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BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet...

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Company presentation March, 2016
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Page 1: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Company presentation March, 2016

Page 2: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

7 « »

Page 3: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Company Overview

Biem Pharmaceuticals is

Pharmaceutical manufacturer with headquarters in

Ankara

Pharmaceutical marketing and distribution company

Proprietary portfolio of high-value branded

pharmaceutical products in Turkey

Global presence advancing in more than 11 countries

Committed to innovative solutions in Oncology,

Hematology, Radiology, Ophthalmology, Neurology

Founded

1989

Biem is founded

in 1989

1990

Biem becomes a

limited company

2012

Emaray & Pamiray is

launched

2014

Launch of Oncology

Portfolio

2015

Launch of Intensive

Care Portfolio

Biem becomes

Incorporated

Biem becomes exclusive

distributor of Cutter

2011

Until 2011 Biem is

distributor of Cutter, Miles

Bayer, Talecris

Page 4: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Organization

Board of Directors

General Manager Board of Directors

Consultant

Financial Director

Purchasing

Manager

Marketing and

Medical Director

Accountant HR

Manager

Warehouse

Manager

Warehouse

Officer

Warehouse

Responsible

Group

Manager

Tender

Officer Warehouse

officer TST

Product

Manager

Export Manager

Business D.

Officer

Export

Officer

Export

/İmport

Procuremen

t Officer

Statistic

Manager

P&P

Officer

Science

Responsible

Officer

Reg. Affairs

Officer

Regulatory

Affairs Manager

Satatistic

Responsible

ARGE

Officer

Page 5: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Mission, Vision & Strategy

Our Mission

Our Vision

to become the FIRST REMEDY

for saving lives by increasing life

quality with high tech, pioneering

products and

ONLY REMEDY able to provide

drugs produced with innovative

technology without pursuing high

profit margins, for illnesses that

affects only a small percentage of

the population

Our Strategy

to achieve growth in our

therapeutic field with an

innovative approach and

steady growth

always focused to produce the

best quality products, safe and

efficient, by searching innovative

solutions for happy and healthy

lifes

to increase the quality of our health services in all its activities,

while preserving the ethical values of the health industry

Biem as part of its strategy has accelerated its expansion

activities and products portfolio with a big focus on registration

sales, marketing and manufacturing on the domestic and

international pharmaceutical market.

Page 6: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Global Parteners

Biem has key partnership with leading Global Pharmaceutical companies:

Germany

Poland Italy

China

Korea India

Page 7: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

International Business Worldwide

Biem’s Global

Network Azerbaijan Russia Georgia Albania Moldova Phillippines Kuwait Pakistan Chile Equador Colombia

Domestic Market:

a steady growth in the therapeutic market is

expected due to our ongoing portfolio.

International Market:

international business is increasing due to our

overseas sales activity through product registration

in more than 11 countries.

Page 8: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Countinuos Growth Strategy

$0

$1,000,000

$2,000,000

$3,000,000

$4,000,000

$5,000,000

$6,000,000

2012 2013 2014 2015 2016

$1,418,021

$2,031,802

$2,229,682

$3,639,576

$5,823,322

2012

2013

2014

2015

2016

60% growth targeted in 2016

Assests: 20.000.000 USD

Paid in Capital 6.500.000 USD

Page 9: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Product Portfolio

Biem portfolio consists of 27 human products, of which:

Radiocontrast Imaging 14.3%

Oncology 26.9%

Transplantology 10.7%

Intensive Care 21.4%

Opthalmology 28.6%

0.0%

Key moments 2012: launch of the Emaray and Pamiray

2014: launch of the Oncology and Ophthalmology Portfolio

2015: launch of the Intensive Care Portfolio

Page 10: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Product Portfolio: RADIOCONTRAST IMAGING

LOCAL PRODUCTS

Drug Name Active ingredient Treatment Area Launch date

EMARAY®

10,15,20 ml

Gadopentetate

dimeglumine

Magnetic Resonance imaging (MRI) 2012

PAMIRAY® 300/370

50,100 ml

Iopamidol CT Diagnostic imaging agent 2012

GADODIEM ®

287 mg/ml in 10,15,20 ml

Gadodiamide Magnetic Resonance imaging (MRI)

2015

BIEMEXOL® 300/350

50,100,200ml vials

Iohexol CT Diagnostic imaging agent 2015

Page 11: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Product Portfolio : HEMATO - ONCOLOGY

LOCAL PRODUCTS

Drug Name Registration

holder

Active

ingredient

Treatment Area Launch

date

BUSLERA®

6mg/ml

BIEM Busulfan Antineoplastic Agent / conditioning

treatment prior to conventional (HPCT)

