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Soliris Filing Planned In Second-Half Of 2006; "TRIUMPH" Pivotal Aptly Named?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Alexion plans to submit its biologic Soliris for treatment of paroxysmal nocturnal hemoglobinuria in the U.S. and EU in the second half of 2006

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Alexion EXPLOREs priming the PNH market

In advance of a BLA for its paroxysmal nocturnal hemoglobinuria treatment Soliris (eculizumab), Alexion is raising the profile of the orphan blood disorder with a diagnostic study and website. The company says that PNH patients can "go undiagnosed for years." Because PNH "is associated with bone marrow disorders [but] is often misdiagnosed or undetected in these patients," Alexion's EXPLORE study will engage approximately 200 hematologists and 2,000 patients in "the first systemic effort to determine the presence of the PNH blood cell clone" in patients with aplastic anemia, myelodysplastic syndrome and related disorders, the company says. Enrollment will begin this summer. The website - - "will serve as the first PNH-specific, on-line informational resource," Alexion adds. Soliris Phase III data is expected later this year (1Pharmaceutical Approvals Monthly February 2006, p. 10); the company recently said BLA filing was possible by year-end...

Alexion Eculizumab Will Have "Ultra-Orphan" Price; Antibody Enters Phase III

Alexion plans to price its biologic eculizumab for treatment of paroxysmal nocturnal hemoglobinuria similarly to other high-priced agents for very rare diseases, the firm indicated.

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