designed to measure quality metrics related to caring for and preventing heart disease, diabetes and stroke.
