|[August 18, 2014]
Provectus Signs Memorandum of Understanding with Sinopharm-China State Institute of Pharmaceutical Industry, and Sinopharm A-THINK Pharmaceutical Co., Ltd.
KNOXVILLE, Tenn. --(Business Wire)--
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT) (http://www.pvct.com),
a development-stage oncology and dermatology biopharmaceutical company
("Provectus"), announced today that it entered into a Memorandum of
Understanding ("MOU") with Sinopharm-China State Institute of
Pharmaceutical Industry ("Sinopharm-CSIPI"), the leader among all
pharmaceutical research institutes in China, and Sinopharm A-THINK
Pharmaceutical Co., Ltd. ("Sinopharm A-THINK"), the only injectable
anti-tumor drug research and development, manufacture and distribution
integrated platform within Sinopharm Group.
The key component of the MOU provides that "Sinopharm-CSIPI and
Sinopharm A-THINK desire to obtain an exclusive license to commercialize
PV-10 within [the People's Republic of] China territory, and PVCT is
willing to grant such license to Sinopharm."
During the next three months, the parties will seek to enter into a
definitive licensing contract, subject to additional negotiation, due
diligence, and any required regulatory and corporate approvals. The
parties will further address the details of the license; the use of the
technology from Provectus to Sinopharm A-THINK in China; the process for
commercialization; and payments to Provectus (upfront, milestone and
royalties). Provectus intends to manufacture PV-10 in the USA and
Sinopharm A-THINK will distribute PV-10 in China.
The MOU, which is governed by Chinese law, stems from negotiations led
by Network 1 Financial Securities, a financial advisor to Provectus. The
parties met at the headquarters of Sinopharm-CSIPI in Shanghai, China.
In attendance were the senior management members of Sinopharm Group, as
well as senior Provectus personnel. Provectus presented clinical and
nonclinical data of its drug, PV-10. The experts and scientists from
Sinopharm-CSIPI and Sinopharm A-THINK had an extensive and substantial
discussion with the Provectus team. The MOU provides that "the parties
agreed that PV-10 is an advanced innovative drug representing the
oncology research trend worldwide, [which] will provide extensive
economic and social benefits to [the Chinese] market."
In addition, the MOU says that all "parties recognized the achievements
gained during PV-10's clinical trial on melanoma, breast cancer and
cancer of liver, plus the systematic effect on human immune efficacy,
and PV-10 could be applied to other indications such as lung cancer,
pancreatic cancer, prostate cancer and kidney cancer."
The MOU contains customary provisions regarding confidential
information, publicity, and intellectual property, and is non-binding
upon the parties (except for certain non-material provisions). The MOU
shall continue in effect until the earliest of the replacement of the
MOU with a definitive agreement, one month prior written notice by
either Provectus or Sinopharm, or ninety days from the signing of the
China National Pharmaceutical Group Corporation, (Sinopharm) is the
largest medical and healthcare group in China which is directly managed
by the State-owned Assets Supervision and Administration Commission of
the State Council (SASAC), with the core businesses of distribution,
logistics, retail, scientific research and manufacture of healthcare
related products. Sinopharm owns 10 wholly owned or holding
subsidiaries, and 5 listed companies including Sinopharm Group Co., Ltd.
(01099.HK), China National Medicines Co., Ltd. (600511.SH), Beijing
Tiantan Biological Products Co., Ltd. (600161.SH), Shyndec
Pharmaceutical Co., Ltd. (600420.SH) and Shenzhen Accord Pharmaceutical
Co., Ltd. (200028.SZ). The sales revenue of Sinopharm exceeded RMB 160
billion in 2012. It is the only Chinese pharmaceutical company whose
sales revenue�exceeds RMB 100 billion.
For more information, visit: http://www.sinopharm.com.
About Sinopharm-China State Institute of Pharmaceutical Industry
Sinopharm-China State Institute of Pharmaceutical Industry originated
from the Shanghai Institute of Pharmaceutical Industry which was founded
in 1957. Sinopharm-CSIPI is a top bio-science research and
pharmaceutical application-base research institute in China, with the
core businesses of innovation drug development, distribution, logistics,
and scientific research of healthcare related products. It is one of the
National Pharmaceutical Technology Innovation Bases.
For more information, visit: http://www.csipi.com.cn.
About Sinopharm A-THINK Pharmaceuticals Co., Ltd.
Sinopharm A-THINK Pharmaceuticals Co., Ltd., founded in 1997, focuses on
injectable anti-tumor and anti-hepatitis product development. Sinopharm
A-THINK is the only anti-tumor and anti-virus drug development and
manufacture integrated platform within Sinopharm Group, with the core
business of new Oncology drug R&D, manufacture and distribution
About Network 1 Financial Securities, Inc.
Network 1 Financial Securities, Inc., established in 1983, is a
full-service investment bank dedicated to assisting private and public
companies capitalize on the rapidly changing global capital markets.
Network 1 Financial Securities is registered member of the Financial
Industry Regulatory Authority (FINRA), the NASDAQ Stock Market, and the
Securities Insurance Protection Corporation (SIPC); and it is registered
as a broker-dealer with the U.S. Securities and Exchange Commission
(SEC (News - Alert)).
For more information, visit: http://www.network1financial.com
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 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 letter 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, 2013, and in our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2014), and the
our determination, based on guidance from the FDA, whether to
proceed with or without a partner with a phase 3 trial of PV-10 to
treat locally advanced cutaneous melanoma and the costs associated
with such a trial if it is necessary;
our determination whether to license PV-10, our melanoma drug
product candidate, and other solid tumors such as liver cancer, 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 liver cancer;
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.