GEROPHARM Group. Pharmaceutical Manufacturing and Distribution. Innovative biotechnology. R&D Center

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1 GEROPHARM Group

2 GEROPHARM Group Pharmaceutical Manufacturing and Distribution Innovative biotechnology R&D Center The Headquarter company: business development strategies, sales and marketing GMP compliant manufacturing site Full cycle production All aspects of drug and pharmaceutical development and its industrial application 2

3 Achievements More than 10 drugs in company s portfolio Including Cortexin 10 mg, Cortexin 5 mg, Retinalamin, Pineamin, Memantinol, Levetinol, Recognan, Pregabalin Rinsulin R, Rinsulin NPH More than 15 projects in the pipeline 2 projects funded by the Federal Programs of the Russian Government More than 3 billion rubles Total investment in technological innovations and R&D in Presence in all regions of the Russian Federation and 14 countries 3

4 GEROPHARM in Figures 15 years of successful work in the pharmaceutical market TOP-20 Over 20% among Russian pharmaceutical companies (production of its own original products) of stable turnover growth during the last 3 years 2 times higher than the overall growth rate of the Russian pharmaceutical market 3 billion rub. turnover in 2015 ТОР-30 rated in Russia s fast-growing high-tech companies based on the national rating system TehUspeh * four times during the period of highly qualified specialists (full-time employees) * TehUspeh is the most prestigious Russian rating that assesses the potential of innovative businesses. Established by the Russian Venture Company (RVC OJSC) in cooperation with Association of Innovative Regions of Russia (AIRR). The methodology of the rating has been developed with due consideration of most established international practices such as: The World's Most Innovative Companies (Forbes), TOP 100 Global Innovators 2012 (Thompson Reuters), The Global Innovation 1000 study of R&D spending (Booz&Co) and attested by PwC. 4

5 GEROPHARM Turnover in Turnover, mln. ruble Official USD/RUB exchange rates fixed by Central Bank of Russia Min Max Average 67,79 72,88 61,32 31,78 32,68 34,04 33,47 49,18 30,38 29,39 31,07 31,91 38,

6 GEROPHARM: all regions of the Russian Federation Surgut Murmansk Khanty- Mansiysk Norilsk Saint-Petersburg 185 representatives Moscow Yakutsk Krasnodar Kazan Omsk Khabarovsk Novosibirsk Krasnoyarsk Vladivostok Irkutsk Chita 6

7 GEROPHARM Develops Export Belarus St.-Petersburg Moscow Commodity markets 14 countries Ukraine Moldova Kazakhstan Mongolia Turkey Georgia Armenia Azerbaijan Turkmenistan Kyrgyzstan Tajikistan Uzbekistan Vietnam Representations 7

8 Partnerships Worldwide 8

9 Key people GEROPHARM Group President and CEO Petr Rodionov VP for Strategic Development Lola Maksumova, MD, PhD GEROPHARM-Bio Director Dmitry Burovik, PhD, MBA Head, Clinical Affairs Head, Business Development Head, Biotechnology Deputy Director, Drug Development & Regulatory Affairs Igor Shchemelinin, MD Artem An, MSc, MBA Andrey Semenyuk, PhD Irina Nikitina, PhD 9

10 Strategy

11 Strategy Innovative development Creation of a modern infrastructure for the development and production of drugs, including APIs Development of biotechnology Cutting edge technology for drug discovery and development Expansion of the product portfolio Original products and generics launch and saturation of the market with affordable medications produced with high quality standards Export development Expanding into new markets through branch offices and distribution channels 11

12 Priorities of GEROPHARM Creation of innovative technological platforms Development of crucial technologies Investment projects in regional clusters Build strong collaborations and partnerships worldwide Integrated approach in accordance with PHARMA *, BIO * State Federal Programs which aim to develop strong local pharmaceutical industry 12

13 GEROPHARM - Contributions to the Development of the Russian Pharmaceutical Industry 2001 Launch of original drugs Cortexin and Retinalamin Active participation in development of the St.Petersburg cluster 2011 R&D Centre opened for in-house Drug and Pharmaceutical Development 2013 Participation in workgroups with the federal authorities on industry reforms GEROPHARM is included in the federal target program for the development of priority medicines within the import substitution initiative The launch of generic drugs 2015 GEROPHARM- Bio plant is ready to provide 30% of insulin needs of the Russian Federation 2006 A technology for the production of insulin is developed 2013 GEROPHARM-Bio opens its own GMP facility 2014 Foundation of the new GMP facility was laid in St. Petersburg New biotech laboratory unit is opened in the R&D center to further strengthen and speed up development of biological products 13

