Approval Supports Company’s Planned Filing Position
DUBLIN, Ohio--(BUSINESS WIRE)-- On Friday, July 22, 2011, it was disclosed in a private company press release that the U.S. Food and Drug Administration (FDA) had approved use of sulfur colloid (Kit for the Preparation of Technetium Tc99m Sulfur Colloid) to locate lymph nodes in breast cancer patients. This approval was stated to be based on a literature review of past clinical trials. Importantly, in gaining approval, this statement indicates that the performance of sulfur colloid was compared only to vital blue dye alone.
The use of the vital blue dye as a comparator to support regulatory approval strategy is the same with which Neoprobe seeks FDA approval for Lymphoseek. Neoprobe believes that such an approval of sulfur colloid on this basis validates Neoprobe’s regulatory approach. Further, as opposed to a literature-based trial review conducted by others, Neoprobe will seek approval on the basis of comparison to vital blue dye in carefully designed, controlled and well executed clinical trials meeting current regulatory standards.
“This action reinforces the need for agents such as Lymphoseek in advancing care for cancer patients,” said Dr. Mark Pykett, Neoprobe’s President and CEO. “We and our regulatory advisors believe this FDA decision strongly confirms the regulatory pathway we have followed and reinforces the important role Lymphoseek can have in cancer-patient management.”
From a commercial perspective, Neoprobe has diligently prepared for, and always intended to, market the multiple advantages of Lymphoseek over sulfur colloid. The Company looks forward to demonstrating these advantages in the marketplace and believes it has the appropriate product positioning and strategic partners to be successful. The approval of sulfur colloid has not changed Neoprobe’s previously stated plan to submit the new drug application for Lymphoseek during the third quarter.
Neoprobe also announced that it will plan to release earnings for the second quarter of 2011 after the market close on Wednesday, July 27, 2011, followed by an earnings and business update conference call with the investment community prior to the market open on Thursday, July 28, 2011. Details related to the conference call will be released separately later today.
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 www.neoprobe.com.
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.
Brent Larson, Sr. VP & CFO, 614-822-2330
Michael Rice, 201-408-4923
Public Relations/Media Relations
Makovsky & Co.
Mark Marmur, 609-354-8135
KEYWORDS: United States North America Ohio
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Medical Devices Oncology Pharmaceutical FDA