Halozyme Therapeutics Inc (HALO)

[friendofthedevil]

Perspective.

While there is little doubt this petition comes from parties interested in limiting HyQvia's market, I'm not sure these proposed warnings would dissuade use at all. Even if the FDA were to adopt the petition's language, word for word, the black box part of the label would be lost in all the black ink already draped across these products. Have a look at the labels as they are now:

http://labeling.cslbehring.com/PI/US/Privigen/EN/Privigen-Prescribing-Information.pdf

http://www.grifols-pi.info/inserts/gamunex.pdf

http://www.baxter.com/products/biopharmaceuticals/downloads/gamliquid_PI.pdf

Physicians are used to black box warnings and the local thought-leading immunologist or expert in the field will have discussed the use of the new HyQvia at some Medical Conference or Scientific Meeting and will feel comfortable with the new risks (as they feel comfortable with the current risks outlined above).

HyQvia wasn't going to take this market by storm right away regardless. Baxter doesn't have enough IgG product to expand very rapidly and the real ramp-up was always going to be in a couple of years. By then, I would think any theoretical doubts about fertility and fecundity would be fading.

I do think, though, the label here will affect the conversation about chronic use with insulin. It should have NO effect on future use with chemo eg: I think the US use of ph20 with Roche/Genentech products is only a matter of time.