Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), today provides
an update on its commercial and clinical development efforts with
respect to its Lymphoseek® (technetium Tc 99m tilmanocept)
injection, the first and only FDA-approved receptor-targeted
lymphatic mapping agent, and the Manocept™ immunodiagnostic
development pipeline.
2015 Commercial
Highlights
In 2015, the Company created and executed a new
commercialization strategy for Lymphoseek to better leverage the
label expansion approved by the FDA in October 2014 and, over time,
accelerate its market penetration. This included a complete refresh
of the brand, moving away from a feature-based selling approach to
a customer-centric one focused on the benefits to the surgeon and
patient.
In concert with the rebranding efforts, the Company also
recruited, hired and trained a new salesforce in the latter part of
the second quarter of 2015. The new direct sales team focused on
targeting the highest priority territories. The Company anticipated
the sales team’s contributions would be most significant starting
the fourth quarter of 2015 and onward based on the four- to
six-month sales cycle of Lymphoseek.
The initial launch of the new commercialization strategy
resulted in the following during 2015:
- Grew sales by 141% year over year,
based on preliminary unaudited Lymphoseek sales to Navidea of $10.2
million for 2015 representing total brand revenue of approximately
$20 million;
- Ended the year at an annualized sales
run rate for Lymphoseek of over $15 million in revenue to Navidea,
which does not reflect the opportunity for additional growth in
existing and expansion sales territories throughout 2016;
- Achieved an increase of 55% in “average
daily doses sold” from the end of 2014 through the end of
2015;
- Increased penetration into large
accounts - nearly tripling the number of accounts that averaged
more than 20 doses per month in 2015 versus 2014; and,
- Expanded the network of cancer centers
and hospitals that use or plan to use Lymphoseek which now includes
17 of the top 20 US Best Hospitals for Adult Cancer as reported by
the most recent U.S. News and World Report.
Rick Gonzalez, President and Chief Executive Officer, said, “We
enter 2016 with positive momentum behind our new commercialization
strategy. We expect our sales team’s strong contributions to
continue to accelerate product revenues throughout the year. In
addition, European sales revenues are expected to be generated from
commercialization efforts to begin in the fourth quarter. In
parallel, our R&D team is aggressively advancing our
immunodiagnostics pipeline focused on significantly larger market
opportunities including Rheumatoid Arthritis (RA), which has a
prevalence of approximately 3.8 million patients in the U.S. and
Europe. We will share additional details on our plans for 2016,
including an update on Macrophage Therapeutics and the sale of
NAV4694, during our upcoming year-end earnings conference
call.”
Clinical Development
Update
The Company continues to work toward a more focused development
program using its Manocept platform in immunodiagnostics, including
the FDA label expansion for Lymphoseek (Tc99m tilmanocept) into RA
and Kaposi’s sarcoma (KS). Importantly, the costs of these
development programs will be defrayed by NIH grants awarded to the
Company in 2015 totaling over $3.8 million.
In the next 90 days, the Company intends to:
- Advance Lymphoseek Label Expansion into
RA:
- Meet with the FDA before
the end of March 2016 to share preclinical results on
the intravenous route of administration (IVROA) and
discuss and agree on the Phase 1 and 2 clinical plan for our
Rheumatoid Arthritis (RA) immunodiagnostic program. This is a
follow-up meeting to the one that took place in May 2015, where the
Company and the FDA confirmed requirements for a preclinical
submission package for the use of Lymphoseek in IVROA; and,
- Finalize preparations to initiate a
Phase 1 pilot trial evaluating subcutaneous injection of Tc99m
tilmanocept in active RA subjects in the first half of 2016. During
the second half of 2016, the Company intends on initiating a
subsequent Phase 1/2 registrational trial of IV-administered Tc99m
tilmanocept for the RA immunodiagnostic application.
- Support the existing Lymphoseek label
in Lymphatic Mapping:
- Expand patient enrollment in the
FDA/EMA mandated pediatric trial for children with melanoma,
rhabdomyosarcoma, or other solid tumors who are undergoing lymph
node mapping and who meet special criteria for pediatric sentinel
node biopsy. Since the first patient was dosed in December 2015,
two new sites have been added including Cincinnati Children’s
Hospital Medical Center;
- Enroll first patient at the MD Anderson
Cancer Center in the Company’s multi–center cervical cancer
study;
- Initiate patient enrollment in the
Investigator Initiated Study (IIS) endometrial cancer study
directed by Dr. Michael McHale at UC San Diego Health System;
and,
- Expand patient enrollment in the
cardiovascular immunodiagnostic study, an IIS study in
collaboration with Massachusetts General Hospital. Based on
encouraging findings in the first patients dosed, we are very
excited by the potential and are seeking to accelerate and expand
this funded program using a protocol for IVROA.
About LymphoseekLymphoseek® (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 received European approval in
imaging and intraoperative detection of sentinel lymph nodes in
patients with melanoma, breast cancer or localized squamous cell
carcinoma of the oral cavity.
Accurate diagnostic evaluation of cancer is critical, as results
guide therapy decisions and determine 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 600,000 new cases of
breast cancer, 160,000 new cases of melanoma and 100,000 new cases
of head and neck/oral cancer diagnosed annually.
Lymphoseek Indication and Important Safety
InformationLymphoseek 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 InformationIn 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 NavideaNavidea Biopharmaceuticals, Inc. (NYSE MKT:
NAVB) is a biopharmaceutical company focused on the development and
commercialization of precision immunodiagnostic agents and
immunotherapeutics. Navidea is developing multiple
precision-targeted products and platforms including Manocept™ and
NAV4694 to help identify the sites and pathways of undetected
disease and enable better diagnostic accuracy, clinical
decision-making, targeted treatment 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 and in Europe in November 2014. Navidea’s
strategy is to deliver superior growth and shareholder return by
bringing to market novel products and advancing the Company’s
pipeline through 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160202006665/en/
Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate CommunicationsorDavid Schull or Chris
Hippolyte,
858-717-2310david.schull@russopartnersllc.comChris.hippolyte@russopartnersllc.com
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