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DEVELOPMENT OF A NEW DRUG FOR THE TREATMENT OF HUMAN
REPRODUCTIVE SYSTEM CANCERS
ANO National Innovation Institute MUYZHNEK Ekaterina L.
Chief Scietific Officer
CEZAROX®
Project:"Development of a new drug to treat cancer of the reproductive system"
Indication: Ovarian cancer - one of the most hard to cure cancers of women's reproductive system (the 1-st place in the structure of oncological female mortality).
Regimen - adjuvant therapy
Based on non-toxic synthetic drug substance (diidolylmethane - DIM) with: - proven multitargeted antitumor activity - high selectivity and safety - activity on molecular targets responsible for tumor relapses and metastases
Unique technology of manufacture of the liquid DIM formulation - high bioavailability: > 10 times more in comparison with BR-DIM (BioResponse, USA) - maximal therapeutic effect
Patent protection (7 RF patents, 1 international application). Publications in international and RF scientific journals
Completed pre-clinical phase (in vivo study).Studied pharmacokinetics and pharmacodynamics (healthy volunteers)
CEZAROX® is an exclusive anti-tumor drug! Why?
Market potential
Market of targeted drugs,$ bln**
500
400
300
200
100
02009 2012 2015 (forecast)
Market growth – 11% annually
** - “Remedium”, 2012
Market segments: Geographical markets: Russia, CIS- countries, Europe, USA Product markets: Oncology
Companies-consumers:- Treatment-and-prophylactic establishments - Oncological dispensaries
Potential Cezarox® market $ 200 mlnCezarox® inclusion in treatment regimens in RF
= public purchases for $ 50-70 mln
RF market of drugs for the treatment of reproductive system diseases:
~$ 200 mln - 2012~$ 1 bln - 2015
World market of RS-drugs ~ $ 10 bln
Russian Federation
200
630
1000
2800
- Reproductive System- Oncology- Targeted drugs/Oncol.
2012 2015
ProductThe main obstacles in oncology:1. Low selectivity of conventional drugs, high toxicity, harmful side effects2. Tumor multidrug resistance3. High rate of relapses. Metastasis
Time, h 0 2 4 6 8 10 12
350
300
250
200
150
100
50
DIM, ng/ml
Cezarox®, 100 mgBR-DIM®*, 100 mg
Plasma concentration – Time profiles of DIM following an oral dose (100 mg) of Cezarox® (10 healthy volunteers) and BioResponse DIM (BR-DIM) (8 healthy volunteers) in humans
Pharmacokinetics: Сezarox® and BioResponse DIM
Cezarox® - oil-filled capsules containing 100/150 mg of 3,3’-diindolylmethane (DIM) as active substance – a drug for treatment of tumor disea-ses of reproductive system
High selectivity, absence of toxicity and side effects Multitargeted anti-tumor activity (>20 of molecular targets) High bioavailability of active substance (DIM) ! Maximal realization of therapeutic potential of DIM ! Overcoming resistance of standard chemotherapy Decreased rate of relapses and metastases
Cezarox®: Unique active substance + Technology =
New solution of the main oncological problems !
5 mln. rub.
Preclinical study
Grant SKOLKOVO
40 mln. rub.
Clinical trials(I phase)
Grant SKOLKOVO/ Co-investor
funds
Extention of productionDistribution
Launch Sales start
Co-investor funds
Capital needs and financial plan2011-2012 2013-2014 2014-2015 2016
Investments
Grants
90 mln. rub.Clinical trials
(II phase) RegistrationProduction
Grant SKOLKOVO/ Co-investor
funds
Final result – registered drug Cezarox and its launch
Total sales (next 5 years)
2016- 2017 150 mln. rub./y
2018-2020270 mln. rub./y
Total: 1 bln. 110 mln. rub.
Commerciali-zation
scheme
- Commercialization through investor's distribution network in Russia, Kazakhstan, Ukraine- License sale for sales in Europe and USA- State purchases of the RF Ministry of Health
Exit strategy- repayment of investors's shares
Work
Costs
Vsevolod I. Kiselev Scientific Manager of the Project, Dr. Sci. Biol., Professor, Corresponding Member of RAMS, Winner of the RF Government Award (2005, 2011)
Valery Yu. Alakhov Scientific consultant, Professor of Armand Frapier Instit. (Quebec Univ, Canada), Member of NIH Invest. Project evaluation Committee in oncology
Georgy A. Frank Head of the Department of Clinical Researh, Professor, Correspоnging Member of RAMS, Winner of the RF Government Award (2008)
Fazlul H. Sarkar Scientific consultant, Ph.D., Distinguished Professor of Department of Pathology & Oncology Karmanos Cancer Institute, Detroit, USA
Team