Biotech Values

[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.