3M Drug Delivery Systems 3M Integrated Dose-By-Dose ......3MTM Integrated Dose-By-Dose Counter Integrated into the 3M actuator ―Retains patient familiarity and product identity ―Maintains

3M Drug Delivery Systems

3M Confidential. 1 27 September 2013 . All Rights Reserved. © 3M


3M™ Integrated Dose-By-Dose Counter September 2013



FDA guidance (Mar 2003)

― Dose indicator or counter recommended for all new products for oral inhalation

― Should give clear indication of when label claim number of doses is approaching (or exceeded)

― Close to 100% accuracy

• But specifically designed to avoid undercounting (dose dispensed but no count registered)

― Lock-out is optional

― Dose-by-dose indication

Seretide™ launch in Europe and ProAir®,

Ventolin® and Dulera® launch in U.S.

― Dose-by-dose count and display

Symbicort® launch in U.S.

― Dose-by-dose indication

Why consider a dose counter?

Ventolin® is a registered trademarks of GlaxoSmithKline. Seretide™ is

a trademark GlaxoSmithKline. Symbicort® is a registered trademark of

AstraZeneca. Dulera ® is a registered trademark of Merck & Co., Inc.

ProAir® HFA is a registered trademark of Teva Respiratory, LLC.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071731.pdf



Counter

Individual count down

from 120 doses

Indicator

Increments with every shot fired

from 200 doses

3MTM

Integrated Dose-By-Dose Counter



Listening to the patient …

Patient focus group research fielded

by an external agency experienced

in asthma market research

UK – 3 locations

USA – 3 locations

No significant differences in reactions

to the dose counter design across

markets

Sample included all FDA

named groups

Children interviewed in

pairs with parents present

Adults interviewed

in groups

Elderly interviewed in pairs

Mix of male and female

respondents

Ranging from moderate to

severe sufferers of asthma

Source: data on file, primary asthma patient market research, 2006-2007

96 interviews completed from Dec 2006 - Jan 2007



Deliver what patients want

Patients want a simple, reliable, accurate dose counter that is integrated into their actuator…

…providing them with greater control and sense of security…which also allows parents and

caregivers a reliable method of monitoring medication Source: data on file, primary asthma patient market research, 2006-2007



FDA approved and fully commercialized

3M technology

― In conjunction with an MDI product

Designed to be accurate and robust

Individual dose-by-dose display

Integrated into the actuator

Patient-approved – easy to see exactly

how many doses remain

3MTM




Make your product count Differentiate your metered dose inhaler

The first FDA approved* integrated dose counter

available to clients

Individual dose-by-dose counter

Integrated to maintain look and feel

of inhaler

Designed with the patient in mind

Highly accurate and robust

Ideal for:

― Lifecycle management to protect market share

― New metered dose inhaler developments

― Generic product to match innovator products

Seretide® vs. 3M Dose

Counter

Seretide® (fluticasone

propionate/salmeterol

xinafoate) is a marketed

product and trademark of

GlaxoSmithKline. * In conjunction with an MDI product



Defining the industry standard with our commercialized dose-by-dose counter

Building on our experience by commercializing our dose-by-dose indicator in 2015

And now the industry feedback …

Source: based on VoC collected at core industry conferences, various years



Suitable for products up to 120 doses

Designed to be accurate and robust

― Displacement-driven

― Designed to overcome tolerance

challenges of dose counting

Individual dose-by-dose display

― Increments and displays individual doses

― Counts down from label claim

3MTM


Integrated into the 3M actuator

― Retains patient familiarity and

product identity

― Maintains inhaler size

(manufacturability and ergonomics)

Compatible with current marketed valves



Dose indicator for 200 dose products

― Displays an analogue count

(200, 180, 160…)

― Increments with every shot fired

― Displays numbers with options for

colour coding at end of life

Utilises the same working principle as the

approved and commercialised dose counter

― Proven indicator design, currently

in commercialisation

― Displacement driven, accurate and robust

Integrated into 3M actuator

― Retains patient familiarity and

product identity

― Maintains inhaler size

(manufacturability and ergonomics)

Compatible with current marketed valves

3MTM

Integrated Dose-By-Dose Indicator



Generation 1 dose counter in commercial production

since 2010

― Compatible with specific valve / canister

combination

Generation 2 production scale up ready for counter

and indicator customer delivery

― Samples available on request

― Expanded design capability to be compatible with

multiple valve and canister combinations

― Suitable for registration stability, clinical studies,

or commercial product

Manufacturing status



Ready for program assessment? Required technical and market data

TECHNICAL

Valve Type and target Valve delivery volume

(e.g., 3M 63mcl, Vari, BK357, etc. )

Can type(s) (plain / coated / size) required

(e.g., 5ml, 10ml, 14ml, 19ml, 22ml)

Number of shots in product

(i.e., <= 120 for DC, 120 to 200 = DI

Check willingness to transition or stay with

Mk 6 type adaptor [square mouth]

Nozzle geometry, if known

(diameter, jet length)

Formulation information

(molecule, solution/suspension,

propellant system)

COMMERCIAL

Anticipated volumes Post-launch

(i.e., per annum)

Anticipated launch date

Markets in which product is to be sold

(e.g., Europe, USA, Global)

Customer expected response date

(Minimum evaluation time – 3 days)



MDI specialists from start to finish

MDI pioneer, with over 50-year track record

Global team of experts passionate about

helping our customers succeed:

― First MDI

― First CFC-free MDI

― First single-cycle FDA review

― First FDA approved* integrated dose

counter available to clients

* In conjunction with an MDI product



Delivering your dose counter solution

FDA, patients and product lifecycle

management are driving the need to

have the right dose counter

3M dose-by dose counter is becoming

the industry standard

― Accurate, robust, reliable, integrated

― Compatible with a wide range of

cans and valves

― Available as a counter or indicator

― FDA approved* and commercialized

* In conjunction with an MDI product



Contact 3M Drug Delivery Systems

US: (1) 800 643 8086

UK: (44) 1509 613626

Japan: (81) 3 3709 9671

Singapore: (65) 6450 8888

China: (86) 21 22103008

Argentina: (54) 11 4469 8338

India: (91) 80 2233 1414

Thank You

www.3m.com/dds

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3M Drug Delivery Systems 3M Integrated Dose-By-Dose ......3MTM Integrated Dose-By-Dose Counter Integrated into the 3M actuator ―Retains patient familiarity and product identity ―Maintains