Healthcare Industry News: sentinel lymph node
News Release - July 20, 2011
Neoprobe Establishes European Business UnitEntity Enables Lymphoseek Registration, Commercialization in EU
DUBLIN, Ohio--(Healthcare Sales & Marketing Network)-- Neoprobe Corporation (NYSE Amex: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has established a European business unit to address EU development and commercialization needs for its novel technologies, including Lymphoseek® (99mTc-tilmanocept).
The European business unit underscores Neoprobe’s expanding focus on realizing global commercialization opportunities as the Company continues development of its near- and long-term pipeline. Europe in particular is an important market for Neoprobe, with an established radiopharmaceutical industry and strong clinical practice of lymphatic mapping in a variety of cancers, including breast cancer and melanoma. Among European Union countries, breast cancer and melanoma together account for over 400,000 estimated new cases annually, comparing similarly to the annual incidence rates observed in the United States.1,2
To access international markets, Neoprobe intends to leverage its development strengths to identify and establish relationships with key partners who can provide marketing, sales and distribution capabilities using existing infrastructure for Lymphoseek and other products.
“Establishing a European presence marks an important step for Neoprobe in maximizing the value of Lymphoseek and the potential of the Company’s pipeline,” said Mark Pykett, President and Chief Executive Officer of Neoprobe. “This development builds on positive Neoprobe activities in the U.S. where the submission of the Lymphoseek New Drug Application to the U.S. Food & Drug Administration remains on target for the third quarter of 2011.”
“With the establishment of our European entity, Neoprobe is taking steps to advance Lymphoseek in international markets. The global cancer diagnostics and treatment landscape provide significant opportunities for Lymphoseek to positively impact patient care and advance the standard of medical practice,” said Thomas Tulip, Executive Vice President and Chief Business Officer of Neoprobe. “In Europe, we believe the partnership potential for Lymphoseek is strong based on the discussions we have held to date. Finalizing EU distribution relationships remains an important focus for our Company going forward.”
Lymphoseek is a proprietary radioactive diagnostic tracing agent being developed for use in connection with gamma detection devices in a surgical procedure known as Intraoperative Lymphatic Mapping. Two Phase 3 multi-center clinical trials (www.clinicaltrials.gov, trial registration numbers NCT00671918 and NCT01106040) for Lymphoseek in patients with breast cancer or melanoma have concluded. A third Phase 3 clinical study to evaluate the efficacy of Lymphoseek as a sentinel lymph node tracing agent in patients with head and neck squamous cell carcinoma is currently ongoing (www.clinicaltrials.gov, trial registration number NCT00911326).
Neoprobe is a biomedical company focused on enhancing oncology patient care and improving patient benefit through radiopharmaceutical product development. Neoprobe is actively developing two radiopharmaceutical agent platforms – Lymphoseek® and RIGScanTM CR – to help surgeons better identify and treat certain types of cancer. Neoprobe’s subsidiary, Cira
Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe’s strategy is to deliver superior growth and shareholder return by bringing to market novel radiopharmaceutical agents and advancing the Company’s pipeline program through continued investment and selective acquisitions. For more information, please visit
The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements within the meaning of the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
1 Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer. 2010 Mar;46(4):765-81. Epub 2010 Jan 29.
2 Statistical Information Team, Cancer Research UK, 2011.
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