Momenta Pharmaceuticals, Inc. (MNTA)

[Goo111]

This is not a question of how Copaxone is regulated, rather a question of how Copaxone will be regulated (see slide 18 below). I think Copaxone is unaffected, but I'm confused about the slides...

Slide 17.

Expanded Scope of a Biological Product

Protein Definition
– Any alpha amino polymer with a specific defined sequence that is greater than 40 amino acids in size.

Chemically synthesized polypeptide definition
–Any alpha amino acid polymer that (1) is made entirely by chemical synthesis; and (2) is less than 100 amino acids in size

Slide 18.

As of March 23, 2020, an application for a biological product approved under section 505 of the FD&C Act will be deemed a biologics license application (“BLA”) licensed under section 351 of the PHS Act.



Slide 21 also has some "first-to-be-approved" exclusivity remarks that I haven't thought about yet...

Exclusivity

1st Interchangeable Product
– The 1st biological product to be licensed as interchangeable is granted a period of exclusivity.
– During the exclusivity period, a subsequent biological product relying on the same reference product cannot be licensed as interchangeable.
–Exclusivity calculus is based on date of approval, date of first commercial marketing, and patent litigation milestones.