By Mary Welch
Diatide Inc. scored its second FDA approvable letter in 10 months, this time for NeoTect, a scintigraphic imaging product for suspected malignant lung tumors.
The company's new drug application (NDA) will be approved by the regulatory body after Diatide clarifies certain details and formally agrees to post-approval requirements.
"The majority of the FDA's issues were about chemistry and manufacturing," said Kris Piper, vice president of regulatory affairs for Londonderry, N.H.-based Diatide. "They are all resolvable, and we expect to answer the FDA by mid-January."
NeoTect (formerly P289) is a small synthetic peptide combined with technetium-99m. When a patient is suspected of having lung cancer, an X-ray or computed tomography scan is usually taken. However, both of those procedures can only determine if a mass - or tumor - is present, not whether it is malignant. The next step usually is a biopsy or open-chest surgery.
With NeoTect, such invasive, costly procedures are avoided. When the peptide is injected, it attaches itself to the somatostatin receptor on a 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.
Diatide's marketing partner, Nycomed Amersham plc, of London, submitted a marketing approval application to the European Medicines Evaluation Agency in late November. The two companies will share marketing duties in the U.S. for both AcuTect and NeoTect.
Nycomed paid a $2 million milestone to Diatide for the NDA submitted in June, and will pay another milestone when final approval is granted. The FDA has given NeoTect priority review status.
AcuTect, Diatide's other product, was approved by the FDA in September for the scintigraphic imaging of acute venous thrombosis (blood clots) in the lower extremities.
About 130,000 Americans each year show a solitary pulmonary nodule (SPN), or spot on an X-ray, said Ron Kinder, vice president and chief operating officer of Diatide. Sales of NeoTect could reach $50 million annually, he said. About two-thirds of all those patients will have a malignancy, allowing for the use of NeoTect again during follow-up exams.
Piper said development of NeoTect and AcuTect "sort of clogged up the pipeline lately." The company has two other imaging agents, P748 for pulmonary embolism and P483H for infection, that are expected to enter Phase III trials next year. Also expected to advance next year is P773, for imaging atherosclerotic plaque; that product is now in a Phase I study.
Diatide's stock (NASDAQ:DITI) closed Thursday at $7.25, up $0.25. n