GENEVA & MOSCOW–(BUSINESS WIRE)–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.
FOR MORE INFORMATION
– Web www.selexis.com
– LinkedIn www.linkedin.com/company/selexis-sa
– Twitter www.twitter.com/SelexisSA
– Facebook www.facebook.com/SelexisSA
Contacts
Selexis Media Inquiries
Kelly Conlon
Sam Brown Inc.
+1
207-233-2430
kellyconlon@sambrown.com
Selexis Company Inquiries
Robert Meister
Head,
Corporate Communications
+1 602-953-1716
robert.meister@selexis.com
Generium Media Inquiries
Vsevolod Letsko
PR manager
Generium
Tel.:
+7 (495) 988-47-94 ext. 7020
pr@generium.ru
Generium Investor Inquires
Dmitriy Mamykin
The head of
international department
Generium
Tel.: +7 (495) 988-47-94
ext. 7073
bd@generium.ru