Replies to post #113145 on Biotech Values

[DewDiligence]

Goldman Sachs just issued a report saying that the non-approval MNTA received in Nov 2007 relating to Lovenox immunogenicity was a Minor Deficiency letter. This is contrary to my understanding of what happened, but I thought it was worth mentioning.

[dewophile]

re immunogenicity

MNTA and TEVA - I think the general consensus on the board was that impurities (and associated consequences like immunologenicity) were likely to be one of the hang-ups in the Teva ANDA. And per the list provided by HPT that would fall under Major Deficiency:


Quote:
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Responses to the following examples of deficiencies would result in a major amendment. This should not be considered an all-inclusive listing.

1. Manufacture of a new batch of drug product (with supporting information) for any reason; for example:

• Composition change or reformulation

• Change in the source of a drug substance

• Change in manufacturing site

• Need for a new bioequivalence study (21 CFR 320.21)

• New in vitro study for a specific product (e.g., metered dose inhalers)

• Change in major manufacturing process

• New strength of the product

• Unacceptable impurities or impurity levels (21 CFR 314.94(a)(9))

• Unacceptable excipients found during the review (21 CFR 314.94(a)(9))
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i'm not so sure i agree clark. if you recall amphastar stated in their lawsuit they got their level of impurity down to very low level but still faced immunogenicity hurdle. i stated on this board that i think teva likely did too, but that the more significant immunogenicity hurdle was that related to the innate immunogenicity of the product itself (e.g. Abs to PD4)