Replies to post #64173 on Biotech Values

[jshaffer85]

Re: MNTA


Does the FDA's acceptance of the application as a 505(j) shed any light on how they view MNTA's technology? There are analysts out defending TEVA stating that generic Copaxone will likely fall under the new biologics legislation, implying clinical work will be necessary.

I think these analysts are underappreciating the possibility that MNTA's technology may give them a unique advantage that will avoid the need for clinical work.

Of course only time will tell but M-enoxoparin approval would be a giant step towards generic Copaxone approval.

[Biowatch]

MNTA I'm sure you meant a "complex drug," as opposed to a small protein drug, as COPAXONE is not a protein in the context of traditional biologics.

I was mixing apples with oranges in my comment, so thank you for catching my mistake. Copaxone is a mix of polypeptides, so sort of counts as a protein, but not really... :-)

When a CP gets filed, it becomes a matter of public record and published on an FDA website within a few days. The "citizen" is often a lawyer at a local firm, but who paid them to petition isn't public. What happens at the OGD is a black box, as rkrw pointed out.

[DewDiligence]

Controlled Chaos (MNTA, TEVA)

This phrase might be used to characterize the process by which Copaxone is manufactured. Teva likes to use the word random to describe the polymerization and de-polymerization of the peptide chains at each step in the manufacturing process.

However, the process is surely not random, and the use of the word random is propaganda on Teva’s part, IMO, to make it seem that replicating Copaxone is a hopeless task.

I thought Craig Wheeler did a nice job on MNTA’s CC to dispel the notion of randomness. Wheeler clarified for some of the less-than-brilliant analysts on the call that MNTA has reverse-engineered Teva’s production process. Sameness of the finished molecule is achieved by assuring sameness of the process.

It is MNTA’s proprietary informatics technology that makes such reverse engineering possible for a drug as complex as Copaxone. I doubt that any other company can do it, although some may try.


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