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OFFICIAL WEBSITE and Message from the CEO
http://navidea.com/about-us/message-from-ceo.html
BOD
http://www.navidea.com/investors/corporate-governance/board-membership.html
Management
Board of Directors
Navidea's management team and board of directors are leaders in research, development and commercialization of precision diagnostic and radiopharmaceutical imaging agents.
Gordon A. Troup
Chairman of the Board
Retired President of Nuclear Pharmacy Services,
Cardinal Health, Inc.
Peter F. Drake, Ph. D.
Founder and General Partner,
Longevity Growth Partners
Brendan A. Ford
Partner, Talisman Capital Partners
Michael M. Goldberg, M.D.
Managing Partner
Montaur Capital Partners
Perry A. Karsen
Chief Operations Officer, Celgene Corporation
Erik K. Rowinsky, M.D.
Former Chief Medical Officer and Executive Vice President of Clinical Development and Regulatory Affairs
Imclone System Inc.
Management
Navidea's management team and board of directors are leaders in research, development and commercialization of precision diagnostic and radiopharmaceutical imaging agents.
Ricardo J. (Rick) Gonzalez, Chief Executive Officer
Thomas H. Tulip, Ph.D. President and Chief Business Officer
Rodger A. Brown Vice President, Global Regulatory Operations and Quality Assurance
David S. Casebier, Ph.D. Vice President, Chemistry, Manufacturing and Controls
Frederick O. Cope, Ph.D., F.A.C.N., C.N.S. Senior Vice President and Chief Scientific Officer
Stephen B. Haber, Ph.D. Vice President, Development
Brent L. Larson Executive Vice President and Chief Financial Officer, Treasurer and Secretary
William J. Regan Senior Vice President, Global Regulatory Strategy
Cornelia B. Reininger, M.D., Ph.D. Senior Vice President, Chief Medical Officer
Navidea Enters Lymphoseek® Development and Commercialization Agreement for China
Navidea Biopharmaceuticals, Inc. 4 Sept 2014
DUBLIN, Ohio--(BUSINESS WIRE)--
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) has entered an exclusive agreement with a wholly-owned subsidiary of Hainan Sinotau Pharmaceutical Co., Ltd., a pharmaceutical organization with a broad China focus in oncology and other therapeutic areas, who will develop and commercialize Lymphoseek® (technetium Tc 99m tilmanocept) Injection in China. In exchange, Navidea will earn revenue based on unit sales to Sinotau, a royalty based on Sinotau’s sales of Lymphoseek and up to $2.5 million in milestones from Sinotau, including a $300,000 upfront payment. Lymphoseek is a novel, receptor-targeted, small-molecule radiopharmaceutical approved in the U.S. for use in lymphatic mapping to assist in the detection of lymph nodes in patients with breast cancer or melanoma and for use in guiding sentinel lymph node biopsy in certain oral cancer patients.
As part of the agreement, Sinotau is responsible for costs and conduct of clinical studies and regulatory applications to obtain Lymphoseek approval by the China Food and Drug Administration (CFDA). Upon approval, Sinotau will be responsible for all Lymphoseek sales, marketing, market access and medical affairs activities in China and excluding Hong Kong, Macau and Taiwan. Navidea and Sinotau will jointly support certain pre-market planning activities with a joint commitment on clinical and market development programs pending CFDA approval. In addition to the $300,000 upfront, Navidea is eligible for $700,000 in milestones up to and through product approval, and an additional $1.5 million in sales milestones.
“This agreement is part of our goal to make Lymphoseek available to as many physicians and cancer patients around the world as quickly and effectively as possible,” said Thomas Tulip, Ph.D., President and Chief Business Officer of Navidea. “We selected Sinotau as a partner in China given their success in developing and filing for market approvals on more than 20 drugs, their pharmaceutical sales and marketing experience, and their established relationships with hospitals and clinicians throughout China.”
“Our partnership combines Navidea’s expertise in radiopharmaceuticals, clinical development and manufacturing with our extensive development, regulatory, sales, and marketing capabilities,” commented Xu Xinsheng, Sinotau President and CEO. “The goal will be to offer a novel radiopharmaceutical to potentially spare patients from unnecessary surgery and which can play a critical role in staging and directing cancer treatment. We look forward to giving physicians this new tool in the fight against the many types of cancers common in China, such as breast, oral, and gastric cancers and contributing to bettering the lives of those afflicted with these conditions."
http://finance.yahoo.com/news/navidea-enters-lymphoseek-development-commercialization-113000092.html
Regulations for Implementation of the Drug Administration Law of the People's Republic of China
http://www.sfda.com/regulations-for-implementation-of-the-drug-administration-law-of-the-peoples-republic-of-china.html
DUBLIN, OH, July 17, 2014 -- Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced the results of voting at its 2014 Annual Meeting of Stockholders (the Annual Meeting) held July 17, 2014. Approximately 79 percent of outstanding shares were represented at the meeting.
