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

Thank you!

Cezarox®