By Mary Welch
For the second time in less than a year, Diatide Inc. has submitted a new drug application to the FDA. This time, the Londonderry, N.H.-based firm is seeking approval for P829 as an imaging agent for diagnosing lung cancer. Diatide's collaborator, Nycomed-Amersham, of London, has agreed to pay a $2 million milestone payment for the NDA filing.
"This is a good product and there is an urgent need for it," said Richard Dean, president and CEO. "This is part of our growth strategy, which will be to provide near-term revenue for the company. It's exciting to file our second NDA within 10 months of our first one, for AcuTect, and to get an approval letter 11 days after that filing."
P829 is a small-molecule, synthetic peptide combined with technetium-99m that can make the diagnostic procedure easier after an X-ray or computed tomography (CT) scan. When a patient is suspected of having lung cancer, an X-ray or CT scan is usually taken, but those procedures can only determine if a mass — or tumor — is present, not whether it is malignant or not. The next step usually is a biopsy or open chest surgery, both of which are invasive and costly. With P829, that is no longer the case.
Product Could Hit The Market In 2000
Injected P829 peptide attaches itself to the somatostatin receptor on the tumor. After a two-hour wait, the patient is scanned with a gamma camera, which can pick up the gamma signal emitted by the technetium. "If a bright light goes off," Dean told BioWorld Today in a May interview, "it means cancer." (See BioWorld Today, May 12, 1998, p. 1.)
P829, which, pending FDA approval, should be available by 2000, is still lacking a name. "I've got to get my marketing guys on that. We better come up with something pretty quick," Dean said.
Under its marketing agreement with Nycomed-Amersham, P829 is licensed to the recently merged British-Norwegian company for regulatory approval and distribution in Europe, South Africa and parts of the Middle East. In the U.S., the companies will copromote the product. Nycomed plans to file for European regulatory approval within 30 to 60 days. Diatide, which has 70 employees, gets another $2 million milestone upon regulatory approval. To date, the company has received more than $17 million from the 1995 collaboration. (The company has not yet received the check for the FDA filing milestone.)
The company expects AcuTect, a diagnostic test for finding acute venous thrombosis, to be on the market by the third quarter of this year. Diatide reported 1997 revenues $4.1 million. (See BioWorld Today, Feb. 24, 1998, p. 1.)
The company's stock (NASDAQ:DITI) closed Tuesday at $8.375, up $0.25. *