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Appendix F.3

Russia’s Pharmaceutical and Biotechnolgy Sectors

1. PLAN FOR PHARMA 2020

The plan was set forth by Prime Minister Vladimir Putin, February 2008, to provide a basis for developing the pharmaceutical industry. However, funding began only in 2010. Given the uncertainties in moving forward, the timetable is widely recognized as being overly optimistic; and some anticipated outcomes may not materialize, even after delays. But the program was codified in a government decree in April 2012, and implementation efforts are under way. (Decree of the Chairman of the Government of the Russian Federation, April 24, 2012, No. 1853P-P8, Complex Program for Development of Biotechnology in the Russian Federation from Now until 2020)

Objectives by 2020:

•   Russian producers’ share of domestic market: 50 percent.

•   Innovative products in domestic market: 50 percent.

•   Average value per product: $40 million.

•   Number of innovative molecules: 200.

•   Full-cycle production of products within category of “national security”: 400.

Milestones:

•   By 2012: Import substitution of generics.

•   By 2014: 40 licenses for domestic manufacture of Russian products.



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Appendix F.3 Russia’s Pharmaceutical and Biotechnolgy Sectors 1. PLAN FOR PHARMA 2020 The plan was set forth by Prime Minister Vladimir Putin, February 2008, to provide a basis for developing the pharmaceutical industry. However, funding began only in 2010. Given the uncertainties in moving forward, the timetable is widely recognized as being overly optimistic; and some anticipated outcomes may not materialize, even after delays. But the program was codified in a govern- ment decree in April 2012, and implementation efforts are under way. (Decree of the Chairman of the Government of the Russian Federation, April 24, 2012, No. 1853P-P8, Complex Program for Development of Biotechnology in the Russian Federation from Now until 2020) Objectives by 2020: • Russian producers’ share of domestic market: 50 percent. • Innovative products in domestic market: 50 percent. • Average value per product: $40 million. • Number of innovative molecules: 200. • Full-cycle production of products within category of “national security”: 400. Milestones: • By 2012: Import substitution of generics. • By 2014: 40 licenses for domestic manufacture of Russian products. 229

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230 APPENDIX F.3 • By 2019: Import substitution for 140 drugs and vaccines. • By 2020: Domestic innovations for 20 exports. Achieving domestic innovations for export (2016–2020): • Financing: Grants, venture financing, industry financing. Initial state investment of $1 billion, and eventually industry investment of $1 billion. • Drugs based on postgenomic period achievements. • Research centers for drug design. • New generation of research specialists, together with consultations with foreign scientists. 2. INTERESTS OF RUSSIAN BIOTECHNOLOGY SOCIETY AND BIOINDUSTRY ASSOCIATION A. Regional Biotechnology Programs: Tatarstan Republic, Chuvash Republic, Kirov Oblast, Penza Oblast, Karelia Republic, Tomsk Oblast, Novosibirsk Oblast, Kaliningrad Oblast, Belgorod Oblast, Voronezh Oblast. B. Enhancement of Business Structures: Microgen production of vaccines. Rosagrobioprom production of animal drugs. Bioprocess Group production of genetically engineered products. Biotechnology Corporation development of biofuels. Biochem Zavod development and production of animal feed proteins and biofuels. C. Other Initiatives: • State program of “Biotechnology Development” (BIO 2020). • Technology platforms: “Medicine of the Future,” “Bioindustry and Bio- resources,” “Bioenergy.” • Ten new investment projects. • Skolkovo and Rusnano megaprojects. • New venture funds. • Target program of Russian Academy of Sciences, “Fundamental Science for Medicine.” • Increased funding for Federal Target Programs and for Russian Fund for Basic Research. • Outreach through new journals, Web sites, and conferences. • Increased educational opportunities for young scientists. SOURCE: Representatives of Russian Biotechnology Society and Bioindustry Association, September 2011.

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APPENDIX F.3 231 3. EXAMPLES OF INVESTMENTS BY COMPANIES REGISTERED IN RUSSIA • Russian-led joint venture SynBio is a $105 million public-private part- nership. Rusnano invested $42 million, and the remainder was by Russian-owned HSCI, Russian-owned Pharmasynthez, U.K.-owned Lipoxen, and German-owned SymbioTec. The owners invested cash, stock, and intellectual property. First prod- ucts include (a) drugs based on Histone H1 for cancer and other diseases, and (b) Poplyxen for biobetters aimed at diabetes mellitus, Alzheimer disease, chronic kidney disease, and cardiovascular disorders. • BIND Biosciences, with an investment by Rusnano of $25 million, is to develop new therapeutics against cancer, inflammatory diseases, and cardiovas- cular disorders. Rusnano has also invested $25 million in Selecta Biosciences, which is developing synthetically engineered vaccines for smoking cessation, type 1 diabetes, cancer, and allergies. Both companies were cofounded by profes- sors at Harvard Medical School. • Another Rusnano-funded company at $4.5 million, BiOptix Diagnostics, is a maker of label-free biodetectors. • Also, Rusnano invested $26 million in Panacela Labs, a subsidiary of Cleveland BioLabs. SOURCE: www.genengnews.com/keywordsand tools/print/3/25235/; accessed March 10, 2012. 4. EXAMPLES OF OTHER INVESTMENTS BY INTERNATIONAL COMPANIES • Viiv, a venture of GlaxoSmithKline and Pfizer, agreed to supply bulk products, technology, and expertise to the Russian firm Binnopharm, which will carry out secondary manufacturing and packaging of drugs for HIV treatments. • Roche granted TeaRx development and commercialization rights for treatment of patients in Russia at risk of thrombosis. TeaRx is scheduled to launch clinical studies in 2012 in Russia. TeaRx may add additional drugs to its portfolio. • ChemRar and Pfizer have announced a collaboration focused on drugs and vaccines for cardiometabolic infection and oncological diseases. • Johnson and Johnson signed a Memorandum of Understanding with ChemRar in June 2012 to launch a number of initiatives within the next 5 years for the treatment of tuberculosis, cancer, and hepatitis C.

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232 APPENDIX F.3 5. DEVELOPMENT OF RUSSIAN BIOTECHNOLOGY PLATFORMS FOR NEW PRODUCT DEVELOPMENT • Platform participants assessing inputs from state representatives and experts in a wide array of fields, including: o Forest biotechnology o biotechnology Food o Aquaculture biotechnology o Industrial biotechnology o Agricultural biotechnology o Ecobiotechnology • Participating institutes include: o Siberian State Medical University o Lomonosov Moscow State University o Russian Technologies State Corporation o Kurchatov Institute for Atomic Energy • Specific priority areas for the near future include: o Biorefineries o Platform chemicals o Bioplastics and biomaterials o Biocatalysis o Transgenic plants and animals o Valorization of waste o and paper Pulp o Functional foods and feeds SOURCE: Russian Biotechnology Association, September 2011. Updated during subsequent discussions in Moscow.