Gary Stiles is under pressure. With the company's top-selling Effexor, worth $3.7 billion last year, facing generic competition in July 2010, analysts are watching Wyeth's pipeline closely. The firm has been hit by a series of recent setbacks, including an FDA thumbs-down for bifeprunox, the atypical antipsychotic schizophrenia Wyeth developed with Solvay, and an approvable letter on Pristiq, the planned Effexor follow-on, for the vasomotor symptoms of menopause. Stiles is undaunted.
“I don't see that we need any one drug to take over for Effexor,” he says. “We have a very deep, broad-based pipeline with a number of things in Phase III.” Particularly important among them is a pending NDA on Pristiq for major depressive disorder. “The questions about vasomotor symptoms don't apply there,” he says. “It's safe and effective, and there's significant morbidity associated with major depressive disorder.”
Wyeth's newest entries—antibiotic Tygacil, cancer drug Torisel and contraceptive Lybrel—are showing great promise, he says. He's bullish on Aprela, Wyeth's bazedoxifene-plus-estrogen for postmenopausal osteoporosis and vasomotor symptoms of menopause. “We think this will be a paradigm-shifter,” he says. Also on the front burner is methylnaltrexone, a treatment for opioid-induced constipation which Wyeth is collaborating with Progenics Pharmaceuticals.
But Wyeth's great hope is its multi-platform Alzheimer's push, which Stiles hopes will bear out the firm's tactic of throwing everything it's got—vaccines, biologics and small-molecule compounds—up against a disease target and seeing what sticks. The most advanced of the crop—bapineuzumab, which Wyeth is partnering with Elan—will move to Phase III clinical trials this year. “If it works, it will really change the course of Alzheimer's,” he says. Where the current generation of Alzheimer's drugs aims to slow the progress of dementia and boost cognition, bapineuzumab has showed promise for clearing the beta amyloid plaques believed to be a cause of the disease. Clinical trials of an earlier version were halted when some patients developed encephalitis.
Stiles is also talking up Wyeth's oncology franchise. Toricel, already approved for renal cell carcinoma, is in late-stage trials for mantle cell lymphoma. The firm has three new molecules in Phase II—for breast cancer, CML and non-Hodgkin's lymphoma—and Stiles is confident they will move into Phase III. “We're excited that we have this kind of a range of drugs,” he says. “It's not just a wish list but we have data in all those areas that are very encouraging.”
Stiles likens Wyeth's structure, wherein a core team manages a cross-platform portfolio of products aimed at a given disease, to conducting an orchestra. “The conductor can say, ‘Hey, the violins are doing well. We should focus on that rather than the trombone.' If you're a trombonist, it's only the trombones that matter.”
He and his wife, an executive recruiter, live in Collegeville, PA, and have two grown kids back in North Carolina. Between travels, they enjoy art collecting and hitting the elliptical. “We're exercise nuts,” says the 58-year-old cardiologist. “I try to practice what I preach.”
He has a pretty prominent pulpit these days. “I've always liked to help people, and I've always been interested in science,” he says. When he was four, he told his parents he wanted a doctor's bag for Christmas. He never did put that bag down. After receiving his MD from Vanderbilt University School of Medicine and completing his residency in internal medicine, he moved to Duke University and, over the next two decades, assumed ever greater leadership roles, including leading the 900-person clinical research institute and serving as CMO, before joining Wyeth in 2004. As a doctor, he could care for hundreds of patients. “Coming here, I can influence the health of millions of people. Nothing is more fulfilling than seeing the impact Prevnar makes on babies and little kids. Last year we were able to prevent 31,000 hospitalizations of children. What more could a physician ask for?”
Gary Stiles, MD
Chief medical officer and EVP, Wyeth
Chief medical officer and EVP, Wyeth
VP/CMO, Duke University Department of Medicine
Chief of cardiology, Duke University Dept. of Medicine