Biotech Values

[ThomasS]

MNTA: I'd imagine it goes like this (this post is not directed towards you):

1. Identify lucrative, branded biologic to be copied with near-term patent expiration (0-4) years out.
2. Establish methods of copy
3. Copy biologic, achieving sameness
4. Refine analytics and manufacturing processes to ensure sameness of bulk product
5. Determine Regulator(s) requirements for establishing sameness, manufacturing criteria, etc.
6. Make step #4 = #5
7. Submit application(s) to Regulator(s)
*8. Await innovator lawsuits

* If Teva/SNY-like innovators involved

Considering the lead time and expense required for steps 1-4, why would MNTA (or any competent entity) wait for step 5 to appear in granite? My guess is that MNTA is well along steps 1-3 for several molecules. Upon achieving step 5, they could then partner with a deep-pocketed Pharma for further action, such as clinical trials for step 6 or regulatory/legal/muscle assistance for steps 7&8. Essentially, they did this with Sandoz.