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Corporate / October 2014
History
HISTORY• 49 years ago, a small team of scientists with limited financial resources, set the foundation for a modern and dynamic pharma-ceutical company.
• ELPEN’s philosophy “We care for People” inspires and drives all of us at ELPEN and aspires further expansion in our activities.
STRATEGYTo maintain its leading position and top quality ELPEN: • Dedicates significant financial resources to R&D.• Aims to enter new therapeutic areas.• Invests in and secures new strategic partnerships with selected multinational companies.• Enhances and enriches its product portfolio.
ELPENHALER®
The Elpenhaler® is ELPEN’s proprietary, worldwide patent protected, breath-activated, multi single-dose dry powder inhaler. Advantages:• Robust construction, accurate dosing, medication protection, ease of use, taste and visual verification of drug uptake. Additional use:• administration of other medications that could be delivered via the lungs in the treatment of local or systemic diseases.
ROLENIUM®
Rolenium® is ELPEN’s fluticasone/ salmeterol combination product for the treatment
of asthma and COPD, launched in Greece in November 2009.
• Strengths: 100/50 mcg
250/50 mcg500/50 mcg
• 3rd brand of the Greek ICS + LABA the market, with 17% m.s.
ELPEN Pharma GmbH• ELPEN’s subsidiary• Founded: February 2012 in Berlin, Germany.• Offers high quality medicinal products in various therapeutic categories.
ELPENHALER® PRODUCTS, UPDATEFour Elpenhaler® medications have been developed to date. Their registration status and market presence is as follows: • Formopen® (formoterol): Registered and launched in 5 countries• Fluticapen® (fluticasone): Registered and launched in 5 countries• Rolenium® (fluticasone + salmeterol): Registered in 27 EU countries and launched in 9 countries• Pulmoton® (budesonide + formoterol): Registered and launched in 2 countries
Further worldwide registrations are on-going and new launches are planned in the near future for all products above.
1965 1970 1990 2002 2009 2012 2013
VISIONTo offer:• Pharmaceuticals of unparalleled quality • To be a socially responsible company towards our fellow human and the Greek economy.
RESEARCH & DEVELOPMENTEstablishment of the first private fully fledged R&D facility in Greece. ELPEN’s R&D unit facilitates the internal development of selected generics, and the establishment of strong collaborations with major academic and private research institutes in Greece and abroad, and operates a state of the art Experimental and Research Center.
EX
PERI
MENTAL - RESEARCH CEN
TER
ΕΡΕΥΝ
ΗΤΙΚΟ - ΠΕΙΡΑΜΑΤΙΚΟ ΚΕΝ
ΤΡΟ
INDUSTRIAL FACILITIESElpen establishes its own production facilities, which turn the company into a leading player in the Greek market.The company owns over 10,000m2 in facilities, which operate according to international GMP and ISO standards.We possess full production lines of: Oral Solids, Oral Liquids, Dry Powder Inhalation, Injectable & Lyophilized products. In independent & dedicated facilities, we operate the production of Oral Solid Penicillin.
EXPORTSEstablishment of the Exports Department of Elpen. The company wins its first major National Tender and organizes local private market product portfolios with the aid of carefully selected local partners.
HISTORY• 49 years ago, a small team of scientists with limited financial resources, set the foundation for a modern and dynamic pharma-ceutical company.
• ELPEN’s philosophy “We care for People” inspires and drives all of us at ELPEN and aspires further expansion in our activities.
STRATEGYTo maintain its leading position and top quality ELPEN: • Dedicates significant financial resources to R&D.• Aims to enter new therapeutic areas.• Invests in and secures new strategic partnerships with selected multinational companies.• Enhances and enriches its product portfolio.
ELPENHALER®
The Elpenhaler® is ELPEN’s proprietary, worldwide patent protected, breath-activated, multi single-dose dry powder inhaler. Advantages:• Robust construction, accurate dosing, medication protection, ease of use, taste and visual verification of drug uptake. Additional use:• administration of other medications that could be delivered via the lungs in the treatment of local or systemic diseases.
ROLENIUM®
Rolenium® is ELPEN’s fluticasone/ salmeterol combination product for the treatment
of asthma and COPD, launched in Greece in November 2009.
• Strengths: 100/50 mcg
250/50 mcg500/50 mcg
• 3rd brand of the Greek ICS + LABA the market, with 17% m.s.
ELPEN Pharma GmbH• ELPEN’s subsidiary• Founded: February 2012 in Berlin, Germany.• Offers high quality medicinal products in various therapeutic categories.
