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Navidea Biopharmaceuticals Receives Complete Response Letter From FDA For Lymphoseek® NDA Due To Manufacturing Deficiencies

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Lymphoseek ® (technetium Tc 99m tilmanocept) Injection. In the CRL, the FDA noted the decision was focused on issues with third-party Lymphoseek contract manufacturing, and was not related to any efficacy or safety data filed within the Lymphoseek NDA.

Lymphoseek is a novel agent that has been studied in lymphatic mapping procedures performed to help stage breast cancer and melanoma. Lymphoseek is a receptor-targeted radiopharmaceutical designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.

“Receiving a Complete Response Letter is clearly disappointing. However, we remain steadfast in our belief that Lymphoseek holds significant promise in improving the lives of patients who undergo lymphatic mapping procedures to stage solid tumor cancers, such as breast cancer and melanoma,” said Mark Pykett, V.M.D, Ph.D., President and CEO of Navidea Biopharmaceuticals. “We are already working closely with the FDA and our third-party contract manufacturers to address all requirements to support the shortest possible NDA resubmission and review. We remain confident that our clinical data clearly demonstrate the value of Lymphoseek in accurately identifying lymph nodes that most likely harbor cancer while producing no clinically significant adverse effects,” Pykett added.

Navidea Biopharmaceuticals will provide additional information during a conference call scheduled for 4:45 p.m. EST, September 10, 2012. The conference call can be accessed as follows:

     
CONFERENCE CALL INFORMATION
TO PARTICIPATE LIVE:         TO LISTEN TO A REPLAY:

Date:

Time:

 

Toll-free (U.S.) Dial in # :

International Dial in # :

   

Sept 10, 2012

4:45 PM ET

 

(877) 407-9205

(201) 689-8054

       

Available until:

Toll-free (U.S.) Dial in # :

International Dial in # :

 

Replay passcode:

  Account #

  Conference ID #:

   

Sept 25, 2012

(877) 660-6853

(201) 612-7415

 

 

286

400036

               

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 stage 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, in patients with breast cancer or melanoma.

Lymphatic mapping is a procedure in which lymph nodes that may contain tumor metastases are identified and biopsied to determine if cancer has spread beyond the primary tumor. Accurate staging of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to the American Cancer Society, approximately 229,000 new cases of breast cancer and 76,000 new cases of melanoma are expected to be diagnosed in the United States in 2012.

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