- In preparation for the anticipated completion of the merger between Astex and Supergen, I am working to update the Supergen (soon to change its name to Astex Pharma $ASTX) research page.
- See below the jump for an archive of notes from eight different webcasts between October 2010 and April 2011 that I did not previously post to the blog. Pertinent info will of course be incorporated into the SUPG research page.
- Note that I also have a ton of hand-written notes from the April 2011 Joint Analyst and Investor Day held by Supergen and Astex - I will try my best to get these loaded to the site by the time this merger closes!
- Click here to access all prior blog posts related to Supergen, including ASCO 2011 data for Dacogen and Amuvatinib and detailed info on the merger with Astex
- Total demethylator maket increasing, Dacogen US share up to 41%, also up ROW
- Dacogen elderly AML data will presented at medical conference 2011
- SGI-110 clinical trial sites have initiated, plan to dose pts in November
- SGI-110: two dosing regimens- either could continue into p2 portion of trial
- SGI-110 100 mg/mL solution, dose <1 mL, should limit injection site reactions
- MP470 (amuvatinib) concluding preparations for p2 proof of concept study. Simons 2 stage design with 21-50 pts- small cell lung cancer who do not respond to Pt-based therapies or quickly relapse (sounds like timing has definitely slipped into 2011)
- SGI-1776 DLT has been identified as QTC prolongation- evaluating this carefully for all new and ongoing pts, also working on backup compounds with better in vivo cardiac profile- need to make decision whether to kill drug or use at lower doses. Will not have two PIM kinase inhibitors in the clinic at the same time
- Will present preclinical data November 2010 at EORTC/NCI/AACR meeting
- June 2011 Vidaza goes off orphan drug designation, $CELG is beginning to decrease sales and marketing efforts
- Hypomethylator market- now are seeing more tx cycles per pt, drives higher sales levels
- More Vidaza scripts (perhaps when go generic) leads to more Vidaza failure pts that would then switch to Dacogen (but won't say what % of Dacogen pts are vidaza failures- but Vidaza share of 1st prescriptions is 60%)
- Dacogen half-life is in minutes, SGI-110 much longer half life
- Amuvatinib p2 trial will start 1q2011 in SCLC pts refractory to Pt-etopiside therapy. 10 ctrs, 21 pts in first stage, if successful enough, expand to 50 pts. Would plan to partner before phase 3
- SGI110 phase 1 trial will start "in the coming weeks"
- Weekly dosing of SGI-110 is as effective as 5 day daily dosing of Dacogen
- Worldwide hypomethylator market is about $750m and growing about 10% per year
- SUPG receives Dacogen royalties for 20 years after approval in each nation
- Complete data from phase 3 elderly AML trial (failed OS primary endpt) will be presented at ASCO 2011 or earlier
- Eisai plans to file sNDA for Dacogen based on these data in 1q2011
- Dacogen US orphan drug status extended to November 2013 based on pediatric trial
- Dacogen vs Vidaza head to head trial will read out in about 19 months (~ June 2012)
- Vidaza goes generic June 2011, but don't predict that this will have much impact on Dacogen sales (many Dacogen pts are Vidaza failures)
- SGI-1776 was terminated after 14 pts due to cardiac toxicity- still advancing backup PIM kinase inhibitor compounds
- Amuvatinib p2 trial to start 1q2011
- Amuvatinib owe 1% royalty to Univ of Arizona
- Mgmt basically ruled out the possibility of share buyback in response to analyst question
- Amuvatinib preparing to go into p2. Inhibits DNA double strand break repair and synergizes with chemotherapy. ~200 pts dosed so far. 21 pts in first stage of p2 POC, then potentially 29 more
- SGI-110 dose escalation trial- 5 daily doses or weekly dosing on 28 day cycle. Then a dose expansion component in AML and MDS pts, hope for data later in 2011
- Amuvatinib evaluated in over 180 pts so far
- p2 trial will involve 10 centers and initiate 1h2011 (timeline slipped again)
- PIM kinase program- hopeful for next candidate "sometime in the future"
- Expect 2010 net income in the range of $11-12m
- No drugs approved for AML- Eisai will file 1q2011 in US and $JNJ will file "this year"
- Meeting presentation of elderly AML dacogen data sometime in 2011
- 2010 net income $16.3m, over $120m cash on hand at year-end
- "Our financial profile clearly permits us to consider opportunities to acquire assets that are expected to be accretive"
- "We do not expect to raise money in 2011"
- 2010 worldwide hypomethylator market >$900m, growing at 10% annual rate
- $52.5m Dacogen royalties in 2010
- Elderly AML data will be presented at major medical conference in 2011
- Amuvatinib p2 SCLC trial will start 1h2011. Abstract submitted to present final p1b data at ASCO
- GSK continue to "progress satisfactorily"
- 2011 Forecast: Dacogen royalties flat to up 5%, range $52-55m, R&D expenses $29-32m, G&A ~$10m, net income <$14m
- Will host analyst day in April
- Q&A session:
- Will not start another amuvatinib trial before readout of SCLC trial (how much less enthusiastic could they act towards this glacially moving program?)