At the Annual Meeting, Navidea’s stockholders:
| | · | Elected Michael M. Goldberg M.D. to the Navidea Board of Directors to serve for a term of three years; |
| | · | Voted in support of the Board-sponsored proposal to approve the Company’s 2014 Stock Incentive Plan; |
| | · | Approved, on an advisory basis, the compensation of the Company’s named executive officers; and, |
| | · | Ratified the appointment of BDO USA, LLP to act as the Company’s independent registered public accounting firm for 2014. |
The final results are subject to verification by the independent election inspectors and will be reported in a Form 8-K to be filed by Navidea with the Securities and Exchange Commission in the next few days.
Following the formal business portion of the Annual Meeting, Dr. Michael Goldberg, Navidea Interim CEO, and other members of the Navidea executive team made a series of presentations to stockholders in attendance at the Annual Meeting, including overviews on the following:
| | · | Lymphoseek® (technetium Tc-99m tilmanocept) Injection U.S. commercialization, label expansion and global partnering activities; |
| | · | Manocept™ CD206 targeting platform update, including a discussion of the new R-NAV venture; and, |
| | · | Neurodegenerative pipeline development status. |
In December 2013, the FDA granted Fast Track designation to Lymphoseek for sentinel lymph node detection in patients with head and neck cancer and we submitted a supplemental New Drug Application (sNDA) with the FDA seeking approval for the marketing and sale of Lymphoseek for the same indication. In assessing the data-rich submission, the FDA chose to separate the filing into two applications based on the proposed labeling extensions requested and the scope of information provided. The first sNDA, aimed at Lymphoseek’s use as a sentinel lymph node detection agent in patients with head and neck cancer, was accepted for review by the FDA in February 2014, and was granted Priority Review. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target review date for the first Lymphoseek sNDA of June 16, 2014. In March 2014, the FDA accepted for review the second sNDA to support broader and more flexible use of Lymphoseek in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other product capabilities. Under PDUFA, the FDA has set a target review date for the second sNDA of October 16, 2014.
ABOUT NAVIDEA BIOPHARHARMACEUTICALS: http://navidea.com/about-us/history/
TO SEE NEAR TERM CATALYSTS FOR NAVIDEA BIOPHARMACEUTICALS READ THIS:
Lymphoseek PDUFA DATE April 30, 2013
AZD4694
RIGScan
Publications for Lymphoseek http://navidea.com/development-programs/publications/bibliography.html
LATEST NEWS:
http://seekingalpha.com/article/2081013-navidea-the-future-of-the-company-will-be-borne-on-the-back-of-lymphoseek?source=yahoo
Navidea: The Future Of The Company Will Be Borne On The Back Of Lymphoseek Mar. 11, 2014
AZD4694" was compared head to head to the "Gold Standard"
http://finance.yahoo.com/news/head-head-study-comparing-navidea-120000885.html
5 Reasons To Buy Navidea Biopharmaceuticals - Seeking Alpha
http://seekingalpha.com/article/605661-5-reasons-to-buy-navidea-biopharmaceuticals
Navidea Biopharmaceuticals Elects to Extend Evaluation Period for Option to License Parkinson's Disease Imaging Agent
http://www.marketwatch.com/story/navidea-biopharmaceuticals-elects-to-extend-evaluation-period-for-option-to-license-parkinsons-disease-imaging-agent-2012-06-26
Neoprobe becomes Navidea Biopharmacuteuticals
http://ir.navidea.com/phoenix.zhtml?c=68527&p=irol-newsArticle&ID=1645017&highlight=
"
http://lifetechcapital.com/ltc/2015/02/navidea-navb-note-2-27-15/
http://internalmedicine.osu.edu/infectiousdiseases/directory/faculty/larryschlesinger/
http://www.navidea.com/about-us/board-of-directors/eric-rowinsky.html
http://www.bc.edu/schools/cas/biology/facadmin/williams.html
http://vet.osu.edu/rosol-thomas-j
http://cancer.ucsf.edu/people/profiles/mcgrath_michael.3373
http://internalmedicine.osu.edu/rheumatology/directory/faculty/waeljarjour/
http://www.bcrfcure.org/researchers/mark-i-greene
David Sidransky, M.D.
http://championsoncology.com/about-us/board-of-directors/
Other info links
New Drugs Online http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=5548
The efficacy of Tilmanocept in sentinel lymph mode mapping and identification in breast cancer patients: a comparative review and meta-analysis of the ??mTc-labeled nanocolloid human serum albumin standard of care. http://www.ncbi.nlm.nih.gov/pubmed/22729510
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This alert presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health.
