Company receives European CE Mark approvalAfter months of negotiation with the Food and Drug Administration, intraoperative probe developer Neoprobe announced this month its intention to seek a strategic partner for the development of RIGScan
Company receives European CE Mark approval
After months of negotiation with the Food and Drug Administration, intraoperative probe developer Neoprobe announced this month its intention to seek a strategic partner for the development of RIGScan CR49, a monoclonal antibody-based radiopharmaceutical used in the surgical detection of metastatic colorectal cancer. The Dublin, OH, company reported that it has hired Lehman Brothers for help in evaluating its corporate strategic assessment efforts.
Neoprobe makes devices used during surgery to track injected radiopharmaceuticals. The company's products can detect radioisotopes such as indium-111 and technetium-99m, but Neoprobe has long planned to develop its own monoclonal antibody for use with its probes to take advantage of the more effective targeting properties of these agents.
Neoprobe's plans were delayed, however, when the company received a nonapprovable letter from the FDA in December for RIGScan's biologics license application (BLA). The FDA has requested data that support the clinical and patient benefit of RIGS-positive test results, and Neoprobe and the FDA have agreed to preliminary clinical trials that will include both RIGS and control group patients and provide for interim data analysis. The delay prompted Neoprobe to cut its staff by 20% earlier this year in an effort to cut costs (SCAN 3/4/98).
The biggest problem arising out of the FDA's review of the agent is that Neoprobe's BLA must remain open until the company submits more clinical amendments, which may take as long as two years. Because it will take so long to resubmit, Neoprobe is seeking a partner to help develop the agent. The company declined to comment further on its plans for RIGScan.
On the positive side, Neoprobe said it planned to decrease its reliance on RIGScan by focusing on new therapeutic technologies in its R&D pipeline, such as activated cellular therapy (ACT), a method of treating oncology patients. The company reported that it hopes to see increased revenues from sales of its Neoprobe 1500 probes, which are now being sold by Johnson & Johnson's Ethicon Endo-Surgery division. In addition, Neoprobe received approval to apply the CE Mark to its Neoprobe 1500 19-mm chrome and 14-mm probes.
Neoprobe also announced second-quarter (end-June) revenues of $1.3 million, slightly up from last year's $1.1 million. The net loss for the quarter was $5.3 million, compared with $7.2 million in the second quarter of 1997. The company's operating expenses declined from last year, at $6.3 million in the second quarter, as compared with $8.7 million in 1997.