Biotech Values

[ThomasS]

MNTA: Further color from the Stanford Webcast:
M-Enoxaparin
Still confident of the literature and MNTA's characterization of the molecule, will not give FDA blow-by-blow updates to investors... waiting for a final FDA pathway to discuss with investors.
Expect 2-3 months away from the patent resolution based on the Jan 8 Appeals Court; the 180-day exclusivity clock starts upon issuance of the Court's ruling (if patent invalidated).
"Potentially on the market in the 2008 timeframe"

Called the current pps a very good investment opportunity in MNTA and a "call option on the Enoxaparin ANDA"

Citizen's Petition from Sanofi: They believe the petition helped their case, and, they in fact support it.

FoB Program candidates are still totally free for partnering.

M-118
Complete M-118 PIIa trial and make data available in the "second half of the year."
Commence 2 planned PIIb M-118 studies in 2H 2008 (medical management of unstable angina PCI)
Confirmed active partnering discussions for M-118 for partnering after PIIa with "appropriate Pharmaceutical partners." --IMO, this could be big news if/when it occurs, due to the potential market size.

Cash burn guidance is $55-60M in 2008

Advance generic Copaxone program toward FDA filing; will not discuss timelines further due to competitive concerns
(stated want to be first-to-file, obviously). Believe their characterization tech is necessary for this complex molecule.
Litigation regarding Copaxone patents will be paid by Sandoz, if necessary (2014 patent expiration)

Seemed excited by the Oncology candidate; moving towards clinical studies in support of an IND. "Could provide some interesting news over the next couple of years."

Good discussion of FoB pathway in EMEA and M-Enoxaparin filing in EMEA (as a biosimiliar).