Summary of BSC presentation from anonymous Yahoo poster:
TLRK Sept 9 webcast notes-Part I
by: mewatsonx 09/09/03 05:52 pm
Msg: 1167 of 1169
From today's Bear Stearns Healthcare Conference presentation (note: I missed the first few minutes of the broadcast, and a few in the middle) --
I'll put the BLOCKBUSTER statement first. This is an EXACT QUOTE:
1) "... and we're looking forward to doing additional deals of the magnitude of the Amgen deal; one more by the end of the year, and another one in the first half of next year,
and these discussions are ongoing and active now." If that doesn't make you giggle like a school girl with an anatomically correct Ken doll -- heaven help you! *L*
2) T67 - Now enrolling pivotal Phase 3 trial for HCC. Will give an update at year end on enrollment and when we might expect the 100 patient interim analysis by the Data Safety Monitoring Board. T67 binds tubulin, same as Taxol. HCC is one of the most common cancers, and THE most common in some Asian countries. No approved chemo agents for it. Doxorubicin is the only standard-of-care
chemo agent. It has minimal efficacy, lousy side effects, NO indication of survival benefits, and its use is based on studies conducted in the 1970s. T67's side effect profile is UNUSUALLY GOOD for chemo agents in general; confident it is superior to doxo.
Phase 2 study results: Partial response rate of about 10 percent. Stable disease rate of 40%. Significant reductions in alpha-feta protein (which is a good marker for efficacy in HCC). 70% of stable disease patients lived more than 3 1/2 months, out to about 1 year.
The figure given for doxo was unclear to me, he said something like 50% survival to 6 months -- I'd really like to get a clarification of the relative survival statistics because this is critical.
Single digit incidence of myelosuppression - none at Grade 4.
3) T607 - will complete enrollment in all FOUR phase 2 trials (four different tumor types) this year, "and early next year
be at a decision-making point for T607."
4) T487 - for inflammatory disease - will initiate phase 2 proof-of-concept psoriasis study this year, and a P2 POC rheumatic arthritis study Q1 next year. Both trials: will enroll about 40 patients, moderate to severe disease, versus placebo, once daily dosing for 28 days. When discussing psoriasis, mentioned they are confident T487 will not lead to the immune suppression found with other agents.
5) T131 for type 2 diabetes - binds the PPAR-gamma target quite differently from Actos and Avandia - hence the absence of their classic side effects. More potent at glucose reduction. Phase 1 study showed no clinically significant side effects via lab tests. Study participants were healthy - experienced no reduction in glucose (this is the DESIRED result in normal subjects). Dosing is once daily. Upregulated adiponectin is believed to be a marker for efficacy - it WAS increased by T131. The Phase 2 trial -
non-severe diabetics, versus placebo, 28 days,
not on alternate therapy and having failed diet and exercise therapy. Multiple endpoints:
insulin level, glucose level, hemoglobin A1-C,
lipids, adiponectin. Trial starts BEFORE THE END OF THE YEAR.
(continued...)
TLRK Sept 9 webcast notes-Part II
by: mewatsonx 09/09/03 05:54 pm
Msg: 1168 of 1169
(...continued)
TWO ONGOING DEVELOPMENT DEALS PREVIOUSLY SIGNED:
6) A phase 1 trial with Merck for an HIV integrase inhibitor. (NOTE: This is a replication enzyme, like protease and reverse transcriptase. I believe there are no HIV drugs in this class on the market yet.)
7) A phase 1 trial has been COMPLETED by Lilly
for a factor 10A inhibitor. Planning to move to phase 2 rapidly in the coming months.
For treatment of deep vein thrombosis, pulmonary embolism, etc. Could compete with heparin for acute use, and warfarin for chronic use.
With BOTH deals, TLRK gets milestone payments and royalties.
8) Financial estimates: 25-30M revenues this year; 90M burn; have about 2 years worth of cash without additional partnerships.
9) The Amgen deal - will get 125M, plus up to
21M for each selected oncology target, plus a good royalty stream (would LOVE to know what the royalty stream is...). And, of course, Amgen bought a load of TLRK shares. SOME OF THE TARGETS HAVE ALREADY BEEN SELECTED AND WORK ON THEM IS ONGOING.
10) They have discovered plenty of disease targets to allow them to license some, and develop others on their own, retaining all rights. I've found that this is a recurring theme - they keep emphasizing that they are going to keep some of the drug development inhouse.
11) Expect 1-2 INDs per year, ALL WITH POTENTIAL BILLION DOLLAR MARKETS.
Well, folks, if I've messed any of this up, please let me know. I'd say it was a very exciting presentation. Statement #1 (above) is
the one that hit me in the gut. It's a helluva
comment, if true (can't shake memories of
Enron...you know?)
Cheers.
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