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Sandoz Announces New Data on Proposed Biosimilar Rituximab

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.

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars and currently markets three biosimilars worldwide. Sandoz has a leading biosimilar pipeline and plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

About the ASSIST-FL study
The study is a prospective, multi-center, randomized, double-blind, active-controlled, parallel-group, confirmatory Phase III trial comparing the efficacy, safety, PK and PD of GP2013 plus CVP versus MabThera® plus CVP. 629 patients were recruited across 159 centers in 26 countries, all with previously untreated advanced stage follicular lymphoma. The study is comprised of a combination treatment phase (six months), a maintenance phase (two years), and follow-up until three years after randomization. Having completed the combination phase, Sandoz is now reporting these data with results from the maintenance phase of the study expected in 2018.

About GP2013
GP2013, the Sandoz proposed biosimilar MabThera®, is being studied in a global development program which includes a comprehensive comparison of the biosimilar candidate and the reference product at the analytical, pre-clinical, and clinical levels. This includes a PK and PD study in rheumatoid arthritis (ASSIST-RA), an evaluation of the impact of transitioning from the reference product to the proposed biosimilar rituximab (ASSIST-RT) and a confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL). The development program also includes five pre-clinical studies.

About Sandoz
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high- quality medicine. Our portfolio of more than 1000 molecules, covering all major therapeutic areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached more than 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

*  MabThera® is a registered trademark of F. Hoffmann-La Roche AG

[1] Jurczak W et al. A Phase III efficacy and safety study of the proposed rituximab biosimilar GP2013 versus rituximab in patients with previously untreated advanced follicular lymphoma. Accessed December 2, 2016.

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