Optimer Pharmaceuticals
Based: San Deigo Why It's Fierce: Lead products are well advanced and moving fast. Optimer is preparing to launch a Phase IIb/III study of OPT-80, an antibiotic designed to attack the growing number of cases of C. difficile-associated diarrhea. Phase II cured 41 out of 45 patients, and there's data to back up the developer's belief that they can push it through the pipeline. Optimer licensed OPT-99 (gastroenteritis and urinary tract infection) from a Japanese group and has a co-marketing deal with Par Pharmaceuticals for OPT-80 (PAR-101) that triggered a $12 million equity investment. The first half of enrollees for the OPT-80 trial should be lined up by the end of the year, with early efficacy readouts expected in the spring of 2007, according to CEO Michael Chang. With the compound fast-tracked by the FDA, a rolling Phase III will provide pivotal data. OPT-99 goes directly into two small Phase III trials with a heavy package of trial data already prepared. Optimer plans to file for marketing approval as early as the third quarter of next year and will build out its commercial arm to sell it. Those royalties will be used to support Optimer's work in oncology and inflammation, which offer some major upside. Their lead oncology candidate is OPT-22, a therapeutic cancer vaccine designed to kill targeted cancer cells. One study, which tracked 27 women with advanced breast cancer over five years, finished with 21 of the patients still alive. Their oncology candidate is in Phase Ic with positive early efficacy data and a late-stage trial is being set up in Taiwan. Optimer's fourth round of venture capital raised $22.2 million, and the company has garnered a total of $69.9 million to date. What to look for: Chang expects to arrange more licensing deals this year for OPT-80, and he is hoping that relatively swift regulatory approval for OPT-22 for oncology in Taiwan will lead the way to FDA approval. A licensing pact for oncology with a large pharma organization would also fit company plans., and definitive Phase III data would set the stage for an IPO in 2007. |
