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through the skin quickly, not have any odor, and stay mostly out of broad circulation in the bloodstream, Singh says. (When I visited her office last week, she insisted that I rub a little on my hand to prove her point that it absorbs quickly and has no odor.)
We’ll soon know whether this actually works against pain when the results come in from the 350-patient clinical trial at about 30 sites in the U.S., which are expected to be available within days, Singh says. The study randomly assigned patients with acute soft-tissue injuries (like an ankle sprain or tennis elbow), to take either Ketotransdel three times a day, or a placebo cream. Patients were monitored for seven days, with a goal of showing pain relief after three days. Patients are asked to say how severe their pain is on a scale of 1 to 10, after they got the drug.
If this trial is successful, then Transdel plans to move on to test Ketotransdel in the really big markets of chronic pain—things like osteoarthritis, which affects more than 20 million people in the U.S.
“It reminds me of Botox. We took one product forward for a number of applications. The potential here is tremendous,” Singh says. She adds, “Everyone has pain. Why would you take Advil when you can apply this and not worry about complications?”
Timing is also quite good for anybody to come along with an effective new pain reliever. Vioxx and Bextra are off the market, and the FDA has raised some concerns about high doses of acetaminophen (Tylenol) potentially causing liver damage. Much has been made about abuse of opioid-based pain relievers like oxycodone (Oxycontin), that are narcotic and can be addictive.
Transdel has its eyes on two competitors in the market. One is the diclofenac epolamine (Flector Patch), marketed by Bristol, TN-based King Pharmaceuticals (NYSE: KG), and the other is diclofenac sodium (Voltaren Gel) marketed by Chadds Ford, PA-based Endo Pharmaceuticals (NASDAQ: ENDP).
The Transdel drug should have advantages because a cream doesn’t have issues with sticking to the skin, or causing annoyance in the shower, like a patch, Singh says, and the gel from Endo has a strong medicine-y odor. (Singh again insisted that I rub some of the Endo gel on the back of my hand to see for myself. To be fair, I thought the smell went away pretty quickly.)
Importantly, these products have set economic benchmarks that look pretty attractive to a little company like Transdel, which has only spent $13 million to get through Phase III clinical trials. IBSA, the company that got FDA approval of the Flector Patch, sold the product for $100 million in upfront payments to Alpharma (later acquired by King). Endo paid Novartis $85 million in upfront cash last year, and agreed to make a one-time milestone payment of $25 million if the Voltaren Gel exceeds annual sales of $300 million.
The Flector Patch generated $130 million in sales in 2008, although it still has a way to go before it reaches Alpharma’s projections of $500 million in annual sales.
Transdel will need to find a partner with sales and marketing muscle, and management that “believes in the product,” Singh says, if it’s going to generate a big return on investment. But she let it rip when asked about this product’s potential.