Conclusions

Innovations in the manufacture of tPA and, in particular, the development of engineered product variants, provide a fascinating insight into how technical advances have impacted upon the pharmaceutical biotechnology sector as a whole. Like many early biopharma-ceuticals (e.g., blood factors and insulin), first-generation tPA was simply a recombinant version of a native human protein. In contrast, second-generation tPA-based products are engineered in order to tailor their therapeutic characteristics. tPA-based products command a not insignificant proportion of the total global biopharmaceutical market. Combined sales of Genentech's Activase and TNKase products alone reached US$185 million in 2003. Their therapeutic effectiveness, coupled with the significant and growing incidence of AMI worldwide, ensures that this group of therapeutic agents will remain a prominent category of biopharmaceutical for many years to come.

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