Cheshire-Based Drugmaker Cancels Joint Effort

By Marc Silvestrini, Waterbury Republican-American, Conn.

Apr. 4–Alexion Pharmaceuticals Inc. said Tuesday it has canceled a joint effort with Procter & Gamble Co. to produce a drug that would reduce the risk of death in patients who have had coronary bypass surgery or angioplasty.

The two companies began their collaboration in January 1999. The drug, an anti-inflammatory antibody fragment known as pexelizumab, failed to meet its primary goal of reducing mortality rates in moderate-to-high risk patients within 30 days of undergoing heart bypass surgery or angioplasty in a late-stage clinical trial that ended in 2006.

The late-stage, or Phase III, trial involved about 5,700 bypass and angioplasty patients at more than 300 sites, both in the United States and abroad.

The drug also failed to lower mortality rates in patients undergoing coronary graft surgery in an earlier Phase III trial. The former partners agreed to split manufacturing, commercialization and development costs, Alexion said in a March 30 filing with the U.S. Securities and Exchange Commission.

Proctor & Gamble has agreed to retain responsibility for future development, manufacturing and commercialization costs for the drug outside the United States, and Alexion will receive royalties on those sales, the filing said.

Cheshire-based Alexion obtained approval from the U.S. Food and Drug Administration last month to market a drug called Soliris. The drug is a treatment for patients suffering from a rare and potentially life-threatening blood disorder known as paroxysmal nocturnal hemoglobinuria, or PNH. Soliris is based on an anti-inflammatory antibody called eculizumab.

Alexion last week set the price for Soliris at more than $389,000 per year, but said it is determined to make the drug available to anyone who needs it.

The company said it would help needy patients find financial aid, either from insurance companies or other sources, and would establish its own charitable foundation.

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