Replies to post #145675 on Biotech Values

[DewDiligence]

If IVIG works [for AD] what would other immunoglobulin makers need to do to get approved. Would they need full efficacy studies in the patient population? That would still give Baxter a pretty big head start (though capacity will be an issue).

If IVIG pans out in AD, the situation will be a colossal mess; here are some predictions:

• All of the plasma-protein companies will be swamped with demand for IVIG and will be unable to keep up.

• Docs will prescribe whatever brand of IVIG they can get insofar as they are basically fungible.

• BAX’s “use” patents for treating AD will be of little value, IMO.

• The price of IVIG will surely go up unless the government steps in and imposes a freeze.

• The big losers will be the patients who currently use IVIG for generalized immunodeficiency and will have trouble obtaining enough product.

In short, this will be like nothing we have ever seen before in the history of the drug/biotech industry.

[DewDiligence]

BAX receives CRL on HyQ (as expected):

http://finance.yahoo.com/news/baxter-confirms-receipt-complete-response-200100862.html

The letter requested additional preclinical data to support the biologics license application. The primary issues raised in the letter focused on non-neutralizing antibodies generated against recombinant human hyaluronidase and the possible effects of these antibodies on reproduction, development and fertility. Baxter plans to file an amendment to the BLA for HyQ following additional discussions with FDA. Individuals enrolled in ongoing HyQ studies in the United States will now be treated with Baxter’s immune globulin therapy without Recombinant Human Hyaluronidase.

The last sentence sounds bearish for HyQ’s near-term approval chances.

HyQ is a formulation of Gammagard IVIG that contains HALO’s recobinant hyaluronidase to enable sub-q administration.