Allergan challenges Celgene's Abraxane patent

Ireland-headquartered Allergan (NYSE: AGN) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration seeking approval to market paclitaxel protein-bound particles for injectable suspension, 100mg/vial.

Allergan’s ANDA product filing is a patent challenge to Celgene’s (Nasdaq: CELG) originator drug Abraxane, and the news pushed the company’s shares down 2.45% to $95.14. Celgene said it has received a Paragraph IV Notice Letter advising of the ANDA submission, which it is considering, but stressing that the company intends to vigorously defend its extensive intellectual property rights relating to Abraxane.

The drug is indicated for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy; locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy; and metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.