geropharm group · 2017. 6. 5. · geropharm in figures 3,9 bln rubles revenue in 2016 35% revenue...
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GEROPHARM GROUP
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ABOUT GEROPHARM
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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
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GEROPHARM IN FIGURES
3,9 BLNrubles revenue in 2016
35%revenue growth to the indicator of 2015
>1,2 MLNpacks of insulin GEROPHARM put on the market
4,7 BLNRubles total investment in technological innovations and R&D in 2013–2016
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LEADERGEROPHARM became the largest manufacturer of the human insulin in the Russian Federation by the end of Q3, 2016 with the share of 23%
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GEROPHARM IN FIGURES
>10drugs in company’s portfolio
>15
projects in the pipeline
>650highly qualified specialists (full-time employees)
14countries and all regions of the Russian Federation in which company is presented
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2,02,3 2,4
2,9
3,9
2012 2013 2014 2015 2016
Revenue, bln. rub
GEROPHARM REVENUE IN 2010-2016
34,04 33,47
67,79 72,8883,59
28,95 29,93 32,66
49,1860,27
2012 2013 2014 2015 2016
OFFICIAL USD/RUB EXCHANGE RATES BY CENTRAL BANK OF RUSSIA
max
min
average
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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 - 2020*, BIO - 2020
* State Federal Programs which aim to develop strong local pharmaceutical industry
PRIORITIES OF GEROPHARM
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Launch of original drugs Cortexin® and Retinalamin®
16 YEARS OF SUCCESSFUL WORK IN THE PHARMACEUTICAL MARKET
R&D Centre opened for in-house Drug and Pharmaceutical Development
2013
GEROPHARM-Bio opens its own GMP facility
The launch of generic drugs:Levetinol®, Memantinol®
2001
2011
Foundation of the new GMP facility was laid in St. Petersburg
2014
2015
GEROPHARM-Bio plant is ready to provide 30% of insulin needs of the Russian Federation
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GEROPHARM put on the market more than 1,2 million packs of insulin. This is 82% higher than the indicator of 2015.
Launch of Pineamin®, Recognan®
2016
2017
Launch of production line - pharmaceutical substances for original drugs
Launch of production line - recombinant human insulin and biosimilar insulin analogues
2018
Launch of full pipeline of analogues to the Russian market
2018 -2020
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Vietnam
Belarus
Ukraine
Moldova
Georgia
AzerbaijanArmenia
Turkey
Kazakhstan
Kyrgyzstan
Tajikistan
TurkmenistanUzbekistan
Mongolia
Brand office
St.-Petersburg
Moscow
GEROPHARM DEVELOPS EXPORT
PRODUCTS MARKETED IN
14 COUNTRIES185 REPRESENTATIVES OF SALES
FORCE IN RUSSIAN FEDERATION
Head office9
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PRODUCT PORTFOLIO
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ORIGINAL DRUGS. NEUROLOGY
Cortexin® , Cortexin® for children are used with in 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
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ORIGINAL DRUGS. OPHTALMOLOGY
Retinalamin® is used within the comprehensive treatment of:
compensated primary open-angle glaucoma
diabetic retinopathy
post-traumatic and post-inflammatory central retinaldystrophy
myopic disease
central and peripheral tapetoretinal abiotrophy
Russian design of packaging is shown. Packaging is adapted to each country’s regulatory requirements12
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ORIGINAL DRUGS. GYNECOLOGY
Gynecology is a new area of specialization forGEROPHARM. Pineamin® is the original drug, produced by technology of peptide extractions fromthe pineal glands.
Pineamin® – the first in class premium injectabledrug for alleviating symptoms of menopause. Thedrug has remarkable rejuvenating effects along withhigh safety profile and tolerability. It acts centrallythrough "PPGT class effect" (Polypeptides of PinealGland Therapy).
Russian design of packaging is shown. Packaging is adapted to each country’s regulatory requirements
LAUNCH OF THE DRUG - 2016
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GENERIC DRUGS. NEUROLOGY
Levetinol® (INN: levetiracetam)
the current standard of remission in epilepsy
an 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
Russian design of packaging is shown. Packaging is adapted to each country’s regulatory requirements14
Dosage forms: 250 mg, 500 mg, 1000 mg
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GENERIC DRUGS. NEUROLOGY
Memantinol® (INN: memantine)
the current medicine for dementia treatment
included in the list of Essential and Vital Medicines, and in the approved standards of Dementia treatment, validated by the Ministry of Health of the Russian Federation
various sets pills: №30, №90
Russian design of packaging is shown. Packaging is adapted to each country’s regulatory requirements15
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GENERIC DRUGS. NEUROLOGY
Recognan® (INN: citicoline) is a neuroprotective agent which has a wide range of therapeutic indications:
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
Russian design of packaging is shown. Packaging is adapted to each country’s regulatory requirements16
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.
