Date: Thu, 18 Dec 1997 18:19:19 GMT Server: Apache/1.0.5 Content-type: text/html Content-length: 11184 Last-modified: Tue, 21 Oct 1997 20:16:56 GMT
"1996 was a year of Olympic achievements for Neoprobe Corporation. We reached new heights in our progress toward providing tomorrows for cancer patients everywhere because of the dedicated efforts of the Neoprobe RIGS team, including staff, patients, physicians, and others worldwide who gave their maximum effort."
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Neoprobe achieved a number of significant milestones in 1996 that brought us closer to the launch of RIGScan CR49, our first surgical cancer detection product, from filing our first product marketing applications with the U.S. and European regulatory authorities to creating a marketing alliance unique to the biotechnology industry. Our accomplishments this year also enhanced our financial position and intellectual property holdings, putting the company on strong footing for the future. A public offering in April of 1.75 million shares of Neoprobe common stock at $18.50 per share raised $32.4 million. We received an additional $15 million from the exercise of more than 99 percent of 2.3 million outstanding series E warrants. Our marketing partnership agreement brought Neoprobe $2 million and the commitment of another $3.5 million upon marketing approvals in Europe and the U.S. along with funding for future research projects. With its strong cash position, Neoprobe is poised to make the transition to commercialization of our first product. RIGScan CR49 Progress Neoprobe achieved two major goals this year by submitting our first product marketing applications in both the U.S. and Europe. We filed a Biologics License Application (BLA) with the United States Food and Drug Administration (FDA) for RIGScan CR49 in December. Earlier in the year, we were among the first companies to file a "dossier," a similar marketing application, to the centralized European regulatory authorities for approval by the Committee for Proprietary Medicinal Products (CPMP). Neoprobe believes that both applications could be approved in 1997. |
The first comprehensive, multicenter results from the company's pivotal studies with RIGScan CR49 for metastatic colorectal cancer were discussed at the Society of Surgical Oncology's 49th Annual Cancer Symposium. The data showed that RIGScan CR49 accurately identified tumor in more than 90 percent of patients and helped surgeons find additional pathology-confirmed cancer in a significant number of patients. For the first time, pivotal phase III trial data for RIGScan CR49 were presented at the American College of Surgeons (ACS) Clinical Congress. John Daly, M.D., Surgeon-in-Chief, New York Hospital, presented the paper to a capacity crowd of ACS surgeons. Neoprobe reached another significant goal when we signed a unique marketing agreement with United States Surgical Corporation (USSC), Norwalk, Conn.,
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President and Chief Operating Officer John L. Ridihalgh, Ph.D. Chairman of the Board and Chief Executive Officer |
giving USSC exclusive worldwide sales and marketing rights to RIGS surgical detection products. Neoprobe will recognize the full revenue of RIGS product sales, retain primary responsibility for product development and manufacturing, and maintain customer contact through its distribution service responsibility. USSC, the foremost creator and developer of new surgical markets, will promote and sell the product, conduct physician training, and provide research and development royalties to Neoprobe.
Under the guidance of our new vice president of marketing, Neoprobe attained record sales of the Neoprobe 1000 device for use with the intraoperative lymphatic mapping (ILM) technique for malignant melanoma and, investigationally, breast cancer. Our new regional sales force realized nearly $1 million in product revenue, most of it in the fourth quarter of 1996. In addition to generating revenue, these instrument sales are a strategy to place probes in surgical suites and in the hands of trained surgeons worldwide in anticipation of launching RIGScan CR49 in 1997.
Together, Neoprobe and USSC began developing future gamma detection devices and establishing a number of centers of excellence for lymphatic mapping training in addition to the well established program at the H. Lee Moffitt Cancer Center and Research Institute, Tampa, Fla.
It was truly a monumental day at Neoprobe in January 1997 when we received our first marketing approval for RIGScan CR49 in South Korea with our partner in the Korean peninsula, Damon Pharm Ltd. of Seoul. Damon Pharm also has exclusive marketing and distribution rights in Thailand, Taiwan, Singapore and Malaysia.
Advancing the Pipeline |
"The RIGS technology is important because it solves a very real problem. The dream we are beginning to realize is that our technology will have a profound impact on how cancer surgery is done by helping the surgeon find cancer that otherwise goes undetected."
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cancer patients. We prepared for commercial-scale RIGS/ACT cell processing through an agreement for use of cGMP facilities with Cellcor, a wholly owned subsidiary of Cytogen Corporation. Neoprobe entered into an investment and license agreement with XTL Biopharmaceutical, Ltd. of Rehovot, Israel, for exclusive rights to XTL's Trimera XTL for developing ACT products and for producing fully human monoclonal antibodies for RIGS and radioimmunotherapy (RIT). Looking Forward As 1997 unfolds, we will focus on continually advancing our pipeline of RIGS surgical cancer detection products and activated cellular therapy products for the treatment of cancer and chronic viral conditions. We will also participate proactively in the regulatory reviews of RIGScan CR49, and, with USSC, set the stage for product launch. As we near commercial introduction of our RIGS technology, we are conscious of its importance to people whose lives it may save, to doctors who will perform better cancer surgeries with better information, and to Neoprobe's future innovative developments. This report shares the thoughts, hopes, and dreams of a patient, a surgeon, and a visionary about a technology valuable to them and to you, our shareholders. Sincerely,
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