14 Drugs

15 GEROPHARM controls the full life cycle of drugs - from design to delivery to the consumer Pharmaceutical Development Preclinical Trials Clinical Trials Registration Manufacturing Distribution GCP GLP GMP GDP 15

16 GEROPHARM is the only manufacturer * of original drugs Cortexin and Retinalamin Russian design of packaging is shown. Packaging is adapted to each country s regulatory requirements. CORTEXIN effective neuroprotective drug RETINALAMIN ophthalmic drug stimulating retina regeneration The company has been producing drugs since Manufacturing is performed under the company s patented technology. Over the years Cortexin and Retinalamin have become widely popular among the specialists in the fields of neurology, neurosurgery, ophthalmology, neonatology and pediatrics due to their pharmacological properties. GEROPHARM products are sold not only at pharmacies. They are also purchased by hospitals and the products are included in the official lists and protocols of the leading medical and preventive treatment facilities in Russia. * official website of the State Register of Drugs

17 Neurology. Cortexin, Cortexin for children Cortexin is used within the comprehensive treatment of: the blood supply to the brain craniocerebral trauma and its consequences different types of encephalopathies cognitive disorders acute and chronic encephalitis and encephalomyelitis epilepsy asthenic conditions (suprasegmental autonomic disorders) reduced learning capacity psychomotor and speech retardation in children different types of cerebral palsy Russian design of packaging is shown. Packaging is adapted to each country s regulatory requirements.

18 Neurology. Levetinol, Memantinol Levetinol : Contemporary standard of remission in epilepsy Optimal option for treatment of most patients with epilepsy High efficacy and tolerability vs other AEDs Treatment choice for mono - and combined therapy in focal and generalized epilepsy Treatment choice for initial therapy with very short titration period Memantinol : Contemporary medicine for dementia treatment High quality manufacturing with GMP standard (full cycle of manufacturing meet the requirements of Good Manufacturing Practice based on the high-purity substances) Included in the list of Essential and Vital Medicines, and in the approved standards of Dementia treatment, validated by the Ministry of Health of Russian Federation Officially registered various sets pills: 30, 90, 60, 120 Russian design of packaging is shown. Packaging is adapted to each country s regulatory requirements.

19 Neurology. Recognan Recognan (INN: citicoline) is a neuroprotective agent which has a wide range of therapeutic facilities. Recognan is used to treat: ischemic stroke (post-stroke rehabilitation) acute and recovery stage of traumatic brain injury cognitive and behavioral impairment associated with neurodegenerative and cerebrovascular diseases mental and cognitive dysfunction Recognan is adjusted to human physiology more than any other identified neuroprotective agent. It makes Recognan the treatment of choice in therapy, prevention and improvement of nervous system functional activity. Russian design of packaging is shown. Packaging is adapted to each country s regulatory requirements. 19

20 Neurology. Pregabalin Pregabalin is a potent gabapentinoid and structural analogue of the neurotransmitter GABA. It is a ion channel modulator that has rapid analgesic, anticonvulsant and anxiolytic effects. Pregabalin is used to treat: Neuropathic pain Epilepsy Generalized anxiety disorder Fibromyalgia Russian design of packaging is shown. Packaging is adapted to each country s regulatory requirements. 20

21 Ophtalmology. Retinalamin Retinalamin is used within the comprehensive treatment of: compensated primary open-angle glaucoma diabetic retinopathy post-traumatic and post-inflammatory central retinal dystrophy myopic disease central and peripheral tapetoretinal abiotrophy Russian design of packaging is shown. Packaging is adapted to each country s regulatory requirements.

22 Gynecology. Transition period management. Pineamin Pineamin the first in class premium injectable drug for alleviating symptoms of menopause. The drug has remarkable rejuvenating effects along with high safety profile and tolerability. It acts centrally through PPGT class effect (Polypeptides of Pineal Gland Therapy). PPG peptides are the integral part of Pineamin. Peptides work by stimulating endogenous melatonin secretion from corpus pineale (epiphysis cerebri) which known to regulate waive secretion of gonaliberin, FSH and LH Pineamin doesn t exert any mitogenic effects on the endometrium based on the clinical data of 180 days of observation Pineamin doesn t affect liver function and blood coagulation system Pineamin has rejuvenating effect on the aging skin The drug is administered as short courses of injection 2-4 times a year. Post-injection effect lasts several months. Russian design of packaging is shown. Packaging is adapted to each country s regulatory requirements. 22

23 Endocrinology. Rinsulin R and Rinsulin NPH Own unique patent protected technology process of the insulin substance synthesis Produced in the various drug forms: vials, cartridges, pre-filled multidose disposable pens Low level of impurities of insulin substance that corresponds to pharmacopeia requirements* * USP and Ph.Eur pharmacopoeia reference standard of impurities Russian design of packaging is shown. Packaging is adapted to each country s regulatory requirements.

