This week, Provectus secured Chinese patent protection for the manufacturing process for rose bengal, the active pharmaceutical ingredient (API) in PV-10, and said it is working to find a local partner.
China is not the only target market according to CFO Peter Culpepper, who told in-Pharmatechnologist.com “we are seeking similar patent protection in India” adding that “we do plan to seek a partner for PV-10 in India.”
“China, India and other large jurisdictions outside US and EU are important to Provectus for regional license transaction potential and ability to provide local country presence on the ground, which is relying on the strength of a partner in those respective countries.”
Culpepper also indicated Provectus is seeking a partner with multiple market access, explaining that: “We also plan a global partner led by the US and Europe as we embark on and make progress with our Phase III melanoma study in the US and also the combo 1b/2 study, followed by the liver 1b/2 study.”
The Knoxville, Tennessee-based firm is developing PV-10 for cancers of the breast, skin and liver and has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the latter two indications.
The most advanced PV-10 programme is for the treatment of locally advanced cutaneous melanoma, the Phase III protocol for which was submitted to the FDA last November.
The US and European skin cancer market has become a lot more crowded in the two years since PV-10 completed its Phase II trial.
Six new melanoma drugs have been approved in the US since 2011: Bristol Myers Squibb’s Yervoy (ipilimumab) and Opdivo (nivolumab); Roche’s Zelboraf (vemurafenib); GSK’s Tafinlar (dabrafenib) and Mekinist (trametinib); and Merck & Co’s Keytruda (pembrolizumab).
In Europe, Yervoy has been available to treat melanoma since 2011, as have Zelboraf and Tafinlar since 2012 and Mekinist since 2013. Keytruda and Opdivo, which belong to a new therapeutic class, the PD-1 inhibitors, were filed for European Medicines Agency (EMA) review last year.
But this, combined with news of Provectus’ plans in Asia, does not indicated the firm has given up on Western markets.
Culpepper told us “We believe our drugs have very significant potential in the US and EU. There is no direct competition for PV-10 in our indications of interest, and even in melanoma our oncology investigational drug PV-10 is for stage 3 patients where there is no standard of care other than clinical trials!
“For stage 4 patients, we expect PV-10 to be combined with the newer melanoma drugs since they still don’t work well enough by themselves” Culpepper continued, citing the patent application it filed with Pfizer as evidence of progress being made in this area.
He reiterated that: “China is not at all less competitive for us” and added “we are more than able to match the competition and beat it in the US.”