Here is some interesting material from the research report:
Key Questions and RBC'sTake
1. Why is SGI-110 potentially better than
Dacogen and Vidaza?
SGI-110’s pro-drug formulation allows for much longer exposure of
decitabine, up to 3x as long, in a steadier continuous concentration, which
also potentially reduces the severity of side effects. The longer exposure
allows for a higher degree of LINE 1 hypomethylation, which has been
shown to heighten responses, especially in MDS. SGI-110 will also be in a
more convenient subQ formulation rather than IV.
2. How is SGI-110 going to compete with
generic Dacogen (May 2013) and generic
SGI-110 will have to compete with generic Dacogen, which may come on
as early as May 2013, though generic Vidaza may or may not be available
(due to its complex formulation where generic manufacturers are likely to
encounter trouble obtaining bioequivalence data needed for approval).
However, SGI-110 would compete with potential Dacogen and Vidaza
generics only in the MDS setting in the US. For AML, neither Dacogen nor
Vidaza is approved in the US, thereby leaving a wide-open market for SGI-
110. Also, SGI-110 may work in the relapsed and/or refractory settings,
likely after patients fail Dacogen or Vidaza.
3. Is Astex’s royalty stream not going to cease
when Dacogen goes generic (May 2013)?
Dacogen royalties are expected to decrease on US sales beginning Q3/13
(rather than May 2013) as Astex recognizes Dacogen royalties on a onequarter
lag. However, despite genericization in the US, Dacogen is sold in 22
other countries ex-US and was newly approved in Europe for elderly, chemoineligible
AML. Thus, while royalties are expected to decrease for US sales,
Dacogen royalties will still be existing off of growth in sales outside the US.