1. IPHAR
DRUG DEVELOPMENT
FOR FOREIGN
AND DOMESTIC
MARKETS
2013 Copyright © iPhar
President
Veniamin Khazanov
Professor, MD, Ph.D., D.Sc.

2. IPHAR IS A HOLDING COMPANY
Main activities:
 Development of innovative drugs for Russian and Global
market
 Contract services - preclinical and clinical studies of drugs
(over 60 studies for Russian and foreign customers in the
last 3 years)
2013 Copyright © iPhar

3. APIs screening
Project “packaging”
Attraction of investments
IP protection
Drug formulation
Technology scaling
Preclinical research
Clinical trials
Registration
Pilot manufacturing
Commercialization
Manufacturing
and Sales
Customers
Development and
Commercialization
2013 Copyright © iPhar
 Russian and foreign drug
manufacturers
 Startup companies
IPHAR – DRUG DEVELOPMENT SERVICES

4. Commercialization
department
(preparing
projects, attraction of
investments, IP
protection)
Management
(planning, managemen
t and control of all
activities – from idea
to implementation)
Clinical department
(clinical trials of new
drugs in Russian
clinical centers)
Technological
department
(development and
scaling drug synthesis
technology)
R&D center
specializing in
preclinical trials of drug
safety and efficacy
Team
(over
60 employees,
6 D.Sc.,
12 PhD)
STRUCTURE OF IPHAR
2013 Copyright © iPhar

5. INTERACTION WITH OTHER ORGANIZATIONS
Substance synthesis:
TSU, OOO “Novohim”
(Tomsk), NIOC SB RAS
(Novosibirsk), OAO
“Organica”
(Novokuznetsk), etc.
Laboratory analysis:
TSU, TPU
(Tomsk), institutes of SB
RAS
(Novosibirsk), institutes of
RAMS and RAS (Moscow)
Clinical trials:
clinical centers of
Tomsk, Novosibirsk, Kemer
ovo and other Russian
cities
Russian and
foreign
pharmaceutical
companies
IPHAR
2013 Copyright © iPhaR

6. ADVISORY BOARD
Professor Khazanov V. (iPhar) – pharmacologist, biochemist.
Developer of over 100 drugs. Creator of a group of companies
specializing in drug development and manufacture.
– a prominent Russian chemist, inventor of 8
original drugs, author of 10 monographs on drug synthesis and
development.
Prof. Salakhutdinov N. (Scientific Institute of Organic Chemistry,
Novosibirsk) – major Russian specialist in medical chemistry and
drug synthesis.
Prof. Gogvadze V. (Karolinska University, Sweden), D. Sci. –
a major scientist in the field of molecular biology and toxicology.
Dr. Schwarz J. (Nano Essentials Inc., Canada) – formerly one of
the heads of formulation department of TEVA (Israel).
Dr. Cleverley S. (ISIS Innovation, UK) – expert of Oxford
University technology transfer center.
Prof. Granik V.
2013 Copyright © iPhar

7. 2013 2014 2015 2016
1. Antiulcer drug – peptic ulcer and GERD
2. Anti-inflammatory - rheumatism, arthritis
3. Anti-Parkinson drug - Parkinson's disease
4. Antiplatelet - cardiovascular disease
DEVELOPMENT OF INNOVATIVE DRUGS
FOR GLOBAL MARKETS
2013 - 2015 IPHAR plans to complete preclinical studies
of 4 innovative drugs and start clinical trials:
2013 Copyright © iPhar

8. Product – new molecule based on pyridopyrazindione with a new
mechanism of action on H+/K+ ATPase: a reversible potassium-
independent proton pump inhibitor.
IP: Patent RU 2465274, priority date 05.03.2010; PCT/RU2011/000103;
US application 13/602,239 dated 03.09.2012 (allowance for a patent
dated 21.03.2013); EPO application 11750980.2 dated 04.10.2012;
Ukraine and EAPO applications.
Competitive advantages compared to the best drugs on the market
(proton pump inhibitors ):
• reversibly inhibits enzymes of gastric mucosa;
• does not suppress normal gastric acid secretion level;
• does not inhibit gastrointestinal peristalsis;
• reduces the risk of night-time acid “breakthrough” and “rebound” –
sudden increase in acidity after cancelling the drug.
Consumer benefits – sustained normal digestion level in long-term
treatment, reduction in adverse effects incidence and disease recurrence.
ANTIULCER DRUG
2013 Copyright © iPhar