- Will discuss preclinical programs (epigenetics, cancer metabolism, PIM kinase)
- During 2010 increased headcount ~80 to >95, mostly in R&D
- US market share 60% by sales to Vidaza, 40% Dacogen
- "Continues to be good publication and activity of physicians" for dacogen in AML
- Generally a 2% price increase twice a year
- Most of market growth is outside US- especially by Vidaza in EU, harder to get visibility into sales penetration in recently-approved markets
- analyst introduction: 8 ongoing cancer trials (I'm not sure how they get to this number)
- amu entering p2 trial shortly "this year" (I still see this getting delayed yet again or perhaps killed right after the Astex merger is approved before starting the trial-something is up or it wouldn't take so long to start a 21 pt trial)
- 2 phase 2 POC readouts 2012- amu and sgi110
- goal is to close Astex merger early july
- >180 pts amuv so far
- later said amu trial to initiate in the 2nd qtr w/ 10 ctrs. high hurdle to move to 2nd stage...mentioned again they are disciplined and will quickly kill un-promising drugs
- SGI110: phase 1 portion of trial will compare two dosing schemes: regimen 1- days subq days 1-5 of 28 d VS weekly sc 3/4 weeks in 28 day cycle. Pick one for p2 component in tx-naive pts
- 1st gen hypomethylators- halflife too short for solid tumors
- discovery program mentioned were pim and axl kinases
- 60.36m shares, 11.13m options. 71.49 fully diluted
- 2011 net income 10.9-11.4m guidance
- astex ecpt to bring in >50m in time that need to pay 30m
- amuv data accepted for presentation at asco 2011
- will not raise money in 2011
- eAML filings in US and EU 2011 (Still no explanation for why Eisai did not file in first qtr as per guidance), here about approval 2012
- Will present at Noble Financial Capital Markets conference 5/17
- Annual shareholders mtg will be held in June
- ~$130m cash balance 3/31/11
- Amuvatinib p2 trial will start within this qtr- named "ESCAPE"
- Expect filings this year for elderly AML in US and EU. Final data at "ucoming mtg" [weird that they did not specify ASCO because the presentation titles have been announced as I posted earlier]
- SGI110 p2 data will be available in 2012
- Final p1b data for combo study of 5x chemotherapies with amuvatinib at ASCO [click the above link for this presentation details too]
- ye2010 Astex had $28m US on hand
- $1.3m astex transaction and $0.7m stock based compensation (more than double same period last year) in 1q11
- 3/31/11 71.9m fully diluted shares. 60.4m shares outstanding and 11.5m options, no warrants
- q&a session:
- worldwide hypomethylator mkt just shy of $1b annually, growing 5-10%. In US 40% dacogen mkt share, this has been relatively stable
- GSK epigenetics collaboration- making alot of progress. hard to predict synergy w/ astex discovery platform.
- $2.5-3m transaction costs for merger. bulk of which will be in 1h2011. "saved shareholders a lot of money by not hiring an investment bank"
- Focused on amuv and 110 and considering combined portifolio after closing- didn't want to comment on next IND candidate...said each company have early stage mol's with potential, but no definite decision. mentioned pim and axl kinase inhibitors (running neck and neck...these are likely candidates in the near future)