Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) today announced
it has received a $1.1 million refund of the previously paid
Prescription Drug User Fee Act (PDUFA) filing fee related to the
granting of orphan drug status of Lymphoseek® (technetium Tc 99m
tilmanocept) injection in head and neck cancers. Lymphoseek was
granted Orphan Drug Designation by the FDA in September 2014 for
use in sentinel lymph node detection in patients with cancer of the
head and neck. Additionally, Platinum Partners, Navidea’s major
investor, reaffirmed its support of the Company through the
remaining $31.8 million available under the previously announced
line of credit.
“We share Navidea’s belief in Lymphoseek’s commercial potential
and the diagnostic and therapeutic promise of the Manocept™
platform,” said Mark Nordlicht, Chief Investment Officer, Platinum
Partners. “Following recent regulatory approvals and the hiring of
Rick Gonzalez as CEO, we are fully committed to providing the
organization with access to the outstanding line of credit. While
Platinum believes the Company’s financial strength will improve
with each day’s sales under the new broader label, we are confident
this funding vehicle is in the best interest of shareholders and
access to it, to the extent that it becomes necessary, can minimize
Navidea’s cost of capital.”
“We believe we have sufficient capital resources to attain our
immediate goals and realize the full commercial potential for
Lymphoseek,” said Rick Gonzalez, Navidea Chief Executive Officer.
“We are in a position to manage our available cash with our
expected growth in revenue and gross profit, our ability to further
reduce our operating costs and, if needed, our access to capital
under the line of credit from Platinum Partners.”
The original line of credit was executed on July 26, 2012 with
Platinum Partners, (formerly Platinum-Montaur Life Sciences, LLC).
Under the terms of the transaction, Platinum Partners originally
committed to extend up to $15 million in debt immediately to the
Company, with an additional $20 million which became committed upon
approval of Lymphoseek, and yet an additional $15 million
potentially available on terms to be negotiated. To date, the
Company has drawn $3.2 million under the credit facility. No
conversion features or warrants are associated with the
facility.
About Lymphoseek
Lymphoseek® (technetium Tc 99m tilmanocept) injection is the
first and only FDA-approved receptor-targeted lymphatic mapping
agent. It is a novel, receptor-targeted, small-molecule
radiopharmaceutical used in the evaluation of lymphatic basins that
may have cancer involvement in patients. Lymphoseek is designed for
the precise identification of lymph nodes that drain from a primary
tumor, which have the highest probability of harboring cancer.
Lymphoseek is approved by the U.S. Food and Drug Administration
(FDA) for use in solid tumor cancers where lymphatic mapping is a
component of surgical management and for guiding sentinel lymph
node biopsy in patients with clinically node negative breast
cancer, melanoma or squamous cell carcinoma of the oral cavity.
Lymphoseek has also been recommended by CHMP for European approval
in sentinel lymph node detection for melanoma, breast cancer or
squamous cell carcinoma of the oral cavity.
Accurate diagnostic evaluation of cancer is critical, as it
guides therapy decisions and determines patient prognosis and risk
of recurrence. Overall in the U.S., solid tumor cancers may
represent up to 1.2 million cases per year. The sentinel node label
in the U.S. and Europe may address approximately 235,000 new cases
of breast cancer, 76,000 new cases of melanoma and 45,000 new cases
of head and neck/oral cancer in the U.S., and approximately 367,000
new cases of breast cancer, 83,000 new cases of melanoma and 55,000
new cases of head and neck/oral cancer diagnosed in Europe
annually.
Lymphoseek U.S. Indication and Important Safety
Information
Lymphoseek is a radioactive diagnostic agent indicated with or
without scintigraphic imaging for:
- Lymphatic mapping using a handheld
gamma counter to locate lymph nodes draining a primary tumor site
in patients with solid tumors for which this procedure is a
component of intraoperative management.
- Guiding sentinel lymph node biopsy
using a handheld gamma counter in patients with clinically node
negative squamous cell carcinoma of the oral cavity, breast cancer
or melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity
reactions were reported, however Lymphoseek may pose a risk of such
reactions due to its chemical similarity to dextran. Serious
hypersensitivity reactions have been associated with dextran and
modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be
asked about previous hypersensitivity reactions to drugs, in
particular dextran and modified forms of dextran. Resuscitation
equipment and trained personnel should be available at the time of
Lymphoseek administration, and patients observed for signs or
symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer.
Adhere to dose recommendations and ensure safe handling to minimize
the risk for excessive radiation exposure to patients or health
care workers.
In clinical trials, no patients experienced serious adverse
reactions and the most common adverse reactions were injection site
irritation and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM
About Navidea Biopharmaceuticals Inc.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a
biopharmaceutical company focused on the development and
commercialization of precision diagnostics and radiopharmaceutical
agents. Navidea is developing multiple precision diagnostic
products and platforms including Manocept™, NAV4694, NAV5001, and
NAV1800, to help identify the sites and pathways of undetected
disease and enable better diagnostic accuracy, clinical
decision-making and, ultimately, patient care. Lymphoseek®
(technetium Tc 99m tilmanocept) injection, Navidea’s first
commercial product from the Manocept platform, was approved by the
FDA in March 2013. Navidea’s strategy is to deliver superior growth
and shareholder return by bringing to market novel
radiopharmaceutical agents and advancing the Company’s pipeline
through selective acquisitions, global partnering and
commercialization efforts. For more information, please visit
www.navidea.com.
The Private Securities Litigation Reform Act of 1995 (the Act)
provides a safe harbor for forward-looking statements made by or on
behalf of the Company. Statements in this news release, which
relate to other than strictly historical facts, such as statements
about the Company’s plans and strategies, expectations for future
financial performance, new and existing products and technologies,
anticipated clinical and regulatory pathways, and markets for the
Company’s products are forward-looking statements within the
meaning of the Act. The words “believe,” “expect,” “anticipate,”
“estimate,” “project,” and similar expressions identify
forward-looking statements that speak only as of the date hereof.
Investors are cautioned that such statements involve risks and
uncertainties that could cause actual results to differ materially
from historical or anticipated results due to many factors
including, but not limited to, the Company’s continuing operating
losses, uncertainty of market acceptance of its products, reliance
on third party manufacturers, accumulated deficit, future capital
needs, uncertainty of capital funding, dependence on limited
product line and distribution channels, competition, limited
marketing and manufacturing experience, risks of development of new
products, regulatory risks and other risks detailed in the
Company’s most recent Annual Report on Form 10-K and other
Securities and Exchange Commission filings. The Company undertakes
no obligation to publicly update or revise any forward-looking
statements.
Navidea BiopharmaceuticalsBrent Larson, 614-822-2330Executive VP
& CFOorSharon Correia, 978-655-2686Associate Director,
Corporate Communications
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