SOURCING QUALITY API - IPhEB Russiaipheb.ru/netcat_files/userfiles/presentations2014/17/03.pdf ·...

SOURCING QUALITY APIAPRIL17, 2014

LUDIVINE PENNANEACHSOLUTION SPECIALIST

AGENDA

• Generics & API Intelligence at Thomson Reuters

• An overview of the Russian market

• Global API manufacturing landscape

• A look into the Indian & Chinese API manufacturing industry

• Are second wave emerging markets becoming a potential

sourcing destination?

• European sources

• Future trends

• Case study : Using Newport to find quality sources of API &

target products matching your strategy

2Source: Thomson Reuters Newport Research Team 2013

GENERIC & API INTELLIGENCE AT THOMSON REUTERS

• 20 years of expertise in global generics

• Unique research that tracks global generic API development

and manufacturing activities

• Intelligence appears in the Newport ™ database, used by

professionals in:

– Strategy, Planning and Product Targeting

– Business Development & Licensing

– Competitive & Business Intelligence

– API Sourcing

– Patents & Intellectual Property

• Serves 300 customers operating in over 40 countries

• Team based in Portland, Maine, USA

Source: Thomson Reuters Newport Research Team 2013 3

©2012 T

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AN OVERVIEW OF THE RUSSIAN MARKET

4

THE RUSSIA MARKET

Opportunities• One of the fastest growing

markets in the world

• Pharma 2020 plan to focus on

bringing 50% of API production

back to Russia

• Drug Reimbursement Initiatives

will promote generic medicines

& API production

• Increase in licensing

agreements, which will boost

deals & investment into

infrastructure for API

production

• Cost efficient clinical trials &

contract research opportunities

Challenges

• Patent and IP protection

(should be alleviated with

Russia’s entry into WTO last

year)

• Region based differences on

what medications qualify for

reimbursement on the

ZHNVLP (or Essential Drug

List) along with the DLO List

• 90% of substances used in

pharmaceutical production are

imported

5

API MANUFACTURING

• Very limited local API manufacturing

– Only 43 Russian-owned groups involved with API manufacturing

– No manufacturing sites inspected by US FDA

• No local API manufacturing by regulated market players yet

– ICN – Kursk owned by Millhouse Capital (UK)

– 4 COS

– 1 held by Biosintez Kombinat for fusidate sodium

– 3 held by Pocard Ltd for immune globulin intravenous (ovine) and ovine

polyclonal antibodies against human low density lipoproteins

• Gaps in technology

– Everything except certain biologics

6Source: Newport Premium™ for Generics, TR Research 2014

©2012 T

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GLOBAL API MANUFACTURING LANDSCAPE

7

GLOBAL API MANUFACTURERS LANDSCAPE

Established: companies with years of experience supplying highly regulated markets

Less Established: companies with less of a track record in supplying regulated markets in terms of the length

of their history or number of products supplied

Potential Future: companies with little or no known experience but have aspirations to become involved in

regulated markets

Local: companies with no record, capability or interest in supplying to regulated markets

Experience in supplying

regulated markets


REGIONAL HUBS – API MANUFACTURING

Source: Newport Premium™ for Generics, TR Research 2014 9

Over 1/4 of the 400+ experienced manufacturers are in India

and China

©2012 T

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A LOOK INTO THE INDIAN & CHINESE API MANUFACTURING INDUSTRY

API MANUFACTURERS INDIA, CHINA & ROW


EVOLUTION OF INDIAN & CHINESE API MANUFACTURING RATINGS (2006 Vs 2013)


India China

2006 2013

REGULATORY FILLINGSUS DMF


REGULATORY FILLINGSCERTIFICATE OF SUITABILITY


US FDA INSPECTION


DRIVERS & CHALLENGES IN INDIA

Drivers

• Cost advantage

• Capital efficiency

− Up-front costs 25-50% less due to

local labor, materials & equipment

− Improved process engineering

drives down costs

• Rich talent Pool

– 125,00 chemical engineers &

25,000 pharmacists graduate each

year

• Capacity increasing annually

– 2000-2004 tripled

– 2nd & 3rd tier companies are now

investing & reaching into regulated

markets

• FDA approved facilities only

eclipsed by the USA

Challenges

• Poor infrastructure

− Power supply, highway system

• Energy cost

• IP theft due to high mobility of

staff between companies

• Increasing reliance on China for

raw materials, intermediates,

base chemicals

• Gap in technology

– Fermentation, steroids, narcotics

• Quality issues


DRIVERS & CHALLENGES IN CHINA

Drivers

• Talented pool of scientists &

engineers

• Lower cost base & economies of

scale

• Scale of infrastructure

• Improving IP & anti-

counterfeiting environment

• Newly revised GMP regulations

• Leadership (cost &/or technical)

in certain product classes :

intermediates, base chemicals,

fermentation-based APIs,

steroids

• Government support for API

export to regulated markets

Challenges

• Environmental costs &

increasing prices

• Risk of technology theft

• Compliance issues– Ongoing training needed to ensure

adherence to SOPs & GMPs

– High turnover rate for qualified and

experienced QA/QC staff

– Lack of an effective QA program

among big groups

• Language barrier

• Limited long-term strategic

planning– Focus on quick targets rather than

sustainable profits

• Limited experience with

supporting patent challenges


COST COMPARISON

Cost Type China India Europe US

Labor $ $ $$$ $$$

Environmental $$$ $ $ $

Energy $$ $$ $ $

IP Protection $$ $$ $$ $$

cGMP

Monitoring$$$ $$ $ $


©2012 T

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ARE SECOND WAVE EMERGING MARKETS BECOMING A POTENTIAL SOURCING DESTINATION?

