after 1 week storage at 50°C for sucrose and mannitol
formulations (specification, page 4, lines 16-18). The data is
said to "confirm the better stability of the formulation
containing mannitol in comparison to that containing sucrose"
(specification, page 4, lines 18-20).
21. The "-subunit percentage for Compositions 1
through 4 after 1 week at 50°C ("-subunit % = 100 at time = 0
weeks) is said to be the following:
1. r-hCG/5000/SO1 (sucrose) 90.2
2. r-hCG/5000/MO1 (mannitol) 94.7
and
3. r-hCG/10000/SO1 (sucrose) 92.4
4. r-hCG/10000/MO1 (mannitol) 95.1
22. According to the specification (page 5,
lines 1-3), Tables 14 and 15 report bioactivity assay8 with no
appreciable bioactivity decrease being observed after 24 weeks at
4°C and 25°C in compositions with mannitol.
23. It is true that Tables 14 and 15 report data at
the 24 week time period for mannitol. No data is reported for
sucrose. Accordingly to the extent the data in Tables 14 and 15
are replied upon to compare r-hCG's stabilized with mannitol vis-
a-vis those stabilized with sucrose, the data are not convincing.
24. Further according to counsel, Table 14 shows that
when evaluated by bioassay of the International Unit content, the
8 Our comments with respect to HPSEC, n.6, supra, also apply to
"bioassay" tests and data reported from those tests.
- 7 -
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next
Last modified: November 3, 2007