Astex Pharma $ASTX will present phase 1 results for their HSP90 inhibitor candidate AT13387 - abstracts will be released May 15th, so stay tuned. There will also be several studies involving DACOGEN (decitabine) but none that are company-sponsored and there will not be development or regulatory filings of DACOGEN in any other indications.
1q-2012 partner updates:
Keep reading for updates regarding 1q-2012 earnings reports from big pharma partners and competitors of ASTX: Johnson & Johnson, Eisai, and Celgene.
There was no comment on DACOGEN current sales or the pending EMA review for approval in the EU for elderly AML on the 1q-2012 Johnson and Johnson $JNJ earnings call.
Astex's US partner for DACOGEN, Eisai, will announce fiscal year-end results May 15th.
DACOGEN's only competitor in the hypomethylator category is VIDAZA (azacytidine) from Celgene $CELG. Here are relevant excerpts from their 1q-2012 earnings call.
"VIDAZA continues to solidify its position in international markets, with 23% growth there, and the product grew 14% globally."
"First quarter 2012 VIDAZA sales were $186 million. Sequential quarterly sales were essentially flat, with year-on-year growth of 14%. Sequential sales in the United States decreased to $74 million but continue to reflect the consistent quarter-by-quarter strong market share and VIDAZA demand trends. International sales of VIDAZA, particularly in the recent launch markets of Germany, Italy, the United Kingdom and Spain, grew 23% year-on-year and 9% over the fourth quarter. The lack of a generic entrant in the U.S., our commercial launch momentum in new markets and our focus on improved duration of therapy should return VIDAZA to positive quarterly growth. Our early Q2 trends for VIDAZA are strong. Multiple strategies to leverage our global MDS franchise continue to be developed. VIDAZA and REVLIMID are being advanced in a series of clinical studies in higher-risk MDS and AML. The initiation of the Phase III study of CC-486, oral azacitidine, in lower-risk MDS is on track for the fourth quarter. Other trials in development will seek to define this novel agent's role in maintenance therapy for acute myeloid leukemia."
Question: "on VIDAZA, just wondering how far out your level of visibility is here in terms of potential generic entry. As from now into the year, wondering what your guidance now presumes in terms of how long you'll be able to maintain VIDAZA revenues in the U.S. before generic entry.
Answer: "we obviously follow the VIDAZA situation very closely, but we don't have any access, any information that would be any different than anybody in the public domain as to the timing of that. We continue to support VIDAZA actively in the U.S. and [indiscernible] international presence. And as you've heard, there is some very encouraging epigenetic work being done presented at the American -- at the AACR meeting early this month about the potential for VIDAZA and ultimately for us oral azacitidine in number of areas of malignancy solid tumors. So that's an important development area for us. But as far as the generics specifically goes, we don't have any more clarity than what's available in the public domain
--So note that both ASTX and CELG have next generation follow-on drugs to extend the lifecycle and broaden the indcations of use for DACOGEN (via SGI-110) and VIDAZA (via CC-486), respectively.