Irvine drug maker Allergan Inc. isn’t sitting on its hands when it comes to the dry-eye market, according to a company official.
“So probably within the next year, you’ll hear about a couple of new entries for us in dry eye,” said Dr. Scott Whitcup, executive vice president, research and development, and chief scientific officer, on the company’s earnings call this month.
Whitcup mentioned a twist on an old standby—Restasis [X], a variant of Allergan’s popular dry-eye prescription drug Restasis, in addition to the new entries.
“We’ve publicly stated that [Restasis X] should enter the clinic next year,” Whitcup said. “We’ve always expected down the line Restasis won’t remain the only prescription dry-eye product.”
Restasis is one of Allergan’s core products—the company has projected the drug to have sales of $850 million to $890 million this year, some 15% of its projected total sales of about $6 billion.
Allergan has historically been known to protect its traditional drug franchises through what analysts have characterized as next-generation product offerings. It’s done that with glaucoma drugs, such as Alphagan and Lumigan.
Whitcup was optimistic about growth in the segment.
“Dry eyes [are] one of the most common conditions, and market and patient demand will continue to grow,” he said.
Figures from the American Academy of Ophthalmology show that nearly 5 million men and women older than 50 have dry-eye syndrome.
Allergan’s development work on other dry-eye drugs comes in the wake of its response to the Food and Drug Administration regarding its guidance for a generic version of Restasis. The drug maker was rocked in late June after regulators said a generic version, whose scientific name is cyclosporine, could be approved without requiring human tests if the generic’s composition was similar enough.
Allergan has argued that the FDA’s proposed testing measures can’t predict clinical safety and efficacy, among other things.
“Regarding the [Food and Drug Administration’s] draft guidance on generics of cyclosporine, we’ll be submitting potent cautionary arguments regarding the scientific challenges of in-vitro assays and patient safety,” Chief Executive David Pyott said on Allergan’s earnings call.
Recruiter Talks Job Opps
Regulatory and quality-control jobs are among the “hot” positions in the medical device industry, according to the head of a Laguna Niguel-based recruitment firm.
“What we’re finding is that over the past four years or so, positions involved in regulatory affairs, quality engineering, quality assurance—both on an international and domestic basis—seem to be growing,” Bob Jeffers, founder of Allen-Jeffers Associates Inc., told trade publication Medical Device and Diagnostic Industry.
Demand for such jobs exists because of the Food and Drug Administration, as well as pending European regulatory changes, Jeffers said.
The European Union recently said it would follow the FDA’s lead in terms of procedures and requirements for clearing medical devices.
Device makers traditionally have first launched products in Europe because that continent’s regulatory process has been seen as less stringent than the FDA’s.
Jeffers noted that there’s declining demand for other positions in the device sector.
“Most of the operations positions and some of the allied engineering functions are disappearing,” he said.
That’s to be expected, “because quite frankly, more and more of the positions are leaving the sunny shores of the United States for Asia—China, Singapore, Korea, Thailand.”
St. Jude Fined
The California Department of Public Health fined St. Jude Medical Center in Fullerton $100,000 this month after an investigation found it wasn’t in compliance with licensing requirements.
The department said in a news release that St. Jude “failed to ensure the health and safety of a patient when it did not follow surgical policies and procedures.”
It was St. Jude’s fifth administrative penalty in total, according to regulators.
“This tragic error began long before the patient’s admission to the hospital; however, the responsibility belongs to us,” St. Jude said in a statement, adding that the hospital’s pathology department discovered the error shortly after surgery.
St. Jude said it has “put stringent safeguards in place to ensure [the surgical protocol] is followed completely.”
It said the changes included a safe scheduling process that requires documentation and medical images to be submitted in advance of surgeries.
Bits and Pieces
Irvine-based healthcare software provider Kareo Inc. received a North American physician practice award from San Antonio-based market research firm Frost & Sullivan. Frost & Sullivan presents the award annually to companies that have “demonstrated excellence that create value for customers, as measured by return on investment on purchasing the company’s products and services,” the company said in a press release. … Debbie Walsh, previous chief executive of Fountain Valley Regional Hospital and Medical Center, is now serving in the same position at USC Verdugo Hills Hospital in Glendale.