NIHR Horizon Scanning Centre, University of Birmingham Email: nihrhsc@contacts.bham.ac.uk Web: www.hsc.nihr.ac.uk
Lymphoseek® for lymphatic mapping and sentinel lymph node location in breast cancer, head and neck cancer and melanoma
TECHNOLOGY
Lymphoseek®, also known as Technetium Tc 99m Tilmanocept, is an injectable radio-labelled tracer that has been designed for lymphatic mapping and sentinel lymph node location in breast cancer, head and neck cancer and melanoma. It has been developed by Navidea™ Biopharmaceuticals.
Lymphoseek® is injected into a primary tumour, and is designed to accumulate in any lymph nodes that drain from it. The radioactive label, technetium-99, can be detected using a hand-held gamma detector and helps to locate these lymph nodes either before or during surgery (lymphatic mapping). The first nodes to which a tumour drains can be located using this technique (sentinel node location). The spread of cancer can often be detected earliest in the lymph nodes and locating these can help to assess and stage the disease, and in planning further treatments. Currently in the NHS, the location, removal and testing of sentinel lymph nodes is carried out routinely for breast cancer and melanoma.
Lymphoseek® is made of a radio-labelled tracer molecule called tilmanocept which is approximately 7 nanometers in size and contains many units of a sugar called mannose. The mannose units bind to a specific receptor, CD-206, which is found in high concentrations on the surface of immune cells called macrophages and dendritic cells which are present in the lymph nodes. The company state on their website that the tracer accumulates within the lymph nodes within 10 minutes of injection and remains there up to 30 hours afterwards. Although no serious hypersensitivity reactions have been reported in clinical trials, Lymphoseek® may pose a risk of reactions due to its chemical similarity to dextran. The tracer is synthetic and not derived from animal or human products.
Technology
ALERT
Horizon Scanning Centre
October 2013
© Navidea Biopharmaceuticals
NIHR Horizon Scanning Centre
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A marketing authorisation application was submitted to the EMA in December 2012 and the company anticipate that Lymphoseek® will be launched in the UK by April 2014 for use in breast cancer, head and neck cancer and melanoma. It is also in trials for use in other cancers. The tracer was approved by the FDA for use in breast cancer and melanoma in March 2013.
POTENTIAL FOR IMPACT
Sentinel lymph node localisation and lymphatic mapping are currently performed using vital blue dye in combination with a non-binding radioactive tracer (sulphur colloid tagged with technetium), although increasingly the tracer is being used alone.
The company suggest that the innovative features of this tracer are its ability to bind to specific receptors in order to label and locate lymph nodes and its small size, which allows faster clearance of the tracer from the injection site than currently available methods. The FDA announcement when this tracer was approved suggests that use of this tracer may increase the number of lymph nodes identified during lymphatic mapping.
If proven to be more effective than current methods of lymphatic mapping and sentinel lymph node detection, this tracer may enable a more comprehensive assessment of melanoma, breast cancer and head and neck cancer. This will depend upon the number of additional lymph nodes correctly identified using this technique as compared with current UK practice.
The impact on patient outcomes of using this tracer will depend on the accuracy of any tests conducted on the identified lymph nodes and the efficacy of any treatments offered in response to these test results.
