Active Pharma-Substance Manufacturing Technology of Recombinant Teriparatide

COOPERATION OPTIONS


LICENSE

FROM 200 MILLION RUR

RESEARCH PARTNERSHIP

FROM 50 MILLION RUR

more detail

ABOUT THE PROJECT

Active Pharma-Substance Manufacturing Technology of Recombinant Teriparatide

A NEW HIGH YIELD BIOTECHNOLOGY METHOD TO PRODUCE RECOMBINANT RTN (1-34).

The AFS basis is the recombinant human parathyroid hormone (PTH), produced using a strain of Escherichia coli. PTH is included in the list of essential drugs (code H05AA) and is one of the most demanded drugs on the world and domestic market, which is used to treat osteoporosis and promotes bone formation by directly affecting osteoblasts, which fundamentally distinguishes it from other drugs, used for osteoporosis treatment, by the mechanism of action. The developed teriparatide production technology is applicable to the manufacturing of Forsteo®(Eli Lilly) biosimilars.

Stage of development

ACTIVE PHARMA-SUBSTANCE MANUFACTURING TECHNOLOGY OF RECOMBINANT TERIPARATIDE

COOPERATION OPTIONS 

LICENSE

FROM 200 MILLION RUR

RESEARCH PARTNERSHIP

FROM 50 MILLION RUR

more detail

ABOUT THE PROJECT

ACTIVE PHARMA-SUBSTANCE MANUFACTURING TECHNOLOGY OF RECOMBINANT TERIPARATIDE

A NEW HIGH YIELD BIOTECHNOLOGY METHOD TO PRODUCE RECOMBINANT RTN (1-34).

The AFS basis is the recombinant human parathyroid hormone (PTH), produced using a strain of Escherichia coli. PTH is included in the list of essential drugs (code H05AA) and is one of the most demanded drugs on the world and domestic market, which is used to treat osteoporosis and promotes bone formation by directly affecting osteoblasts, which fundamentally distinguishes it from other drugs, used for osteoporosis treatment, by the mechanism of action. The developed teriparatide production technology is applicable to the manufacturing of Forsteo®(Eli Lilly) biosimilars.

Stage of development

STAGE OF DEVELOPMENT
& RESULTS OF INTELLECTUAL ACTIVITY STATUS


EFFECT

Teriparatide stimulates the formation of bone tissue through a direct effect on osteoblasts. 

APPLICATION

Used for the treatment of osteoporosis.

Description: Solution for subcutaneous administration, cartridge (syringe-pen).

BENEFITS

Suitable for all osteoporosis cases
One of the best drugs for the treatment of osteoporosis caused by drugs, such as glucocorticosteroids
Included in the list of vital and essential medicines
The international patent for the original Forsteo® drug expired in 2019
Teriparatide's API is identical to the original substance
Low cost of substances due to the availability of own production of key reagents
Lack of reproduced drugs based on teriparatide registered in the Russian Federation
Scalable technology with the possibility of cost optimization
it Is possible to develop oral drug forms

COOPERATION OPTIONS

Options for project implementation include Intellectual Property license agreement and/or further product development together with investor.
license agreement 

Conclusion of agreements on disposal of exclusive intellectual property rights (license agreements). 

Approximate investment amount: 

• Granting the right to use results of intellectual activity - starting at RUB 200 million RUR

• Royalty 5%

Small Innovation Enterprise (SIE)

Creation of the project company as a Small Innovation Enterprise (SIE), the founders of which include IBCh RAS and some investor & scientists-developers.

The aim: to bring research to the market launching stage and to organize product manufacturing and sales.

Approximate investment amount: 

Starting at 510 million RUR 

Small Innovation Enterprise (SIE)

Creation of the project company as a Small Innovation Enterprise (SIE), the founders of which include IBCh RAS and some investor & scientists-developers.

The aim: to reach the further research stage(s) and to sale of the scientific product in the form of sublicensing.

Approximate investment amount:

• Preclinical studies
Starting at 50 million RUR

• Clinical trials, phase 1
Starting at 50 million RUR

• Clinical trials, phase 2
Starting at 100 million RUR

• Clinical trials, phase 3
Starting at 150 million RUR

investment partnership agreements

Conclusion of investment partnership agreements for further research stages on the investor basis with the participation of IBCh RAS.

The aim: to obtain a scientific product or "ready to market" product.

Approximate investment amount: 

• Preclinical studies
Starting at 50 million RUR

• Clinical trials, phase 1
Starting at 50 million RUR

• Clinical trials, phase 2
Starting at 100 million RUR

• Clinical trials, phase 3
Starting at 150 million RUR

• Start manufacturing
Starting at 110 million RUR

• Promotion activities
Starting at 50 million RUR

LICENSES

На деятельность по производству лекарственных средств <br>№ 11719-ЛС-П от 25.06.2012 <br>(срок действия: бессрочно)

FOR THE PRODUCTION OF MEDICINES
№ 11719-ЛС-П OF 25/06/2012
(VALIDITY PERIOD: UNLIMITED)

На работы связанные с использованием возбудителей инфекционных заболеваний III-IV групп патогенности (срок действия: бессрочно)

FOR STUDIES RELATED TO THE USE OF PATHOGENS OF INFECTIOUS DISEASES OF GROUPS III-IV PATHOGENICITY
(VALIDITY PERIOD: UNLIMITED)

DEVELOPERS

The Shemyakin & Ovchinnikov Institute of bioorganic chemistry (IBCh) of the Russian Academy of Sciences is one of the largest Russian scientific organizations. The Institute is a leader in fundamental and innovative researches on the fields of molecular, structural and cell biology, bioorganic chemistry, biophysics, bioengineering, cell technologies, “in vivo” molecular based bioimaging, genome editing, bioinformatics etc. This multidisciplinary structure allows large-scale research at the interface of sciences, where the most interesting scientific discoveries are born today.

The hallmark of the IBCh RAS is the concentration of efforts and resources on solving the most urgent and complicated problems on the field of life sciences. Talented young people and leading specialists, including Russian and foreign science leaders, Nobel Prize laureates and members of the international advisory council of the Institute are involved in.


PUBLICATIONS

1. Development of a pilot technology for obtaining the recombinant teriparatide substance. XXXIII Winter International Youth Scientific School "Perspective Directions of Physico-Chemical Biology and Biotechnology"

Kryukova A.V., Stepanenko V.N., Makarov D.A., Vorobyova T.V., Sokolova I.V., Tereshin M.N., Myagkikh I.V.

M.M. Shemyakin and Yu.A. Ovchinnikov Institute of Bioorganic Chemistry RAS, 2021. С. 150.

CONTACT us

get in touch

On cooperation issues please contact the head of NTI Center project department
Sergey Semenov
E-mail consortium@cnti-ibch.ru
address 16/10, Miklukho-Maklaya St, Moscow, Russian Federation, 117997
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