Scott, thread,
I got this from thestreet.com, but not public elsewhere so far as I can tell. Seems like ISIP should get a boost since it eliminates one of their potential competitors. Comments anyone?
Top Stories: Centocor Halts Remicade Trial on Safety Concern, Notifies Docs
By Jesse Eisinger
Senior Writer
11/19/98 6:32 PM ET
Centocor (CNTO:Nasdaq) has halted a trial of Remicade in Crohn's disease patients due to safety concerns, and it has sent doctors a letter detailing the results.
In the trial, 25% of the 40 patients suffered side effects that appear to be related to immune-system reactions to the drug, generically known as infliximab, the letter says. Remicade was approved in August as a short-term treatment for moderate to severe Crohn's patients, who suffer from inflamed bowels.
Centocor is continuing to look at chronic treatment with the drug to establish long-term safety and effectiveness. Toward that end, the company started a trial six months ago, which was halted "recently," according to a company spokesman. After discussions with the Food and Drug Administration, Centocor notified doctors in what is known in the medical community as a "dear doctor" letter.
Asked why the company didn't disclose either the halting of the trial, spokesman Jason Rubin says, "We didn't think it was that significant an event." Of the company's decision not to disclose the dear doctor letter, Rubin says that Centocor discussed safety issues with the investment community at scientific meetings in recent weeks.
The drug was launched for short-term treatment on Oct. 1. Bulls expect the drug to reach sales of about $30 million this year, while bears think side-effects and weak demand will hold sales far lower. "That [$30 million] remains our target and so far we're off to a good start," says Jason Rubin, Centocor's spokesman. Centocor hopes to win approval for the drug in the much larger market of rheumatoid arthritis patients by this time next year. The company reported revenue of $235 million for the nine months ended Sept. 30.
Centocor stock's closed up 1 1/2 Thursday at 50 7/8 as bulls downplayed the letter's importance. For instance, Rubin, the spokesman, noted that the study involved a small number of patients.
The letter, dated Nov. 10, circulated around Wall Street Wednesday and Thursday, helping to push up the stock of competitor Immunex (IMNX:Nasdaq), which climbed 9 7/16, or 12%, Thursday to close at 86 15/16. The news is considered good for Enbrel, Immunex's drug for treating rheumatoid arthritis patients.
(Also boosting Immunex shares was a Nov. 12 quarterly filing with the Securities and Exchange Commission indicating that Immunex has committed to buy $104 million worth of Enbrel inventory from the contract manufacturer on the drug as of Sept. 30. To one long investor who asked to remain anonymous, that means the company and its marketing partner, American Home Products (AHP:NYSE), are a big first year for the drug, with sales of about $400 million. Also, a rumors circulated that American Home, Immunex's majority owner, might buy the rest of the company for north of 100 a share. Tim Warner, an Immunex spokesman, dismissed the takeout rumor as inaccurate.)
Worries about side effects have been Centocor's single greatest worry about the financial prospects for Remicade, which is an antibody against a natural immune-system protein called tumor necrosis factor. Of special concern is how many times patients can be treated with the drug before they either have an immune response or find that the effect has worn off.
The patients in the study had previously taken Remicade and were being tested to judge the effectiveness of re-treating them two to four years later. Of the 40 patients, 24, received an older, liquid formulation of the drug first, then the new powdered form. Nine of the 10 patients who suffered serious adverse events were given the older formulation initially and the new formulation on being re-treated. Of the 16 remaining patients who received the new formulation both initially and on re-treatment, only one suffered a serious adverse event. Nine of 10 patients had severe muscle pain; seven of 10 had rashes and six ran fevers. All the patients got better within three days.
In the letter, the company notes that "no similar set of delayed adverse events have been observed in other completed clinical trials involving 216 patients receiving 429 re-treatments at intervals ranging from one to 55 weeks." In an ongoing re-treatment study of rheumatoid arthritis patients, 340 subjects have been re-treated and "none of these patients have developed" similar side effects, the letter says. However, the rheumatoid arthritis patients were taking methotrexate, an immune suppressant, in conjunction with Remicade.
One fund manager who owns Centocor says the older formulation might not be as pure as the new, giving rise to the serious adverse events. "I'm not panicked. When you look at Crohn's disease, it's so horrible and nothing else works for it," says the manager, who asked to remain anonymous. "But where it matters is competing with Immunex," adds the manager, figuring that American Home sales reps will make hay with the letter.
|