ELPENHALER® PRODUCTS, UPDATEFour Elpenhaler® medications have been developed to date. Their registration status and market presence is as follows: • Formopen® (formoterol): Registered and launched in 5 countries• Fluticapen® (fluticasone): Registered and launched in 5 countries• Rolenium® (fluticasone + salmeterol): Registered in 27 EU countries and launched in 9 countries• Pulmoton® (budesonide + formoterol): Registered and launched in 2 countries
Further worldwide registrations are on-going and new launches are planned in the near future for all products above.
1965 1970 1990 2002 2009 2012 2013
VISIONTo offer:• Pharmaceuticals of unparalleled quality • To be a socially responsible company towards our fellow human and the Greek economy.
RESEARCH & DEVELOPMENTEstablishment of the first private fully fledged R&D facility in Greece. ELPEN’s R&D unit facilitates the internal development of selected generics, and the establishment of strong collaborations with major academic and private research institutes in Greece and abroad, and operates a state of the art Experimental and Research Center.
EX
PERI
MENTAL - RESEARCH CEN
TER
ΕΡΕΥΝ
ΗΤΙΚΟ - ΠΕΙΡΑΜΑΤΙΚΟ ΚΕΝ
ΤΡΟ
INDUSTRIAL FACILITIESElpen establishes its own production facilities, which turn the company into a leading player in the Greek market.The company owns over 10,000m2 in facilities, which operate according to international GMP and ISO standards.We possess full production lines of: Oral Solids, Oral Liquids, Dry Powder Inhalation, Injectable & Lyophilized products. In independent & dedicated facilities, we operate the production of Oral Solid Penicillin.
EXPORTSEstablishment of the Exports Department of Elpen. The company wins its first major National Tender and organizes local private market product portfolios with the aid of carefully selected local partners.
ELPEN is the Leading Pharmaceutical Company in Greece, ranking 7th among more than 400 multinational and local companies.
Rank Corporation Values, € mill % m.s. Volume mill % m.s. (total market 2.7 € bill) (total 368 mill)1 NOVARTIS 226.056.907 8,4 24.737.134 6,72 PFIZER 206.300.608 7,6 28.807.040 7,83 SANOFI 185.273.823 6,9 25.958.257 7,04 ASTRA ZENECA 152.293.306 5,6 15.149.662 4,15 GSK PHARMA 142.954.457 5,3 25.768.926 7,06 MERCK SHARP DOHME 122.709.685 4,5 7.772.849 2,17 ELPEN 122.474.624 4,5 13.087.303 3,68 VIANEX 109.265.323 4,0 12.370.964 3,49 PHARMASERVE 102.026.673 3,8 4.516.703 1,210 BOEHRINGER INGELHEIM 97.625.714 3,6 13.255.073 3,611 MENARINI 66.787.809 2,5 5.785.469 1,612 BAYER HEALTH CARE 61.289.811 2,3 8.285.013 2,213 LUNDBECK 49.071.879 1,8 2.575.297 0,714 ABBOTT 46.097.332 1,7 6.563.769 1,815 JANSSEN CILAG 44.829.004 1,7 3.756.737 1,016 SERVIER 42.023.726 1,6 5.184.511 1,417 WINMEDICA 33.919.964 1,3 2.395.335 0,7
Successful product selection and dedication to quality by applying the highest production standards and strict quality controls have been amongst the determining factors to ELPEN’s exponential growth.
Greece, IMS, MAT 07/2014
Vision:• To offer quality pharmaceuticals
for the treatment of disease by applying the highest ethical
standards that meet and exceed relevant regulatory requirements• To be an exciting workplace
in which people can realize their professional ambitions, where
self-development and creativity are encouraged and cutting-edge
technologies are applied
ELPEN Group of CompaniesPrivate Company: Family owned, not listedEstablished: 1965 Group: ELPEN Pharmaceutical Co. Inc. Aenorasis SA WinMedica SA ELPEN Pharma GmbH Turnover 2013: €130 million (Group: € 190 million)Employees: 621 (Group: 821) Production Facilities: 10.000 m2 (Pikermi, Attica) Offices: 3.000 m2 (Athens, Thessaloniki, Berlin) Research Facilities: 1.000 m2 (Pikermi) Activities: - Production - Marketing and Sales - Regulatory Affairs - Clinical Development - Exports - R&D
ELPEN Yearly Turnover Progress
ELPEN has enjoyed truly exceptional growth rates in the last years, a trend set to continue.
ELPEN Employees Increase Over The YearsThe successful transformation of ELPEN into a leading local player is due first and foremost to our people, their commitment to ELPEN’ s business goals and their dedication to customer needs.
74
88105
130
140
126 126 128
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
63
130
410
450
522
550560
570 570 570
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
375
621
Over the next years, sales are projected to grow sharply as ELPEN enters new markets and exploits new opportunities and collaborations.
