New interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product

Novartis International AG / New interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• ASSIST-FL trial demonstrates equivalent safety, efficacy, pharmacokinetics and pharmacodynamics of Sandoz proposed biosimilar rituximab (GP2013) to the reference product[1]

Interim data in over 600 adults show potential of GP2013 as an alternative rituximab[1]

Sandoz proposed biosimilar rituximab is the company's first monoclonal antibody candidate

Holzkirchen, December 5, 2016 - Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today announced data from the ASSIST-FL trial. The confirmatory safety and efficacy study shows GP2013 met its primary endpoint of overall response rate (ORR), demonstrating equivalence with the reference product, MabThera^®*, in 629 patients. Results were presented at the 58th Annual Meeting of the American Society of Hematology (ASH).

The combination treatment phase of the ASSIST-FL study - the first of a three-phase protocol - confirms that, for patients with previously untreated advanced follicular lymphoma, the ORR of GP2013 (87.1%) and the reference product (87.5%) were equivalent. Consistent with clinical practice, patients received cyclophosphamide, vincristine and prednisone (CVP) in addition to reference product or GP2013. The final results of the ASSIST-FL study are expected in 2018 after study completion.

"Sandoz recognizes the access challenges that healthcare systems are facing, particularly in long-term cancer care," said Mark Levick, Global Head of Development, Sandoz Biopharmaceuticals. "If approved, our medicine will offer a high-quality biologic treatment option that could free up resources. Not only would this allow for greater investment in new, innovative treatments, it could also provide more patients with blood cancers, like follicular lymphoma, access to potentially life-saving medicine."

The data demonstrated equivalent safety between Sandoz GP2013 and the reference product, with adverse events being consistent with those observed in previous clinical trials. Pharmacokinetics (PK) and pharmacodynamics (PD) were also found to be equivalent. Secondary endpoints of median progression-free survival and overall survival are not yet reported as the study is still blinded and data are evolving.