- 1q11 net sales $247m, revenue to MNTA of $76m (profit 68%, slightly below 4q10 due to product mix)
- some sales in 1q11 due to instocking by 2 significant new customers (not quantified and no future guidance provided by $NVS)
- limited opportunity for nearterm increase in market share b/c they are supply constrained
- "doing all we can to make sure that m356 review proceeds as quickly as posisble. believe approvable as 505j"
- 10's of thousands of patients are on copaxone at avg cost of >$40k per year
- new oral products will impact copaxone sales to some degree in coming yrs, but will remain a significant franchise
- not sure if further word from judge re markman hearing before start of trial 9/2011
- develop IP to protect MNTA's interchangable biologics as well
- FDA: clinical requirements for FOB candidates "will be infleunced by the degree of and sophistication of analytic and process controls used by applicants"
- fda will issue some form of guidance on FOBs by ye11
- MNTA has increased funding for FOB programs and advanced pipeline accordingly. partnership may allow to expand portfoilo.
- can advance FOB drugs thru early trials before partnering to capture more value in partnerships
- "some positive discussions" re m118. if can partner and return to clinic, offers upside
- preparing IND for m402
- investing in novel drug research- hope for multiple new candidates in next year
- Lovenox approval has given MNTA increasing visibility and standing in pharma community-- may set stage for transformative partnership on FOBs
- still have >$200m NOLs remaining
- receiveable at 3/31 is $76m
- Q&A session:
- FOB filing would not occur in 2011 (duh). moving forward rapidly now
- Could an initial FDA application be done by MNTA alone? possible, but goal is to bring in partnership
- m118 still say need partner for p3 trials. finding some receptive discussions. Companies were interested in the science during the first round of talks, but were not bringing in new products (ongoing merger issues, etc). There is a new interest to link hospital injectable to new oral products. plus clinical failures in space. But premature to say that have partnership in hand.
- Is fda guidance a rate limiting step for TOB program? think the FDA guidance this year will be pretty general...don't have high hopes that it will completely define pathway. not rate limiting, think they have the technology need to do pgms and get partner, but does impact review once submit to fda. believe trials will be required at least at first, may get to 505j type pathway eventually. if provide right data, can limit scope of needed trials- confirmatory rather than primary data and allow substituible generic approval
- m-enox capacity- we should assume that they are at max for the time being. buying more heparin won't help, is matter of steel, tanks, etc. can tweak but no new large capaitcity online in forseeable future. if became aware of teva setback, that could cause them to be more aggressive..."don't thinkg teva will give that degree of clarity" [everyone got a good laugh]
- patent settlement evironment- would only discucss philosophically. any deal has to be proconsumer and pro-competition. most settlements have the company continue w/ its generic application
- Will need to bring FOB products forward more in development to command deal with enox/copaxone like economics
- confident that they do not violate teva 2020 marker patents. won't comment on if changed in regulatory filings
- no guidance on approval timeline. pleased w/ how proceeding. dealing w/ backlog issues faced by all generic industry
- fda has prioritized applicatons for generics where there are not any on the market
- copaxone ANDA accepted for review 7/2008.