Pharmacyclics Says EMA Accepts Type II Variation Application For IMBRUVICA

(RTTNews) - Pharmacyclics, Inc. (PCYC) said the type II variation application for IMBRUVICA has been accepted by the European Medicines Agency or EMA.

This submission, filed by strategic partner Janssen-Cilag International NV or Janssen, represents a potential label expansion for IMBRUVICA in the European Union or EU for the treatment of adult patients with Waldenstrom's macroglobulinemia or WM, a rare type of B-cell lymphoma for which treatment options are limited in the EU, according to the company.

Pharmacyclics noted that if IMBRUVICA IS approved, IT would be the first label specifically authorized to treat WM.

Giving a brief description on IMBRUVICA, the company said it is a first-in-class, oral, once-daily, therapy being jointly developed and commercialized in (U.S.) by Pharmacyclics and Janssen Biotech, Inc. Janssen affiliates will hold the marketing authorization and market IMBRUVICA in Europe, Middle East, Africa, as well as the rest of the world, outside the U.S.

The company noted that the acceptance of the WM Type II variation submission for IMBRUVICA triggers a $20 million milestone payment to Pharmacyclics under its collaboration agreement with Janssen Biotech, Inc.