|Critical catalysts in the future for Neoprobe|
|By Patrick Crutcher|
|Monday, 20 September 2010 05:31|
Neoprobe Corporation (OTCBB: NEOP) has been making all the right moves lately. Investors currently are looking forward to an uplisting to AMEX and a NDA for NEOP’s Lymphoseek by the end of year. These are critical catalysts for the future of NEOP. NEOP has been in the medical device business for sometime and has begun transitioning to a biomedical systems focus.
NEOP’s main R&D interests have been on 2 products: Lymphoseek and RIGScan CR. For now, let’s focus on Lymposeek. Lymphoseek (Technetium Tc99m DTPA-mannosyl-dextran) is a proprietary radioactive lymphatic mapping targeting agent. This means that Lymphoseek is designed to identify sentinel lymph nodes that may be predictive of determining whether a patient’s cancer has spread into the lymphatic system. They have run very successful Phase 3 trials in melanoma and breast cancer. They have begun a trial in head and neck cancer for post-marketing claims. They estimate the market for Lymphoseek to be more than $350M.
Lymphoseek also has demonstrated superior site clearance and nodal binding characteristics, increased reliability, and a pain-free injection. Their Phase III breast and melanoma cancer trial results were 97% accurate with a 0% false-negative. Additionally, once Lymphoseek is approved, NEOP has an agreement with Cardinal Health to market and distribute it. They also have begun a 3rd trial, NEO3-09, which is designed to support post-marketing labeling for Lymphoseek after the approval of initial product labeling in the NDA and show superiority over currently used dyes. They hope to get a priority six-month review for Lymphoseek.
Just recently, NEOP presented data from their Phase III trial in breast cancer and melanoma patients, NEO3-05, at TERACHEM Symposium. More importantly, they stressed the following: “The Company today also announced that FDA has confirmed a meeting for early October to review the pre-NDA submission. The Company expects to file the NDA within weeks of the anticipated successful outcome of the final pre-NDA meeting.” Lymphoseek appears to be exactly what this company needs in order to really boost revenues and support development of their RIGScan CR.
Their RIGScan CR is the future of the company and any updates on its’ clinical development will be positives. NEOP’s RIGScan CR is designed to identify and evaluate potentially tumor-associated tissue in patients with colon or rectal cancer. It is a monoclonal antibody-based radiopharmaceutical tracer that binds to metastatic tissue. It provides surgeons with real-time information used to locate tumor components not detectable by conventional methods, and assist in the more thorough removal of the potentially cancerous tissue.
In April, the company filed an IND with the FDA, which includes their request for an SPA for their Phase 3 trial. The device originally came before the FDA in 1997. It’s original BLA was not approved in 1997, citing a lack of documentation quantifying the patient survival benefits. However, a retrospective survival study by Schneebaum et al. 2004, showed a very apparent survival advantage. They hope to have their Phase 3 approved by the FDA soon, as it is already accepted in the EU. The potential market for the RIGScan is roughly $2-3B, based on NEOP’s estimates.
NEOP recently began the process of uplisting to AMEX. This will be an ongoing process, but one would hope the sooner the better. In order to meet some of the requirements, NEOP was able to do a debt-equity swap and has filed a shelf registration. Once it begins trading on a bigger exchange, the stock will have increased volume and they might be able to attract some institutional investors.
NEOP presented recently at Rodman & Ramshaw’s Annual Global Investment Conference on the 13th, webcast can be found here: http://alturl.com/u6gd5
They also have 2 other presentations planned for the rest of the year.
NEOP has recurring revenues that help to offset some of the R&D costs and they have been resistant to diluting shareholder’s value.
We encourage investors to also see their 2010 Annual Meeting results: http://alturl.com/4z4qf
You can also find their most recent 10Q: http://alturl.com/qxa7t
NEOP seems to be on the right path and I look forward to tracking them.