Study results could breathe new life into an old drug for Valeant Pharmaceuticals International.
Last week, a University of Michigan study showed Aliso Viejo-based Valeant’s Efudex cream smoothed rough skin spots and wrinkles, improved color and erased brown spots.
Valeant now sells Efudex for treating early signs of skin cancer. The drug accounted for $61 million of its $657 million in revenue last year.
The study raises the prospect of a new cosmetic use for the drug, which went off patent protection last year.
But one analyst cautions that competition and costs could be too steep to make the marketing of cosmetic Efudex worth it.
“My simple conclusion is that I don’t see how (the study’s) meaningful for Valeant,” said Jonathan Aschoff of Brean Murray Carret & Co., a New York investment bank.
Valeant provided some funding for the study but didn’t directly participate in it.
“So the results are new to us as well,” spokeswoman Laurie Little said.
If Valeant pursues Efudex for cosmetic use, “they wouldn’t make much money from it,” Aschoff said. “There’s a lot of generic competition.”
Efudex’s generic status would weigh on any decision, according to Valeant’s Little.
The company could seek to get what’s called a patent line extension, which would allow Valeant to sell a cosmetic version of Efudex without generic competition, said James Bova, a Costa Mesa-based principal and Southwest region life science sector leader for Deloitte Consulting LLP.
Valeant “will explore its options but will take into consideration the financial feasibility of any clinical trial in our overall development program,” Little said.
The study, published in the Archives of Dermatology, was done on 21 people with sun damaged faces and actinic keratosis, a precursor to skin cancer. The cream caused most of the patients’ faces to become irritated and peel, but the skin that grew back had softer wrinkles, according to a report in Reuters.
Repurposed Drugs
If Valeant decides to develop a cosmetic form of Efudex, it wouldn’t be the first local company to try to capitalize on repurposed drugs.
The prime example is Irvine-based Allergan Inc., which has practically built a business on finding new uses for medical drugs. Its standout drug, wrinkle reducing Botox, was rebranded for cosmetic uses earlier this decade from its Botox neurotoxin, which is used to treat eyelid spasms, crossed eyes, abnormal head position and excessive sweating.
Last year, Allergan found that bimatoprost, the active ingredient in its Lumigan glaucoma drug, helped to grow patients’ eyelashes.
Allergan developed Latisse from those findings and launched it earlier this year. Allergan has said sales of Latisse could eventually top $500 million because it’s relatively inexpensive,Latisse’s average cost to a patient is estimated at $120, compared to $450 to $500 for Botox cosmetic injections and $600 or more for injections of Juv & #233;derm, Allergan’s lower-face wrinkle filler.
Famous Standout
One of the most famous examples of a drug that was developed for something other than its original purpose is Viagra, Pfizer Inc.’s blockbuster sexual dysfunction drug, according to Deloitte’s Bova.
Pfizer originally studied sildenafil, Viagra’s scientific name, for high blood pressure and chest pain, Bova said.
“Pfizer actually had the wherewithal (and) the therapeutic knowledge to develop one of the first sort of lifestyle drugs,” Bova said.
Merck & Co.’s Propecia hair-growing drug, another lifestyle drug, was originally approved as a treatment for an enlarged prostate, according to Bova.
But he cautioned not every drug maker who finds a new direction for a medical drug will pursue the cosmetic rollout.
Drug makers have to take several things into consideration while pursuing what are called “line extensions,” Bova said, including commercial viability and whether they already have a base of doctor customers who prescribe other drugs in the class.
