Replies to post #133603 on Biotech Values

[mcbio]

Other than specific detail on the up-front, it's a pretty vague PR. I would love to have some idea on what kind of royalties MNTA will be entitled to down the road. Are we talking 50/50 split, something in the 20-30% range, 10-20% range, or what? Also, given that this deal only includes up to 6 FoBs, this presumably leaves the door open for MNTA to ink additional FoB deals.

[orangeone]

Sounds like it amounts to MNTA providing analytical services to Baxter. Amounts seem in line with early stage research assets?

[hptaxis]

[DewDiligence]

EMA will issue additional FoB regs in next few months:

http://www.reuters.com/article/2012/01/06/us-medicines-biosimilars-idUSTRE8050ZQ20120106

Guido Rasi, the new executive director of the European Medicines Agency (EMA), told Reuters on Friday the London-based watchdog would issue its final guideline on biosimilar monoclonal antibodies in March or April.

Draft guidelines on the approval process for copies of other drugs will follow in May or June. These will include low molecular weight heparin, such as Sanofi's Lovenox or enoxaparin, and modern analogues of insulin.

However, NVS and MNTA have said that they no interest in a Lovenox FoB for the EU because the prevailing price is too low.

[DewDiligence]

MNTA/BAX—Identities and patent-expiration dates for M923 & M834:

Although BAX and MNTA have not divulged the identifies of the first two FoB’s in the companies’ collaboration, my guesses (from patent applications and offhand webcast comments) are that M923 and M834 are Humira and Orencia (or vice-versa).

Humira goes off-patent in the US in late 2016; Orencia goes off-patent in the US in 2019.

Craig Wheeler has stated that BAX/MNTA will disclose the identity of each FoB in the collaboration when it begins a phase-1 clinical trial. For M923 (the first compound in the collaboration), this disclosure should come in 2014.

[DewDiligence]

BAX/MNTA FoB collaboration: MNTA has the contractual right to opt for profit and expense sharing (rather than receiving royalties on sales) for compounds #3, #4, #5, and #6 when the US IND is filed for compound #3. (Compound #3 in this context means the replacement for M511, which MNTA is now developing on its own.)