BioIntegrator Announced Launch of Neskler(R) -- a Generic of Novartis MS Blockbuster Gilenya(R) in Emerging Markets
SAN FRANCISCO, CA--(Marketwired - Jan 11, 2016) - BioIntegrator LLC (a ChemRar company) of Moscow, Russia announced that it has successfully launched Neskler® -- the first generic of fingolimod in regulated pharmaceutical markets. Fingolimod, the blockbuster small molecule for remitting-relapsing multiple sclerosis treatment, is currently marketed as Gilenya® by Novartis. Following Neskler® registration in Russia in 2014 BioIntegrator prevailed over Novartis in a series of court hearings including the Appeal Committee of the Arbitrary tribunal for Intellectual Property of Moscow. In the most recent decision of December 17th, 2015 the court decided to reject all Novartis claims against Biointegrator LLC and the Russian Ministry of Health. In addition to expanding Neskler® sales in Russia and several countries of EuroAsian Economic Union, BioIntegrator sought partnerships in development of new formulations and indications of fingolimod including market registration and sales in international markets including United States, European Union and other countries.
After four years of development Neskler® has proven to be safe and effective in comparative clinical trials. Russian Ministry of Health approved Neskler for marketing and sales in Russia in November 2014. Multiple sclerosis patient organizations and healthcare providers supported this decision, as BioIntegrator offered a significant advantage in access to drug for patients compared to Gilenya. BioIntegrator had to defend its right to manufacture and market Neskler after Novartis had accused it and the Russian Ministry of Health of breaching Novartis data exclusivity and violating WHO regulations.
"This regulatory and marketing milestone is important for BioIntegrator and ChemRar as it establishes the precedent for other first generics, bio similars and me-better drugs that will appear on the Russian and other high growth markets soon. We believe it will bring a tremendous benefit to both patients and healthcare providers," said Nikolay Savchuk, Board member of ChemRar and Managing Partner of Torrey Pines Investment of San Diego CA.
About Neskler®:
An oral medication for the treatment of relapsing forms of Multiple Sclerosis in adults. Used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability.
About Multiple Sclerosis: Multiple sclerosis is a chronic inflammatory disorder of the central nervous systemand is one of the most common causes of nontraumatic disability among young and middle-aged adults. According to National Multiple Sclerosis Society, relapsing-remitting multiple sclerosis (RRMS) is thought to affect 400,000 people in the US and more than 2.3 million people worldwide. MS-related healthcare costs are estimated to be more than $10 billion annually in the United States.
About BioIntegrator:
BioIntegrator LLC is a ChemRar company engaged in a development and manufacturing of first generics, biosimilars and protein and antibody conjugates for treatment of cancer, rare and autoimmune diseases.
About ChemRar:
ChemRar is Russia's premier pharma enterprise focused on innovation to deliver affordable health care solutions to patients, partners and health care systems across the globe. Selebrating its 25th anniversary ChemRar is committed to reduce therapy costs of chronic diseases such as HIV and viral hepatitis, diabetes, cancer and autoimmune diseases to provide access to affordable treatment to patients globally. ChemRar drug pipeline includes Elpida® best in class ART for treatment of HIV, Aurixim® antibody conjugate for treatment of hematological cancers, gosogliptin for treatment of diabetes, Neskler® S1P1 agonist for treatment of Multiple Sclerosis. With a risk-balanced business model and product portfolio comprising small and large molecules, biosimilars and generics, branded formulations and research services, ChemRar Group is serving its patients and customers globally.
About Eurasian Economic Union:
Eurasian Economic Union (EAEU or EEU) is an economic union of states located primarily in northern Eurasia. A treaty aiming for the establishment of the EEU was signed on 29 May 2014 by the leaders of Belarus, Kazakhstan and Russia, and came into force on 1 January 2015. Treaties aiming for Armenia's and Kyrgyzstan's accession to the Eurasian Economic Union were signed on 9 October 2014 and 23 December, respectively. Armenia's accession treaty came into force on 2 January 2015.