Blog Archives

Cubist Pharma $CBST 2q2011 earnings conference call notes

7/31/2011

0 Comments

This is the first in a series on blog posts providing notes and analysis from the earnings conference calls of the "Big Pharma" (term defined very loosely) partners of the stocks I cover here at BiotechDueDiligence.
Cubist is partnered with Alnylam for an RNAI program against Respiratory Syncytial Civrus (RSV) - get full details at the ALNY research page.
Cubist is co-promoting the antibiotic Dificid (fidaxomycin) with Optimer Pharma - get full details on the OPTR research page.
Click here to access the CBST conference call transcript via Morningstar.
See below the jump for excerpts and notes:

0 Comments

Adolor $ADLR 2q2011 earnings conference call notes

7/31/2011

0 Comments

ADLR released 2q2011 earnings on 7/27/2011- click here for the press release.
For complete background due diligence on Adolor, visit the ADLR research page.
See below the jump for my notes from the conference call:

0 Comments

Archive: Myrexis $MYRX webcast notes

7/27/2011

1 Comment

I am working on updating the Myrexis $MYRX Research page. Below you'll find webcast notes that did not make it onto the blog previously.
Note that Rodman and Renshaw also initiated coverage of $MYRX today with a $6 price target. At last check MYRX was up about 5% on this news in a very weak market. History would suggest that some sort of transaction will follow this coverage from R&R, likely a financing or maybe partnership for inflammation program.

Notes: 2/9/2011 Webcast

Azixa phase 2b study will use a new definition of disease progression. Old: McDonald criteria. New: RANO consortium criteria. Previously it was difficult to distinguish between progression and inflammation in glioblastoma (GBM)- now MYRX can keep pts on study for a few more cycles until can confidently tell the difference
Azixa phase 2b- will assess biomarkers in primary tumor specimens- hope to develop a diagnostic to ID biomarkers association with prognosis and response to the drug
MPC-3100 HSP 90 inhibitor- based on preclinical studies, continual, daily oral dosing is optimal- so now no holiday in the 28 day dosing cycle. Half-life in 12 hours, compatible with once or twice daily dosing
MPC3100 currently enrolling 7th cohort in phase 1 study- still no MTD, may enroll 8th cohort if necessary, will complete 1h2011. But surrogates of activity such as HSP70 levels may give an indication that it is ok to stop without further escalating. Will advance to phase 2 as soon as possible after p1 completion. Are looking at bloodstream concentration in pts, starting with 4th cohort they were at levels that corresponded to anticancer activity in vivo
MPC9528 cancer metabolism inhibitor: companion diagnostic to identify the 40% of tumors that are a good candidate for this drug due to deficiency in a single enzyme, Will use this to decrease the size and cost of clinical trials
IKKalpha program lead has picomolar activity, positive results in collagen preclinical model of rheumatoid arthritis (RA)
cash thru fiscal 2013 (June 30, 2013) without any new licenses of partnerships
Response to question from Piper Jaffrey: currently focusing partnering discussions on cancer metabolism program (9528) and IKKa program, in ongoing discussions with several parties, have term sheets. May want to develop cancer metab program further internally before partnering. Will not take IKKa program into the clinic without a partner

Notes: 4/5/2011 Needham Webcast

take compounds to POC trials as quickly as possible. active partnering disc ongoing.
azixa in avastin-naive pts data asco 2011 hopefully.
No neurotox w/ azixa in 150+ pts- peripheral or CNS
Azixa is either additive or synergistic w/ temazolomide
60-90% of stage 4 melanoma pts have metastases to brain- tends to be the life shortening event.
avastin failure 1 pt with CR- dr broke protocol to keep on trial 6 months in- wasn't convinced scans showed progression vs inflammation- stayed on 18 months and cancer free 6 months out (31 yrs old)
reduced azixa by one dose level b/c hadn't combined with radiation before (part a of new trial)- haven't seen additive tox yet, so probbably return to full dose for part b. currently enrolling only in US (pending approval to enroll in india). preliminary data hope for asco 2012
first public disclosure of mpc-3100 structure (see above)- able to prodrug this molecule-interested because it is poorly soluble, must be formulated with Captisol excipient (see $LGND page) for oral tablet (need lots of it, means large pill burden). prodrug is soluble, don't need captisol (reduce pill burden from 8 down to 1 tablet). 0767 prodrug will open IND w/ eye to substituting this in later phase clinical trials
only other oral HSP90 inhibitor also uses captisol, but is not able to be prodrug'd (not immediately sure which company's compound he was referring to)
3100: cohort 7 of phase 1 trial, no DLT yet. no hepatic or renal tox. (no mention of ocular tox yes or no) grade 1 diarrhea and nausea- handle with immodium
expect to finish p1 by middle of 2011 then move on to p2
9528 syngergy w/ PARP inhibitors, DNA damaging agents- hope to file IND later 2011
IKKepsilon is oncogene in breast cancer, also key regulator of innate immunity- program morphed from cancer to into looking at for autoimmune diseases. 100 pmolar compounds and highly selective, in process of identifying best lead for IND. don't know of anyone else with this target. have COM patents on leads
Have been able to reduce inflamm in collagen-induced RA semi-prevention model (done offsite, dosed once daily at two doses). also did once daily dosing (half life is an hour) tx of established disease- achieved stat-sig results w/ lower dose- done by potential partner and not yet allowed show data
"entirely" focused on these 4 pgms.
his obective is to change fact that MYRX has always traded at discount to net cash
initiate comparative arm phase 2 for 3100 while bringing along prodrug. perhaps swap in p3 (obviously a bit of earlier work with the new compound would have to be done to satisfy the FDA)
Would also like to look at IKK pgm in lupus but haven't yet b/c takes 7 months to establish animal
goals for 12 months-
actively enroll azixa GBM trial. advanced data asco 2012
complete 3100 p1 mid 2011, initiate comparative arm p2 while brining up proddrug to replace "lets say for a p3"
File IND for MPC9528
ID IND candidate for IKK
q&a session: no questions

