Diatide gains approval for lung imaging agent

NeoTect joins AcuTect in peptide agent portfolio

Radiopharmaceutical firm Diatide has received Food and Drug Administration approval for its NeoTect peptide-based lung imaging agent. NeoTect is the second Diatide product to receive FDA approval in the past 12 months; AcuTect, a peptide-based agent for imaging deep vein thrombosis, was cleared in September 1998 (SCAN 10/14/98).

NeoTect combines a small-molecule synthetic peptide with a molecule of technetium-99m and is intended to aid physicians in distinguishing between benign and malignant lung masses, according to Diatide. The agent is expected to be available for sale and shipment shortly after Labor Day, said Richard Dean, Diatide president and CEO. As a result of the FDA clearance, the company will receive a $2 million milestone payment from Nycomed Amersham shortly.

Londonderry, NH-based Diatide had formed an alliance with Nycomed in 1995 for R&D financial support and milestone payments in exchange for a five-year marketing and promotion option (SCAN 8/30/95). Although Nycomed Amersham sold its 1.5 million shares of Diatide common stock in June 1999 to a group of private investors (SCAN 6/23/99), the pharmaceutical giant continues to maintain a marketing and sales arrangement with Diatide.

Nycomed Amersham has filed a marketing authorization application (MAA) with the European Medicines Evaluation Agency for NeoTect. The EMEA has accepted the application as valid and NeoTect is expected to receive approval in late 1999 or early 2000, Dean said.

Results of a multicenter phase III clinical trial for NeoTect presented at the 1999 Society of Nuclear Medicine meeting concluded that the drug was effective for differentiating between benign and malignant pulmonary nodules, Dean said. Diatide’s core radiolabeled peptide technology was also the focus of an SNM educational session. Further clinical trials are now under way, evaluating NeoTect’s effectiveness at detecting melanoma and breast cancer.

“We believe there will be a significant amount of off-label investigation,” Dean said. “We are also developing a therapeutic agent using the same targeting component of NeoTect and including a beta-emitting radioisotope, rhenium-188, with it, to treat cancers without harming adjacent normal tissue.”

Other Diatide therapeutic agents under investigation include Stanamet, designed to relieve bone pain due to metastatic lung, breast, and prostate cancer.

The first half of 1999 has been active for Diatide. In addition to gaining FDA approval for NeoTect, the company won a favorable judgment from the U.S. Patent and Trademark Office in June acknowledging Diatide’s ownership of a peptide containing a specific chelator for linking peptide to Tc-99m (SCAN 6/23/99). This ruling will help settle related patent disputes in the company’s favor, according to Dean.