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GENERIC DRUGS. NEUROLOGY
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
Dosage forms: 75 mg, 150 mg, 300 mg
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ENDOCRINOLOGY. RINSULIN® R ANDRINSULIN® 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
* USP and Ph.Eur pharmacopoeia reference standard of impuritiesRussian design of packaging is shown. Packaging is adapted to each country’s regulatory requirements
Low level of impurities of insulin substance that corresponds to pharmacopeia requirements*
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1,5%
2,2%
2,8%
3,0%3,2%
5,8%
8,4%
7,1%
10,1%
12,4%
23,2%
2%
5% 5%6% 6%
8%
13%12%
15% 15%
22%
0,0%
5,0%
10,0%
15,0%
20,0%
25,0%
2014(q1)
2014(q2)
2014(q3)
2014(q4)
2015(q1)
2015(q2)
2015(q3)
2015(q4)
2016(q1
2016(q2)
2016(q3)
IMS Health
GEROPHARM'S Internal Data
MARKET SHARE INCREASE OF GEROPHARM’S RECOMBINANT HUMAN INSULIN IN 2014-2016
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CODE/ DRUG
THERAPEUTIC AREA
STAGE
PHARMACEUTICAL DEVELOPMENT
PRECLINICALSTUDIES
CLINICALSTUDIES
REGISTRATION
Insulin Mix Endocrinology
Insulin Lispro Endocrinology
Insulin LisproMix
Endocrinology
Insulin Aspart Endocrinology
Insulin AspartMix
Endocrinology
Insulin Glargin Endocrinology
Insulin Degludec Endocrinology
biosimilar
PRODUCT PIPELINE. INSULIN ANALOGUES
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RESEARCH AND DEVELOPMENT
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RESEARCH & DEVELOPMENT
Full cycle of drug development in accordance with ICH, GLP, GCP, GMP standards
Team of more than 20 PhD scientists with extensive hands-on expertise and experience
Main R&D areas: neurology, endocrinology, ophtalmology
R&D center covers 1500 sq.m.
State-of-the-art technologies: genetic engineering, molecular and cellular biology
20 PhD
1500 sq.m.
Neudorf special economic zone, Saint-Petersburg22
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Synthesis and screening of the original substances
Drug development
Full range of pre-registration studies
Testing and implementation of new technologies in industrial production
R&D EXPERTISE AND FOCUS
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
QUALITY BY DESIGN
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Bioorganic Chemistry
Analytical
Genetic Engineering
Finished Dosage Form
Bioprocess Development
LABORATORIES
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CODE/DRUGTHERAPEUTIC AREA
STAGE
PHARMACEUTICAL DEVELOPMENT
PRECLINICALSTUDIES
CLINICALSTUDIES
REGISTRATION
Evogliptin(DA-1229)
Endocrinology
Metformin IR Endocrinology
Metformin Long Endocrinology
Evogliptin+ Metformin
Endocrinology
TSP + hyaluronic acid
Ophtalmology
TSP + hyaluronic acid (forte)
Ophtalmology
GPh-301 Endocrinology
GPh-201 Ophtalmology
GPh-101 Neurology
GPh-401 Orphan drug
biosimilaroriginal drug generic medical product
PRODUCT PIPELINE
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PRODUCTION
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GEROPHARM-BIO PLANT (OBOLENSK, MOSCOW REGION)
А modern GMP manufacturing enterprise
The control service includes a quality control testing laboratory certified by Rosstandart
Full cycle basis: from scratch substance to the finished filled drugform
Proprietary technology
Advanced technologiesand the latest methodsof control
Equipment of the world leading companies -Stilmas, Olsa, Groninger, Seidenader, Bausch+Ströbel, Uhlmann, Pester
GMP
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Extraction of insoluble protein fraction (inclusion-body preparation)
1 Purification of the insulin protein3
Packaging and labeling7
Purification ofthe recombinant proinsulin protein
2
SUBSTANCE MANUFACTURING
PREPARATION OF FINISHED DOSAGE FORM
Solution preparation4 Aseptic filling5 Inspection6
RINSULIN PRODUCTION: FROM SUBSTANCE TO THEFINISHED DOSAGE FORM
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High industry and social significance recognized at the state level
Innovative manufacturing platform for production of biotechnological drugs on a full cycle basis
Sophisticated technology: the production of pharmaceutical substances
Investment volume: > 2 billion rub.
Location: «Pushkinskaya» industrial area, St. Petersburg
GEROPHARM INDUSTRIAL PROJECT IN ST. PETERSBURG
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Launch of production lines:
2017 – pharmaceutical substances for original drugs
2018 - recombinant human insulin and biosimilar insulin analogues
GEROPHARM INDUSTRIAL PROJECT IN ST. PETERSBURG
Launch of the new pharmaceutical production will fully meet the needs of the population of Russia in insulin and will allow to export a substance.
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WHY WE ARE THE LEADERS?
GEROPHARM is one of the leaders in the field of biotechnology products – in development and production of recombinant human insulin and insulin analogues in Russia
A modern manufacturing site of protein drugs-the first Russian producer of recombinant human insulin which is manufactured on a full cycle basis: from scratch substance to the finished filled form
Creation of modern pharmaceutical infrastructure – R&D center and high-tech production in compliance with GMP standards
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WHY WE ARE THE LEADERS?
One of the priorities is production of activepharmaceutical substances
Production of original drugs by means for treatment of socially significant diseases as well as some generics that have priority in terms of import substitution
Aims to operate as a full cycle - defines the business development strategy, engages in drug development, manufacturing, sales and marketing of its drug products
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GEROPHARM CONSIDERS VARIOUS PLATFORMS OF COOPERATION
In-licensing of original drugs and smart generics to Russian and other CIS markets
Out-licensing of GEROPHARM products
In-house development and co-development of innovative medicines
Contract manufacturing and drug development services
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CONTACTS
Business center "Nevskaya Ratusha"11B, Degtyarny lane,St. Petersburg, 191144, Russian Federation
Tel./fax: +7 (812) [email protected]