February 12th 2014

Pharmapack Paris

Ludwig Weibel +41 71 351 73 22 ludwig.weibel@weibelcds.com CH-9104 Waldstatt, Switzerland www.weibelcds.com

Innovative flexible primary

packaging solutions for reconstitution and drug delivery systems

Our vision

every parenteral drug is made available to the world

in a «ready to use» form

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PUBLIC-HEALTH PROBLEM: SAFETY Switzerland1)

70’000 hospital infections cost CHF 250 million each year.

Error-related deaths amongst hospital patients2) double the

deaths caused by influenza, AIDS and traffic accidents together3).

USA4)

400’000 to 800’000 reported needle stick injuries cost hospitals

1 to 3 billion US$ each year – without the cost caused by

subsequent infections4). (a small stick with a hollow needle may carry over more than 20 pathogens4)) References: 1) Patientensicherheit als Public Health-Problem in Zahlen, Patient safety foundation, Fakten

http://www.patientensicherheit.ch/de/ueber-uns/Patientensicherheit/Fakten.html 2) Source: several actual studies, extrapolation for Switzerland 3) Source: Bundesamt für Statistik, Todesursachenstatistik 2007 4) IV Catheter Needlestick Prevention, B. Braun Melsungen AG, several sources cited in document

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INJECTABLE DRUGS MARKET

Reconstitution System

MiniBag

Carpules 2’600 Mio pcs mostly insulin

and dental

Prefilled Syringes

3’100 Mio pcs market share

stagnating

Ampoules 39’400 Mio pcs

what is the future? Vials

13’400 Mio pcs Vials liquid

8’900 Mio pcs

Vials Lyophilisate 4’500 Mio pcs

Drug Delivery System (prefilled patch pen)

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EXAMPLES OF DEVICES FOR VIALS

13mm collar

liquid products lyophilised products and solvent

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ith

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ety

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ice

20mm collar

13mm collar

20mm collar

solvent vial, 13mm collar

lyophilisate vial, 20mm collar

13mm collar

20mm collar

13mm collar

20mm collar

3ml LuerLock syringe

10ml LuerLock syringe

5ml LuerLock syringe

20ml LuerLock syringe

transfer elements with drip stop / swabbable valve

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PATIENT CENTRIC VIEW

Full integration of all functions and parts

The advantage for the end user is a reduction of

• contaminations

• handling errors

• needle stick injuries

and a gain of time

You can differentiate yourself from competition

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RECONSTITUTION: TODAY/TOMORROW

2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1 17 18 19 20 21 22

today 22 steps

tomorrow 8 steps

remove flip cap

1 3 5 6 8 2

open lid => a) closure

opened, b) solvent

squeezed into vial

pierce rubber stopper

extract drug into syringe

remove syringe

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inject withdraw syringe => automatic protection of needle

disinfect

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PREFILLED PATCH PEN

needle injection

Drug Delivery System ready to use => patch to skin

disposable part: • container (MiniBag) • port • micropump • injection needle

reusable part: • pump drive • needle insertion trigger • battery • controller

attach disposable part to reusable part

steel cannula withdrawn => soft cannula stays in skin

active microinfusion with micropump

The prefilled syringe of the future may be a prefilled patch pen with automatic needle insertion and controlled drug delivery.

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MONO OR MULTILAYER FILM

unlimited material

selection

film: any film

structure that

allows thermo-

sealing

port: molded in

different polymers

compatible with

the inner layer

of the film

port

film

film

«classical» «exotic» «simple» «special»

«symmetric» «assymmetric»

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NEW MANUFACTURING TREND

blown or cast multilayer film

injection molding of parts into cleanroom mother roll

at the cleanroom: mother roll slitting MiniBag forming device assembly

(MiniBag inserted into device)

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ASEPTIC FILLING (PILOT EXAMPLE) 2. closure

lifted

3. if necessary:

remove remaining air with vacuum

5. close with same

closure

4. fill

1. place MiniBag

system

6. take off filled,

ready to use MiniBag system

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KEY BULLET POINTS • sustainable and ecologic thanks to a streamlined, hygienic production and

supply chain

• a Patient-centric view leads to pre-filled MiniBags directly incorporated in

a device, allowing innovative solutions for Patient safety and Compliance

• combine different products in a closed system:

MiniBags can be configurated as multichamber bags with multichannel

ports or may be combined via external channels or transfer devices with

vials via transfer devices

• all functions and parts may be included:

the Patient opens only one disposable package

• scalability and versatility allow to brake human medicine boundaries:

dosages from mice to elephants (e.g. from 0.2 to XXX ml)

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MINIBAG BASED PRODUCT EXAMPLES

Drug Delivery System

Microinfusion-System

Reconstyringe®

intuitive, automatic reconstitution

Squeezer

a totally new way to store and

administer products

disposable part: • container (MiniBag) • port • micropump • injection needle

reusable part: • pump drive • needle insertion trigger • battery • controller

Flyringe®

between ampoules and PFS

drug in MiniBag

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Thank you

www.weibelcds.com

Weibel CDS - safer, easier and faster drug delivery

Booth 234