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Halozyme Therapeutics, Inc. Message Board

  • afriendofthedevilsafriendofmine afriendofthedevilsafriendofmine Nov 6, 2013 2:49 PM Flag

    ViroPharma - moving on

    Not news but from SA:

    ViroPharma is not sitting idly by while competitors attempt to encroach on Cinryze's market share. The company is moving forward with SC Cinryze, despite a setback in its subcutaneous partnership with Halozyme Therapeutics (HALO).

    On August 1, in conjunction with its Q2 results, ViroPharma announced that it was discontinuing the Phase II trial (and overall development) of subcutaneous Cinryze with Halozyme's rHuPH20 technology. However, after observing an "unexpected increase and titer of non-neutralizing anti-rHuPH20 antibodies," ViroPharma, in conjunction with the FDA, halted the study (we note that no adverse events were recorded in relation to these antibodies). Shares of ViroPharma fell on this news, as some investors believed that the company would have to start from scratch on a subcutaneous version of Cinryze. However, ViroPharma disclosed that it had been developing a backup, low-volume formulation of Cinryze parallel to its work with Halozyme, and that it would be moving this formulation forward. On its Q3 earnings call, the company provided more detail on its new timeline for SC Cinryze. ViroPharma expects to begin Phase III trials of its new formulation SC Cinryze in mid-2014, pending the outcome of its end-of-Phase II meeting with the FDA in early 2014. In its latest 10-Q, the company also noted that, "we currently expect our Phase 3 study with the low volume subcutaneous formulation will initiate in mid-2014, and that the study would be conducted during approximately the same timeframe that we anticipated for the rHuPH20 combination product." Ultimately, we believe that the rHuPH20 issue will be immaterial in the long run, as the new version of SC Cinryze has the potential to be released within the company's previous timeline, thereby giving ViroPharma a better opportunity to further defend itself against potential future completion in the prophylactic HAE market.

9.07-0.01(-0.11%)Jul 22 4:00 PMEDT

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