Transcript Teva - Moodle Lille 2

Big Pharma?
Clotilde Bourdon
Olivia Scaccia
Pauline Fontaine
Antoine Henninot
TEVA’S ID
Headquarters : Petak Tikva, Israel
 Stock exchange : Nasdaq
SEAQ International London
Francfort
Tel-Aviv
 Sector : Generics, Branded drugs, Brands
 One of the 20-largest pharmaceutical companies in
the world
 Operating in ≥ 60 countries, 38 000 employees

TEVA AND ITS CONCURRENTS
HISTORY OF THE COMPANY
Imported
medicines
trough
Jerusalem
1901
Teva: public
on the Tel
Aviv Stock
Exchange
only source of
treatments for
the local market
1930
Teva:
pharmaceutical
industry
WW II
1948
Israel
state
1951
HISTORY OF THE COMPANY (2)
Teva Phcal
Industries,
Israel’s largest
drugmaker
1960-70
2nd
innovative
drug, ttt PD
1980-90
Acquisition of
Ikapharm,
and other
companies
1996
2005
Acquisition of
IVAX
QVAR®,
ProAirHFA®
July
2006
HISTORY OF THE COMPANY (3)
MHRA:
expanded label for
Copaxone
+
Strategic
R&D
agreement
with
Jexys Phctls
Dec
2008
Acquisition of
Barr Phtcal
Dec
2008
Laquinimod: « fast
track » designation
(FDA)
Jan
2009
Joint venture with
Lonza Group to
market biosimilars
Feb
2009
Aug
2009
Launch its
generic
version of
the birth
control pill
Yasmin
STRATEGY

Increasing generic Market Share

Increase organic growth through R&D

Redefining Customer Service

Intellectual property

Biopharmaceuticals

Vertical integration

Horizontal integration
STRATEGY BASED ON
 Diversification




:
Products
Geographical
Therapeutic areas
Pharmaceutical technology
 Management’s
flexibility + ability to react to
changing market conditions
 Dynamism
UNBRANDED
GENERICS
Context : growth in generics
1984: Drug Price
Competition and Patern
Term Restoration Act,
in generic drug
manufacturers
Managed
healthcare
expenses
+
Expiration of
patents on
branded drugs
Generic versions
of biologic drugs
EXPANDING GENERIC MARKET
TEVA: THE KING OF GENERIC DRUGS
Largest generic pharmaceutical manufacturer in the
world
 22% of all generic prescriptions in the U.S

oTeva ≥ 300 products within 40 factories, various areas
therapeutics
 =>
Teva Pharmaceutical Industries
is swallowing Big Pharma's market share!
GEOGRAPHICAL EXPANSION
 USA


Ivax: 2005, $7.4 billion
Barr Pharmaceutical: 2008, $7.46 billion
 EUROPE

2008, US generic firm Bentley Pharmaceuticals,
deal = $360 million
 JAPAN


Kowa: 2008, ~ $ 100 million
Taisho: 2009, ~ $ 100 million
 CANADA

Agreement with Novopharm
OPPORTUNITIES FOR TEVA

drugs will lose patent exclusivity (Atorvastatin Calcium – 12.4 billion in
sales)
Hatch-Waxman Act -> + 6 months of sales exclusivity
 lawyers looking for patent weaknesses
 => Lotrel (amlodipine) elements of the patent => public domain
=> $330 million in 6 months
 FDA 218 applications of generics; Teva is challenging the patents of
more than half of them
=> Most robust generic pipeline


=> Big Pharma isn't happy about the way Teva operates
BRANDED
GENERICS
RESPIRATORY PRODUCTS
 2005



: acquisition of IVAX
QVAR® (beclomethasone dipropionate HFA): maintenance treatment of
asthma
ProAirHFA® (albuteral sulfate): relieves the symptoms of
bronchospasms
=> leading competitor in the field of respiratory therapy
RESPIRATORY PRODUCTS

Asthma, COPD , Allergic rhinitis
Easi-Breathe®, breath-activated inhaler (BAI),
 Spiromax™/Airmax™, a multi-dose dry powder inhaler,
 Steri-Nebs™, the blow-fill-seal based nebulizers,
 Cyclohaler®, a single dose dry powder device

 Develop
new medications not based on new molecules but based on
new medical devices
 Match patient’s needs : ease of use and effectiveness
 +++ compliance
RESPHIR OPERATION

