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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM) -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (1527)	5/14/2003 7:26:36 PM
From: software salesperson	Read Replies (2) \| Respond to of 3044

5/14/03 V conference call 1. mark levin V is for mm patients who have received 2 prior therapies and have disease progression on last therapy; will ship next week 2. david schenkein fda has requested study for previously untreated mm patients; 40 ongoing clinical trials; initiate additional p 1 studies later this year 3. ken anderson (one of the world’s leading mm experts)- - dana-farber some patients in trials had up to 15 prior therapies; expected survival was 6 months trial( presumably, summit) is important for 3 reasons: (i) extent and frequency of responses- - indicates that V is a novel agent; 59% stabilized or responded (ii) responses were durable - - statistically significant improvement in survival (iii) clinical benefit - - qol, fewer transfusions, hemoglobin rose preclinical data strongly suggests that V will be much more active when used earlier in disease cycle. he PREDICTS that response rates will be twice as high. In combo therapy, preclinical data PREDICTS additive and synergistic activity, with doxil, for example side effects of thrombocytopenia and neuropathy - - majority of patients had them before they entered trial. 39 patients did not have neuropathy before entering trial and only 1 of those developed grade 3 neuropathy (the implication was that the neuropathy has been overblown by the analyst community; didn’t say anything about thrombocytopenia) he expects that when they study those patients earlier in the disease course who do not have these complications, they will see far fewer of these side effects 4. vaughan kailian 15,000 new cases diagnosed this year in US; relapsed and refractory = 25% X 45,000 patients 75 oncology sales and support staff, averaging 5-7 yrs. pharma sales experience various reimbursement initiatives; securing medicare codes 5. mark levin average course of therapy = $ 20,000 no updated sales estimates 6. q & a (i) to dr. Anderson: how will you use drug? - - relapsed and refractory disease as per label; there will be off-label use (ii) to dr. Anderson : how many patients will be on it in a month? - - no direct answer (iii) breakdown of target market? - - 60% medicare; 28 % hmo; < 10% Medicaid; remainder, self-insured or uninsured (iv) update on label extension to 1st line usage? - - apex in 1-3 prior therapies; will also design study, in combo and standalone, in newly diagnosed mm patients (v) solid tumor update? are you confident that it has similar mechanism of action ?- - no direct answer (vi) codes status? - - need j and c code; until granted, will use misc. code (vii) how much does mlnm receive per treatment course ? - - 20,000 less trade discount (viii) how long does it take for physician to be reimbursed? - - mlnm has set up a program such that physicians are not disadvantaged until they get reimbursed (ix) compendium listing? - - as trial results are published, compendia will be updated; there will be reimbursement for those indications where mlnm has sufficient evidence (x) apex enrollment update? - - complete enrollment by year-end (xi) when newly diagnosed trail to begin? - - still talking with fda (xii) nf-kappa b patent dispute between aria and lly? - - mlnm is confident that mlnm patent position is unassailable (xiii) peak sales ? - - have an undisclosed penetration rate (xiv) T competition? - - don’t see T as a competitor (xv) update on partnership? - - by end of this q (xvi) will V be trackable by ims? - - yes (xvii) to dr. Anderson: will V be used in frontline therapy right away? - - use as frontline therapy will be done in the context of clinical trials (xviii) to dr. anderson: will T patients be switched right away? - - in trial, 83% failed T; T works 30% of time in relapsed and refractory; T works better earlier (xix) will patients in expanded access program be converted to paying customers? - - yes; unsure, the # of patients involved (xx) for dr. Anderson: our physician surveys in 2003 show that 1/3 will use V. is that reasonable? - - no direct answer (xxi) if solid tumors are successful, will supply be an issue? (??)- - no (xxii) V pricing vs. T pricing? - - T pricing depends on duration of treatment; ask celgene ( good vaughan !) (xxiii) european approval update? - - typically lasts a year; expects action next year (xxiv) to dr. Anderson: why would you take responding patients off V? - - anecdotally, complete responders have been taken off for over a year (xxv) how will V safety compare to T in frontline therapy? - - no direct answer (xxvi) will approval affect enrollment in apex study in US? - - this point has been anticipated; mlnm has significantly increased # of sites outside of US (xxvii) to dr. Anderson: please speculate as to how the paradigm for stem cell transplants will likely change as 2nd line therapy? - - V will be used earlier with a higher response rate; role of transplant will change to secondary role (xxviii) since average patient will only use 2/3 vial, will you reuse vials? (??)-- - no ( I have a question: does a financial institution actually pay this guy a salary ?) (xxix) is it reasonable to assume a longer ttp and more infusion than in p 2 trial since the label population and the trial population are different? - - no direct answer 7. impressions a spectacular call. flawless execution, which makes it easy to see why V sailed through the fda. clearly, the star of the call was Dr. Anderson, who answered every question with equanimity and class. he used “expect”, “predict”, “suggest’ and “strongly suggest” in a precise, deliberate way ( which would make any, former, contemporary analytic philosopher smile, as well as mlnm mgmt) . also, he does not get drawn into analyst speculation, unless he labels it as such. the analyst community believes that a V deal alone is coming. it’s my judgment that the deal will be for the entire oncology franchise. So the deal will likely be greater than the analysts are expecting. a special congratulations to julian. sales