1 Comment

Archive: Ligand $LGND webcast notes

7/23/2011

0 Comments

As I update the Ligand research page due to increasing investor interest and upcoming catalysts (including Promacta HCV phase 3 data and Carfilzomib NDA filing), I am posting some webcast notes that did not make it onto the blog previously.

Notes: 2/15/2011 Webcast

Rob McKay (Business Development) joined from ISIS about a year ago
19.6m shares outstanding
(Vfend tablets- Cydex got royalty- are now generic)
One approved molecular may launch over the next year or so (I think referring to Nexterone from Prism)
Promacta first approval was based on a single 6 week trial, should launch in Japan 1q2011
GSK has not said when Promacta HCV data will be released. 3q2011 date based on clinicaltrials.gov website, LGND expects data by ye2011
Promacta backup compound has 5-7 yr longer patent protection and higher royalties to LGND
SARM program goal is to be better drug that testosterone- spare adverse effects on prostate, breast, uterus
Phase1 SARM data will be released 2q2011, this is a key pivot point for partnering discussions
Muscle health is a new target of interest for pharma research focus
previous experience with SERM drugs- from partnerships with PFE and WYE, both molecules approved
Cydex captisol drug master file with FDA (DMF) saves partners 3-4 yrs of formulation work and $10-20m in expenses
Prism- launch planning is underway, could launch in 2011
Cydex has partnerships with many companies that LGND also has partnered with
Conbriza will be the 3rd legacy LGND product to garner royalty income in 2011
In 4 yrs, decreased operating expenses from $85m to $16-18m
Chart shows new potential Cydex licenses 2h2011, Cydex clopidogrel (Plavix) license 1q2011

Notes: 3/2/2011 Citi Webcast

LGND acquired three companies during recession for total of $40m, their peak valuations were $1.7B combined (Pharmacopeia, Metabasis, Neurogen)
Nexterone (from Cydex partnership with Prism) will launch within a year or so
Promacta has now received full approval from FDA- now included data from 6 month study in ITP and chronic liver data and 2 yr safety data
SARM phase 1 will complete and data released 2q2011

0 Comments

Archive: Infinity Pharma $INFI webcast notes

7/19/2011

0 Comments

I am working on updating the INFI research page, so posting to archive these Infinity Pharma webcast notes that did not make it onto the blog earlier.

Notes: 4/15/11 Biocentury future leaders webcast (no slides, no q&a)

IPI926- first ever trial in chondrosarcoma. chemo/radiation not effective. 100 pts 2:1 vs palcebo, PFS endpt
gemzar is SOC for pancreatic cancer, median survival <6 months. response rate 5-8%
dense fibrotic shell around tumor...combo with IPI926 allowed gemzar to better perfuse tumor in transgenic mouse model- doubled survival
IPI926 just completed p1b portion- 3 doses of 926 w/ std dose of gemzar (data to be presented asco 2011). 60 pts per arm p2 poriton 1:1
will announce addl p2 trials this year for IPI-926 (this was the major focus of the presentation, one slide each on other pipeline assets)
hsp90- IPI504-2 ongoing trials both in NSCLC. One is to try to replicate finding that ALK translocation pts did best in single agent. 2nd is combo with docetaxel (data presented at asco 2011 along with plans for future of this pgm)
Calistoga- delta specific PI3k inhibitor showed "stunning data." IPI-145 is 10-20x more potent for delta. and adds gamma inhibition too. lots of crosstalk between these isoforms. gamma isoform plays role in trafficing to site of inflammation
FAAH breaks down anandamide- mol produced to relieve pain.IPI- 940- blocks this enzyme, get more natural analgesia. same MOA as medical marijuana
tx this pgm differently compared to other assets, transfer to purdue now as starting p2
hsp90 pgm was partnered when the mundi/purdue partneship put into place- therefore is excluded and self-funded
sufficient cash and committed funding to drive pgms thru value inflection and into 2014

0 Comments

<<Previous

Cubist Pharma $CBST 2q2011 earnings conference call notes

Adolor $ADLR 2q2011 earnings conference call notes

Archive: Myrexis $MYRX webcast notes

Archive: Ligand $LGND webcast notes

Archive: Infinity Pharma $INFI webcast notes

Categories

Archives