Lanoteplase Genetics Institute

Abstract

Lanoteplase, a modified form of a tissue plasminogen activator (t-PA) lacking fibronectin finger-like and epidermal growth factor domains, was developed by the Genetics Institute for the potential treatment of thromboembolic disorders. Suntory, the Japanese licensee, has filed an NDA in Japan for the treatment of acute myocardial infarction (MI) [301222]. It was also licensed to Bristol-Myers Squibb (BMS) for worldwide development (excluding Japan, China, South Korea and Taiwan) [178225]. BMS conducted phase III trials for acute MI [272490] but discontinued development and returned the license to Genetics Institute during 1999 [359688]. In February 1999, Lehman Brothers predicted the drug had a 60% probability of reaching market, with an estimated first launch date in 2000. The analysts predicted peak sales would occur in 2006, with peak sales of $200 million in the US and US $100 million in the rest of the world at that time [319225].