Provectus Biopharmaceuticals’s Novel Synthesis Patent Application Allowed by European Patent Office, Patent Issued by Japan
05 May 2015 - 8:00PM
Business Wire
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
http://www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company (“Provectus” or the “Company”), announced
that it has received notification of allowance from the European
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. At the same time, the Japanese Patent
Office has issued a patent for the same intellectual property.
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
additional information about Provectus, please visit the Company’s
website at www.pvct.com or contact Porter, LeVay & Rose,
Inc.
FORWARD-LOOKING STATEMENTS: This release contains
“forward-looking statements” as defined under U.S. federal
securities laws. These statements reflect management’s current
knowledge, assumptions, beliefs, estimates, and expectations and
express management’s current views of future performance, results,
and trends and may be identified by their use of terms such as
“anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “predict,” “project,” “will,” and other similar
terms. Forward-looking statements are subject to a number of risks
and uncertainties that could cause our actual results to materially
differ from those described in the forward-looking statements.
Readers should not place undue reliance on forward-looking
statements. Such statements are made as of the date hereof, and we
undertake no obligation to update such statements after this
date.
Risks and uncertainties that could cause our actual results to
materially differ from those described in forward-looking
statements include those discussed in our filings with the
Securities and Exchange Commission (including those described in
Item 1A of our Annual Report on Form 10-K for the year ended
December 31, 2014) and the following:
- our determination, based on guidance
from the FDA, whether to proceed with or without a partner with the
fully enrolled phase 3 trial of PV-10 to treat locally advanced
cutaneous melanoma and the costs associated with such a trial if it
is necessary to complete (versus interim data alone);
- our determination whether to license
PV-10, our melanoma drug product candidate, and other solid tumors
such as cancers of the liver, if such licensure is appropriate
considering the timing and structure of such a license, or to
commercialize PV-10 on our own to treat melanoma and other solid
tumors such as cancers of the liver;
- our ability to license our dermatology
drug product candidate, PH-10, on the basis of our phase 2 atopic
dermatitis and psoriasis results, which are in the process of being
further developed in conjunction with mechanism of action studies;
and
- our ability to raise additional capital
if we determine to commercialize PV-10 and/or PH-10 on our own,
although our expectation is to be acquired by a prospective
pharmaceutical or biotech concern prior to commercialization.
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper, CFO,
COO866-594-5999 #30orPorter, LeVay & Rose, Inc.Marlon Nurse,
DM, SVP – Investor Relations212-564-4700orBill Gordon – Media
Relations212-724-6312
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