LOI Signed at ESMO GI Addresses Melanoma and
Cancers of the Liver
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT,
http://www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company (“Provectus” or the “Company”), announced
today that it has signed a Letter of Intent (the “LOI”) with
Boehringer Ingelheim (China) Investment Co. Ltd. (“Boehringer”).
The purpose of the LOI is to lay a foundation for the two parties
to collaborate in bringing PV-10, Provectus’ novel investigational
drug for cancer (“PV-10”), to market in mainland China, Hong Kong
and Taiwan. Maxim Group LLC acted as strategic advisor to Provectus
in structuring and negotiating the LOI.
Under the terms of the LOI, Boehringer will provide certain
commercially reasonable support in the aspects of product
registration with the China Food and Drug Administration (“CFDA”),
communication preparation, market intelligence and other assistance
to Provectus in China to the extent that is within Boehringer’s
approved business scope and permissible by Chinese laws.
In return, Provectus will grant Boehringer the first priority to
be the exclusive collaborator of Provectus in China for PV-10 in
the event that PV-10 is successfully registered and approved by the
CFDA. The exclusive collaboration may take the form of exclusive
distribution and promotion, exclusive licensing or other agreement,
subject to both parties’ mutual agreement. At the appropriate time,
Provectus and Boehringer will enter into a definitive agreement,
including a non-compete provision, for PV-10 to be exclusively
developed, distributed and promoted through the collaboration
within China, although there can be no assurance that the parties
will enter into a definitive agreement.
In the LOI signed today at the European Society for Medical
Oncology (ESMO) World Congress on Gastrointestinal Cancer 2015 in
Barcelona, the two parties have agreed to meet regularly and
maintain effective communication in order to move forward with the
registration and commercialization of the product and assess the
potential cooperation between them in China, which may be adopted
in a form of exclusive commercial supply, distribution and
promotion, partnership or any other forms suitable to both parties’
interests.
Stephen Doyle, Vice President and Head of Specialty Care, China,
at Boehringer, said, “We are impressed with the work the management
of Provectus and its researchers have done so far in developing
PV-10 as a potential treatment option for melanoma and cancers of
the liver. At Boehringer Ingelheim we are committed to research and
development in areas of high unmet need such as liver cancer. If
successful, we believe that many Chinese patients could benefit
from being treated with PV-10. Because of this, and the data
generated so far, we are prepared to provide the commercially
reasonable support Provectus may need to get PV-10 through the drug
development and registration approval process in China.”
Peter Culpepper, CFO and COO of Provectus, said, “We are excited
about the potential of PV-10 in China and in commencing a working
relationship with Boehringer Ingelheim to bring PV-10 to market
there. We are confident that Boehringer Ingelheim’s expertise in
navigating the regulatory requirements in China will prove
beneficial to us, and we are also confident that a commercial
collaboration will benefit both companies. In addition, we believe
that a successful partnership with Boehringer Ingelheim in China
will provide us with experience in dealing with regulatory systems
outside the US and help us take PV-10 to a global marketplace.”
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany,
Boehringer Ingelheim operates globally with 146 affiliates and
a total of more than 47,700 employees. The focus of the
family-owned company, founded in 1885, is researching, developing,
manufacturing and marketing new medications of high therapeutic
value for human and veterinary medicine.
Social responsibility is an important element of the corporate
culture at Boehringer Ingelheim. This includes worldwide
involvement in social projects, such as the initiative “Making more
Health” and caring for the employees. Respect, equal opportunities
and reconciling career and family form the foundation of the mutual
cooperation. In everything it does, the company focuses on
environmental protection and sustainability.
In 2014, Boehringer Ingelheim achieved net sales of about
13.3 billion euros. R&D expenditure corresponds to
19.9 per cent of its net sales.
For more information please visit
www.boehringer-ingelheim.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, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150702005066/en/
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper, CFO,
COO866-594-5999 #30orPorter, LeVay & Rose, Inc.Marlon Nurse,
DM, SVP – Investor Relations212-564-4700orTodd Aydelotte – Media
Relations646-428-0644
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