Meanwhile, Vancocin may also lose market share to a drug being developed by Optimer Pharmaceuticals Inc.
Earlier in November, San Diego-based Optimer said its drug candidate OPT-80 was slightly more effective than Vancocin in a late-stage study of patients with gastrointestinal infections. Patients on OPT-80 also relapsed less than their counterparts on Vancocin.
Both drugs would compete in treating CDI, or clostridium difficile infection, which affects the colon. It is most commonly obtained by patients in hospitals following treatment with antibiotics. Still, OPT-80 is years away from reaching the market.
Record Vancocin Sales Should Continue ViroPharma reported record Vancocin sales of $65.9 million in the third quarter 2008, an increase of 29% year-overyear, and $8 million above our forecasts. This was the second quarter in a row Vancocin sales blew-away expectations. These solid Vancocin sales were driven by a combination of growing awareness among physicians and early (or pre) adoption of the new IDEA/SHEA guidelines, along with price increases taken over the past year. The ViroPharma 5-person specialty seems to be making significant progress in educating and increasing awareness on the benefits of Vancocin over metronidazole. In fact, we would not be surprised to see management increase the size and reach of the Vancocin salesforce in 2009. In mid November 2008, ViroPharma shares took a hit on news from a competitor s trial in Clostridium difficile Infection (CDI). Results from Optimer Pharmaceutical s phase III program testing OPT-80 vs. Vancocin demonstrated 92.1% of patients treated with OPT-80 (per protocol population) achieved clinical cure vs. 89.8% for Vancocin. In addition, only 13.3% of patients treated with OPT-80 experienced a recurrence vs. 24.0% for Vancocin (p = 0.004). Patients treated with OPT-80 had a global cure (cure with no recurrence within four weeks) of 77.7%, which was greater than Vancocin at 67.1% (p = 0.006). Although this very impressive data in-favor of OPT-80, we do not expect it to have any impact on Vancocin use until 2011 at the earliest. Optimer has not yet filed for approval of OPT-80. We remind investors that this type of headto- head data showing the superiority of OPT-80 over Vancocin is similar to data showing the superiority of Vancocin over metronidazole and it has taken the past several years for the use of Vancocin to build in the face of generic metronidazole. The IDEA/SHEA guidelines still do not reflect the full advantages of Vancocin over metronidazole, and it will be several years before they are updated again to include OPT-80 if it is approved. Plus, but the time OPT-80 comes to market in 2011, we expect Vancocin to be generic and contributing less than 25% of ViroPharma s top-line.
Years? How do you figure years? based on where they are with their trials, I think they will file an NDA by mid 2009 at the latest. They also have been granted fast track status by FDA which would mean a 6 month review process at the longest. If you have more insight let me know. I could be wrong but that is based on what I have read. Thanks!
..... In addition to the threat of generic competition, Vancocin also could face competition from a branded product in the future. Last week, Optimer Pharmaceuticals Inc. of San Diego announced study results that the company said shows its experimental gastrointestinal infection drug, OPT-80, was more effective than Vancocin in terms of cure rates and reductions in relapse rates.
Optimer’s drug is still in clinical testing and is not on track to hit the market, pending FDA approval, until the second half of 2010.