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Optimer Pharmaceuticals Inc. Reports Operating Results (10-Q)

November 03, 2010 | About:

Optimer Pharmaceuticals Inc. (OPTR) filed Quarterly Report for the period ended 2010-09-30.

Optimer Pharmaceuticals Inc. has a market cap of $367.6 million; its shares were traded at around $9.4 with and P/S ratio of 411.5. Optimer Pharmaceuticals Inc. had an annual average earning growth of 19.2% over the past 5 years.

Highlight of Business Operations:

In addition, in September 2010, we reported additional data from our two fidaxomicin Phase 3 trial at the Annual Interscience Conference on Antimicrobial Agents and Chemtherapy, or ICAAC, which showed that fidaxomicin was superior to vancomycin in treatment of CDI patients suffering a recurrence. In the two fidaxomicin Phase 3 trials, a separate stratum was constructed of subjects who had experienced a prior CDI episode and recurred within three months of entering the study. The 178 subjects with recurrent CDI were randomized to be treated with either fidaxomicin or vancomycin and 128 of these subjects were subsequently evaluable for recurrence within the study. Following treatment, 35.5% (22/62) of the subjects who received vancomycin experienced another recurrence compared to 19.7% (13/66) among the subjects who received fidaxomicin (p=0.045). This equates to a 45% reduction in repeat CDI recurrence with fidaxomicin. The data also indicated that fidaxomicin was superior to vancomycin in preventing recurrences and in promoting global cure in patients requiring concomitant antibiotics. The analysis from the Phase 3 trials indicated that in patients receiving concomitant antibiotics, those treated with fidaxomicin versus vancomycin had a significantly lower CDI recurrence rate (17% vs. 28%, p=0.039) and had a significantly improved global cure rate (73% vs. 60%, p=0.013). At the same time, among subjects who received no concomitant antibiotics, recurrence in vancomycin-treated subjects was double that of fidaxomicin-treated subjects (23% vs. 11.5%, p<0.001).

In February 2007, we regained worldwide rights to fidaxomicin from Par under a prospective buy-back agreement. We paid Par a one-time $5.0 million milestone payment in June 2010 for our successful completion of the second pivotal Phase 3 trial for fidaxomicin. We are also obligated to pay Par a 5% royalty on net sales by us or our affiliates of fidaxomicin in North America and Israel, and a 1.5% royalty on net sales by us or our affiliates of fidaxomicin in the rest of the world. In addition, in the event we license our right to market fidaxomicin in the rest of the world, we will be required to pay Par a 6.25% royalty on net revenues we receive related to fidaxomicin. We are obligated to pay each of these royalties, if any, on a country-by-country basis for seven years commencing on the applicable commercial launch in each such country.

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