TEVA and PHR: campaign for asthmatic patients in France

Brands+ Unbranded generics

Two main objectives:
- role of the pharmacist in the therapeutic education of the patients
- enhance the proper use of medicines and improve patient
compliance
WOMEN’S HEALTH
 Barr
Pharmaceutical
Plan B™ OTC/Rx (levonorgestrel) emergency oral contraceptive,
 Enjuvia™ (synthetic conjugated estrogens, B) hormone therapy to treat
moderate-to-severe vulvar and vaginal atrophy associated with
menopause,
 Seasonique® : next generation extended-cycle oral contraceptive
product continuous hormonal support

Women’s Health

2009 : generic version of the birth control pill Yasmin rather
than licensing it from Bayer Schering
=> branded generic « Ocella »
TEVA +
IVAX
BIOSIMILARS
ShlomoYanaï, PDG de Teva « Nous avons identifié les biosimilaires comme des
relais de croissance majeurs dans notre stratégie à long terme,
et nous sommes en train de consolider nos connaissances, nos capacités et nos
infrastructures pour positionner Teva comme un leader de
ce marché »
BIOPHARMACEUTICALS AND BIOGENERICS



Biogenerics = important long-term growth opportunity
Cancer, Arthritis, Rare genetic disorders =
faster-growing segments of the global pharmaceutical market +
major contributors to prescription drug costs
Primary biopharmaceutical products =
INF alpha 2b
 GCSF (granulocyte colony-stimulating factor)
 hGH (human growth hormone) in the U.S. (agreement with Savient)


TevaGrastim® = the 1st GCSF biosimilar marketed yesterday in UE
TEVA + SICOR 2003 : ACQUISITION
US manufacturer Sicor, for $3.4 billion
=>Teva: access to Sicor’s injectable products and biosimilar development
capacity

TEVA + COGENESYS 2008 : ACQUISITION
expanded biopharmaceutical pipeline
=> take advantages of CoGenesys biological technology

TEVA + LONZA JANUARY 2009 : SIGNED A JOINT VENTURE
develop, manufacture and market a portfolio of biosimilars
 highly complementary companies => leading position in the emerging
biosimilars market

COGENESYS: ALBUMIN-FUSION TECHNOLOGY


division within Human Genome Sciences Inc. (HGSI), 2005
fusing the gene that expresses human albumin +
the gene that expresses a therapeutically active protein

=> long-acting protein drugs => long-acting treatment options

efficacy and safety similar to or better than that of existing protein drugs

more convenient dosage schedules
CoGenesys: Pipeline


growth hormone and interferon alpha (by HGS and Novartis)

Zablin, phase 3 ended

Submits FDA licencing for hepatite C chronic

Once every two weeks
GLP-1 (being developed by GlaxoSmithKline under license from HGS)


B-type natriuretic peptide (BNP). CoGenesys' lead clinical candidate, Cardeva, is a long-acting
form of BNP (treatment of chronic heart failure)


Albiglutid, Phase III, once a week or less
advancing toward the clinic for outpatient.
Albugranin, a long-acting form of Granulocyte Colony Stimulating Factor (GCSF),

readied for clinical development,

treatment of febrile neutropenia associated with chemotherapy
27
TEVA’S IDEAS FOR THE COMING YEARS

difficult to copy

BUT Teva is eager to produce "biogeneric" versions of drugs
"The good news for us is that, because [biogenerics] require highcost investments, we're only going to see a few competitors”
(Teva's R&D chief)

US : No legal way to sell generic copies of biologics BUT Teva isn't
waiting idly: sells them in Europe and is ramping up production
capacities
BRANDS
TEVA INNOVATIVE R&D
3 Therapeutic Fields
o
o
o
Central nervous system (CNS )
Autoimmune (AI) diseases
Oncology
COPAXONE

1997 : 1st major branded products : the multiple sclerosis treatment
Copaxone
1st innovative drug developed in Israel that won FDA approval,
Teva’s best seller
MULTIPLE SCLEROSIS

myelin is lost
scars= scleroses (“multiple sclerosis”)
MULTIPLE SCLEROSIS (CONTINUED)
• ≥ 2 million patients
• 4 different forms of MS
•++++ : Relapsing-Remitting form manifested by relapses
followed by remission (incomplete at times : disability
progression)
COPAXONE®: ACTION ON RRMS

limits the formation of new lesions in the CNS

brain atrophy

the average relapse rate in people with RRMS

regulates inflammation at the site of brain lesions + controls
neurodegeneration + enhances repair

slows the in the NAA (N-acetyl aspartate), marker highly correlated
with progression of disability in MS
AZILECT®: 2ND TEVA’S INNOVATIVE DRUG

