West Coast Editor
SAN FRANCISCO As damp-skinned throngs with rising blood pressures jammed the hallways of the Westin St. Francis hotel here for the annual JPMorgan H&Q Healthcare conference, Alexion Pharmaceuticals Inc. president and CEO Leonard Bell stepped out of the registration line long enough to talk about the next step for his company’s heart drug, pexelizumab.
“It’s been our lead drug now for five years,” Bell said of the drug, formerly known as 5G1.1-SC, an anti-inflammatory C5 inhibitor monoclonal antibody fragment, which is entering a 3,000-patient Phase III study.
Pexelizumab is being developed by Alexion, of Cheshire, Conn., in collaboration with Procter & Gamble Pharmaceuticals, an affiliate of Procter & Gamble Co., of Cincinnati. Last month, Alexion changed its deal with P&G to share more equally in development and commercialization, handling about half of sales efforts and reaping about half the profits. (See BioWorld Today, Dec. 13, 2001.)
“We’ve started dosing patients already, and it will probably take about 12 to 18 months to enroll the trial,” Bell told BioWorld Today. “We’ll have data probably six months after that.” He was slated to present the news during a presentation at the conference Monday afternoon.
Alexion disclosed in November that the FDA had given clearance for the trial, called “Pexelizumab for Reduction in Infarction and Mortality in Coronary Artery Bypass Graft Surgery,” or “PRIMO-CABG.” (See BioWorld Today, Nov. 14, 2001.)
“The endpoint is [reducing] death or myocardial infarction,” Bell said. “Either you die, or you don’t die, but have a heart attack. We have data on 900 patients already behind us. The idea when you build up to a pivotal trial is to have a fair amount of data underneath you, so there’s less guesswork in that final trial. The same drug is in two 900- to 1,000-patient [myocardial infarction] trials.”
Behind pexelizumab in the Alexion pipeline is 5G1.1, a fully humanized whole antibody (as opposed to single chain), which “is going to be in Phase IIb [rheumatoid arthritis] trials very shortly,” Bell said. “We’ve completed a pilot trial in dermatomyositis, and we’ll discuss with the FDA whether we’ll go forward with a pivotal trial.”
Further back in the pipeline, Bell said, “we have another antibody that binds to the thrombopoetin receptor and stimulates platelet production. We expect it to go into the clinic as a cancer adjunct.”
The company has about $349 million in cash, “enough to bring us through development, and other indications as well. The next milestone for us is an approved drug, and this should bring us forward to all of our filings with the FDA.”
Alexion’s stock (NASDAQ:ALXN) closed Monday at $22.50, down 69 cents.
Trials of coronary disease drugs are known to be challenging because they typically require large patient enrollments. Big participation was hardly a problem for the traditional JPMorgan H&Q event this year, said Carole Newman, vice president of media relations for JP Morgan. The conference has signed up more than 5,000 attendees, she said.
“We set another record,” Newman told BioWorld Today. “What’s curious is that our investors could be stay-at-home participants because we’re webcasting, but that hasn’t stopped them. The value of eye-to-eye contact and these meetings is very valuable. You can’t replace the handshakes and contacts people make here. There’s a lot of chitchat in the halls who’s investing in what. It’s definitely the place to be this week.”
The conference continues through Thursday.