Generium Launches First Biosimilar of Dornase Alfa; Becomes Sixth Approved Product Using Selexis SUREtechnology Platform

GENEVA & MOSCOW–(BUSINESS WIRE)–Selexis SA and Generium JSC today announced that a sixth Selexis SUREtechnology Platform™-generated biological product has been approved for marketing. The latest approved product, dornase alfa inhalation solution, is used together with antibiotics, bronchodilators, and steroids to control symptoms of cystic fibrosis. Generium is the first company in the world to develop and market a biosimilar of dornase alfa.

According to the National Institutes of Health, cystic fibrosis is an inherited disease characterized by the buildup of thick, sticky mucus that can damage many of the body’s organs. The disorder’s most common signs and symptoms include progressive damage to the respiratory system and chronic digestive system problems. The features of the disorder and their severity varies among affected individuals.

“This biologic’s market approval in Russia represents another major milestone for Selexis and we are pleased to recognize the work of Generium in delivering the fifth and sixth approvals using our SUREtechnology Platform,” said Igor Fisch, PhD, CEO, Selexis SA. “There are currently 122 clinical programs in development utilizing our platform. The increasing number of Selexis-generated research cell banks used in clinical programs, and now a sixth marketed product, continue to validate the value of our scientific innovation. We are extremely proud of our ability to help our partners address complicated and intractable diseases by developing complex protein therapeutics faster, safer and more cost efficiently.”

“We believe patients will be able to maintain a higher quality of life on our dornase alfa inhalation solution,” said Prof. Dmitriy Kudlay, CEO, Generium JSC. “The orphan drugs market has been growing significantly over the last several years. Biotechnology, as a science, is developing rapidly, providing new products for the treatment of the most severe and 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 protein. 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 120 drug products in clinical development and the manufacture of six commercial products. As part of a comprehensive drug development process, the Company’s technologies shorten development timelines and reduce manufacturing risks. 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.

Contacts

Selexis Media Inquiries
Kelly Conlon

Sam Brown Inc.

+1 207-233-2430

[email protected]

Selexis Company Inquiries
Robert Meister

Head, Corporate Communications

+1 602-953-1716

[email protected]

Generium Media Inquiries
Vsevolod Letsko

Head, External Communications

Generium

Tel.: +7 (495) 988-47-94 ext. 7020

[email protected]

Generium Investor Inquires

Dmitriy Mamykin

Head, International Department

Generium

Tel.: +7 (495) 988-47-94 ext. 7073

[email protected]