Navigate the Astex Pharma ASTX Research Pages
- Introduction (background, summary, links, valuation, financials, outlook, upcoming catalysts)
- Supergen-Astex merger (details on transformative transaction in 2011)
- DACOGEN (aka decitabine, marketed product for myelodysplastic syndrome MDS by Eisai and JNJ)
- AT13387 (HSP90 inhibitor for cancer)
- SGI-110 (follow-on to Dacogen for MDS and AML)
- Amuvatinib (aka MP470 in development for small-cell lung cancer SCLC)
- AT7519 (CDK inhibitor for multiple myeloma)
- Fragment-based Drug Discovery Collaborations (via Astex Ltd side of merger)
- Pipeline (other assets in development)
- Montigen (proposed spin-out transaction info and assets)
Dacogen (decitabine)
- Marketed product for MDS, partnered w/ Eisai in North America and JNJ outside NA (approved in 30 countries, sublicense from MGI/EIsai, so SUPG got 50% of upfront and milestones)
- 20-30% royalty (for 20 yrs after approval in each country) escalating in 2.5% increments every $50m up to $200m annual sales to get 30%, 12.5m remaining possible milestones from Eisai and $5m from JNJ (approvals in Japan and EU)
- Have 40% of US MDS market share (competes w/ 5aza Vidaza- goes generic in 5/2011-celgene is no longer promoting)
- Trial in additional indication of elderly AML (>65 years old, 100k pts per year)- phase 3 trial w/ 485 pts, primary endpt of OS vs AraC with SPA, 6/2010: did not meet primary endpt (pos trend and 2nd endpts), but Eisai (sNDA) and JNJ (EMEA) still intend to file 1q11 and present at ASCO11. 1q2011: now says Eisai filing 2q2011, JNJ filing in 2011
- Eisai filed the sNDA with the FDA on 5/6/2011, and SUPG announced that it had been accepted for review (click here for PR). No announcement was made about it receiving priority review, so the PDUFA should be in March 2012.
- 6/2011: elderly AML data presented at ASCO - click here for PR - click here for abstract and my comments.
- planning AML pediatric trial- give 6 months addl exclusivity thru 11/2013]
- sNDA for 5 day dosing approved 3/2010.
- p4 head to head vs Vidaza ongoing in MDS-(10/2010: data around time goes off orphan drug status).
- Eisai predicts $300m worldwide sales 2011, 400 US oncology sales reps.
- Very little current market in EU, AML approval would get 10 yrs orphan drug designation there
- Royalties one qtr in arrears so first quarter results each year should reflect the highest blended royalty rate to SUPG
- 2010 10k: "eleven issued patents and 30 patent applications, having projected expiration dates ranging from June 5, 2022 to September 27, 2024, granted or pending in the jurisdictions of the U.S., Australia, Canada, Europe, Japan, China, India and Hong Kong."