Clinical-stage dermatology company Provectus Biopharmaceuticals, which works in the fields of oncology and dermatology, has been granted allowance of its patent application from both the European Patent Office and the Japanese Patent Office for part of the development process of its lead product to treat melanoma. The patents cover the synthetic process for the production of the active pharmaceutical ingredient (API) in PV-10, a small molecule called Rose Bengal.
The patents awarded by the European and Japanese authorities are meant to cover the process of Rose Bengal and Related Xanthenes manufacturing, which is based on the reduction of previously unknown transhalogenated impurities that are present in commercial grade Rose Bengal in uncontrolled quantities, as announced by the company in a press release.
The company has adjusted the substance’s identification and control in accordance with the guidelines from the International Conference on Harmonisation (ICH) in order make it fit for phase 3 clinical trials that are being planned to study the treatment in melanoma patients, as well as suitable for commercial purposes. The European patent will protect Rose Bengal API until 2031 against any possible process on affecting the amount of transhalogenated impurities in Rose Bengal.
“The allowance of the European patent and the issuance of its Japanese equivalent further the protection of our novel synthesis process for the manufacture of Rose Bengal,” said the CTO of Provectus, Eric Wachter. “We already are protected in the US market, and the Chinese Patent Office notified us of its allowance in January 2015, safeguarding PV-10 in China.”
“With our patient enrollment now open for our phase 3 clinical trial investigating intralesional PV-10 as a potential treatment for melanoma, Provectus is determined to ensure that we maximize shareholder value by building the strongest intellectual property protections into our portfolio as possible. We believe that these patents will further strengthen our Company’s position for not only PV-10 in melanoma, but also its potential value as a treatment for other indications,” he added.
The patents now issued by the European and Japanese offices are similar to the one granted to the company in September 2013 by the US Patent Office, the U.S. Patent 8,530,675, “Process for the Synthesis of 4,5,6,7-tetrachloro-3′,6′-dihydroxy-2′,4′,5′,7′-tetraiodo-3H-spiro[isobenzofuran-1,9-xanthen]-3-one (Rose Bengal) and Related Xanthenes.” In addition, last January, the company also announced the approval from the Chinese Patent Office for the same synthetic process.