the future of generic dry powder inhalers

© Aedestra Ltd 2016

Dry Powder Inhalers: Annual Conference 2016

The Future of Generic DPIs

Philippe RoguedaAedestra Ltd

London, 16 June 2016



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Aedestra is a product development company in the field of inhaled drug product.

We make developing inhaled products easy, so you can focus on delivery. We drive initiatives; you realise opportunities.

We guide clients to develop the right product in the right way by providing strategic and technical expertise: reducing cost, time and risk.



Gx DPIs: What's happening?

Where is it going?

Future market opportunities

Influence of the East on the West

Con

tent

Out

line



Generic DPIs: What's happening?

News

New filings

New regulations

Clinical trials

Players



Most Gx developers have focused on Advair® Diskus®.

2 developers have filed Gx Advair® in the US (Mylan, Hikma), and 3 have been approved in Europe (Elpen, Sandoz, Celon). Other options are available in other countries.

Only one filing of Gx Spiriva® HandiHaler® in Europe so far. Other options available in India and other countries.

One DPI product has been filed with in vitro data only in EU: formoterol DPI.

A number of Gx DPI products have been filed in South America, India, China, Turkey…these would merit a full review of their own.

Key messages What’s HappeningW

hat's

hap

peni

ng?



Where is it going?

Generics vs super generics

Balkanisation of the market

Molecules vs. devices

Generic devices



Many devices, few molecules.

Most competitors focusing on Advair Diskus.

Propriatory devices have advantages but are expensive: they work well for Gx of blockbuster products but not for smaller products.

Market is being fractionated with many devices.

Too many devices confuse patients, who already are not compliant with their therapies.

Off-the-shelf devices are needed to reduce development costs and increase patients’ compliance.

Telehealth (electronic monitoring) may change the game and make it more difficult for generic products to be introduced.

Key messages: Where is it going?W

here

is it

goi

ng?



Future market opportunities

The DPI market

New products

Generics penetration

Costs analysis

Future products



A few new products will be worth generecising, but likely to be expensive: Ellipta range and Q portfolio.

The low hanging fruits are gone.

Super generics might be better options economically.

Combination (triple?) products will certainly be on the cards.

Telehealth, digital monitoring, could render Gx manufacturing even more difficult.

Key messages Future Market OpportunitiesFu

ture

mar

ket o

ppor

tuni

ties



Influence of the East on the West

From API to finished dosage form

Development of an ecosystem of CROs, CMOs

COPD and Asthma in Asia

The economics of therapies in Asia

Regulations and trade barriers



Influ

ence

of t

he E

ast

The Asian market for inhalers is vast. It is hard to tell how this will influence product choices.

Most companies are vertically integrated: from API to dosage forms.

India is very advanced in Gx DPI manufacturing.

China is catching up on the DPI market.

Both India and China suffer from the same issues:-poor quality standards.-lack of product knowledge.

Key messages from the East



Merxin is a generic inhaled device supplier that supplies off-the-shelf generic devices to accelerate and reduce the cost of the development inhaled products.

MRX001 a generic version of Diskus® is its leading product.

Merxin Ltd was incorporated in the UK in January 2016.

Merxin is currently raising funds and clients’ interest.

Philippe Rogueda is a co-founder and director of Merxin Ltd.

Mer

xin

Ltd

Generic Medical Devices Made Easy

www.merxin.com



THE LEADING OPEN ACCESS NETWORK OF INHALATION DRUG DELIVERY SPECIALISTS

www.inhalationasia.org

Inhalation Asia: The leading open access network of inhalation a drug delivery specialists in Asia.

A conference on inhalation drug delivery technology every 2 years.

Founded in 2011 by Philippe Rogueda (CEO) and 3 partners in India, China and the UK.

Blog on Twitter, WeChat and LinkedIn.

Next conferences: Innopack China: 21 June 2016, Shanghai

Inhalation Asia 2017: 13-15 Sept 2017, Hong Kong

Inha

latio

n As

ia



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tact

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