SYNTHESIS PATENT ALLOWED BY EUROPEAN PATENT OFFICE.
The pending European patent and issued Japanese patent cover 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 occur 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 investigational product and for commercial pharmaceutical use. Once issued, the European 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 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. 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.
About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals, Inc. specializes in developing oncology and dermatology therapies. PV-10, its novel investigational drug for cancer, is designed for injection into solid tumors (intralesional administration), thereby reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and cancers of the liver. The Company has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications. PH-10, its topical investigational drug for dermatology, is undergoing clinical testing for psoriasis and atopic dermatitis. Provectus has completed phase 2 trials of PV-10 as a therapy for metastatic melanoma, and of PH-10 as a topical treatment for atopic dermatitis and psoriasis. Information about these and the Company's other clinical trials, including its current phase 3 study in melanoma, can be found at the NIH registry, www.clinicaltrials.gov.
For more information, visit www.pvct.com or call 212/564-4700.