Alexion Pharmaceuticals, Inc. and Alexion Pharma International Sarl 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.
Alexion’s accelerated plans for the launch of Soliris in Japan are based on recent approval of the price for Soliris(R) (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.”