> The Future is Today
Tecnimede Group (GTM)
Tecnimede started in 1980
Privately-owned company
Headcount of 700 employees
130.000.000,00€ turnover in 2015
Tecnimede Group is dedicated to the improvement and preservation of human life
and health, through the development and commercialization of pharmaceutical
products, with a strong focus on quality and technological innovation.
Atlas Pharm Plant (Morocco)
2011
1999
Tecnimede Maroc MKT & Sales
Tecnimede España MKT & Sales
2009
Labor Qualitas Research &
Development Campus
1998
Atlantic Pharma Plant (Sintra/Portugal)
2008
EU GMP’s, Anvisa GMPs (Brésil), Saudi Arabia GMPs, Jordan GMPs
& ISO 9001:2000 compliance
West Pharma Plant
(Lisbon/Portugal)
1995
EU GMP’s & ISO 9001:2000 compliance
2013
Tecnigen (Italy) Atlanticpharma (Brazil)
MKT & Sales
2015
Altadis (Colombia)
MKT & Sales
The history of GTM
1980
Tecnimede MKT & Sales
Atlantic Pharma
• State of art manufacturing plant
• Facilities cover 5.000 m2, implemented in an area of 43 000 m2
• Oral dosage forms, Creams, Ointments, Suppositories, injectables (small volume), Liquids, Suspensions with capacity for more than 30 million packs
• EU GMP’s, Anvisa (Brazil) GMPs, GCC GMPs, Jordanian GMPs & ISO 9001:2000 compliance
West Pharma
• Facilities cover 3 000 m2
• Oral solid dosage forms with capacity for 12 millions pack units
• EU GMP’s & ISO 9001:2000 compliance
The manufacturing capacity of GTM
Atlas
• Facilities cover 3.400 m², implemented within an area of 10.000 m²
• High Potency Active Products in oral solid dosage forms
• Capacity for 4 millions pack unit
• Complying with EU GMP
• Planned certifications: Anvisa (Brazil) GMPs, GCC GMPs, Saudi FDA GMP’s, Jordanian GMP’s, USFDA GMP’s & ISO 9001:2000 compliance
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The manufacturing capacity of GTM
The strategy of GTM
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Research & Development
(R&D)
The strategy of GTM
The activities in R & D
Group’s Number of Listed Patents (35 patents)
New chemical entities
Alternative processes, New salts
Pharmaceutical Composition
New indications
Among the most innovative companies in Portugal (Ranking by number of patents)
Research of new chemical entities (3 NCEs already patented)
Research of new fixed combinations
Generic drug development (15 files per year)
Development of new synthesis routes
Development of pharmaceutical formulations, including modified release forms and sterile forms
Analytical Process development and validation
Pharmacological screening
Toxicological studies
Clinical studies
Cell Culture
Under EU & ICH regulatory compliance, ISO 17 025 and GLP certification
The activities in R & D
The activities in R & D
New chemical entities
• TM-01 (metabolic disorders)
• TM-02 (prevention and treatment of the Mycobacterium)
• TM-03 (CNS)
Development of Pharmaceutical Formulations
• Development of generic formulations (15 files per year)
• Development of new fixed combinations;
• Development of new formulations (modified release)
Generic formulations: Bioequivalence/ Bioavailability studies
• New therapeutic indications and new fixed combinations: Pre Clinical studies, Phase II and III Clinical studies
• CROs: Anapharm, Algorithme, Biopharma (Clinical part); Anapharm Europe (Analytical Part)
• 45 scientific publications in peer-review journals
The activities in R & D
Universities of Pharmacy in Portugal
Universities of Pharmacy in Spain
Universities of Pharmacy in Italy
Unique collaboration with the University of Coimbra and its research centers
UC/Tecnimede – nonprofit research organization (50:50) that conducts contract research and development for Tecnimede and other partners
UpCells – the first unit for Advanced Therapies designed in GMP standards (Good Manufacturing Practice), for handling and obtaining vaccines based on dendritic cells and natural killer cells for the treatment of various cancers and autoimmune diseases.
The investments made in R&D activities enabled Tecnimede Group's entry in 26th place on the list of national companies that in 2011 invested the most in R&D.
More than 80 people working in R&D with a background on life sciences, chemistry and engineering
More than 45 scientific articles and posters published in peer-review journals
The investments in R & D
NET INVESTMENT - R&D (thousand euros)
0 2.000 4.000 6.000 8.000
10.000 12.000 14.000 16.000 18.000
2012 2013 2014 2015 2016*
Regulatory compliance with EU / ICH, ISO 17025 and GLP certification
The investments in R & D
• Total area: 3000 m2
• Laboratory area: 1500m2
• Including facilities for development of high potency compounds
Campus I&D do GTM QUINTA DA CERCA
CAIXARIA DOIS PORTOS
PORTUGAL
The strategy of GTM
International Expansion
14
Tecnimede Maroc
• Started in 1999
• Number of molecules: 49
• Total turnover in 2015: 13 million Euro
• Headcount of 82 employees
• Partnerships with local companies: Sothema, Zenith Pharma, Afric-Phar
Tecnimede España
• Started in 2009 - Marketing and Sales
• Number of molecules: 79
• Total turnover in 2015: 15.5 million Euro
• Headcount of 40 employees
International Operations >>>branches
Tecnimede Italie
• Started in 2014 - Jully - Marketing and Sales
• Number of molecules: 50
• Total turnover in 2015: 3 million Euro
• Headcount of 25 employees
International Operations >>>branches
2014 : Brazil
Espagne Italy
Morocco
2015 : New branch in Colombia
+ 100 Countries
+ 1.409 MA’s granted or in evaluation
+ 80 different molecules
International Operations >>>License-out
Currently with sales
International Operations >>>Europe
Albania
Austria
Belgium
Belarus
Bosnia Herzegovina
Bulgaria
Cyprus
Czech Republic
Croatia
Denmark
Finland
France
Georgia
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Lithuania
Luxemburg
Macedonia
Moldova
Netherlands
Poland
Romania
Russia
Serbia
Slovakia
Spain
UK
Ukraine
19
International Operations >>>Other Territories
Currently with sales Futures Sales
(ongoing registrations)
Algeria
Angola
Australia
Azerbaijan
Caribbean Countries
Chile
Colombia
Ecuador
Hong-Kong
Iraq
Lebanon
Macao
Morocco
Mozambique
Peru
Singapore
Sudan
Tunisia
Vietnam
Venezuela
Bahrain
Brazil
CIS Countries
China
Costa Rica
Egypt
Ethiopia
Guatemala
Iran
Jordan
Kuwait
Malaysia
Mexico
New Zealand
Oman
Panama
Pakistan
Philippines
Qatar
Saudi Arabia
South Africa
South Korea
Thailand
Taiwan
UAE
USA
West African Countries
Yemen
Development of new generics: opportunity for creating balanced markets and higher access to products
Development of difficult-to-make products: biosimilars, new oral release solid forms and depot injectables
Basic research oriented to clinical unmet needs: Neurosciences, Tuberculosis and Pain
Modernization of existing infrastructures
New infrastructures: New robotic warehouse
The strategy of GTM – the near future
Accelerate International Expansion: Obtain GMP certification for new plant – Atlas – with relevant world authorities
Partnerships with International companies: networking and technology exchange
The strategy of GTM – the near future
Thank you!
More information at www.tecnimede.com
TECNIMEDE, S.A.
Rua da Tapada Grande nº 2
Abrunheira - 2710-089 Sintra, Portugal
Tel.: 351.21.0414100
Fax: 351.21.9410839