Replies to post #106785 on Biotech Values

[acgood]

was TEVA's ANDA for lovenox also submitted in 2005?

[HattieTheWitch]

Dew, do you anticipate that NVS's earnings will be released before market open, or after the close?

Another question if I may, am I reading right that the conference call is tomorrow morning?

Thank you.

[DewDiligence]

MNTA 2010-2011 News Flow

[Removed entry for NVS’ 3Q10 financial report, which has already occurred.]


Lovenox

• 1-Nov-2010: MNTA’s 3Q10 financial results and conference call. The revenue line in MNTA’s income statement and the discussion on the CC will shed some light on the profit margin of generic Lovenox and the resulting cash-flow projections for MNTA during the next few quarters. (We already know from NVS’ 3Q10 financials that generic Lovenox is selling at roughly a $1.1B annualized rate: #msg-55778832.)


Copaxone

• Timing uncertain: Scheduling of trial on Copaxone patents.

• Timing uncertain: FDA feedback on the Copaxone ANDA. MNTA would presumably disclose these details only if they were deemed to have a material affect on the probability or timing of eventual FDA approval.

• Feb 2011: Expiration of 30-month Hatch-Waxman stay pertaining to NVS/MNTA’s Copaxone ANDA. Unless there’s a non-appealable judgment in the patent case before this date, Feb 2011 is the soonest MNTA/NVS could obtain final FDA approval to market generic Copaxone.


M118

• Timing uncertain: M118 partnership followed by start of phase-2b trials. (Phase-2b trials in ACS are sufficiently large and expensive that MNTA will almost certainly not conduct such trials without a partner: #msg-41897705.)


Other programs

• 1H11: IND filing for M402, MNTA’s proprietary heparin-based cancer drug, followed by the start of a phase-1 trial.

• Timing uncertain: One or more FoB partnerships.