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Strategic international cooperation in the life sciences sector: Eversheds Sutherland advises Otsuka on its cooperation with R-Pharm to fight multidrug-resistant tuberculosis in the Russian Federation and the Commonwealth of Independent States

  • Germany


    Global legal practice Eversheds Sutherland has advised Otsuka on a licensing agreement with Russian pharmaceutical company R-Pharm to commercialize Deltyba™ (delamanid) for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in the Russian Federation and the Commonwealth of Independent States (CIS).

    Under the terms of the agreement, Otsuka’s German subsidiary Otsuka Novel Products GmbH (ONPG) has granted R-Pharm the license to register Deltyba™ in the Russian Federation and commercialize the product following regulatory approval. Otsuka and R-Pharm have also entered into discussions to develop a technology transfer plan to facilitate local manufacturing of Deltyba™. Following the successful submission of a regulatory dossier in the Russian Federation, R-Pharm may expand registration and commercialization activities in additional CIS countries.

    The Russian Federation has one of the highest TB burdens in the world. In 2015 more than 15,000 Russian citizens died from TB and, along with India and China, accounted for nearly half of global MDR/Rifampicin resistant-TB cases that year. At the same time, the Russian Federation is also playing a leading role in bringing together international organizations, national governments, tuberculosis experts and other stakeholders to address the global TB crisis. The country will play host to the first WHO Global Ministerial Conference, November 16 and 17 in Moscow.

    The agreement between ONPG and R-Pharm has significant impact on the healthcare sector in the Russian Federation and the CIS as with the agreed cooperation both companies seek to jointly fight pulmonary MDR-TB among adults in Russia and the CIS.

    Otsuka is a global healthcare company headquartered in Tokyo, Japan that researches, develops, manufactures and markets innovative products with a focus to meet unmet global medical needs such as TB. R-Pharm is a Russian private pharmaceutical company operating over the entire Russian Federation and the CIS countries. The company is in particular active in manufacturing, marketing, local market access as well as sales and distribution of innovative pharmaceutical and biotechnological products.

    Eversheds Sutherland Munich partner Dr. Tobias Maier comments:

    „Advising Otsuka on this strategic transaction shows Eversheds Sutherland’s strong expertise in the life sciences sector and the international coverage and capabilities of our network. We are pleased to have contributed to this important cooperation that will certainly have a sustainable impact on the Russian healthcare sector.“

    Otsuka has been advised by an international team under the overall lead of Munich Partner Dr. Tobias Maier and Associate Magdalena Anna Kotyrba. Further team members were Dr. Christian Mense (Partner, Corporate), Dr. Stefan Diemer (Partner), Christina Söllner (Counsel, both Tax), Steffen Morawietz, Nadine Friese (all Regulatory & IP, Associates, Munich), Simon Crossley (Partner, Cambridge, UK, Regulatory & IP) and Lee O'Connell (Head of Legal and Compliance Consulting, Cardiff, UK), Konstantin Suvorov, ARTA LLC, Moscow, Best Friends Firm, Regulatory & IP).

    Eversheds regularly advises international companies from the pharmaceutical and life sciences industry in all areas of business law. Most recently the German team assisted Horizon Pharma on the acquisition of Raptor Pharmaceutical.

    This information is for guidance purposes only and should not be regarded as a substitute for taking legal advice. Please refer to the full terms and conditions on our website.

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