2014

BEASTIN®

25mg /100 mg

BIEM Bendamustine

hydrochloride

Antineoplastics, Alkylating

agent/Chronic Lymphocytic Leukemia,

Non-Hodgkin Lymphoma,

2014

OCLADRA®

10mg/5ml

BIEM Cladribine Antineoplastics, Antimetabolite / Hairy

Cell Leukemia

2014

VOTRON®

250mcg/ml vial

BIEM Palonosetron Anti-vomiting and anti-

nausea/Chemotherapy side effects 2012

IMPORTED PRODUCTS

BIEMIB®3,5mg BIEM Bortezomib Mantle cell Lymphoma, Non-Hodgkin

Lymphomai Multiple Myeloma

2015

LETROKS®

2,5 mg tablet

Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009

OXALIMEDAC®

50 mg/10 ml

100 mg/20 ml

Medac Oxaliplatine Antineoplastic agent/Colon cancer 2010

Page 12: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Product Portfolio: TRANSPLANTOLOGY

IMPORTED PRODUCTS

Drug Name Registration

holder

Active

ingredient

Treatment Area Launch date

PANOLIMUS®

0.5 /1/ 5 mg

capsules

PANACEA

BIOTEC.

Tacrolımus Organ and tissue

transplantology 2012

PANOSPORIN®

25/50/100 mg

capsules

PANACEA

BIOTEC.

Cyclosporıne Organ and tissue

transplantology;Dermatology

(psoriasis, athopic dermatitis

vs.)

2012

LOCAL PRODUCTS

EMFER®

100mg/5 ml

ampoules

BIEM Iron sucrose Haematinics (iron supplements) 2014

Page 13: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Product Portfolio: INTENSIVE CARE

LOCAL PRODUCTS

Drug Name Registration

holder

Active

ingredient

Treatment Area Launch Date

BIEMPARIN®

4mg/4ml

BIEM Heparine

sodium

Anticoagulant therapy 2016

SEDOZOLAM®

5mg/5ml, 15mg/3ml

BIEM Midazolam Anesthetic/Hypnotics/Sedative/Preoper

ative Sedation; 2016

BIEMEFRIN®

4mg/4ml

BIEM Norepinephrine Antihypotensives/Acute hypotension 2014

MRSACIN®

50mg

BIEM Tygecycline Antibiotic/Antibacterial for systemic use 2014

TROZASIN ®

200 mg/

BIEM Voriconazole Antifungal, Systemic/Invasive

aspergillosis; Nonneutropenic

candidemia;

2016

Page 14: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Product Portfolio: OPHTHALMOLOGY

IMPORTED PRODUCTS

Drug Name Registration holder Active ingredient Treatment Area Launch date

SICCAPROTECT® Ursapharm

Polyvinyl

alcohol+dexpanthenol

Artificial tears/Dry eyes

syndrome 2010

10 ml eye drops

VITAMIN A-POS ® Ursapharm Retinyl Palmitate

Vitamin/conjunctivitis

and atrophic change of

the cornea 2004

5 gr eye cream

FLUOROPOS®

Ursapharm Fluorometholone

Antiinflamation

agent/Steroid for

topical ophthalmic use 2005

5 ml eye drops

PREDNIPOS®

Ursapharm Prednisolon

Antiinflamation

agent/Steroid for

topical ophthalmic use 2007

10 ml eye drops

LOCAL PRODUCTS

ZARIDINEX ®

BIEM Ofloxacine

Anti-infective quinolone

antibiotics/bacterial eye

infection 2014

0,3% Ophthalmic

solution

ENFLUAT®

BIEM Ketorolac

tromethamine

Nonsteroidal anti-

inflammatory drug for

ophthalmic use 2014 0,4% Ophthalmic

solution

Page 15: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Future of BIEM

New Manufacturing Oncology Facility in Ankara

Page 16: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Future of BIEM

• Enable company to start business in US and European countries • Sustain a steady growth on the Turkish market by adding

innovative oncology products according standards • Established a new facility based on EU/ FDA GMP standards

1. Purpose of EU GMP/ FDA GMP standard facility

• Injection and Lyophilized: 120.000 units • Tablet: 14.000.000 units • Capsules: 410.000 units

2. Project Capacity Oncology Drugs Annualy

• Land Acquisition in Ankara Organized Industrial Zone 2: 18,000 m2

• 2015, September : Project Start

• 2016, August: Start Construction

• 2018, July : Complete Construction

3. Current Process

Development of innovative next generation oncology products to

expand domestic and global market share

Page 17: BIEM ILAÇ SANAYI VE TICARET A.S - Dossier & Finished Dosage … · 2017-09-12 · 2,5 mg tablet Celon Farma Letrozol Antineoplastic agent/Breast cancer 2009 OXALIMEDAC® 50 mg/10

Thank you Address:Turgut Reis Cad. No:21

Tandoğan/Ankara

Phone: (0312) 230 29 29

Fax: (0312) 230 68 00


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