Complex Generics Overview - Outlooks and Challenges

5th Regulatory Conference:
Evolving Global Regulatory
Environment
April 13-14, 2012
ITC Maratha | Mumbai, India

5th Regulatory Conference: Evolving Global Regulatory Environment
April13-14, 2012 | ITC Maratha | Mumbai, India
2

Presentation by
Sanjay Chaturvedi (Ph.D)
Vice President and Head – Global Sales and Marketing (API)
Dr. Reddy’s Laboratories Limited,
Hyderabad, India
sanjayc@drreddys.com
Overview of Complex Generics,
Current Industry
Outlook and Challenges

3

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Disclaimer

What are SuperGenerics?
•  Simple definition : Improved versions of existing drugs which have
lost patent protection
•  The “active” ingredient is already approved
•  Terms used : Innovative G / Super G / Advanced G
Includes:

Modiﬁed
release

TD
patches

Nasal

delivery(Inhalers)

Implants

Depots

Also
Includes:

Narco<cs

Speciality
Inj.

Advantages of SuperGenerics
•  Quicker ----à faster acting
•  Kinder ----à Kinder on the body ( less side effects )
•  Tougher----à Improved efficacy
•  Convenient --à Better compliance
•  Stand out from the crowd---àProduct Differentiation
•  Unique ------à Patentability
•  Limited competition ----à
•  More acceptable--à Less regulatory hurdles than NCEs

Marketable
!
-‐-‐-‐-‐à
(
Premium
pricing
&
Be=er
ROI
)

Comparison
RegistraAon

at
FDA

ANDA
505(b)2

NDA

NDA/BLA

Patent

PosiAon

Weak-‐
Medium

Medium-‐
Strong

Strong

Types of SuperGenerics
7

New
Use

New
Salts

New
Synergis<c
Combina<ons

of
generic
single
en<ty

formula<ons

New
Dosage
Forms

InjecAon
Vs
Oral

ER/MR
Vs
immediate
release

Nanotechnology

Needle
free
injecAon
devices

Transdermal

Transmucosal

Intranasal

Pediatric
FormulaAon

Geriatric
FormulaAon

Drug
Repurposing

SuperGeneric Approvals
8

SuperGenerics by Therapy
9

Event Name, Location5th Regulatory Conference: Evolving Global Regulatory Environment
DRIVERS AND VALUE PROPOSITION
What are the drivers and value proposition for SuperGenerics ?

Commodity Generics : High Competition
•  Competition in the generics market is becoming increasingly intense
•  Low cost producers expanding globally
•  Branded Pharma becoming involved either through subsidiaries or
through authorized generic agreements.
•  Consolidation à Severe competition
•  There is still room for growth in the more mature generics markets,
with governments examining methods of increasing generic usage
even further.
•  Pricing pressures - Growth but less profits
Low
compeAAon
&
higher
proﬁtability

are
the
criAcal
drivers
for

innovaAve
generics

Risk & Reward
Increasing
risks, costs
Commodity
Generics

Biogenerics

Supergenerics

Proprietary
Brands

Decreasing

reward

SuperGenerics can elevate both the therapeutic and commercial value of
a drug
13

TherapeuAc
performance
Commercial performance

Patentable
Higher Margins (
premium
pricing
)
CompeAAve differenAaAon

Limited compeAAon

Low development cost

(Low
investment
-‐-‐à
Low
risk)
Short Ame to market
-‐
Be=er

ROI

Increased bioavailability

Enhanced pharmacokineAcs

Novel targetability

Improved compliance

Side
effect
benefits

More efficacious

SuperGenerics – Value Proposition

Max
by
any

generic
player

Incremental

value

generated
by

a

supergeneric

Taxol

patent
expiry

$mn

Supergenerics
can
generate
7-‐10
Ames
the
value
of
plain
generics

Value of a SuperGeneric

MARKET REALITY CHECK
Are global generic companies placing their bets on Super generics ?

16

Global Pharmaceutical Market ($ bn)
Source- KRChoksey Research
559
605
649
715
780 809 850
900
950
1015
1070
0
200
400
600
800
1000
1200
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
CAGR 7.7%
CAGR 5.8%
Generics Market size ($ bn)
90
155
Generic penetration in regulated market, %
90
155
Value
0
50
100
150
200
2009 2015
9.5% CAGR
11.7
10.4
8.8
16.216.3
11.2 12.2
20.8
0
5
10
15
20
25
US Europe Japan Canada
2007 2012

SuperGenerics Players
17

•  Most
supergeneric
companies
are
small
with
only
a
few

products
in
development
-‐
Specialize
in
a
narrow
therapy
area

•  Focusing
on
licensing-‐in
very
late
stage
drugs
for
a
narrow

therapy
area
and
just
one
market,
rather
than
early
in-‐house

development

•  Hanmi,
Impax,
Sra<va

SuperGeneric
Only

•  See
patents
on
supergenerics
an
easier
op<on
to
challenge

than
product
patents
on
NCEs

•  Well
placed
to
develop
supergenerics,
par<cularly
in

countries
where
branded
generics
predominate.

