Launch of Generium’s Omalizumab Biosimilar for Atopic Bronchial Asthma Marks Selexis’ Ninth Commercial Product

Third Biosimilar to Reach the Market Under Selexis/Generium Commercial License Agreements

GENEVA & MOSCOW--(BUSINESS WIRE)--Selexis SA and Generium JSC today announced that Genolar^®, Generium’s biosimilar of omalizumab, is now commercially available in Russia for the treatment of persistent atopic bronchial asthma and resistant chronic idiopathic urticaria. Genolar is the third Selexis SUREtechnology Platform™-generated biosimilar to reach the market under commercial license agreements between Generium and Selexis. It marks the ninth marketed biologic product to leverage Selexis’ SUREtechnology Platform™.

Genolar is a recombinant humanized IgG1k monoclonal antibody (mAb) biosimilar that binds to free human immunoglobulin E (IgE). Genolar is used to improve the control of moderate to severe persistent asthma that is caused by an allergy, the symptoms of which are not sufficiently controlled by the use of inhaled glucocorticosteroids in patients aged 6 years and older. The biosimilar is also indicated for use for the treatment of chronic (long-term) spontaneous urticaria (itchy rash) in patients with elevated IgE who do not respond to treatment with antihistamines in ages 12 and older.

“Our collaboration with Generium is a proof of Selexis’ ability to provide to our clients stable and scalable high-titer cell lines for cost effective clinical and commercial production, and we’re thrilled to play a continued role in the success of Generium’s programs,” said Roland Hecht, PhD, Selexis chief business officer. “Individuals coping with chronic diseases such as atopic asthma deserve access to novel, affordable medicines. The introduction of effective biosimilars like Genolar makes that possible, while also aligning with Selexis’ patient-centric mission.”

Atopic asthma is the most common form of asthma, affecting 70–90% of children and about 50% of adult sufferers. Exposure to environmental proteins called allergens is responsible for the characteristic symptoms. Chronic idiopathic urticaria is chronic hives that occur for a total duration of six weeks or more that have no clear trigger.

"Our longstanding partnership with Selexis has brought forth multiple therapeutic solutions in the fields of hematology and pulmonology for the development of CHO-generated biosimilar products,” said Daniil Talyanskiy, Generium chief executive officer. “Selexis’ reputation as a leading cell line developer is unparalleled and vital to our success bringing high-quality biologics to the Russian healthcare system."

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 150 drug candidates in preclinical and clinical development and the manufacture of nine 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.

FOR MORE INFORMATION

- Web www.selexis.com
- LinkedIn www.linkedin.com/company/selexis-sa
- Twitter www.twitter.com/SelexisSA
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About Generium

GENERIUM is a biotechnology company, the leader in the Russian pharmaceutical market for orphan diseases. The Company possesses its own R&D park, which is capable of developing any biotech product, from molecule design to commercial production. GENERIUM's manufacturing facilities are organised in strict compliance with international GMP standards. The Company's plants produce a unique variety of biotech products and are capable of manufacturing any kind of biomedical cell products. Additional information can be found at www.generium.ru/en.

FOR MORE INFORMATION

- Web www.generium.ru
- LinkedIn https://www.linkedin.com/company/ibc-generium
- Facebook www.facebook.com/generiumru
- Instagram https://www.instagram.com/generium_pharmaceuticals/

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