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 … Next Page »