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Baxalta Announces Priority Review Status Granted by Health Canada for irinotecan liposome injection (nal-IRI) for New Drug Submission

BANNOCKBURN, Ill.--(BUSINESS WIRE)--Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced that Health Canada has granted Priority Review status for its New Drug Submission (NDS) for irinotecan liposome injection, also known as "nal-IRI". Baxalta is seeking marketing approval of nal-IRI from Health Canada for the treatment of patients with metastatic adenocarcinoma of the pancreas previously treated with gemcitabine-based therapy.

Priority Review allows for expedited review of critical new drugs faster than the standard timeline. Review by Health Canada is expected to be conducted in the second half of 2016. Baxalta is responsible for the development and commercialization of nal-IRI outside of the U.S. and Taiwan under the exclusive licensing agreement with Merrimack Pharmaceuticals, Inc.

“We are encouraged by the decision Health Canada has made to review our NDS of nal-IRI on an expedited timeline,” said Salim Yazji, M.D., vice president and global therapeutics head, Oncology, Baxalta. “Pancreatic cancer is one of the few cancers for which survival has not improved substantially over the last few decades, largely due to late diagnosis, aggressiveness of the disease and limited treatment options. This is an important milestone for our joint efforts to bring nal-IRI to more patients worldwide and fight this devastating cancer of the pancreas to help fill a significant unmet medical need.”

The application is based upon the results of an international Phase 3 study (NAPOLI-1) conducted among patients with metastatic pancreatic cancer (mPaC) who previously received gemcitabine-based therapy. In combination with 5-fluorouracil (5-FU) and leucovorin (LV), nal-IRI achieved its primary and secondary endpoints by demonstrating a statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control group of patients who received a combination of 5-FU and LV. The most common Grade 3 or higher adverse events in patients receiving nal-IRI and 5-FU/LV were neutropenia, fatigue and gastrointestinal effects. This was the first global Phase 3 study in a post-gemcitabine setting to demonstrate a survival benefit in the treatment of this aggressive disease.

Baxalta and Merrimack recently enrolled the first patient in an exploratory Phase 2 clinical study of nal-IRI in previously untreated, metastatic pancreatic adenocarcinoma to assess the safety and efficacy of the...