NYTimes article today on CEPH (reqires FREE registration):
nytimes.com
Excerpt:
Rising sales of Provigil and the company's two other main drugs, all of them licensed from other companies, have made Cephalon one of the fastest-growing biotechnology companies and one of the few profitable ones. And they have meant a resurrection for Dr. Baldino, who has long been a subject of controversy, especially after the failure of an earlier Cephalon drug.
But the growing sales of Provigil are also raising questions about the company's promotion of the drug and about society's use of it. Already, some doctors say, Provigil is showing signs of becoming a lifestyle drug for a sleep-deprived 24/7 society, used by people who need to pull all-nighters for work or school or who just want to sleep less so they can work or play more.
"People think they can now burn the candle at both ends and not have to pay for it if they take this drug," said Dr. David Slamowitz, a sleep disorder specialist at the National Jewish Medical and Research Center in Denver. But even if a person doesn't feel the need for sleep, he said, doing without it can be harmful.
How far the use of Provigil will extend could be determined in the coming months. By year-end, Cephalon hopes to have results of a clinical trial in which Provigil is being tested to reduce sleepiness in people who work the graveyard shift.
If the trial is successful, the company will ask the Food and Drug Administration to expand the approved uses of Provigil from just narcolepsy to excessive sleepiness associated with any medical condition. That would allow the company's sales force to begin calling on general practitioners rather than just sleep specialists, neurologists and psychiatrists, potentially expanding sales to the billion-dollar range.
"There are no warts on this drug," Dr. Baldino, 49, who has a doctorate in pharmacology, said with characteristic bluntness at his office in this suburb of Philadelphia. "The only question is how big we can make it."
SALES of Provigil are expected to exceed $200 million this year, up from $150 million last year, the company says. Cephalon's overall product sales, helped by an acquisition, are expected to nearly double, to at least $430 million. The company said it expected to earn $1.08 to $1.10 a share this year, excluding extraordinary items, compared with 19 cents before extraordinary charges last year. The company's stock is down 37 percent since the beginning of the year, closing on Friday at $47.33. But it has generally done better than many biotech stocks. |
