Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a biopharmaceutical company focused on treating cancer and psoriasis using the Rose Bengal compound, similar to companies like Dendreon Corporation (Nasdaq: DNDN) and Human Genome Sciences (Nasdaq: HGSI), could be set to unlock significant value by going-it-alone with its PV-10 and PH-10 clinical trials.
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a biopharmaceutical company focused on treating cancer and psoriasis using the Rose Bengal compound, could be set to unlock significant value by going-it-alone with its PV-10 and PH-10 clinical trials. While many other pharmaceutical companies typically partner early in the clinical trial process, Provectus has maintained control in a move that could give it significant leverage once approved by the U.S. Food and Drug Administration (FDA).
Late-Stage Trials Offer Increased Leverage
Most early-stage pharmaceutical companies partner with larger commercialization partners during Phase I or II clinical trials, since Phase III trials involve greater patient populations and are more expensive to undergo. However, partnering earlier in the clinical trial process also involves giving up more equity in the drugs or treatments being developed, since it involves more risk for the partner.
As a result, well-capitalized pharmaceutical companies, like Provectus Pharmaceuticals, that can take clinical trials through Phase III and to an IND without a commercialization partner can negotiate on far more favorable terms. And with a cancer drug targeting metastatic melanoma, as well as other indications down the road, these favorable terms could translate to significant value for shareholders.
Strong Safety, Robust Efficacy and Enormous Markets
Provectus’ PV-10 for the treatment of metastatic melanoma has shown robust safety and efficacy data, while targeting a significant end market. Using the Rose Bengal’s unique ability to selectively target and kill cancer cells, the company has demonstrated an objective response in 49% of subjects and locoregional disease control in 71% of subjects in Phase II clinical trials. Interestingly, PV-10 also demonstrated a unique “by-stander” effect whereby untreated tumors were also positively affected.
The global melanoma therapeutics market was worth about $351 million in 2009 and is expected to grow at a compound annual growth rate of 16.8% for the next eight years to reach $1.42 billion by 2017, according to a report by Research and Markets. Given PV-10’s robust efficacy, established safety, and ability to treat bystander tumors, many analysts see strong potential moving forward.
With its unlicensed late-stage drug treating an enormous and growing end market, Provectus Pharmaceuticals (OTCBB: PVCT) may be a bargain at its current $100 million market capitalization. As a result, this is one stock that biotechnology and pharmaceutical investors may want to take a closer look at as it approached Phase III trials for its PV-10 treatment for metastatic melanoma.