SAN FRANCISCO -- Investors interested in eavesdropping on some biotech trash-talking might want to tune in to an important psoriasis medical meeting being held here next week.
Now we admit, a bunch of dermatologists chattering in the halls of a San Francisco hotel might not titillate the eardrums
Allen Iverson-Kobe Bryant
feud, but for biotech observers, some juicy stuff will be thrown around the
International Psoriasis Symposium
, which runs June 19-24.
The best showdown will come between
and a tag team comprising
. Both sides have a lot riding on the meeting because testing on their respective psoriasis drugs is largely completed and the drugs are about to be submitted to U.S. drug regulators. And while the companies won't admit it publicly, they have already been slinging mud at each other. The stakes are high: The 5 million American psoriasis sufferers could spend as much as $2 billion on new drugs annually by 2005.
Case in point: Xoma CEO Jack Castello, at his recent shareholder meeting, seemed to imply that rival Biogen's drug, Amevive, could cause patients to fall victim to all sorts of bad things, namely infections, cancers, even AIDS. Now, Castello did not specifically link Amevive with these nasty diseases. But he did talk at length about possible problems that occur when a patient's T-cells, or immune cells, are depleted. And guess what? Amevive works by suppressing, or eliminating, certain types of T-cells.
Not that Biogen is above the fray. The company, angered by Xoma's put-downs, reportedly sent out a little Care package to institutional investors (the company won't own up to it). Inside the package, a copy of which was obtained by
, was a March 2000 research study that raised potentially serious safety questions about the Xoma/Genentech drug, dubbed Xanelim. And while not necessarily the source, Biogen is also benefiting from speculation that Xanelim patients are suffering from severe relapses of their psoriasis symptoms, bad enough that the drug's
Food and Drug Administration
submission might be delayed.
examined this issue.
Investors should look for potentially market-moving conference news starting on Thursday and continuing through Saturday, as each company makes multiple presentations about its latest research results. Biogen needs Amevive because sales of its biggest money-maker, the multiple sclerosis drug Avonex, are showing signs of weakness. Xoma is just plain desperate to push any drug to market. In 20 years, the company is still shooting blanks. Genentech, with its existing stable of profitable drugs, has less riding on Xanelim.
With stakes as high as this, and both camps facing off in dueling presentations, conference attendees and investors will get a very clear view of how the drugs stack up against each other and their odds for success.
Here's a quick rundown of the big issues:
The company and its researchers will be taking the wraps off late-stage testing of Amevive. Partial results, released earlier this week, showed the drug was very effective in reducing psoriasis symptoms in patients, and with few side effects. Based on these results, the company says it will file for approval with the FDA and in Europe by the end of the year, putting it ahead of Xanelim.
Those results, and the likelihood of a year-end filing, will be examined during the conference.
What everyone wants to know: What effect does Amevive have on a patient's immune system, and could that possibly lead to potential safety problems -- and problems with the FDA? Remember, Amevive works by eliminating a certain kind of T-cell, a fact that critics -- including Xoma's Castello -- have jumped on to raise concerns that the drug might compromise a patient's immune system.
Kathleen O'Donnell, Biogen's spokeswoman, says the so-called "T-cell depletion" saga will get a full airing at the conference.
"This issue has been raised, but it's really not an issue," she says. "We're seeing a good safety profile and when the data is presented and discussed, you'll get the whole picture."
If Biogen can clear up the safety issue, Amevive looks promising. In previous studies, the drug has proven to have a long-lasting effect, which means patients can go as long as an average seven to 10 months in between courses of treatment before their psoriasis returns.
The drug does have some disadvantages: It is given either intravenously or with a deep-muscle injection, both of which require a doctor to give the injection. By comparison, Xanelim is a shot given just under the skin, which can be done by the patient at home.
And earlier studies also suggest that Amevive takes longer to start working than Xanelim.
There is a little more mystery surrounding Xanelim coming into the meeting because the companies have been fairly reticent about releasing detailed results from their late-stage tests. So, the first thing people will jump on next week is the chance to see hard numbers.
Those numbers, and their interpretations, should settle some big questions hanging over the drug's effectiveness and safety. At the top of the list: How quickly do psoriasis patients relapse once they stop taking the drug? Published reports quoting patients suggest that Xanelim doesn't work as long as Amevive. And in some cases, the psoriasis returns worse than before.
This is an important point, because if patients are relapsing quickly, they'll have to take Xanelim continuously. That kind of dosage could require Xoma and Genentech to delay their FDA filing while they wait for an ongoing test to be completed. The 12-month test, begun in January, is designed to prove the drug's long-term safety. At this point, the companies say they will make a decision on filing, or not filing, with the FDA by the end of the year or the first quarter of next year.
Xanelim works differently than Amevive, so the T-cell depletion issue has not cropped up. But there's been a persistent rumor that patients taking Xanelim might be at a higher risk for blood cancer or other immune system problems. The companies have tried to knock this talk down, but it will be raised again.
So far, Xoma and Genentech are keeping a tight lid on what exactly will be talked about at the conference. Genentech spokeswoman Wendy Emanuel says detailed results from the Xanelim tests will be discussed, but she won't give details.
Some other companies that might make waves at the conference:
: This biotech firm may just be the sleeper hit of the conference. Several midstage tests for its experimental psoriasis drug, MEDI-507, have been completed, with results to be talked about next week. MedImmune has been very tight-lipped about its progress so far, leading some to believe it has a winner on its hands.
Observers will be looking especially hard to see whether some of the more optimistic MEDI-507 rumors are true. Namely, that the drug combines the long-term effectiveness of Amevive with the easy administration and quick-acting mechanism of Xanelim. Caution advised here though, because pivotal, late-stage tests have not started yet, which puts the drug well behind its rivals.
Johnson & Johnson
: Its drug Remicaide has shown results equal to, or better than, those of Amevive in early tests. But those trials were small, so skeptical observers will be looking for the pharmaceutical giant to put more convincing evidence on the table.