Scott Whitcup is looking to mine Botox.
The head of research and development at Irvine-based Allergan Inc. is developing other uses for the drug maker’s cash-cow wrinkle remover.
Whitcup, a doctor who’s been with Allergan since 2000, took over as the company’s executive vice president of research and development in July. He replaced longtime research head Lester Kaplan, who retired.
The bid to find new Botox uses didn’t start with Whitcup, though it now falls to him. Last year, Botox was approved for severe underarm sweating. And the drug maker is working to get the drug OK’d for migraine headaches. Other potential uses are in the works.
“It’s really a therapeutic approach,” Whitcup said. “It’s more than just a medication,there have been well over 100 different potential uses of Botox that actually have been written about.”
A possible use of Botox could be to treat overactive bladder, according to Whitcup.
“Again, a big unmet medical need,” he said.
Then there’s benign prostate hypertrophy, a condition that comes with male aging. Allergan plans to look at Botox as an early stage treatment, Whitcup said.
“With age, the prostate grows and causes urinary difficulty,” he said. “It’s an area where there are some medications but still a lot of room for improvement.”
The effort isn’t an urgent one for Allergan. As a cosmetic treatment, Botox has the market to itself and made up a third of Allergan’s $511 million in third-quarter sales.
But competition is in the offing. Ireland’s Elan Pharmaceuticals PLC has a potential rival product and Inamed Corp. and Mentor Corp., both of Santa Barbara, are working on ones of their own. But real competition could be years off.
That gives Allergan, a maker of eye and skin drugs, some time to find new uses for Botox.
“As you go down the road, researchers will find additional uses for Botox for non-cosmetic surgery areas,” said David Anast, publisher of the Biomedical Market News in Costa Mesa. “That’s the next frontier.”
Whitcup’s efforts go beyond Botox. He oversees a team of some 1,100 workers in Allergan’s research operation, the vast majority in Irvine.
Through the first nine months of 2004, Allergan spent $256 million, or 21% of its revenue, on research and development. That’s up from a few years ago and higher than the research spending percentage at some rivals. But it’s lower than the 40% of sales spent on research by Elan, another midsize drug maker.
“In pharmaceutical companies, R & D; is the life blood,” Whitcup said. “If we come up with true differentiated products that address unmet medical need, it clearly will support growth.”
Whitcup has a track record to live up to: Allergan has “come across a four-year period where we’ve had a large number of approvals,” he said.
Those include glaucoma treatments Lumigan and Alphagan P. The latter is a different version of Allergan’s original Alphagan released after the company dropped a fight against generic rivals. Another is Restasis, which is billed as the first prescription drug for dry eyes.
In the works is memantine, a glaucoma pill that Whitcup said could be the first to preserve vision, as opposed to most traditional pressure-relieving eye drops or beta blockers.
“Anyone potentially at risk of losing their vision from their glaucoma would take memantine in addition to their glaucoma eye drops,” he said.
Another opportunity for Allergan is drugs to treat diseases of the eye’s retina. Allergan is in third-phase trials for Posurdex, an implant placed in the back of the eye that releases dexamethasone, an anti-inflammatory drug, into the retina.
Allergan acquired Posurdex as part of its 2003 buy of Oculex Pharmaceuticals Inc., a development-stage drug company based in Sunnyvale. At the time of Whitcup’s promotion, Allergan called him “an important strategist” in the Oculex buy. In the company’s skin care group, Allergan is working with the Food and Drug Administration on gaining approval for oral tazarotene for psoriasis, according to Whitcup.
Regulators sent Allergan a “non-approvable” letter for oral tazarotene last year and asked for a risk management program, an extra clinical study and manufacturing changes.
Whitcup contends the drug maker’s relationship with the agency wasn’t affected by the tazarotene hang-up, which caused some worry on Wall Street.
“The key in working with the agency is to make sure that you have true collaboration and communication,” Whitcup said. “Drug development is a long process, and it’s becoming more complicated.”
Allergan’s “failure rate of compounds in development is substantially less than other pharmaceutical companies,” he said.
The research and development unit’s work could take Allergan into new treatment areas, such as urology, pain treatment and gastroenterology.
“We want to keep a subspecialty focus but also feel it’s important to follow the science,” Whitcup said. “So, as we look at opportunities within the R & D; portfolio, we assess a number of things.”
Allergan adjusts its research efforts on a regular basis to make sure the company is “investing our R & D; dollars where they make the most sense for the company,” he said.
Allergan Chief Executive David E.I. Pyott made research spending a priority when he took over seven years ago. In Pyott’s first year, 1998, Allergan spent 9.9% of its sales on research, about half of the percentage spent now.
“It appears that Allergan is in better position regarding their pipeline than they were five years ago,” said Anast of Biomedical Market News.
The trend should continue, Anast said, “as long as David Pyott is there.”
Whitcup, like other members of Allergan’s senior management, said he has a close relationship with Pyott, the soft-spoken, multilingual Scotsman who’s refined Allergan’s focus.
Pyott’s “strategy has been to focus added resources on R & D;, so clearly that fits well with my strategy,” Whitcup said. “We want to be entrepreneurial and nimble and avoid bureaucracy.”
When a decision needs to be made, Whitcup said he walks the hall to Pyott’s office and gets “the answer in minutes, as opposed to what in other companies may take months.”
Before Whitcup came to Allergan, he was clinical director of the National Eye Institute, a unit of the National Institutes of Health. He was responsible for building the institute’s clinical research program and promoting new eye treatments.
A graduate of Cornell University Medical College in Ithaca, N.Y., Whitcup did his ophthalmology residency at Harvard University. He’s also got a background in internal medicine,he did that residency at the University of California, Los Angeles.
Whitcup, who was vice president and head of Allergan’s eye drugs before his promotion, said he still sees a few patients.
