Polpharma Biologics Announces Global Commercialization Deal for Biosimilar Natalizumab, a Key Multiple Sclerosis Medicine

GDAŃSK,Poland,Sept. 3,2019 -- Polpharma Biologics S.A. ("Polpharma Biologics") today announces that it has entered a global commercialization agreement with Sandoz AG for a natalizumab biosimilar. The medicine is currently in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS). Under this agreement,Polpharma Biologics will be responsible for the development,manufacturing and supply of the collaboration biosimilar.

Polpharma Biologics is a European biopharmaceutical company focused on the development and manufacturing of biosimilar and novel biologic drugs. The company,with other associated companies within Polpharma Biologics Group,offers a fully integrated biologics service from cell line development to commercial product supply.

"This important commercial agreement marks a significant milestone in Polpharma Biologic's ongoing commitment to producing more affordable,high-quality biopharmaceuticals for patients worldwide",said Jerzy Starak,Chairman of Polpharma Biologics."We are delighted to combine expertise with our collaboration partner Sandoz AG to expand patient access to this important treatment option for RRMS. Natalizumab is the first of a number of late-stage pipeline developments we expect to be announcing in the near future."

Around 85% of people with multiple sclerosis (MS) are diagnosed with RRMS[1]. In addition to the personal burden of MS for patients and families,affordability is a significant challenge for MS medicines globally. A recent report highlighted that affordability was stated as the most common challenge accessing MS therapy in 46% of the 90 countries included[1]. Elsewhere it has been highlighted that providing access to disease-modifying therapies (DMTs) for MS represents a considerable challenge for healthcare systems[2].

Natalizumab,a DMT,offers patients a valuable therapeutic option for treating RRMS. Polpharma Biologic's collaboration partner will commercialize and distribute the medicine upon approval in all markets through an exclusive global license. Other specific terms of the agreement are confidential.

About Polpharma Biologics

Polpharma Biologics is a European biopharmaceutical company focused on the development and manufacturing of biosimilar and novel biologic drugs. Polpharma Biologics Group operates across centers of excellence in Poland,the Netherlands and Switzerland providing fully integrated solutions along the biopharmaceutical value chain. Polpharma Biologics Group offers cell line development,product and process development,clinical and commercial scale manufacturing to support its proprietary pipeline and portfolio of products,high quality contract development and manufacturing services to industry partners around the globe.

Polpharma Biologics: www.polpharmabiologics.com

References

Multiple Sclerosis International Federation. The atlas of MS international report. Available from: http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf [Last accessed: September 2019].

D'Amico E,et al. Pharmacoeconomics of synthetic therapies for multiple sclerosis. Expert Opin Pharmacother 2019:1–10.

Media contacts

Edward Oliver

Ruder Finn UK

+44(0)20-7438-3095

+44(0)789-409-5426

eoliver@ruderfinn.co.uk