9. The drug is based on a new small molecule (terpenoid
derivative), differing in its properties from the known antiparkinson
compounds.
IP rights - OOO«Rionis»: patent RU 2418577, priority date 24.12. 2009;
PCT/RU2010/000778; US application No. 13/518,814 dated 22.06.2012;
EPO application 10844832.5 dated 20.07.2012; EAPO application.
Competitive advantages :
•does not cause dyskynesia and other motor and non-motor adverse
effects, present in levodopa;
•effectiveness – as good as levodopa, unlike most competitors
(dopamine agonists or MAO and COMT inhibitors);
•can potentially have neuroprotective action and eliminate some non-
motor disorders of Parkinson disease;
•can be used to treat drug-induced parkinsonism.
Consumer benefits :
1) Makes safe and long-term PD monotherapy possible;
2) Slows down the disease progression;
3) Eliminates non-motor disorders.
ANTI-PARKINSON DRUG
2013 Copyright © iPhar

10. Product - the new patented compound - N-[3-(4-nitrophenylamino)-indole-
2-ilmethylene]aminoguanidine hydrochloride with a new mechanism of
action - selective inhibition of inducible NO-synthase.
IP: Patent RU 2478618, priority date 15.03.2010; PCT/RU 2011/000142;
US application 13/634,840 dated 13.09.2012; EPO application 11756610.9
dated 12.10.2012; Ukraine and EAPO applications.
The main advantage of the drug over the worldwide used analogs
(NSAIDs) is the absence of dangerous ulcerogenic effects, because its
pharmacological target is NO-synthase and not cyclooxygenase.
Efficiency - the new compound exhibits anti-inflammatory action as potent
as voltaren and indomethacin in peritonitis and arthritis models (ED50 –
50 mg/kg, mice, rats)
Safety - the compound has low toxicity (LD50>5000 mg/kg, mice).
Market. There are no direct market analogs of the new drug. World market
of NSAIDs amounts to $10 billion.
ANTI-INFLAMMATORY DRUG
2013 Copyright © iPhar

11. Product – a new molecule - indolinone-3 derivative with a new mechanism
of action - a nitric oxide donor and a stimulator of soluble guanylate cyclase
and cGMP synthesis.
IP: Patent RU (application № 2011144895 dated 08.11.2011);
PCT/RU2012/000884.
Competitive advantages: Unlike aspirin, the new molecule does not have
ulcerogenic side effect. Unlike the known antiplatelet drugs, it has anti-
hypertensive and cardioprotective properties, reducing xenobiotic load, the
incidence of adverse effects and costs of cardiovascular disease treatment.
Efficacy is proven in in vitro (GC activity) and in vivo models (platelet
aggregation, parenchymal hemorrhage, hypertension). Effective doses:
10 -7 mol in vitro, 4-12 mg/kg (per os), 0,01-1,0 mg/kg (intravenously).
Low toxicity - LD50 = 8900 mg/kg in oral administration in mice.
Market. The world antiplatelet drug market amounts to $15 billion.
The novel drug aims to be a possible alternative to clopidogrel and new
antiplatelet drugs (prasugrel, ticagrelor) used in CVD treatment.
ANTIAGGREGANT (ANTIPLATELET DRUG)
2013 Copyright © iPhar

12. Product – a new molecule – glycyrrhetic acid derivative, a structural
analogue of the known compound - Bardoxolone methyl (Reata
Pharmaceuticals/ Abbott Laboratories), which underwent Phase III clinical
trials as antioxidant inflammation modulator for the treatment of chronic
kidney disease in type 2 diabetes.
Mechanism of action – modulator of activity of transcription factors
Nrf2k,NFkB and PPAR.
Promising areas of application:
1) Oncology;
2) Neurodegenerative diseases (Alzheimer's disease, Parkinson's
disease, multiple sclerosis).
IP: Patent RU 2401273 dated 30.03.2009; Russian patent application №
2012129738 dated 13.07.2012
Efficiency: proven anti-tumor activity in vitro at doses of 0,5 – 5x10-6 mol
Low toxicity - LD50 > 5000 mg/kg in oral administration in mice.
ANTICANCER DRUG
2013 Copyright © iPhar

13. IPHAR
President: Veniamin Khazanov,
Professor, MD, Ph.D., D.Sc.
Address: Elizarovykh str. 79/4, Tomsk, Russia
Tel./fax: +7(3822)248721
Mob.: +79138295599
e-mail: gen_dir@iphar.ru
www.iphar.ru
2013 Copyright © iPhar