*From 2010 onwards turno-vers were greatly affected by numerous price decreases in Greece
Marketing and Sales Force Teams comprise together approximately half of ELPEN employees (350 people). They are one of the larg-est and most effective pharmaceutical sales teams in Greece, covering more than 24,000 medical doc-tors (12,000 in the hospital sector and 12,000 in the private sector) in all major medical specialties. They also visit 3,500 pharmacies all over Greece.
ProductsELPEN specializes in branded generics and branded pharmaceuticals through collaborations with multinational companies:
SPECIALTY % by values (YTD, 7/2014)
CARDIOLOGY 53
CENTRAL NERVOUS SYSTEM 10
RESPIRATORY 10
ANTIMICROBIALS 8
GASTROINTESTINALS 8
HAEMATOLOGY 4
UROLOGY / GYNECOLOGY 2
REST 5
Furthermore, eight (8) of ELPEN’s major products are included in the top 100 best performing product list:
Product (API) Rank Value (€ mill)
Lepur® (simvastatin) 15th 19,9
Copalia® (valsartan + amlodipine) 34th 12,8
Rolenium® (fluticasone + salmeterol) 47th 10,3
Copalia® HCT 49th 10,3(valsartan + amlodipine + HCTZ)
Entact® (escitalopram) 57th 9,0
Penrazol® (omeprazole) 59th 8,8
Clovelen® (clopidogrel) 69th 8,0
Carvepen® (carvedilol) 88th 6,6
Greece, IMS, MAT/07/2014
The quality of our products has won the trust of the local medical and pharmaceutical community and along with our ethics, has given ELPEN the confidence of conducting business like a multinational pharmaceutical company.
BRANDED PHARMACEUTICALS
43%BRANDED GENERICS
57%
Quality Policy:• ELPEN implements a quality policy to cater for the needs of its prod-
ucts, while fully complying with the standards required by law.
• The company’s management is committed to the implementation of
an integrated Quality System that is fully aligned with ISO
9001:2000, the Good Manufacturing & Laboratory Practices and the Good
Storage & Distribution Practices.
Branded Pharmaceuticals, Biosimilars & Generics
Licensing-in, Marketing & Distribution Collaborations
We continuously seek and evaluate products that have completed or are under late stage clinical develop-ment (ph.III / registration trials) and products registered or under registration in Europe. We are interested in discussing various types of collaborations:
• Co-Marketing &/or Co-Promotion
• Marketing & Distribution
• Co-Development
• Contract Manufacturing, and
• Third Party Services (Product Development, Preparation and submission of registration e-CTD dossiers, Monitoring of the registration process, Contract Manufacturing)
and we welcome all proposals for collaborations for Greece, Cyprus, Germany and the Balkans regarding products in the following specialties:
Anti-infectiveCardiology
Gynecology
Hematology
Biosimilars
MedicalDevices
Metabolicdisorders
Nichemarkets
Gastrointestinal Disease Oncology
Musculoskeletal disorders
Neurology
OTC
Respiratory
Renal Diseases
Genitourinary
CollaborationsOur experience is extensive in all types of partnerships including contract manufacturing, third party services, licensing-in, co-marketing, co-promotion and distribution. Thus ELPEN and affiliate companies enjoy a reputation for being the partner of choice for the Greek market as shown below:
International Partnerships & Collaborations
COLLABORATION TYPE COMPANY SINCE PRODUCT (API)
Third Party Services Aceto, DE 2000
Actavis, US 2012
Pharmacare, IT 2004
Distribution/ Bayer, DE 2001 Octegra® (moxifloxacin)
Marketing & Sales 2014 Xarelto® (rivaroxaban)
Baxter, US 2009 Brevibloc® (esmolol)
Ekuberg Pharma s.r.l.,IT 2013 DermoXEN® (OTC: 96% natural active principles)
Ferring, CH 2012 Tractocile® (atosiban)
2012 Zomacton® (somatropin human recombinant)
2012 Glypressin® (terlipressin)
Hospira, US 2006 Retacrit® (epoetin-z)
2009 Nipent® (pentostatin)
2011 Nivestim® (filgrastim)
Nordic Pharma, NL 2012 Teysuno® (tegafur, gimeracil, oteracil)
Venture Life, UK 2013 NeuroAge® (OTC: iron, pantothenic acid, uridine, cytidine, l-glutamine)
Licensing – in Italfarmaco, IT 1991 Legofer® (iron protein succinylate)
Co-marketing Lundbeck, DK 2005 Entact® (escitalopram)
Menarini, IT 2011 Hypoloc® (nebivolol)
2011 Hypoloc plus® (nebivolol HCTZ)
Novartis, CH 2007 Copalia® (amlodipine + valsartan)
2007 Copalia® HCT (amlodipine + valsartan + HCTZ)
2009 Jalra® (vildagliptin)
2009 Zomarist® (vildagliptin + metformin)
Pfizer, US 2009 Zarator® (atorvastatin)
Recordati, IT 2009 Zaneril® (lercanidipine + enalapril)
Co-promotion Sanofi, FR 2009 Cholestagel® (colesevelam)
ELPEN offers great experience in all necessary aspects for the dynamic introduction and promotion of pharmaceuticals in Greece.