EVIDENCE
PUBLISHED PAPERS Sondak VK, King DW, Zager JS et al. Combined analysis of phase III trials evaluating [99mtc]tilmanocept and vital blue dye for identification of sentinel lymph nodes in clinically node-negative cutaneous melanoma. Annals of Surgical Oncology 2013;20(2):680–688. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3560941/ Wallace AM, Han LK, Povoski SP et al. Comparative evaluation of [(99m)tc]tilmanocept for sentinel lymph node mapping in breast cancer patients: results of two phase 3 trials. Annals of Surgical Oncology 2013;20(8):2590-2599. http://www.ncbi.nlm.nih.gov/pubmed/23504141 Tokin CA, Cope FO, Metz WL et al. The efficacy of Tilmanocept in sentinel lymph mode mapping and identification in breast cancer patients: a comparative review and meta-analysis of the 99mTc-labeled nanocolloid human serum albumin standard of care. Clinical and Experimental Metastasis 2012;29(7):681-686. http://www.ncbi.nlm.nih.gov/pubmed/22729510 Leong SP, Kim J, Ross M et al. A phase 2 study of (99m)Tc-tilmanocept in the detection of sentinel lymph nodes in melanoma and breast cancer. Annals of Surgical Oncology 2011;18(4):961-969. http://www.ncbi.nlm.nih.gov/pubmed/21331809 Wallace AM, Hoh CK, Limmer KK et al. Sentinel lymph node accumulation of Lymphoseek and Tc-99m-sulfur colloid using a "2-day" protocol. Nuclear Medicine and Biology 2009;36(6):687-692. http://www.ncbi.nlm.nih.gov/pubmed/19647175
NIHR Horizon Scanning Centre
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Wallace AM, Hoh CK, Darrah DD et al. Sentinel lymph node mapping of breast cancer via intradermal administration of Lymphoseek. Nuclear Medicine and Biology 2007;34(7):849-853. http://www.ncbi.nlm.nih.gov/pubmed/17921035 Wallace AM, Hoh CK, Ellner SJ et al. Lymphoseek: a molecular imaging agent for melanoma sentinel lymph node mapping. Annals of Surgical Oncology 2007;14(2):913-21. http://www.ncbi.nlm.nih.gov/pubmed/17146742 de Paulis T. Drug evaluation: Lymphoseek - Neoprobe's sentinel lymph node imaging agent for use in cancer patients. Current Opinion in Investigational Drugs 2006;7(12):1100-1107. http://www.ncbi.nlm.nih.gov/pubmed/17209528 Ellner SJ, Hoh CK, Vera DR et al. Dose-dependent biodistribution of [99mTc]DTPA-mannosyl-dextran for breast cancer sentinel lymph node mapping. Nuclear Medicine and Biology 2003;30(8):805–810. http://www.ncbi.nlm.nih.gov/pubmed/14698783 COMPLETE UNPUBLISHED STUDIES
Clinicaltrials.gov. Evaluation of sentinel lymph nodes in head and neck squamous cell carcinoma. http://clinicaltrials.gov/show/NCT00911326 Accessed 26 September 2013.
Final results are awaiting submission for publication and published interim results are listed below: Marcinow AM, Hall N, Byrum E et al. Use of a novel receptor-targeted (CD206) radiotracer, 99mTc-Tilmanocept, and SPECT/CT for sentinel lymph node detection in oral cavity squamous cell carcinoma. Initial Institutional Report in an Ongoing Phase 3 Study. Journal of the American Medical Association. Otolaryngology Head and Neck Surgery 2013;139(9):895-902. http://www.ncbi.nlm.nih.gov/pubmed/24051744 Comparison of false negative rates (FNR) & overall accuracy (AC) of sentinel lymph node biopsy (SLNB) in phase 3 99mTc-tilmanocept (TcTM) vs ACOSOG Z-0360 99mTc-sulfur colloid (TcSC) in head/neck squamous cell cancer (SCC). Society of Nuclear Medicine and Molecular Imaging. June 2013. Abstract No. 512. http://jnumedmtg.snmjournals.org/cgi/content/meeting_abstract/54/2_MeetingAbstracts/512 ONGOING STUDIES
No ongoing studies in breast cancer, head and neck cancer or melanoma were identified for this alert.
INFORMATION FROM
This Alert is based on information from the company and a time-limited internet search.
MORE NEWS:
Governor Patrick, Industry Representatives Join Navidea Biopharmaceuticals
http://www.marketwatch.com/story/governor-patrick-industry-representatives-join-navidea-biopharmaceuticals-to-open-new-business-and-commercialization-facility-in-andover-ma-2012-06-07
PRESS RELEASES
http://finance.yahoo.com/q?s=navb
Navidea website site map
http://www.navidea.com/sitemap.html
FDA Approval
http://ir.navidea.com/phoenix.zhtml?c=68527&p=irol-newsArticle&ID=1795851&highlight=
Navidea Biopharmaceuticals Resubmits New Drug Application for Lymphoseek® to FDA
http://ir.navidea.com/phoenix.zhtml?c=68527&p=irol-newsArticle&ID=1752222&highlight=
Navidea Biopharmaceuticals Receives Complete Response Letter from FDA for Lymphoseek® NDA Due to Manufacturing Deficiencies
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Lymphoseek http://ir.navidea.com/phoenix.zhtml?c=68527&p=irol-newsArticle&ID=1702280&highlight=
ADZ4694 http://ir.navidea.com/phoenix.zhtml?c=68527&p=irol-newsArticle&ID=1704234&highlight=
Navidea Obtains Positive EMA Guidance for Lymphoseek in EU http://ir.navidea.com/phoenix.zhtml?c=68527&p=irol-newsArticle&ID=1655424&highlight=