24 Research and Development

25 R&D center in the Neudorf special economic zone in St. Petersburg Full cycle of drug development in accordance with ICH, GLP, GCP, GMP standards State-of-the-art technologies: genetic engineering, molecular and cellular biology Test Analytical Laboratory accredited by the Federal Accreditation Service (Rosakkreditatsiya) for compliance with National Standard ISO/IEC and Federal law 412 Team of more than 20 PhD scientists with extensive hands-on expertise and experience in drug development, chemistry and pharmacology R&D center covers 1,500 sq.m. in Neudorf special economic zone (pharmaceutical cluster of St. Petersburg) 25

26 R&D Expertise and Focus Synthesis and screening of the original substances Drug development Full range of pre-registration studies Testing and implementation of new technologies in industrial production Quality by Design GEROPHARM develops sophisticated technologies in drug development utilizing its expertise and knowledge in the pharmaceutical industry. These endeavours require financial investments as well as time and continued diligence 26

27 Quality is the foundation of GEROPHARM work Pharmaceutical quality system Measures corrective and preventive Analysis GMP ISO 9001 Management of changes Monitoring of system processes and product quality The Quality Control Department at GEROPHARM employs more than 60 highly trained and experienced personnel to monitor and control all stages of the process chain. 3 employees are certified by the Ministry of Health of Russia as QPs (equivalent of EU Qualified Person) 27

28 R&D Laboratories Bioorganic Chemistry Analytical Genetic Engineering Finished Dosage Form Bioprocess Development 28

29 Product Pipeline Stage Code/ Drug Therapeutic Area Pharmaceutical Development Preclinical Studies Clinical Studies Registration Insulin Mix Endocrinology Insulin Lispro Endocrinology Insulin Lispro Mix Endocrinology Insulin Aspart Endocrinology Insulin Aspart Mix Endocrinology Insulin Glargin Endocrinology Insulin Degludec Endocrinology original drug generic medical product biosimilar 29

30 Product Pipeline Code/ Drug Therapeutic Area Pharmaceutical Development Stage Preclinical Studies Clinical Studies Registration Evogliptin (DA-1229) Endocrinology Metformin Endocrinology Evogliptin +Metformin Endocrinology Vilon Ophtalmology Vilon forte Ophtalmology GPh-301 Endocrinology GPh-101 Neurology GPh-201 Ophtalmology GPh-202 Ophtalmology GPh-501 Urology original drug biosimilar generic medical product 30

31 Production

32 GEROPHARM-Bio Plant (Obolensk, Moscow region) А modern GMP manufacturing enterprise Proprietary technology Full cycle basis: from scratch substance to the finished filled drug product Advanced technologies and the latest methods of control Equipment of the world leading companies - Stilmas, Olsa, Groninger, Seidenader, Bausch+Ströbel, Uhlmann, Pester A Pharmaceutical Quality System: GMP and ISO 9001 The control service includes a quality control testing laboratory certified by the Federal Agency for Technical Regulation and Metrology 32

33 Rinsulin production: from substance to the finished dosage form Substance manufacturing Extraction of insoluble Purification of protein fraction the recombinant (inclusion-body preparation) proinsulin protein Purification of the insulin protein 4 Solution preparation Preparation of finished dosage form Aseptic filling Inspection Packaging and labeling 33

34 GEROPHARM-Bio Plant, Moscow region The plant can provide 30% of the needs of the Russian Federation for insulin 34

35 GEROPHARM-Bio Plant, Moscow region State-of-the-art equipment in a GMP compliant environment 35

36 GEROPHARM-Bio Plant, Moscow region Quality control points throughout the production process 36

37 GEROPHARM Industrial Project in St. Petersburg (town of Pushkin) High industry and social significance recognized at the State level Sophisticated technology: the production of pharmaceutical substances Project designer and consultant - AECOM, FAVEA Investment volume: > 2 billion ruble Project completion: 2017 Location: «Pushkinskaya» industrial area, St. Petersburg 37

38 Corporate Social Responsibility

39 Social programs: Creating a Better Future. Included in the list of social projects of GEROPHARM: children's rehabilitation center support, cultural activities, awareness-raising activities about socially significant diseases and a variety of educational projects. 39

40 Contacts

41 Contacts Lola Maksumova, MD, PhD Vice President, Strategic Development Artem An, M.Sc., MBA Head of Business Development Ekaterina Artemyeva, MPR PR and Media Relations Director

42 Business center "Nevskaya Ratusha" 11B, Degtyarny lane, St. Petersburg, , Russian Federation Tel./fax: +7 (812)