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«The Company of Decade - the Russian pharmaceutical products manufacturer»

Research & Development

In 2011, the Company's personnel started the manufacture of four new products. Following the introduction, in 4Q2010 of new legal regulations, the period of registration of new pharmaceutical products in the Russian Federation was extended, and as a consequence, the procedure of application to the Ministry of Healthcare and Social Development changed.

Such products as Next®, Cyclovita®, Akorta® which were scheduled for initial manufacture in 2011, will be registered and put into production in 1Q2012. Product Maxicold®, coated tablets, was registered in 2011 but the beginning of its manufacture was moved to 1Q2012 due to the need to complete the reconstruction of the production facilities. The manufacture of product Maxispray®, registered in 2011, was moved to 1Q2013 for the same reason.

Terpincod®N, product containing codeine, was also registered in 2011, but was taken off production due to the decree of the Government of the Russian Federation No. 599 dated 20 July 2011 stipulates that from 1 June 2012 pharmaceutical products containing a small amount of codeine will only be sold with a doctor's prescription.

Name of product:

Therapeutical segment \ product status:

Sales value (RUR mln)

Scheduled date of production commencement

Medira®
(capsules)

Biologically active food supplement\ OTC

1.863

February 2011 года

Gluconorm®
(coated tablets)

A10B – hypoglycemic agent\OTC

6.297

May 2011

Water for injections in bottles, 2,4,5,8,10 ml

V07AB – solvent \OTC

0.106

April 2011

Azitrox®
(500 ml capsules No. 2)

J01F – antibiotic-azalid\ Rx

6.522

December 2011

In 2012, we are planning to register and start the manufacture of 11 new products

The products which are scheduled to enter the manufacturing stage in 2012 are new brands, such as Next® and Cyclovita® and also extensions of product lines of already existing brands such as Codelac®, Complivit®, Octolipen®, Maxicold®, Neosmectine®.

Name of product:

Therapeutical segment \ product status:

Sales value (RUR mln) 

Scheduled date of production commencement

Next®
(coated tablets)

N02B – combined analgesic \
OTC

22.274

March 2012

Maxicold®
(coated tablets)

N02B – product for cold and fle symptoms \
OTC

22.274

April 2012

Akorta®
(coated tablets)

C10A -
hypolipidemic agent \ Rx

5.835

April 2012

Cyclovita® (coated tablets)

Biologically active food supplement \ OTC

0.380

May 2012

Neosmektine® (powder with new taste)

A07B – antidiarrheal agent \ OTC

3.654

May 2012

Glimepiride
(4 ml tablets)

А10B - hypoglycemic agent \ Rx

6.297

August 2012

Octolipen®
(
600 ml tablets)

А16A - metabolic agent \
Rx

7.550

October 2012

Complivit® Ophtalmo for children
(poweder suspension)

Biologically active food supplement \ OTC

1.420

Novermber 2012

Codelac®NEO (drops)

R05D- central antitussive agent \ OTC

1.154

November 2012

Codelac®NEO (Syrup)

R05D-central antitussive agent \ OTC

1.154

December 2012

Bromdeksin syrup (without alcohol)

R05C- expectorate mucolytic agent \OTC

14.453

December 2012

Alongside the research and development and putting into production of new pharmaceutical products (generic products, new pharmaceutical forms of products and original combinations of known pharmacologically active substances) there is also co-operation with various pharmaceutical companies for the purpose of manufacturing pharmaceutical products under the trade marks of these companies.

In 2011, following the transfer of packaging and quality control know-how and the completion of the registration procedure, the manufacture of Revlimid® (Celgene) and Tamiflu® (Hoffmann la Roche) commenced at the Company's production facilities. The filling, packaging and quality control know-how transfer for Prezista® (Johnson & Johnson) was also completed, as well as the full cycle manufacture localisation for Mildronate® (Grindeks).

Roche (Switzerland) and the group of companies Pharmstandard have completed the localisation of production of Mabthera® (rituximab) in the territory of the Russian Federation. The result of this partnership was the succeful transfer of the final stages of production of this biotechnological original product to the modern plant of OJSC Pharmstandard-UfaVITA.

Johnson & Johnson LLC, a pharmaceutical subdivision of Janssen, and OJSC Pharmstandard-UfaVITA signed a Memorandum of Intent outlining the main areas of co-operation as regards the localisation of full cycle manufacturing of Velcade® (bortezomib) included in the list of strategically important pharmaceutical products approved by a government Decree in July 2010.

Within the framework of the Company's co-operation with its partners, the first production facilities for the manufacture of cytostatic agents, in conformity with European GMP (Good Manufacturing Practice) standards, will be established in Russia.

The transfer of packaging and logistics know-how for the production of Actemra® (Hoffmann la Roche) and the commencement of its manufacture are scheduled for 2012. The transfer of know-how for full-cycle production of Velcade® (Johnson & Johnson), the transfer of the production know-how for Eurespal® syrup (Servier), the stage-by-stage transfer of the know-how for the manufacture of metered-dose asthma inhalers (Triniti-Chiesi) have been in process since 2010. These projects are scheduled to be completed in 2014.

Clinical trial in 2011

In October 2011, the Company began clinical trials of Arbidol® - ARBITR, in compliance with the laws and regulations of the Russian Federation stipulating procedures for clinical trials as well as with the international guidelines for clinical trials ICH-GCP. The main purpose of the trial was to obtain additional information regarding safety and effeciency of Arbidol® (INN - umifenovir) used for the prevention and treatment of flu and colds, including the information regarding possible resistance to Arbidol of certain virus strains. This trial will take place withing the framework of post-registration product study.

In 2011, the Company started the development of post-registration clinical trials of three products: Phosphogliv® capsules, Afobazo®l tablets and Amixin® tablets. The purpose of the trials is to obtain additional data about safety and efficiency of these products and about new indications to be added to the registration documents, including new indications use of Afobazol® for the treatment of children. The trials are scheduled to commence in 2012. 

Biotechnological project Generium

OJSC Pharmstandard is a participant in biotechnological project Generium whose mission is development and introduction of high-tech pharmaceutical products. At the beginning of 2012 one of the participants of IBC Generium received a Skolkovo Fund resident status.

One of the most significant building stones of the project since its conception, was the creation of R&D centre Generium (NauchTechStroy Plus LLC) is a Russian technology cluster, the only one of its kind in the country.

The project was developed and realised through co-operation between JSC Pharmstandard and a group of Russian pharmaceutical companies.

In March 2012, during his working trip to Vladimir Region for a meeting of the Presidential Commission for Modernisation and Technological Development of Russia's Economy President of the Russian Federation Dmitry Medvedev visited biotechnology centre Generium.

The Scientific Research Centre has been designed to provide the best possible conditions for the researchers and operational staff to realise their full potential. Apart from the research and production facilities, the Centre includes a living quarter for the employees and their families designed to accommodate 600 people.

The main objectives of R&D Centre Generium (NauchTechStroy Plus LLC)

• Reproduction of know-how for the manufacture of biotechnological vital and essential pharmaceutical products

• Development of new advanced forms using cell, genetic engineering and protein technologies

• Introduction to the market of 8 - 10 new genetically engineered pharmaceutical products annually

• Collaborations with leading Russian and foreign scientific centres for the purpose of realising long-term scientific projects

• Organisation of local and international scientific advisory council

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