Replies to post #146404 on Biotech Values

[pcrutch]

Actually the CRL is much worse because of the following paragraph that HALO gave. All of their programs are on hold now.

Halozyme has been in contact with the Center for Drug Evaluation and Research (CDER) regarding the impact on Hylenex® recombinant (hyaluronidase human injection). CDER is the division of FDA regulating the other investigational rHuPH20 programs, including insulin and PEGPH20. After reviewing the data, CDER has confirmed that there is no need for actions against Hylenex or clinical programs in the Hylenex IND.

http://finance.yahoo.com/news/halozyme-confirms-baxter-received-complete-200500804.html

[dav1234]

HALO -54% a/h

[jq1234]

It might be over reaction. I'll listen to the conference call later to get more information. It depends on where it is tomorrow, I might be a buyer here. It is not new recombinant enzyme can produce non-neutralizing antibodies, some might be neutralizing antibody, at least initially in many patients. The question is what percentage of patients do, and whether those who do result in any adverse reaction, and whether they continue to develop antibody after long term use.

For example, Cerezyme, a recombinant enzyme, 15% patients develop antibody within the first year, mostly within 6 months, but rarely after one year. Half of those who do develop antibody tend to have hypersensitivity symptoms. But for rHuPH20, according to PR, it seems there is no known AE. To me, FDA is cautious here to figure out long term effect, I think mainly due to rHuPH20 isn't therapeutic by itself, rather just convenience, unlike other approved therapeutic enzymes.