- we have now built a dedicated FUSILEV sales force w/ 40 reps, calling on oncologists specializing in CRC (sharp contrast to generic - no promotion effort). current shortage is accelerating uptake. now 15-20% market share (expect continued growth). sales do not depend of shortage. fusilev has own unique j code for reimbursement, unlike generic. we plan additional fusilev studies, including in acute lymphoblastic leukemia. strong patent protection in US, important revenue stream for the next 10 years
- ZEVALIN- $24m sales first 9 months, basically tracking last years sales, believe we can meaningfully increase in coming years. announced today that we are "set to reposition zevalin in marketplace" rebranding (to be led by AMGN and PFE veteran who led lunesta program) to be unveiled at ASH annual meeting Dec 10-13. There is disconnect between impressive response data and use by clinicans. we will address that in coming months [we've heard this before]...address physicians, pts, payers. expanded clinical development (aggressive lymphoma indications including large b cell) and MA programs. 7 ASH abstracts, 6 oral. including single dose of zevalin vs 2 year of rityuxan maintenance (randomized phase 2), which will be the basis for phase 3 trial. We have been breaking barriers since acquired the drug, elimination of bioscan requirement (11/20 PDUFA), unique opportunity to reposition in marketplace. pharmacoeconomic study ongoing - believe will supoort preferential positioning over rituxan maintenance.
- We will direct fusiled profits to help zevalin and other pipeline programs build shareholder value without having to raise capital
- 2 NDA filings within next 12 months
- apaziquone, if approved would be the only agent in superfiical bladder cancer - expect rapid adoption. significant milestones from partners
- belinostat - synergistic target markets to zevalin
when would fusilev stuides start? would this be registrational? look for indications where generic is commonly used, believe we would be better. Examples: pediatric and adult ALL (methotrexate followed by leucovorin), start at some point in 2012. Would be exploratory study to determine signal
zevalin new registrational trial timing? early 2012 (maybe late 2011) Will be registitrational type trial, randomized zevalin vs observation [SOC] (after RCHOP response)...200 pts per arm, take 2 years to accrue, about 2 years folowup, so 4-5 yrs total to complete.
bioscan related to relaunch of zevalin? no details now, just highlights. PDUFA date is "tailwind to repositioning", which will go on regardless. one dose zevalin gets same results as 2 yrs continueous tx on rituximab. means more freedom for patient...value proposition intact w/ or w/o positive FDA approval decision
pricing strategy? we were hoping for price increases? We are a very socially responsible company [LOL]. We have not taken any increases up until now, but would consider increase after bioscan removal (which costs $3500 to healthcare system)
$200m in bank, what is plans/acquisitions philosophy? We want to build SPPI to a company with $0.5-1b sales, we have no discovery operations, so have to pay for new assets. no fundraising needed for day to day operation
apaziquone and belinostat - when will we get pivotal data? apaz data could be available by midyear 2012. belinostat - not until all patients meet final outcome, could be 3q2012 but can't be sure. We will file both, or at least start rolling NDA process in 2012 [big difference, as I have been saying, with regards to belinostat NDA and PDUFA timing]
Fusilev is at $164m annual run rate...you had talked about $180m in europe sales...what do estimate peak sales at? this is why i don't like to give forward guidance, I've been wrong (fusilev better than expected, zevalin worse). $180m figure includes pricing controls, no shortage of generics, availability of many drugs. US is a different situation, possibility to increase prices. if we got 100% of market, we would get $800m-$1b in sales. It would be easy to get $300-400m, though not in the next year
sales: are they reorders vs new acccounts? hard to give that info, we have been very busy trying to open accounts, signing up longterm contracts. now penetrating tier 2 community doctors with 40 reps after starting with the big players. It will be another quarter or 2 before more isnight.
Fusilev shortage status- we are getting differing reports? we know only what you know. have heard it is abating. increased manufacturing and importing product.
Did sales effort shift from fusilev to zevalin cause dip? i would like to describe it as flat, can't look at quarterly [why not?] have to have gammacamera, oncolgist plus nuclear medicine. still expect continued slow pace of growth. but how many drugs w/ 93% RR?
Will there be an increase in sales personnel for rebranding? our plan is not to increase salesforce. first direct efforts to payer and patient education. 250 doctors prescribe the drugs. We can easily double and triple sales with same size force
any communication with fda re PDUFA? routine things go on, nothing specific i can point to.
sNDA with oral formulation? I wouldn't predict this but both apaziquone and belinostat have possibility of being on market in 2014
apaziquone status in japan and korea? have started some trials in japan at this time.
will there be a gap in revenue during rebranding? need to rework reimbursement? if bioscan removed, whole new package insert (now must do a test dose with indium 111, scan, wait 48 hrs, scan again). certainly there will be transition time, but I can't predict that. we expect a slow ramp up again. we don't expect any changes or additional work from last several quarters
breakdown between large vs community buyers? we ship thru distribution, right now can see if go to large institution, don't have further insight. 80% of business is with community, 20% hopsitals via sales force. think hospitals will switch more quickly.
capital allocation decisions? continue share buybacks or just response to recent weakness? plan is to continue buying (one way of using the $200m cash in bank)
additional sales and marketing for apaziquone and belinostat in the next 2 yrs? we are looking at higher 2012-2013 expenses, but there will be new revenue too. We don't use CROs - 1/3 to 1/5 cost and faster. can start/stop/slowdown any project at any time.
cost of bladder cancer launch? $50/100/150m? Allergan AGN pays 65% r&d, then launch/market 50/50 split. Belinostat very synergistic to zevalin sales force (hematology/oncology target same doctors with same salepeople), so far less cost vs if it was first drug. can't give precise dollars and cents at this time, but let's keep talking offline.