Research & Development
In 1,000 m2 facilities at Pikermi, equipped with state-of-the-art instrumentation we perform research n the following sectors:
1. Developing new Branded Generics / Applied Research The departments of Patent Affairs, Formulation, Analytical Methods, Regulatory Affairs, and Clinical Affairs
collaborate in the development of the selected products, so as to ensure these will be the first generics to be launched in the Greek pharmaceutical market, as soon as originator patents expire.
Our Dry Powder Inhaler, the Elpenhaler® and the related branded generics were developed for the treatment of asthma and COPD. Products comprise: Formopen® (formoterol), Fluticapen® (fluticasone), Rolenium® (flutica-sone/salmeterol), and Pulmoton® (budenoside / formoterol).
2. Collaboration with Greek Universities and Research Institutions in projects of common interest The projects are co-financed by the Greek Secretariat of Research and Technology. ELPEN participates as the
Industrial Partner by financing up to 50% of the total budget. Aims of the projects include the study of disease mechanisms, possible therapeutic interventions as well as
development of new formulations and technologies in the areas of Cardiology, Respiratory diseases, Endo-crinology and Oncology.
3. The Experimental – Research Center Elpen Ranking by the International Scientific Bodies in the top 5 in Europe, for its contribution in
Research Activities and Training Workshops The Center, is the first and largest laboratory for Experimental Biomedical Research and Training in Greece that
originates from the private sector.
The Experimental Research Centre activities for apply biomedical research and training include: 1. Scientific Partnerships on innovative research ideas with clinics and laboratories of Greek Universities,
the Greek National Health System and the private Hospital sector 2. International Research Collaborations 3. Experimental Projects of ELPEN with the General Secretariat for Research and Technology, the European
Union and other bodies 4. Preclinical (in vivo) Experimental Research on new molecules where ΕLPEN retains exclusive rights 5. National & International Conferences and Meetings.
> 600 presentations in international meetings
> 180 publications in peered review Journals
> 100 awards, from many Greek and Foreign Scientific Societies
Special Award for Investment
in R&D, (July 2005, June 2014). The Athens
Chamber of Commerce and Industry Selection from the
entire industrial sector
Exports
Our goal is to form successful strategic alliances and to become the partner of choice in offering services and lifesaving innovative and branded generic pharmaceuticals all around the world.
We aim at establishing long-term business co-operations with local Agents, Distributors, Manufacturers and Marketers, for our products, services, technologies and know-how, for private markets, national and institutional tenders.
ELPEN has been involved in export activities since the 1990’s and the quality of our regulatory files and our products have been acknowledged in numerous markets around the world.
The Exports team is supported by ELPEN’s GMP certified departments of Product Development, Production, Quality Assurance and Regulatory Affairs to meet all local Quality, Regulatory and Pricing requirements.
Elpen’s Worldwide Presence
ELPEN currently exports its products in four continents, including the following countries:
Europe Africa Asia Oceania
Albania Algeria Azerbaijan Australia
Cyprus Botswana Brunei
Denmark Kenya Hong-Kong
Germany Libya Jordan
Hungary Namibia Iran
Iceland Nigeria Iraq
Italy South Africa Lebanon
Kosovo Tanzania Macau
Malta Tunisia Malaysia
Netherlands Philippines
Norway Singapore
Poland Thailand
Portugal UAE
Sweden Vietnam
UK
Strategy for product leadership & long-term business success by: • Striving to achieve the best possible quality for our
products and services• Allocating significant resources for R&D. The Elpenhaler
products are examples of our commitment to Research.• Maximizing the value of launched brands through com-
mercial investments and proactive life-cycle management• Recruiting and retaining the best sales and marketing
force • Developing strategic alliances with pharmaceutical
companies worldwide
ELPEN Pharmaceutical Co. Inc.
95 Marathonos Ave190 09 Pikermi, Attica, GreeceTel.: +30.210.60.39.326 (-9)Fax: +30.210.60.39.300E-mails: [email protected] [email protected] [email protected]
www.elpen.grC
P/LE
/05/
1014