Precigen Inc. (NASDAQ: PGEN) announced that the U.S. Food and Drug Administration granted orphan drug exclusivity for PAPZIMEOS (zopapogene imadenovec-drba) for treating adults with recurrent respiratory papillomatosis.

The seven-year market exclusivity period runs through August 14, 2032, from the drug's approval date in August 2025. PAPZIMEOS became the first FDA-approved therapy for adults with recurrent respiratory papillomatosis, a rare chronic disease affecting the respiratory tract.

The orphan drug designation applies to treatments for rare diseases affecting fewer than 200,000 people in the United States. According to the company's internal analysis of claims data and electronic health records, approximately 27,000 adult patients in the U.S. have recurrent respiratory papillomatosis.

PAPZIMEOS is currently commercially available in the United States and being prescribed at medical centers and community practices nationwide. The drug is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response against HPV 6 and HPV 11 proteins in patients with the condition.

"This regulatory exclusivity, together with Precigen's patent portfolio covering PAPZIMEOS and its therapeutic use, enhances the product's value by strengthening market protection and long-term revenue potential," said Helen Sabzevari, Precigen's president and CEO.

Recurrent respiratory papillomatosis is caused by chronic HPV 6 or HPV 11 infection and can lead to voice disturbance, compromised airways, and recurrent pneumonia. Traditional management has involved repeated surgeries that do not address the underlying cause of the disease.

Precigen is a commercial-stage biopharmaceutical company based in Germantown, Maryland, that develops precision medicines for difficult-to-treat diseases.