DCI= Rasagiline

2nd generation MAO-B inhibitor

treatment of idiopathic Parkinson’s Disease as:
- monotherapy
- adjunct therapy (with levodopa) in patients with end-of dose motor
fluctuations

Incidence: 1% people over 65
BRANDS: PIPELINE
≥ 11 innovative produts expected
StemEX
• Chemotherapy : medullar aplasia
•Patients requiring bone marrow transplantation
•Pb: Only 15% of patients requiring bone marrow
transplantation: find matching donors
• => StemEx® : Treatment of leukemia and
lymphoma
Stem/progenitor cells isolated from umbilical cord blood
Transplantation to patient
Bone marrow regeneration after graft
• 16 Feb
05 : joint venture Teva Pharmaceutical Industries Ltd Gamida-Cell Ltd => $25 million
• Gamida Cell: world leader in stem cell expansion technologies
and therapeutic products
•Israel, 2009: Gamida Cell-Teva Joint Venture announced :
orphan designation for StemEx® for the treatment of acute
lymphoblastic leukemia and acute myeloid leukemia
•StemEx: currently Phase II/III, reaching of the market in 2011
LAQUINIMOD
•oral medication
major therapeutic advantage compared to
Copaxone, SC administration
•multiple sclerosis (MS)
•Kynurenine pathway inhibitor : TRP metabolism : neuroactive
intermediate NMDA, key role in the communication between SNC and
immune system => inflammation
•Confirm the position as world leader Teva for the treatment of MS
Terfluonamide (Sanofi)
TEVA + MEDIWOUND, 2009

Debrase® Gel Dressing (DGD)= Bromelain based enzymatic debriding
agent (mixture of proteolytic enzymes extracted from pineapple plant stem)

Dissolution (high specificity and selectivity) of eschar in burns

Alternative to surgery and/or lengthy non-surgical procedures

Superior and more cost effective treatment option for burns BUT painful

phase III study, Marketing authorization in Europe during 2010
TEVA + ONCOGENEX :
2009
OGX-011 = custirsen sodium ;
=> adjunct therapy to enhance the effectiveness of chemotherapy
 Blocks clusterin production(cell survival protein) overproduced in
several cancers
 Multiple Oncology Indications:

2010: global Phase III :Metastatic Castrate Resistant Prostate Cancer (CRPC)
 Phase III :1st-Line, in association, treatment of Advanced, Unresectable Non-Small Cell Lung
Cancer (NSCLC) : initiated by early 2011.

key component of Teva branded oncology medicines franchise.
DIAPEP 227
 Treatment
of Type I Diabetes
 modulates
immune response
 Synthetic analog of diabetes epitope HSP 60 in
beta cells (Diapep 24AA (437-460 HSP 60))
 Phase 3 on going, 300 patients
 1st criteria : beta cell function preservation
TEVA IN 2010
FINANCIAL
PART
US $13,9 BILLION IN
2009
SALES WORTH A RECORD
Teva Pharmaceuticals Industries Annual Sales ($M)
Teva Pharmaceuticals Industries Annual Sales ($M)
13.899
11.085
8.408
1.75
2.077
2.519
2000
2001
2002
4.799
5.25
2004
2005
9.408
3.276
2003
2006
2007
2008
2009
MAJOR SALES IN THE NEUROLOGICAL AREA
Therapeutic fields
Neurological/Neurodegenerative
13%
24%
Oncology/ Inflammatory
12%
Respiratory
6%
20%
12%
10%
Gastrology
Infectiology
Other
Cardiovascular Diseases
Teva is the only generics maker with its own
blockbuster drug
COPAXONE IS TEVA’S BLOCKBUSTER DRUG
While the bulk of Teva’s revenues are derived from generics, the
company has one major innovative product, Copaxone
"One of the biggest concerns on Wall Street is, When does Teva become the Pfizer of
generics?" asks Ken Cacciatore, an analyst at Cowen & Co. "When does it become too big to grow?"
KEY FIGURES
Stock
increase
 1.6% since yesterday
 7.17% since 1st January 2010
 39%
for 1 year
 413% for 10 years
JANUARY 11 2010, 28TH ANNUAL J.P MORGAN
HEALTHCARE CONFERENCE :
Date
06/01/10
07/01/10
08/01/10
11/01/10
12/01/10
Dernier
57.2000(c)
56.8400(c)
59.3400(c)
58.9700(c)
58.6500(c)
USD
+0.25%
-0.63%
+4.40%
-0.62%
-0.54%
4 764 000
9 062 100
13 200 100
5 753 900
5 272 600
Variation
Volume
THREATS ?
DARK SIDES

generic drug market => price = main differentiating factor ->
competition -> profit margins

