BIG, BOLD, AND BRASH, Frank Baldino has built Cephalon into one of the nation's most dynamic biotechs. The company, based in suburban Philadelphia, is 20-years-old this year, and is already marking its birthday with a flurry of honors. In January, Cephalon was inducted into the World Economic Forum's Community of Global Growth Companies—a tribute to a 44 percent increase in annual revenue (to $1.67 billion in 2006) and its new footprints in Europe and Asia. The company also made Forbes' list of 25 Fastest-Growing Technology Companies in America, ranked above Amgen, Genentech, and Celgene, thank you very much. On the R&D front, its leukemia treatment, Trisenox (arsenic trioxide), won high praise from the National Cancer Institute as a treatment for newly diagnosed patients, a timely lift to Cephalon's grand scheme to leap from CNS, where it made its reputation, into oncology, where its late-stage pipeline promises lie.

Although Cephalon has yet to launch a single product out of its own discovery program, the company is much envied for its genius at spotting, developing, and promoting neglected drugs. Its first and now flagship drug, Provigil (modafinil), with a narrow sleep-disorder label, delivered more than $700 million last year, at least half of which was for off-label uses ranging from MS fatigue, depression, and ADHD to jet lag, campus cramming, and multipurpose "brain boosting." Actiq (oral mucosal fentanyl), a sluggish-selling painkiller popsicle for cancer patients until Cephalon snagged it from Anesta in 2000 and relaunched it, earned a cool $570 million last year, with more than 90 percent of sales serving off-label uses.

This strategy hasn't always scored, of course. The biotech bought Abbott's anti-seizure drug, Gabitril (tiagabine), in 2001 and sent it through the biotech's standard boot-camp efficiency tests for neuropathic pain and anxiety, among other conditions. But Gabitril has so far shown only middling benefits, while reports that it actually caused seizures in some non-epileptic patients have cramped its off-label style.

Inside Cephalons medicine cabinet

But Baldino is known as much for what he has said as for what he has done—especially when he's angry at FDA. Tracy calls the Cephalon chief's tendency to shoot from the hip "refreshing," adding that, "It's very unusual among pharma CEOs, who generally present a bland, controlled public face and talk out of both sides of their mouth."

Despite being named Neuroinvestment's "CEO of the Year" numerous times, Baldino no longer speaks to Tracy—reportedly offended by unfavorable coverage. Baldino's apparent thin skin makes an odd combo with his raging-bull persona, and, according to Tracy, "in the CNS field, he is the one big CEO whose career stumbles would most likely inspire a feeling of schadenfreude." But Baldino's detractors may be eating their words, given Cephalon's banner year.