The woman who helped bring the famous anti-wrinkle treatment Botox to the U.S. market is working on a pain reliever that she says can compete with some of the best-known drugs in the world—Tylenol and Advil.
Her name is Juliet Singh, and she’s the CEO of a tiny La Jolla, CA-based company called Transdel Pharmaceuticals. Singh, 48, was the director of worldwide regulatory affairs at Irvine, CA-based Allergan (NYSE: AGN) in the late 1990s, where she oversaw efforts to get FDA approval for botulinum toxin (Botox), for eye diseases, before doctors discovered it also helps eliminate wrinkles.
Singh’s latest project is to turn a common pain reliever from a pill form into a topical cream. The goal is to make ketoprofen, a potent non-steroidal anti-inflammatory drug from the same class as ibuprofen (Advil, Motrin), into something people can rub directly on the body part that hurts. Ibuprofen has been approved by the FDA since 1974, and taken by millions of people ever since. But the drug has been known to cause stomach bleeding for some people. That’s a big reason why drug companies in the 1990s sought to make Cox-2 inhibitors like Vioxx and Bextra, which were supposed to be safer on the stomach. But they were ultimately pulled off the market because they raised the risk of heart attack and stroke.
The concept at Transdel is that if you can develop a cream formulation of ketoprofen, it will seep through the skin directly into say, a painful neck, elbow, or ankle, without circulating through the entire bloodstream (and possibly cause stomach bleeding.) The company expects to hear a definite answer from pivotal study of 350 patients by the end of this month, which will determine whether the drug is good enough to win FDA approval. If the company passes this test, it will soon be able to dip its toe into a global market for pain relievers that was worth $19.1 billion in 2008, and is expected to grow to $32.8 billion by 2013, according to market research firm BCC Research.
“I truly think our product will be one of the best in the U.S. market and will be recognized like a Tylenol or an Advil,” Singh says.
Transdel doesn’t have the usual big-time VC backers, and it’s a virtual company with a skeleton crew of just a few employees. The company has burned through about $13 million in capital through the end of June, and its shares (OTC BB: TDLP) trade on the bulletin board, which isn’t the place I usually look to find interesting biotech companies.
But Singh has a credible background, as an endocrinologist by training, a former postdoctoral fellow at Genentech, and as someone who built a track record in regulatory affairs at Baxter Healthcare, Allergan, and Collateral Therapeutics before that company was bought by Schering AG (now part of Bayer AG) in 2002.
Transdel has pinned its hopes on proprietary technology to deliver drugs through layers of skin, fat, and nerves, into underlying muscles feeling pain. The approach has been applied with Ketotransdel, its formulation of ketoprofen, a generic pain reliever that’s available over-the-counter in the U.S. The Transdel drug has been made to absorb 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.
“This is our big gold mine,” Singh says. “Patients and physicians are struggling now about what they should be taking for pain.”