This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

European Medicines Agency (EMA) Continues Marketing Authorization Application (MAA) Review For Lymphoseek®

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the European Medicines Agency (EMA) has provided updated Day 180 feedback and has elected to continue the assessment of the Marketing Authorization Application (MAA) for Lymphoseek ® (technetium 99m tilmanocept) Injection. The updated Day 180 feedback was limited to supplemental product specification data and the NEO3-06 Phase 3 study in Head and Neck Cancer, which was submitted later in the MAA review process at Day 120, leaving less time for evaluation of these new data. The MAA review clock will continue to be stopped at Day 180 to await Navidea’s responses to the updated EMA feedback. During this time, the MAA remains active and Navidea will continue its ongoing process of interacting with the EMA.

"With the Lymphoseek MAA remaining in the EMA’s assessment process, we will continue to work with the EMA to support a positive opinion as early as possible in 2014," stated Mark Pykett, VMD, PhD, Navidea CEO. “We view potentially gaining a positive opinion that would also include Head and Neck Cancer as advantageous. While we prepare our responses to the EMA’s updated Day 180 feedback, we will continue to implement our plans for European market development during 2014 which we believe will support material revenue generation from Europe beginning in 2015, as we have previously disclosed."

Expanding Global EffortsNavidea’s activities in Europe are part of its expanding global strategy for Lymphoseek commercialization. The Company recently announced it has entered into a partnership agreement for Lymphoseek distribution in Canada; partnerships are in process for additional markets. Navidea has also commenced shipment of Lymphoseek to select medical centers in the Middle East. These market expansion activities build on the growth of Lymphoseek sales being seen in the United States, which continue the positive trends recently reported at the Company’s Analyst Science Day on December 5, 2013.

About Lymphoseek ® Lymphoseek ® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek was approved by the U.S. Food and Drug Administration in March, 2013 for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. The Company anticipates continuing development of Lymphoseek into other solid tumor areas that may include head and neck cancers, prostate cancer, thyroid cancer, lung/bronchus cancers, colorectal cancer and others. Lymphoseek was granted Fast Track designation in December 2013 for sentinel lymph node detection in patients with head and neck cancer.

Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to publicly available information, approximately 232,000 new cases of breast cancer, 77,000 new cases of melanoma and 67,000 new cases of head and neck/oral cancer are expected to be diagnosed in the United States in 2013, with approximately 330,000 new cases of breast cancer, 69,000 new cases of melanoma and 95,000 new cases of head and neck/oral cancer diagnosed in Europe annually.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,132.70 -81.72 -0.45%
S&P 500 2,104.50 -6.24 -0.30%
NASDAQ 4,963.5270 -24.3630 -0.49%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs