Biotech Values

[investorgold2002]

sure ..but there is one problem

In case of lovenox there was specific measurement of marker anti-IIA activity which was part of the USP

Do the below provide some hints on markers for copaxone are????

BEGIN QUOTE
Glatiramer acetate partially cross-reacts with myelin basic protein (MBP) on both the humoral
and cellular levels. In addition, it competes with myelin-associated peptides including myelin
oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP) for binding to the MHC
class II molecules.9 Glatiramer acetate binds with high affinity to MHC Class II molecules on
the surface of antigen presenting cells.10 In vitro studies demonstrate that the affinity of
glatiramer acetate is sufficient to competitively displace MBP, MOG and PLP from MHC II.9
Specificity of glatiramer acetate binding is demonstrated by the observation that anti-MHC II DR
antibodies but not anti-MHC I or anti-MHC II DQ antibodies inhibit interaction of glatiramer
acetate with MHC II.9
Induction of suppressor T-cells has been demonstrated experimentally. T-cell hybridomas
established from spleen cells of glatiramer acetate treated animals were shown to adoptively
transfer resistance to EAE in untreated animals and to inhibit antigen-specific proliferation and
interleukin-2 (IL-2) secretion of an MBP-specific T-cell line.11 Inhibition of MBP-specific
effector T-cells by glatiramer acetate has been demonstrated in several in vitro studies. In the
presence of antigen presenting cells, glatiramer acetate competitively inhibits proliferation and
IL-2 and interferon gamma secretion by human MBP-specific T-cell lines while having no effect
on T-cell lines specific for other antigens. Glatiramer acetate alone does not stimulate
proliferation,12,13 IL-2 secretion12,13 or cytotoxic responses in human MBP-specific T-cells14. In
addition, glatiramer acetate has been shown to inhibit MBP-specific T-cell cytotoxicity.14

END QUOTE



but I see no measurement value of these in the USP...which could be challenging for somebody that is going to have to try to prove equivalence ???