A San Francisco hotel conference room will be the focus of the biotech world this morning, as
executives take the hot seat at the JPMorgan H&Q health care conference.
This is the first public appearance for CEO Sam Waksal and his brother and COO Harlan Waksal since the Food and Drug Administration
rejected the company's approval application for the cancer drug Erbitux on Dec. 28. Set your alarm; the shindig starts at 10:30 a.m. PST. The two men are expected to use their allotted 30 minutes of presentation time to shed some light on the Erbitux delay, and hopefully begin to explain how the company is going to dig itself out of the very deep
hole in which it finds itself these days.
But this will only serve as a warm-up to the main event -- a 30-minute question-and-answer session that will give angry, shocked, confused and otherwise curious Wall Street fund managers a chance to vent.
"I'm surprised JPMorgan isn't selling tickets to this thing," says one bemused fund manager, who plans on lining up extra early just to guarantee himself a seat in the room. Another hedge fund manager suggested the Waksals' chat should be a pay-per-view event.
Coincidentally, former Vice President and now-bearded Democratic nomad Al Gore is giving a keynote luncheon speech at the conference today, but you hardly hear anyone talking about it.
A Risky Rule Book
The JPMorgan H&Q conference is now half over -- close to 200 health care companies have already made their pitches to investors -- but the ImClone story is still the big topic of conversation. And because biotech can be a very cutthroat, competitive business, some of ImClone's rivals are trying -- albeit politely -- to take advantage of the company's woes.
At a Tuesday afternoon breakout session with fund managers,
CEO Arthur Levinson made sure everyone in attendance understood that his company wasn't playing by the risky ImClone rule book when it came to developing drugs. Levinson, of course, never mentioned ImClone by name, but everyone in the audience got the hint.
Questioning the decisions by some biotech companies to take "shortcuts" in their clinical trial work, Levinson said Genentech "gravitates towards the more rigorous side of things. We might decide to add six or nine months to a clinical trial, but at the end of the day, that's a good approach."
When asked about Tarceva, the experimental cancer drug and potential Erbitux rival, Levinson and other Genentech executives stressed the comprehensive clinical trial program underway, including multiple phase 2 and phase 3 trials enrolling thousands of patients. And of course, these trials are randomized and controlled with clinical goals, or endpoints, that include having to show a survival benefit, a pointed contrast to the alleged FDA criticism of Erbitux testing.
Earlier in the day,
announced that it had begun a second mid-stage clinical trial of its experimental cancer drug, ABX-EGF, in patients with colon cancer. ABX-EGF, of course, is another potential Erbitux competitor.
ImClone investors obviously are anxious for today's meeting to answer all their questions. It won't happen. The Waksal brothers have already stated that they won't know the full extent of the Erbitux delay until they meet with FDA officials, and that meeting doesn't happen until the end of the month.
More often than not, the breakout sessions at investment conferences tend to be rather genteel affairs. Yes, questions can get pointed, but rarely do tempers flare or accusations fly. This isn't
The Jerry Springer Show
. After all, no one throws chairs. But the unfolding ImClone saga has been one shocking surprise after another, so few people are brave enough to predict the outcome of this morning's meeting.
Odds are pretty good that Sam and Harlan Waksal won't get up in front of the assembled throng and admit to being the illegitimate children of Elvis Presley and a three-headed Martian cocktail waitress. But other than that, anything goes.