Category: Supergen

$ASTX - what is there in the Supergen-Astex merger besides Dacogen?

2/18/2012

The strong rebuke by the FDA and its Oncologic Drugs Advisory Committee (ODAC) to ASTX's attempt to gain approval for DACOGEN (decitabine) for elderly AML patients raised significant doubts as to whether the drug will gain approval in this indication in the US or Europe. If not, increased attention will shift to the rest of the company's pipeline. The slide deck from the companies joint analyst and investor R&D day in April 2011 is a good place to start. Find these presentations below and as always get more details on the ASTX research pages. Look forward to additional analysis of these programs here at BiotechDueDiligence and for Chimera Research Group subscribers.

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Astex Pharma $ASTX notes from Lazard 11/16/2011

12/4/2011

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See below for my notes from Astex Pharma's presentation at the Lazard conference
Select "Supergen" and "Astex Pharma" categories to the right for history of other blog posts about this stock
Complete stock research notes on ASTX page
Complete webcast listings and links to my notes on Upcoming Events page

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Celgene $CELG notes from 3q2011 earnings conference call 10/27/2011

11/9/2011

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Celgene held its 3q2011 earnings call on 10/27 - click here for transcript.
CELG is partnered with LGND for CC-930 and sells Vidaza, the key competitor for Dacogen from ASTX.
See the Upcoming Events page for notes and catalysts for companies I cover and see the Partnerships page for notes from larger company conference calls that is relevant to stocks I follow.

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Astex Pharma $ASTX notes from BIO Investor Forum 10/26/2011

11/6/2011

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Astex Pharma (formerly SuperGen, click for research page) presented 10/26/2011 at the BIO Investor Forum (click for complete biotech webcast calendar) - see my quick notes below:
dacogen is now marketed in 30 countries including china
35% of full time employee efforts devoted to janssen (JNJ) and GSK deals.

AT13387 HSP90 inhibitor

wrapping up 2 phase 1 trials (one internal, one US NCI) - data will be presented at AACR-NCI-EORTC conference 11/12-16.
most potent based on IC50 and preclinical data. No off-target effects (liver, CV)
Does share in common class effect (if drug is pharmacologically active) of visual disturbances which are usually very mild and reversible, lasts 1-2 days. Most drugs share this to different levels.
difference- saw PET and RECIST responses in phase 1, leading to combo phase 2 trial in GIST (have started enrolling patients)
some previous drugs went after single agent hsp90 inhibition, but it is obvious this target works better in combo [this may or may not be true in specific patients populations like ALK+ NSCLC]
focus of development will be in combo, particularly with TKI (you'll see as we roll out phase 2 program next year - run by Astex and NCI, under discussion for other solid tumors)

SGI-110

only developing as subcutaneous formulation, expect 1-2ml injection volume
Currently in dose escalation randomized phase with stratification between MDS and AML
goal is to have clinical proof of concept at end of phase 1/2 trial
dose expansion will be in treatment-naive MDS and elderly AML patients
phase 1/2 data - targeting both ASCO and ASH 2012
working on program for ovarian cancer, consider other solid tumors

Rest of pipeline:

amuvatinib trial hope to have data by end of 2012 [this is the first time they have stated this goal and based on the lack of progress the past few years in this program I will be shocked if this amounts to any substantial data release]
7519: two phase 2 trials ongoing, no further expansion until see this data (MM and CLL)
9283: part of portiolfio that we would like to license/spinout - given to Montigen
Montigen will be small public company with two phase 2 drugs, discovery group that could not be integrated into Cambridge, UK
PIPE investment ($2m ASTX plus public money) into reverse takeover being led by Rodman and Renshaw
Astex's initial 80% stake will be "crammed down" by PIPE and then stepped up by $2m investment
PPM available a little later this year - will have additional details
earnings coming monday 10/31/2011 (check back for link and my notes)
On GAAP basis, will have slight loss 2011, on cash basis will be slightly positive. Guidance will be updated at earnings.

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Astex Pharma $ASTX notes from BioCentury webcast 10/21/11

10/25/2011

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ASTX (click for stock research page) presented 10/21 at the BioCentury Newsmakers Conference (find webcast link and complete biotech webcast calendar on Upcoming Events page)
Continue reading below for my complete notes from presentation:

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$ASTX - what is there in the Supergen-Astex merger besides Dacogen?

Astex Pharma $ASTX notes from Lazard 11/16/2011

Celgene $CELG notes from 3q2011 earnings conference call 10/27/2011

Astex Pharma $ASTX notes from BIO Investor Forum 10/26/2011

Astex Pharma $ASTX notes from BioCentury webcast 10/21/11

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