Allergan Inc.’s bellwether Botox has yet another new use.
The Food and Drug Administration said this month that it approved the cosmetic form of the Irvine-based drug maker’s neurotoxin to temporarily treat moderate to severe lateral canthal lines, known as “crow’s feet,” found around a person’s eye.
Allergan is “pleased that the FDA has approved a new indication” for Botox Cosmetic, said Scott Whitcup, the drug maker’s executive vice president, research and development, in a statement.
The approval “will enhance our ability to work with and train aesthetic physicians on the science of administering Botox Cosmetic to yield the best possible outcomes for patients,” he said.
Botox, in its cosmetic and therapeutic versions, accounted for $970.9 million in sales for Allergan in the first six months of the year.
Allergan said it conducted a 1,350-subject clinical trial for crow’s feet, with 833 of the participants receiving a Botox Cosmetic injection.
Botox Cosmetic’s two competitors aren’t yet approved for crow’s feet treatment. They are Xeomin, which is made by a unit of German drug maker Merz AG; and Dysport, a product of Canada-based Valeant Pharmaceuticals International Inc., which has Orange County roots.
All three are approved for treating brow furrows.
Meanwhile, the United Kingdom’s National Institute for Health and Care Excellence recently endorsed the therapeutic form of Botox as a treatment for women in U.K. countries with overactive bladders.
The institute issued updated clinical guidelines for using the neurotoxin to manage female urinary incontinence in hopes of stopping them from “suffering in silence,” according to British trade publication Nursing Times.
Botox injections should be offered only to patients who haven’t responded to “conservative management,” including drugs, the institute said.
“We know that existing treatments are not always suitable for everyone and welcome a new treatment option that increases patient choice and offers an alternative for people who may not be able to tolerate established solutions,” Robert Dixon, chief executive of the England-based Bladder and Bowel Foundation, told Nursing Times.
The Britain-based Medicines and Healthcare Products Regulatory Agency granted Allergan a license in August to use Botox to treat overactive bladder.
Moody’s Rates Edwards Lifesciences
New York-based Moody’s Corp. assigned Edwards Lifesciences Corp. of Irvine a “Baa3” credit rating this month, a first for the company. Edwards makes replacement heart valves and other cardiovascular devices.
Moody’s said the senior unsecured shelf rating reflects the company’s “leading market position in cardiac valves and hemodynamic monitoring equipment, which helps to offset its small revenue base compared to key competitors and its very high concentration in one product segment.”
Anything less than “Baa” is considered below investment-grade quality in Moody’s rating system.
Moody’s also assigned a stable outlook for Edwards that it said reflects its view “that Edwards will be able to sustain good growth rates and a leading market position in its [transcatheter heart valve] business even as competitors enter the U.S. and European markets.”
The ratings agency added that it believes Edwards will have stronger credit metrics and lower leverage than typical Baa3-rated medical device makers, something it said will help offset the company’s “relatively small size and product concentration risk.”
Moody’s did warn that it could downgrade Edwards if the company experienced “material erosion” in its transcatheter heart valve market share or if growth in the overall market experienced slowing.
“Given its small size, product concentration and competitive landscape, an upgrade is not likely over the foreseeable future,” Moody’s said.
CHOC Gets New COO
Matthew Gerlach is the new executive vice president and chief operating officer of Children’s Hospital of Orange County.
He replaces Debra Mathias, who is now a principal at consulting firm Health Management Associates.
Gerlach was most recently vice president and chief operating officer of Glendale Memorial Hospital and Medical Center. His experience includes executive roles at USC University Hospital, Kaiser Permanente and Queen of the Valley Hospital in West Covina.
