040716_ANDI_VENTIS WEBSITE(new) Printout 1. HOME PAGE. Welcome to our world of Dry Powder Inhalers!

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1 1. HOME PAGE Welcome to our world of Dry Powder Inhalers! Andi-Ventis Ltd, established in 2001 is a joint venture between Medochemie Ltd, Cyprus and Miat SpA Italy, founded to carry out the pharmaceutical and clinical development, the registration and production of inhaled formulations utilizing the Miat-Haler multi-dose Dry Powder Inhaler. The dedicated facility, strategically located in Cyprus, has a development laboratory, manufacturing facility and a fully automated filling and assembly line, all complying with the latest GMP requirements. Our Mission To provide high quality, effective and well known drugs with our Dry Powder Inhaler technologies in order to help people with respiratory problems to breath better. Our capabilities cover: Device development Formulation development Scale-up Stability studies Clinical development Regulatory Affairs Product registration Production Ad hoc development of specific DPI formulations About the founders: Medochemie Ltd manufactures and markets a wide variety of generic pharmaceutical products in oral (solid and liquid), parenteral, topical and rectal form (including penicillins and cephalosporins). In total, Medochemie operates five separate production facilities. Miat SpA invented and developed the Miat-Haler device and is responsible for licensing and commercial agreements worldwide.

2 2 MIAT-HALER DEVICE MIAT-HALER is a patented portable multidose reservoir type Dry Powder Inhaler Device for effective drug delivery to the lungs. Miat-Haler main features fulfil regulatory, care givers and patients needs ensuring, ease of use efficacy safety efficiency 2.1 DEVICE OVERVIEW MIAT-HALER MAIN COMPONENTS Main S i Dose Disc Shaft Top Plu Hopper Shutter Body Collecting Duct Cradle Shutter Spring Mouthpiec e MIATHALER FEATURES AND BENEFITS EASE OF USE No device shaking before inhalation Automatically primes on opening No coordination required Ergonomic mouthpiece Handgrips Device labelling

3 Same device for different formulations EFFICACY Interlock mechanism / audible warning Metering chamber (dose disc) ensuring a standard drug volume / quantity De-aggregation system Lactose-active blend formulation SAFETY Metering chamber can be filled only upon delivery of the previous dose Minimum perceivable shot weight: approx. 6 mg Advance warning of last doses (last doses red tape) Lock-out mechanism Twist closure and desiccant pill Aluminium pouch No parts to be disassembled CFC Free EFFICIENCY Powder filling line in class 10,000 area Fully automatic assembly line in class 100,000 area Usable for up to 200 doses Different strengths just by replacing two components International drug colour codes with one component change, the cap 2.2 PATENTS All patents have been applied in for EUROPE and in many other countries, US included. Patents cover: Device Interlock mechanism De-aggregation system (Razor)

4 2.3 DEVICE OPERATION 3 CURRENT PRODUCTS/FORMULATIONS BECLOMETASONE DIPROPIONATE 100 MCG Launched in Japan in 2003 BUDESONIDE 200 MCG AND 400 MCG Application in UK in IIQ2004, followed by MRP FORMOTEROL FUMARATE 6 MCG & 12 MCG Clinical trials to start IIIQ RESEARCH & DEVELOPMENT Dedicated development laboratories, latest technology instruments and a team of trained scientists make Andi -Ventis capable of research and development of new products and assure constant update and improvement of the existing products.

5 4.1 OVERVIEW OF ANDI-VENTIS R&D Device development Formulation development Scale-up In vitro and In vivo studies Ad hoc development of specific DPI formulations 4.2 CO-DEVELOPMENT OPPORTUNITIES Andi-Ventis can study and set-up specific formulations with the Miathaler device on client demand. We can either work on respiratory or non respiratory drugs requiring inhalation route for improved performance and compliance. 4.3 R&D New products and formulations are developed in the dedicated development area that is environmentally controlled (class ) and GMP approved. Equipment in the development area is the same as in the production area and allows scale up to production batches directly. The methods of analysis for the new products are developed and validated by trained scientists in the Quality Control Laboratory. The newly developed formulations are fully characterized with the aid of the latest technology instruments. Stability studies at normal and stressed environmental conditions are carried on the products under development. In such a way only the formulations with the best performances and characteristics are scaled up to production and proposed for authorisation and subsequent sales marketing. 5 BUSINESS DEVELOPMENT Andi_V entis looks for business opportunities in the respiratory field through licensing its patented Dry Powder Inhaler Miathaler with current and under development formulations. Andi-Ventis is open to evaluate co-developing of formulations with its DPI proprietary technologies and know-how. 5.1 WH Y PARTNERIN G WITH ANDI-VENTIS? Andi-Ventis provides its clients formulations with its Miathaler DPI ready to be marketed. Andi-Ventis in facts develops, registers and produces its Miathaler formulations with in house expert dedicated personnel for each phase of the device formulation development.

