Halozyme Says Roche Work Unaffected by FDA Concerns over HyQ Program
(Page 2 of 2)
profitability have always been the Roche programs, given the size of the programs,” Gustafson said. He added, though, that the company plans to recalculate its projections in the fall for a meeting with analysts and investors scheduled for Oct. 2.
Until the regulatory concerns can be addressed, however, the FDA’s Center for Biologics Evaluation and Research (CBER) asked Halozyme to halt the use of its enzyme in human patients in clinical studies with Baxter and ViroPharma, a Pennsylvania pharmaceutical focused on viral diseases.
In its statement last week, Halozyme said, “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, [fetal] development, and fertility.”
Frost elaborated during the conference call, saying, the FDA was concerned about the absolute levels of antibodies seen in patient blood samples following HyQ injections. There were no signs of any type of allergic reaction, Frost said. In comparing patient blood samples taken before and after the injections, Frost said antibody levels “are orders of magnitude larger than in the general population.”
In contrast Frost said Halozyme has not seen a similar boost in antibody levels in before-and-after studies done with its proprietary drug and herceptin, Roche’s anticancer drug, or in studies that combine rHuPH20 with insulin to treat diabetes.
“There’s no adverse events that have been seen to date associated with anti-PH20 antibodies,” Frost said. “The questions [raised by] the blood products division aren’t based on any animal findings, for example, that we have with the enzyme, which include the full battery of tests, including fertility and development as well as chronic administration. However, due to the magnitude of the titers that were observed, they are essentially asking for pre-clinical safety studies to evaluate the potential risk of exposure to these antibodies in a similar battery of tests in relevant models.”
Halozyme reported a second-quarter net loss of $14 million, or 13 cents a share, compared with net income of $3.1 million, or 3 cents a share, during the second quarter of 2011. The company said second-quarter revenue amounted to $7.8million, compared to $23.2 million for the second quarter of 2011. Frost explained that most of the year-ago revenue was generated by partnership agreements signed at that time.