Teva enjoys : ++ competitive advantages => continue earnings
excess returns + able to purchase competitors at a low price
A GENERIC OF COPAXONE – A HAZARD FOR TEVA?
patent end : 2012
BUT
 Continued growth: RRMS gold standard therapy
 Pure generic of Copaxone unlikely + significant studies
 Proprietary injection device
 Limited competition: slow penetration of competitors


2009 : MHRA : expanded label => treatment of patients with
clinical isolated syndrome suggestive of multiple sclerosis
2009: FDA BLOCKS APPROVAL OF A GENERIC
VERSION OF ITS COPAXONE

Momenta Pharmaceuticals Inc. and Mylan Inc.

Petition : to slow the approval process + prolong market exclusivity

FDA -> no generic version of Copaxone in U.S. market until
2011
COMPETITORS?
Novartis: biogeneric version of Pfizer's Genotropin (a
human growth hormone), Japan
 Merck: plans to develop biogenerics BioVentures
 => "Teva is going to be competing with the big boys,“

says Sanford Bernstein analyst Ronny Gal

Big Pharma : join the generic market:
- Pfizer would expand its portfolio of generics
- GSK: partnership with Indian generic company
ISRAEL: THREAT?
Inaccessible market such as Iran….
 Political, military conflict

PERSPECTIVES
WHAT ABOUT THE FUTUR ?
$31 billion in 2015
 net income of $6.8 billion in 2015
 generics: $135 to $150 billion by 2015
 government reforms: cost savings + $150 billion worth of
brand name drugs losing patent protection in the next
5 years
 boost profits by 14% annually for the next 5 years,
compared with flat earnings at the five biggest pharmaceutical
companies
 So far the drugmaker is on target to reach that goal!

International expansion
Growth in biosimilars
MIX OF GENERICS AND BRANDED REMAINS CONSTANT
SWOT
Strengths
Weaknesses
•Teva-Barr is the largest global generics company
• Acquisitionof Barr limits scope for further large M&A
in the near term
•Growing position in CNS with branded products
•Expertise in patent challenges
Opportunities
Threats
• Make use of economic woes to generate support for
favorable biosimilar legislation in the US
• Early arrival of generic Copaxone
•Further expansion into ex-US markets
• Use of financial strengthto launch at risk
• Shift manufacturing to lower cost countries
• Increasing strength of competing generics companies
• Maturation of US and other key markets
•Declining number of branded drugs to target
WHAT ABOUT JOINING TEVA ?
TALAMPANEL

END OF PHASE III, 2012
Glutamat receptor antagonist, orphan drug
CT 011

Monoclonal antibody against Pd1 protein=> inhib celular
apoptosis
PIPELINE PRODUCTS IN DEVELOPMENT
Project
Indication
Clinical phase
Partner
Formulation
Laquinimod
MS
III
Active biotech
Oral
TV-1102
MS
IIa completed
Antisense
therapeutics Inc
Inj
Pagoclone
Persistent
developmental
stuttering
IIb
Endo
pharmaceuticals
Oral
Talampanel
Amyotrophic
lateral sclerosis
II
Oral
Talampanel
Glioblastoma
II completed
Oral
Adenovirus
vaccines
Respiratory
diseases
III
US department of
defense
inj
Cf Barr acquisition : prevent epidemics of an acute respiratory disease to armed forces personnel/market it
to immunosuppressed patients
PROJECTS IN WHICH THEY HAVE AN INTEREST
Project
Indication
Clinical phase
Partner
Investment
Million $
StemEx
Hematological
malignancies
III
Gamida cell
25
CT-011
Solid tumors and
hematologicl
malignancies
II
Curetech
10.5
Debrase
Removal of burnijured tissue
III in Europe
MediWound
15
Diapep-277
Type I diabetes
III
Andromeda biotech
10