On October 30, 2012, Navidea resubmitted its Lymphoseek new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in response to the complete response letter (CRL) the Company received in September 2012.
On September 10, 2012, Navidea announced that it had received a CRL from the FDA regarding the NDA for Lymphoseek (technetium Tc 99m tilmanocept) Injection. The CRL focused on current Good Manufacturing Practice (cGMP) deficiencies identified during inspections of third-party manufacturing facilities and did not cite any Lymphoseek clinical efficacy or safety issues. Since receipt of the CRL, the Company has worked diligently with its advisors, contract manufacturers and the FDA to address the deficiencies noted in the CRL. While the Company is unable to predict the timing for FDA review, it does believe that the focused scope of the CRL and the corresponding information provided in the Company’s response will facilitate a timely evaluation of the resubmission.
“We continue to believe the FDA review process will involve re-evaluation of only a small portion of the NDA and that the focused information we have provided will support a potentially expeditious review,” said Dr. Mark Pykett, Navidea President and CEO. “Our clear priority continues to be Lymphoseek approval and launch in the U.S. We are committed to providing this novel radiopharmaceutical for use in critical diagnostic procedures for medical professionals, cancer patients and their families.”Other Recent Business and Program Highlights
- Completed the sublicense agreement with Alseres Pharmaceuticals, Inc. for a second promising neuroimaging candidate. NAV5001 is an Iodine-123 radiolabeled imaging agent being developed as an aid in the diagnosis of Parkinson’s disease and other movement disorders and a potential use as a diagnostic aid in dementia.
- Enrolled the first subject in a Phase 2 clinical trial of NAV4694, Navidea’s F-18 PET imaging agent being developed as an aid in diagnosing Alzheimer’s disease.
- Received a Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) for development of our radioimmunoguided surgery (RIGS ®) agent aimed at detecting metastatic cancer, with potential funding of up to $1.5 million over three years if fully funded. The first-year Phase 1 funding of $315,000, which has already been approved, is expected to enable the Company to complete preclinical bridging activities using a RIGS tumor-antigen-targeted monoclonal antibody and prepare a standardized clinical trial protocol.
- Published the results of Lymphoseek Phase 3 clinical trials in melanoma in the online edition of the journal Annals of Surgical Oncology. The data indicated that Lymphoseek met the primary efficacy endpoint in the assessment of lymphatic mapping performance in patients with cutaneous melanoma. The study was titled, “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,” [DOI 10.1245/s10434-012-2612-z].
- Presented data on Lymphoseek at major scientific and medical conferences:
- Lymphoseek Phase 3 meta-analysis data on Lymphoseek and radiolabeled colloidal agents presented at the 32 nd Congress of the European Society of Surgical Oncology by Dr. Frederick Cope.
- Additional podium and poster presentations highlighting similar Lymphoseek Phase 3 results were made at: the American Association of Pharmaceutical Scientists , the European Association of Nuclear Medicine , and the American Society for Radiation Oncology.
- Cornelia Reininger, M.D., Ph.D., joined Navidea as Chief Medical Officer. Previously, Dr. Reininger had a central role in the development of diagnostic radiopharmaceuticals for Alzheimer’s and Parkinson’s diseases for Bayer Healthcare Pharmaceuticals and GE Healthcare and Amersham Health – Diagnostic Imaging.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV