Just one day after announcing the protocol for a Phase III trial of eculizumab, Alexion Pharmaceuticals Inc. raised $77.5 million in gross proceeds through the sale of 5 million shares of common stock.
The shares were priced at $15.50 each, which was based on a five-day average of Alexion's closing stock price, said Leonard Bell, the company's CEO.
"These proceeds we expect to use for general corporate purposes, largely focused on clinical development," Bell told BioWorld Today.
The main reason the company conducted the financing was to support manufacturing, regulatory work and Phase III development of eculizumab in paroxysmal nocturnal hemoglobinuria (PNH) and Alexion's other lead product, pexelizumab, in patients undergoing coronary artery bypass graft (CABG) surgery and in patients experiencing acute myocardial infarction (AMI) treated with primary percutaneous intervention.
The funds raised "certainly should take us through the PNH and CABG Phase III trials under way," Bell said.
Alexion is looking to file a biologics license application for eculizumab in PNH in late 2005 or early 2006 and for pexelizumab in CABG in the second half of 2005.
The underwriters of Alexion's offering include Morgan Stanley & Co. Inc. and SG Cowen & Co. LLC, both of New York. They were granted a 30-day option to purchase an additional 500,000 shares of common stock to cover overallotments. Morgan Stanley is the sole bookrunner for the offering.
The financing involves shares taken from the company's shelf registration filed with the SEC in November to sell up to $150 million in common and preferred stock, debt securities and warrants. With this week's offering, the company has about half of that left on the shelf.
Earlier this week Alexion completed a special protocol assessment process with the FDA for a Phase III program of eculizumab for PNH. The company expects to enroll 75 patients in each of two trials over the next few months. (See BioWorld Today, July 21, 2004.)
It is the third SPA the company has completed in collaboration with the FDA this summer. In June, Alexion entered two similar agreements with the FDA to move pexelizumab into Phase III trials in patients undergoing CABG surgery and in patients experiencing AMI. The CABG surgery trial began enrolling patients this week. (See BioWorld Today, June 15, 2004.)
Both eculizumab and pexelizumab are C5 complement inhibitors. Alexion has orphan drug status for eculizumab in the U.S. and Europe, and plans to keep U.S. marketing rights in-house. The product also is being studied in Phase II for rheumatoid arthritis and membranous nephritis. Pexelizumab is partnered with Procter & Gamble Pharmaceuticals Inc., a unit of Cincinnati-based Procter & Gamble Co.
As of April 30, Alexion had $204.2 million in cash, cash equivalents and marketable securities. Following this offering, the company has about 27 million shares outstanding.
Alexion's stock (NASDAQ:ALXN) dropped 90 cents Wednesday to close at $15.90.