Acquiring

local
companies
in
emerging
markets

•  Teva,
Watson,
Actavis

Generic
Companies

There
are
a
number
of
diﬀerent
types
of
companies
moving
into
the
supergeneric
arena,

including
generic,
drug
delivery,
specialist
brand,
start-‐up
companies
and
university
spin-‐outs.

•  Teva – Supergeneric Engine will provide growth opportunities
–  Teva Investor Presentation 2010
•  Watson – Nearly 50 % of the portfolio consists of innovative generics
–  Watson Investor Presentation 2010
•  Actavis - "The acquisition of Kadian is the latest step in Actavis' strategy to expand our
specialty drug portfolio and is well aligned with our emphasis on bringing complex
controlled-release products to the marketplace," ……………………Actavis US CEO Doug
Boothe.
•  “We’re very pleased to add Alprazolam ODT to our portfolio and complete our Alprazolam
family of offerings, which also includes Alprazolam extended-release and immediate
release tablets,” …………….Actavis Inc. CEO Doug Boothe.
Bets Have Been Placed

Indian Market Overview
•  Carrier based delivery system includes liposomes
•  Variable release products include microencapsulation, ion exchange resins, and osmotic pumps
Market
for

Controlled
Delivery
Systems
expected
to
grow

at
a
CAGR
of
7%
during
2009-‐14

0.1
0.9
2.6
7.2
11.1
1.5
12.2
35.0
101.6
152.3
0.0 60.0 120.0 180.0
Implants
Nasal
System
Trans
dermal
Systems
Carrier
Based
…
Variable
Release
…
$
MN
2008
199621.8
302.6
453.7
0
100
200
300
400
500
1996 2008 2014
$
MN

All the top global generic players including the indian
companies have a ‘supergeneric’ strategy in place and have
made investments accordingly
Modified release , inhalation , speciality inj. Oral contraceptives are the preferred areas

OPPORTUNITY AND CHALLENGES
Opportunity areas and Challenges for development of innovative
generics

SuperGeneric Development Space
Device BioMolecular PhysioChemical

Opportunity Space
Vaginal
Ophthalmic Topical
Inhalable
Injectable
Oral
Nasal
0
10
20
30
40
50
60
70
0 100 200 300 400 500 600 700 800
Number of proprietary delivery technologies
Shareofglobalpharmasalesin2008(%)
23

Source:
MedTRACK;
MIDAS,
IMS
Health,
June
2009,
Datamonitor

Less
commercial
opportunity
among
novel
modes
of

delivery
means
there
are
fewer
proprietary
technologies

%
sales

Greatest
commercial
opportunity

lies
in
the
oral
and
injectable

segments

Within
Oral
segment
-‐

Modiﬁed
release
opportuni<es

dominate

•  Commercial
–  A drawback of the US market for SGs is that generics are normally unbranded generics and do not
require salesforce to promote them thus companies need to recruit sales forces to sell SGs.
–  Eastern and Central European markets are attractive for SGs as they generally support branded
generics, which have higher prices than unbranded generics, but the individual markets are small and it
is often necessary to have a local presence and marketing knowledge to penetrate these markets.
–  Innovative companies are well placed to develop supergenerics as they are already organized to
develop line extensions for lifecycle management of NCEs
–  The authorized generic deals between mega generic companies and multinational innovative companies
•  Technical
–  Formulation development can be tricky and good insights into the technology platforms is a must
–  There are many technology paths to get to the same product – fragmented intense competition
–  Specialized technologies required often are not core competencies of generic companies
•  Regulatory and IP
–  Innovative companies often create patent minefields around their blockbuster NCEs as a lifecycle
planning tactic and this can be an entry barrier
–  While fewer clinical trials are usually required for the approval process in most markets, it may be
necessary to conduct certain trials to prove superiority to other products on the market
–  Regulatory Pathway can be complex
SuperGenerics - Challenges
24

Though
there
is
s<ll
room
for

growth
in
generics
,
balance

between
high
growth
generics
&

high
margin
generics

(supergenerics)
is
cri<cal
for
long

term
success

SuperGenerics
are
deﬁnitely

future
winners
for
global
generic

players

Many
bets
have
been
placed
and

there
is
s<ll
opportunity
to
play

(although
is
comes
with
risks)

Summary

Complex Generics Overview - Outlooks and Challenges

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