Looming competition isn’t driving Allergan Inc.’s desire to find more markets for its flagship Botox, the Irvine drug maker’s research chief says.
“Even in the absence of competition, we would be looking at a lot of these” possible new uses, said Scott Whitcup, Allergan’s executive vice president of research and development.
“Clearly, competition always keeps you a bit sharper, so I think it helps us,” Whitcup said. “But it’s something we would do to address the unmet medical need as well.”
Allergan researchers are looking at Botox, which paralyzes nerves, for several different conditions.
They run the gamut from treating excess urination to migraines and possibly even obesity.
“We like to call it a ‘pipeline in a vial,'” Whitcup said of Botox, famous for its use by cosmetic doctors to smooth wrinkles.
Medical articles mention roughly 100 types of potential uses for Botox, according to Whitcup.
Botox got its start as a medical treatment for excessive blinking and neck spasms. The drug made up 30% of Allergan’s $872 million in first-quarter sales. Botox sales are about evenly split between cosmetic and medical uses.
Some on Wall Street are concerned about potential rivals to Botox.
Earlier this month, Louise Chen, an analyst with Morgan Stanley & Co., downgraded the drug maker’s shares.
One reason: Potential Botox competition from Medicis Pharmaceutical Corp. Scottsdale-based Medicis expects its Reloxin to be approved by the end of 2008 or early 2009, Chen said in her report.
Allergan beat out Medicis in a bidding war last year for Inamed Corp., maker of a wrinkle smoother, breast implants and an obesity treatment.
Inamed, which Allergan bought for $3.2 billion, originally developed Reloxin. Allergan had to divest the drug to satisfy antitrust concerns.
Some doctors may be tempted to switch from Botox when an alternative comes out because of prices, said Alexander Arrow, an analyst with Lazard Capital Markets LLC.
For now Allergan has the market to itself. On Jan. 1, it said it raised the price for Botox by 4%.
Allergan should boost its research and development spending to bolster its pipeline, as well as focus on capturing market share ahead of the potential competition, Chen said.
The company is looking at several uses for Botox, which neared the $1 billion revenue mark last year.
One project, where the drug is injected to fight overactive bladder caused by spinal cord injuries or multiple sclerosis, is in third-stage clinical trials, Whitcup said.
The drug maker’s also looking at Botox for what Whitcup called a larger market: treating overactive bladder conditions where the specific cause isn’t known.
Medications called anti-cholinergics exist for general overactive bladder. But some studies show that 25% to 40% of patients who take those drugs don’t get full relief of symptoms and see side effects, including dry eye and mouth, Whitcup said.
“There’s a need for another therapeutic approach, and Botox may fill that need,” he said.
Allergan anticipates that it could get Food and Drug Administration approval to use Botox to treat overactive bladder starting in 2010, according to Whitcup.
Botox also is being looked at to treat enlarged prostate, another potentially large market, Whitcup said.
“If you look, 50% of men in their 50s will have enlarged prostate,” he said.
Meanwhile, work continues on Botox for migraine headaches. Some doctors already use Botox to treat migraines in what’s known as “off-label” use, or uses other than what the drug is approved for.
Migraine trials are in the third phase. Allergan expects regulatory approval around 2010, Whitcup said.
Allergan is also working on what Whitcup called “second-generation” variations of Botox, though he said that project is in its early stages. The variations could be targeted at specific conditions, including managing pain.
