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Replies to post #4860 on Halozyme Therapeutics Inc (HALO)
Just wait - PFE will have their own SC version of Rivipansel in trials shortly just like Viropharma did with Cinryse.
How is CINRYZE Administered?
CINRYZE is administered by intravenous (or IV) injection, meaning it is injected into a vein in your arm. You can choose to have your injection administered by a healthcare provider or caregiver, or a healthcare provider can show you how to give it to yourself. This is called self-administration.
ViroPharma is working to expand awareness of the benefits of Cinryze relative to existing treatment options for HAE in Europe, and 2012 is not representative of Cinryze’s full potential in Europe. The company’s launch in France, Spain, and Italy has been delayed due to the macroeconomic situation in Europe, which has slowed down the setting of reimbursement rates, hence patients are reluctant to spend the money for this costly treatment. But, sales should be seen in France and Spain from the fourth quarter, and Italian sales should start in Q1 2013, as the company likely expects to gain some reimbursement traction in those markets. ViroPharma is also looking to expand the use of Cinryze here in the United States, and it is attempting to do so via a far more convenient dosing mechanism.
Cinryze is currently administered intravenously, and while it is approved for home infusion, intravenous dosing is inconvenient and cumbersome. ViroPharma, in partnership with Halozyme Therapeutics (NASDAQ:HALO) is studying the safety and efficacy of Cinryze when administered subcutaneously using Halozyme’s Enhanze technology [a proprietary deliver system using recombinant human hyaluronidase enzyme (rHuPH20)], which was licensed to ViroPharma in May 2011. ViroPharma and Halozyme began a Phase IIb trial of subcutaneous Cinryze on December 19. The companies will monitor 40 patients over the course of either one or two 8-week treatment sequences. The trial will have 2 dosing options: 1,000 units of Cinryze with 24,000 units of rHuPH20, or 2,000 units of Cinryze with 48,000 units of rHuPH20. In earlier Phase II trials, patients who took Cinryze subcutaneously had no HAE attacks during the trial, and mild to moderate reactions at injection sites were the most common adverse events reported. According to ViroPharma, the addition of rHuPH20 “resulted in mean C1 INH functional concentrations greater than or equal to 0.4U/mL for 92 percent of the 72 hour post dosing period as compared to 73 percent for 1000U IV.” NO C1 INH antibodies were detected in a 30-day post-treatment follow-up after the last doses of Cinryze were administered. Earlier in 2012, there were some safety concerns with this trial, as the FDA ordered ViroPharma and Halozyme to stop clinical trials while it investigated safety signals related to rHuPH20 antibodies in another company’s clinical trial program. But the FDA lifted its clinical hold in September when it was determined that these safety issues applied only to that other clinical program, and were not “transferrable” to the clinical trials being conducted by ViroPharma and Halozyme. ViroPharma and Halozyme signed their license agreement in May 2011, in which Halozyme granted ViroPharma an exclusive, worldwide license to use Enhanze in combination with Cinryze. ViroPharma paid Halozyme $9 million for the license in May 2011, and paid another $3 million in Q4 2011 when their Phase II program was initiated. Total milestone payments to Halzoyme could reach $41 million for Cinryze ($30 million for 3 other indications), and Halozyme will receive a 10% royalty on any future sales of subcutaneous Cinryze. In its 10-Q filing, ViroPharma also stated: “Additionally, we will pay an annual maintenance fee of $1 million to Halozyme until specified events have occurred.” I view these terms as acceptable, given that subcutaneous dosing of Cinryze will further strengthen the drug’s position in the market.