API MANUFACTURING IN SECOND WAVE EMERGING MARKETS

20

India

China

Emerging

Markets

Esta

blis

hed

Less E

sta

blis

hed

Po

ten

tia

l F

utu

re

Local

Source: Newport Premium™ for Generics, TR Research 2013

API MANUFACTURERS IN EMERGING MARKETS

21

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Local Potential Future Less Established Established

Source: Newport Premium™ for Generics, TR Research 2014

©2012 T

hom

son R

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EUROPEAN SOURCES

22

EUROPE

Drivers

• Quality issues in sources from

India/China

• Long standing relationships

• Strong capabilities in niche

manufacturing (peptides,

controlled substances etc...)

• Indian companies purchasing

EU made API– Approved for FD products bound

for regulated markets

• Secure intellectual property

environment

Sustainability

• Partnership– Developing processes in EU,

manufacturing in India

– Strategic relationships for

advanced intermediates from

China

• EGA proposed regulations to

allow stockpiling & export to

countries with less IPR

• Advantage in specialist driven

APIs– Continued investment into

manufacturing processes

• Legislative measure– cGMP advanced intermediates

– Falsified Medicines Directive


S

©2012 T

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FUTURE PROSPECTS

24

FUTURE PROSPECTS - INDIA

• Greater reliance on China for APIs & advanced intermediates

• Increased costs as Chinese materials become most

expensive & salaries rise

• Increased investment into local market

• Continued emphasis on large batch production

• Expansion into pharmemerging markets through partnerships


FUTURE PROSPECTS - CHINA

• Continued emphasis on large batch production

• Additional companies will expand into finished dose for

regulated markets

• Impact of new GMP regulations

• Greater EHS, waste water treatment enforcement

• Increased costs of labor and raw materials

• Improvements in quality, technical packages, IP

• Many companies will stay focused on local market

• Increased partnerships with Western companies seeking

access to the growing Chinese market


FUTURE PROSPECTS - EUROPE

• Continued investment in process improvement & niche

product manufacturing

• Little incentive for manufacturing to move into second wave

emerging markets

• Continued raw material pricing pressures from China

• Increased focus on quality and reliability


API MANUFACTURERS INVESTING IN SPECIALISED CAPABILITIES• High Potency APIs (HPAPI)

– Requires specialized equipment for containment, operator

training and safety practices

– Lucrative targets for API manufacturers

• Continuous Process & Separation

– Reduction of waste streams

– More Asian companies investing in micro-reactor technology

• Micronization

– Improves formulation and dissolution properties

– Better bioavailability, less API needed

• Quality by Design (QbD)

– Increasing importance to regulatory bodies

– Aims to lower production costs


©2012 T

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son R

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CASE STUDY :

USING NEWPORT TO FIND QUALITY SOURCES OF API

USING NEWPORT TO TARGET PRODUCTS MATCHING YOUR STRATEGY

29

EXAMPLE: ROSUVASTATIN CALCIUMMANUFACTURERS IDENTIFY 1/2

30Source: Newport Premium ™ for Generics, TR Research 2013

EXAMPLE: ROSUVASTATIN CALCIUMMANUFACTURERS IDENTIFY 2/2

Source: Newport Premium ™ for Generics, TR Research 2014 31

EXAMPLE: ROSUVASTATIN CALCIUMUS DMF AVAILABLE


EXAMPLE: ROSUVASTATIN CALCIUMGMP CERTIFICATES

• GMP Certificates: WHO, ANVISA (Brazil), COFEPRIS (Mexico) &

CDSCO (India)

The CDSCO issues GMP certifications for products bound for the

European Union in order to comply with the Falsified Medicines

Directive. The certifications are a written confirmation that the API

manufacturer operates under GMP standards equivalent to those in

the EU


BIOCON LTD MANUFACTURER’S CAPABILITIES & REGULATORY INSPECTIONS

• Regulatory inspections from US FDA, WHO, EMA, Australia TGA,

Canada TPP, German BfArM & UK MHRA


BIOCON LTS MANUFACTURING PROFILE


EXAMPLE: ROSUVASTATIN CALCIUM PARAGRAPH IV CHALLENGE


USING THE TARGET API COMPANIES TO FIND MANUFACTURERS

• Combine your criteria to find the manufacturers that match

your requirements

Source: Thomson Reuters Newport™, Target API Companies Search – April 2014 37

API COMPANIES THAT MATCH YOUR SEARCH

Source: Thomson Reuters Newport™, Target API Companies Search – December 2014 38

USING NEWPORT™ TO TARGET PRODUCTS MATCHING YOUR STRATEGY

Source: Newport Premium™ for Generics, Target Product Search - April 2014 39

Growth >

5% EU

Top 5

Launched

in UK & not

in Russia

Oral

81

Ludivine Pennaneach

Solution Specialist

[email protected]

O +33 (0)1 53 06 20 33

M +33 (0)6 87 60 31 56

Elena Buraeva

Account Manager, Intellectual Property & Science

[email protected]

O +7 495 961 01 00, ext.: 173

M +7 915 267 74 21

THANK YOU, QUESTIONS?

40

mailto:[email protected]

mailto:[email protected]

FOR MORE INFORMATION...

41

http://lifesciences.thomsonreuters.com/

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