<<From your perspective, does this seem like a reasonable approval timeline for a transgenic protein, even in an established indication?>>
Thanks for the clarification on this story. Producing one protein at a time seems to make better economic sense.
The approval timeline you cited does seem unrealistic to me. The info you cited suggests that they are not going to be able to make material in quantities sufficient for clincial trials until sometime in 1998. One year from the start of clinical trials to the submission of a marketing application seems unrealistic to me, even for a well-characterized protein like Factor IX. One year from submission of the marketing application until approval is possible, but it is, I believe, the bare minimum.
PPL, Pharming, and GZTC have extensively cross-licensed with each other. I suspect that PPL could, if they chose to, try to compete with GZTC in the production of serum albumin. But since they are pursuing Factor IX first, GZTC seems to have a substantial head-start on them.
Steve Push
Genzyme Corp.
genzyme.com |
