Generium Launches First Biosimilar of Eculizumab; Becomes Fifth Marketed Product Using Selexis SUREtechnology Platform

Geneva, Switzerland, and Moscow, Russia, April 9, 2019 – Selexis SA and Generium JSC today announced that a fifth Selexis SUREtechnology Platform™-generated biological product has been approved for marketing. The latest approved product is a biosimilar monoclonal antibody, eculizumab, indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Generium is the first company in the world to develop and market a biosimilar of eculizumab.

Paroxysmal nocturnal hemoglobinuria is a rare, life-threatening disease of the blood characterized by destruction of red blood cells by the complement system, a part of the body’s innate immune system. In people with PNH, eculizumab reduces both the destruction of red blood cells and need for blood transfusion. Atypical hemolytic uremic syndrome is an extremely rare, life-threatening and progressive disease that frequently has a genetic component. In most cases it is caused by chronic, uncontrolled activation of the complement system. The disease is characterized by the formation of blood clots in small blood vessels throughout the body, which can lead to stroke, heart attack, kidney failure, and death. Eculizumab significantly improves renal function in patients with aHUS.

“This biologic’s market approval in Russia represents another major milestone for Selexis,” said Igor Fisch, PhD, CEO, Selexis SA. “There are currently more than 115 clinical programs utilizing the SUREtechnology Platform, including nine Phase 3 programs. The increasing number of Selexis-generated research cell banks used in clinical programs, and now a fifth marketed product, validate our ongoing scientific innovation and our commitment to helping our partners address complicated and intractable diseases by developing complex protein therapeutics faster, safer and more cost efficiently.”

“The joint efforts of Russian, U.S. and Swiss scientists have made it possible to achieve significant progress in the development of high-tech medicines for the treatment of rare diseases such as a PNH and aHUS, with the economic benefits of local production,” said Dmitriy Kudlay, CEO of Generium. “We believe working with Selexis improves the quality of our products and we are proud to take another step forward in helping the clinical community in Russia in their fight against rare diseases."

Selexis’ SUREtechnology Platform is based on Selexis SGE^® (Selexis Genetic Elements) — novel human DNA-based elements that control the dynamic organization of chromatin across mammalian cells. These elements increase transcription rates of transgenes by rendering the expression cassette independent of the locus of integration and thus allowing higher and more stable expression of any recombinant proteins. SUREtechnology improves the way cells are used in the discovery, development and manufacturing of recombinant proteins.

The Selexis SURE CHO-M Cell Line™ is a proprietary high-performance mammalian cell line derived from CHO-K1 cells. The genome of Selexis SURE CHO-M Cell Line has been fully sequenced and is used to characterize the sequence of the transgene, identify transgene integration loci and to document the monoclonality of cell populations. Selexis SURE CHO-M Cell Line is used for the production of therapeutic recombinant proteins and monoclonal antibodies.

About Selexis SA

Selexis SA, a JSR Life Sciences Company, is the global leader in cell line development with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop and commercialize innovative medicines and vaccines. Our global partners are utilizing Selexis technologies to advance more than 115 drug products in clinical development and the manufacture of five commercial products. As part of a comprehensive drug development process, the Company’s technologies shorten development timelines and reduce manufacturing risks. JSR’s CDMO service offering leverages the full capabilities of Selexis’ proprietary SUREtechnology Platform™ to offer an end-to-end solution to the industry. More information is available at www.selexis.com.

About Generium

Generium is the leading Russian biopharmaceutical company, focused on developing and commercializing diagnostic systems and pharmaceutical products for the treatment of orphan diseases, infection diseases, cancer, multiple sclerosis, myocardial infarction and strokes. Generium consists of a high-end R&D center and a fully integrated manufacturing plant. Generium has more than 30 innovative products in the pipeline, including enzymes, monoclonal antibodies and ATMPs. Generium is headquartered in Moscow, Russia. Additional information can be found at www.generium.ru/en.

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