6 5.2 AREAS OF INTEREST Dry Powder Inhaler drugs: Respiratory drugs Non respiratory Drugs to be delivered via the lungs 5.3 SCIENTIFIC PARTNERS Andi-Ventis cooperates with centres of excellence in the field of lung diseases such as Universities and qualified delivery technology companies (Vectura Limited, UK, ). Andi-Ventis since 2002 is also one of the sponsors of the two international projects; GINA (Global Initiative on Asthma), established under the auspices of the World Health Organization (WHO) and GOLD (G lobal Initiative for Chronic Obstructive Lung Diseases), 6 LICENSING Andi-Ventis looks for licensing out opportunities for its different Miathaler formulations either in early development phases or when available for registration and marketing. We look for licensing out our DPI formulations in the EU via Mutual Recognition Procedures (MRP) marketing authorisations and outside EU through national applications/registrations. 7 FACILITY Andi Ventis is a new facility located in Limassol, Cyprus and dedicated to the development and production of DPIs. In the same plant are Warehouses, Production Areas, Quality Control Laboratories, Development Laboratories and Service Areas. The facility was built in 2001 and validated in 2002, bearing in mind the latest GMP standards. Sophisticated equipment generates classified controlled air as well as purified water. Interlocked doors assure maintenance of differential pressures between different rooms. Personnel flow is separated from material flow, according to GMP rules therefore materials are moved from room to room by means of transfer hatches and the personnel follow strict gowning procedures and undergo thorough and extensive GMP training.

7 7.1 DEDICATED PLANT DPI formulations are delivered directly to the lungs, therefore in Andi Ventis the production takes place in areas environmentally controlled by sophisticated monitoring systems that continuously measure and keep within specifications Temperature, Relative Humidity and Particle Count. The production equipment is custom made and allows the production of DPI formulations in a closed system. The filling and assembling of the device is done by means of a completely automatic line specifically engineered for the Miat-Haler. Automatic machines can provide on line labeling and packaging in single aluminum pouch. RECEIVING OF MATERIAL The incoming material is received in the dedicated receiving area. Here the outer containers are checked for integrity, cleanliness and content and then transferred on to clean plastic pallets. Through transfer hatches, they are delivered to the sampling area of the factory where the Quality Control personnel take samples for Quality Control testing in a suitable cabinet under laminar flow filtered air. After release by the Quality Control, materials are placed in dedicated warehouse location. DISPENSING The material flow is separated from the personnel flow according to GMP rules. Dispensing of active raw material and excipients is the first step and it is done in appropriate areas under laminar flow in order to avoid contamination of material. Dispensing of device components from the warehouse to the environmentally controlled filling and assembling area is done through interlocked transfer hatches. BLENDING The blending process, to obtain the formulation, takes place in the dedicated blending room where customized blending equipment allows production of the blend in a closed system. Care is taken to protect personnel while handling sensitizing materials with special protective equipment. FILLING AND ASSEMBLING Filling and assembling of the devices is performed in 4 steps with a fully automated custom made machine. Every assembly step is automatically followed by a control step for correct assembling before the next step takes place. In such a way no defective devices will arrive in the packaging area.

8 LABELLING/PACKAGING The devices can be automatically labeled on line on one or both sides of the case and batch information can be printed on the labels. The devices are then packed in individual aluminum pouches by an automatic machine that can add variable data. The devices are then packed in their final containers and transferred to the finished product warehouse through dedicated transfer hatches. After Quality Control and final Quality Assurance approval only products of a guaranteed high quality are released and sent to the market. 7.2 QUALITY CONTROL In the Quality Control Laboratory the device components, the raw material, the excipients, as well as the finished products, are checked according to validated procedures and methods of analysis with the aid of the latest technology instruments. Trained scientists that develop and follow sophisticated and accurate methods of analysis ensure that only the best quality of device components and raw material will reach the production areas. More than 70% of the people working in the Andi-Ventis Quality Control laboratories have a university degree in relevant subjects (Pharmacy, Chemistry, Chemical Engineering etc). Safety and care of the patient are our aim, and top priorities. Quality Control of our finished products is performed according to well defined internal procedures and with appropriate methods of analysis and instruments. The Quality Control Department guarantees that the patients will receive only safe and effective products, of assured quality. Our Quality Assurance team ensures that the latest cglp rules are being followed by making regular self inspections and ensuring comprehensive in-house and external training for all personnel. In built quality systems have been addressed from the early stages of development, and maintained until the final product is released to the market. 8. CONTACT INFO For any further additional information you can contact us at: deliverysyst@miat.it