Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) and Alexion Pharma International Sàrl today announced that the launch of Soliris (eculizumab) as a treatment for patients with PNH in Japan will begin in the third quarter of 2010, approximately three months earlier than previously expected.
“We appreciate the rapid action of the government in Japan, where much of the early research in PNH took place, to finalize the NHI reimbursement and listing for Soliris”
Reimbursement Process in Final Stages
Alexion's accelerated plans for the launch of Soliris in Japan are based on recent approval of the price for Soliris® (eculizumab) in Japan by an advisory committee of Japan's Ministry of Health, Labour and Welfare (MHLW). The approval positions the MHLW to list Soliris for reimbursement through Japan's National Health Insurance (NHI) system. Following this listing, Alexion will begin discussions with individual hospital treatment centers to place Soliris on their formularies, a process expected to take an additional one to three months in individual cases.
PNH is an ultra-rare, debilitating and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Soliris, a first-in-class terminal complement inhibitor, is the first therapy approved in Japan for the treatment of patients with PNH. Soliris received orphan drug designation from the MHLW in 2009 and was approved for marketing under the Ministry's priority review process in April 2010.
"We appreciate the rapid action of the government in Japan, where much of the early research in PNH took place, to finalize the NHI reimbursement and listing for Soliris," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "We expect to provide this life-transforming therapy to increasing numbers of patients throughout Japan in the third and fourth quarters. As we continue to diversify our global access operations, the upcoming launch of Soliris in Japan represents our first major expansion into the Asia-Pacific region."
2010 Guidance Revised Upward for Revenues and Non-GAAP Net Income, and Narrowed for SG&A
In light of the earlier than anticipated commercial launch of Soliris in Japan in the second half of this year, the Company has also announced today that it is raising its previously issued guidance for full-year 2010 revenues and non-GAAP net income. Alexion is revising upward its previously announced guidance for 2010 revenues, from the previous range of $505 to $520 million, now to a higher range of $515 to $530 million. Alexion is also revising upward its non-GAAP earnings per share (EPS) guidance from the previous range of $1.60 to $1.65 for non-GAAP diluted EPS now to a higher range of $1.63 to $1.68. Guidance for non-GAAP Selling, General and Administrative (SG&A) expenses remains within the previously announced range of $185 to $195 million, and is now narrowed to $190 to $195 million, reflecting expenses associated with earlier launch in Japan. Guidance for 2010 R&D expenses remains unchanged; thus, guidance for total operating expenses remains within the previously announced range of $280 to $295 million, but is now narrowed to $285 to $295 million. All other items of previously announced 2010 guidance remain unchanged. Non-GAAP results conform with U.S. GAAP in all regards except that share based compensation and non-cash taxes are excluded in the non-GAAP reporting.
The Company notes that 2010 guidance has been revised upward despite the impact of recent and anticipated measures related to healthcare reimbursement in the U.S. and some European countries, as well as recent weakness in the Euro and the British pound.
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