BioIntegrator, LLC Announces the Second Market Registration of Nescler®, a First Generic of the Novartis MS Blockbuster Gilenya®

BioIntegrator, LLC Announces the Second Market Registration of Nescler®, a First Generic of the Novartis MS Blockbuster Gilenya®

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SAN DIEGO, May 16, 2016 /PRNewswire/ — BioIntegrator, LLC, a member of the ChemRar group of companies (Moscow, Russia), announced today the successful launch in Belorussia of Nescler®, a unique oral formulation of fingolimod, the blockbuster small molecule for treatment of remitting-relapsing multiple sclerosis. Following the initial registration of Nescler in Russia in 2014, the drug has been gaining access to other emerging markets, with subsequent registrations planned in the countries of the Eurasian Economic Union (EAEU), Middle East and North Africa region (MENA) and the Association of Southeast Asian Nations (ASEAN).

Belorussia, along with Russia, Kazakhstan, Kyrgyzstan and Armenia, is a part of the Eurasian Economic Union founded in 2000 (known as the Eurasian Economic Community until 2014) to create a single regional market with unified regulatory procedures for the territories of its member states. The EAEU pharmaceutical market has been growing rapidly ever since due to the increase in average income, aging population and extensive government support. Currently, the EAEU pharmaceutical market is one of the most profitable markets in the region, with the Belorussian, Kazakh and Russian markets experiencing some of the highest growth rates among the emerging markets in the world.

“The availability of Nescler, a generic drug developed by BioIntegrator for treatment of multiple sclerosis, is of tremendous importance for patients and health providers alike, especially in rapidly growing markets where the demand for affordable top-quality medicines is high,” said Nikolay Savchuk, Ph.D., Board member of ChemRar. “By lowering the cost of therapy, generics make it more accessible, and we hope that Nescler’s regulatory and marketing success in the high growth markets will pave the way for other first generic and biosimilar drugs.”

About Nescler:

Nescler® (fingolimod hydrochloride 0.56 mg) is a unique oral formulation of fingolimod developed by BioIntegrator, a ChemRar Group company. It reduces the rate of relapses in relapsing-remitting multiple sclerosis by approximately one-half over a two-year period and has been approved for treatment of chronic MS. Additional therapeutic applications are under investigation in ongoing clinical trials. With its therapeutic efficacy for MS proven in bioequivalence clinical trials and confirmed by numerous comparative preclinical studies, Nescler is currently the first generic of the Novartis drug Gilenya® in regulated markets.

About BioIntegrator:

BioIntegrator, LLC is a Russian biotechnology company developing and manufacturing first generics, biosimilars, as well as protein and antibody conjugates for treatment of cancer, rare and autoimmune diseases. Nescler® is the first drug in the BioIntegrator’s pipeline of MS treatments for development and registration in multiple markets. For more information, visit www.biointegrator.com.

About Multiple Sclerosis (MS):

Multiple sclerosis is a severe progressive neurological disease that affects the central nervous system and may cause disability among young and middle-aged adults. According to the National Multiple Sclerosis Society, relapsing-remitting multiple sclerosis (RRMS) is thought to affect over 2.3 million people worldwide, with the U.S. alone spending about $9 billion on MS therapy annually.


Nikolay Savchuk
Managing Partner
Torrey Pines Investment
6605 Nancy Ridge Drive
San Diego, CA 92121
t. +1858-724-0581
f. +1858-345-3761

SOURCE BioIntegrator, LLC         http://www.biointegrator.com


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May 18, 2016 / News