On January 26, 2015 Provectus Biopharmaceuticals reported that it has received notification of allowance from the Chinese Patent Office for its patent application protecting the synthetic process used to produce the small molecule Rose Bengal, the active pharmaceutical ingredient (API) in PV-10, the Company’s lead oncology drug candidate (Press release Provectus Pharmaceuticals, JAN 26, 2015, http://www.pvct.com/pressrelease.html?article=20150126.1 [SID:1234501388]).
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The pending Chinese patent covers the same process as the one granted by the US Patent Office in September 2013, as 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." The application details a new process for the manufacture of Rose Bengal and related iodinated xanthenes in high purity. The allowed claims cover the process under which pharmaceutical grade Rose Bengal and related xanthenes are produced, reducing the formation of certain previously unknown transhalogenated impurities that currently exist in commercial grade Rose Bengal in uncontrolled amounts. The requirement to identify and control related substances is in accordance with International Conference on Harmonisation (ICH) guidelines for manufacture of API suitable for phase 3 clinical trial material and commercial pharmaceutical use. Once issued later this year, the patent is expected to provide protection for Rose Bengal API to 2031 and covers any hypothetical process that controls the amount of transhalogenated impurities in Rose Bengal through the awarded Jepson style claims.
Eric Wachter, CTO of Provectus, stated, "The issuance of this patent will enhance the protection of our novel synthesis process for the manufacture of Rose Bengal covering the entire Chinese market. As we prepare to begin our phase 3 clinical trial for intralesional PV-10 as a treatment for melanoma and as we discuss with Chinese interests licensing PV-10 for other indications, it is important that we defend our intellectual property in this way. We are pleased that the Chinese authorities have been so helpful in this, and we will continue to protect our stockholders’ interests in this way as we seek out partners globally to further develop our product line."