FDA acceptance of ibrutinib NDA triggers milestone for Pharmacyclics

California, USA-based Pharmacyclics (Nasdaq: PCYC) said yesterday (August 29, 2013) that the US Food and Drug Administration has accepted for filing its New Drug Application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib, for two B-cell malignancy indications: previously treated mantle cell lymphoma (MCL) and previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Analysts at Credit Suisse have put a net present value for ibrutinib for CLL/MCL in the USA of $43.35 per share (73% of total) for Pharmacyclics. The company’s shares, which have already risen 93% so far this year, gained nearly 5% to $117.11 yesterday.

The FDA's acceptance of the NDA triggers a $75 million milestone payment to Pharmacyclics under its collaboration agreement with Janssen Biotech, a unit of US health care major Johnson & Johnson (NYSE: JNJ). The deal with Janssen involved $150 million upfront and further potential payments of $825 million to Pharmacyclics.