İstinye Mah. Balabandere Cad. No: 14 34460 Sarıyer / İSTANBUL T: (0212) 323 17 30 F: (0212) 362 12 48 www.arvenilac.com.tr

We designtechnology

for the future and we provide

futurefor humanhealth

as Arven,a Toksoz Group Company,

We designtechnology

for the future and we provide

futurefor humanhealth

as Arven,a Toksoz Group Company,

ARVEN is growing with the motto "We design technology for the future and we provide future for human health"

Arven Capabilities include,

but not limited to:• Development

• Large Scale production

• Global Market Access

• Global Regulatory Expertise

• Clinical

Arven’s Global Growth Pillars: biotechnology & inhalation

Toksoz group started to develop inhalation products and biologics in 2007. Main goal

of the company is to focus on specific product areas and -difficult to make- products.

Taking into account the rapidly changing dynamics of global regulatory environment,

Toksoz Group decided to start up Arven dedicated only to development and

manufacture of inhalation products and biologics.

To support this vision, Arven established teams of highly qualified and dedicated

research scientists, as well as build a brand new 28,000 square meter

manufacturing facility located in the Kirklareli, Turkey.

Arven strives for developing products for global market, with strategy of

“One Product Globally”.

ManufacturingFacility

To support this goal,

28.000 m2 of manufacturing site

under construction in

Kırklareli, Turkey

will start operations in

mid of 2016.

• Biotechnology Products Development & Manufacturing

Microbial Based Biosimilars Development & Production

Mammalian Based Biosimilars Development & Production

Fill & Finish

• Inhalation Products Development & Manufacturing

Development of Patent Protected Multi-unit Dose Dry Powder Inhaler Sanohaler®

Development of DPI Formulations

Production at Commercial Scale

Development of both product groups are

carried out according to international guidelines

(WHO, ICH, FDA, EMA)

Arven Perspectives on

Candidate biosimilar Targeted diseases Status

ARV_MIC_01/

VENFILAR Neutropenia Registration

ARV_HMAB_01 Several autoimmun disorders Development

ARV_HEDMAB_01 Cancer Development

ARV_HEDMAB_02 Cancer Development

ARV_HEDMAB_03 Respiratory infection Development

ARV_HEDMAB_04 Allergic Development

ARV_HEDMAB_05 Multiple Sclerosis, Chron’s Disease Development

ARV_CHMAB_01 Non-hodgin lymphoma Development

ARV_CHMAB_02 Cancer Development

ARV_MIC_02 Neutropenia Development

biotechnologyArven is the first Turkish company developing a biosimilar

for global markets, including USA and EU

Development of biosimilars are carried out according to international guidelines and regulations including WHO, ICH, FDA and EMA

Arven’s expertise includes:

• Production of therapeutic proteins

• Determination of Quality of therapeutic proteins

• Head to head comparison with reference products

•Analytical similarity studies

• Bioassay studies

• Receptor binding studies and others

• Sanohaler was developed as a DPI device with its own patented design to enable inhalation at different flow rates

• Cyplos Sanohaler(salmaterol/fluticasone) 50/100 mcg, 50/250 mcg and 50/500 mcg Powder for Inhalation received Regulatory approval by Turkish Ministry of Health in 2011 and

registration of Cyplos with other Regulatory authorities,

including FDA and EMA, are ongoing.

inhalation

Further development of the device is

ongoing by taking into consideration the high demand to the product from differents

markets. Main target of Arven is to introduce this unique device to international markets with numerous

formulations including different drug substances.

Inhalation Projects Dosage Form &Strength Targetted Disease Device Status

Salmeterol / Fluticasone 50 / 100 mcg, 50/250 mcg, 50/500 mcg Asthma / COPD Sanohaler Marketed Powder for Inhalation

Formoterol fumarate / Budesonide 200mcg/12mcg, 400mcg/12mcg Asthma / COPD Capsule Device Marketed Capsule for Inhalation

Tiotropium Bromide 18mcg Capsule for Inhalation and COPD Capsule Device Under registration

Indacaterol 75 mcg / 150 mcg / 300 mcg COPD Capsule Device Development Capsule for Inhalation

Aclidinium bromide 0,375 mg Powder for Inhalation COPD Sanohaler Development

Fluticasone / vilanterol 92/22 mcg, 184 mcg/22 mcg Asthma / COPD Sanohaler Development Powder for Inhalation

Glycopyrronium bromide 63 mcg Capsule for Inhalation COPD Capsule Device Development

Indacaterol / Glycopyrronium bromide 85 mcg / 43 mcg Capsule for Inhalation COPD Capsule Device Development

Umeclidinium bromide 65 mcg Powder for Inhalation COPD Sanohaler Development

Umeclidinium bromide / vilanterol 55 mcg / 22 mcg Powder for Inhalation COPD Sanohaler Development Powder for Inhalation

Arven is the first Turkish company developing Sanohaler, a patent protected Dry Powder Inhalation (DPI) device and globally introducing

Cyplos (salmaterol/fluticasone) with Sanohaler device

Sanohaler, as a DPI device, has outstanding characteristics

• Regular dosing during entire use of device

• Capability of fixed and sufficient dose inhalationat different inspiratory flow rates

• No need to have specific hand-skills to use the device

• Ease of use with short training

• Ergonomic with suitable dimensions

• Only a few simple steps for dosing

• Dose indicator specifically printed on the blister assuring patients of

correct number of remaining doses

precise,reliable

Salmeterol/Fluticasone Propionate