UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
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FOREST LABORATORIES, INC.
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Building the Future
A Focus on Our Products & Therapeutic Categories
Forest Laboratories, Inc.
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Francis I. Perier, Jr.
Executive Vice President, Finance & Administration and Chief Financial Officer Forest Laboratories, Inc.
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Safe Harbor
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These
statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to time in Forest Laboratories Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking
statements contained in this rerelease to reflect new information or future events or developments.
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Building the Future
A Focus on Our Products & Therapeutic Categories
Forest Laboratories, Inc.
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Howard Solomon
Chairman and Chief Executive Officer Forest Laboratories, Inc.
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Building the Future
A Focus on Our Products & Therapeutic Categories
Forest Laboratories, Inc.
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Marco Taglietti, MD
President and Chief Medical Officer,
Forest
Research Institute, Inc.
Senior Vice President, Research & Development, Forest Laboratories,
Inc.
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Sustainable Growth Beyond
2012
Forest Laboratories,
Inc.
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Creating Sustainable Growth Beyond 2012
Our Late Eight strategy to replace Lexapro sales
nebivolol Launch, Bystolic®
milnacipran Launch, Savella®
ceftaroline
Launch, Teflaro®
roflumilast Launch, Daliresp®
aclidinium Under Review
linaclotide Under Review
levomilnacipran NDA in
2012
Cariprazine NDA in 2012
All are on the market or on their way to the market!
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Creating Sustainable Growth Beyond 2012
The Next Nine Viibryd strategy to replace Lexapro sales
nebivolol Launch, Bystolic®
milnacipran Launch, Savella®
ceftaroline
Launch, Teflaro®
roflumilast Launch, Daliresp®
aclidinium Under Review
linaclotide Under Review
levormilnacipran NDA in
2012
cariprazine NDA in 2012
All are on the market or on their way to the market!
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Strategy and Execution
Product Selection
Science-based and
market-relevance
Thoughtful and thorough due-diligence
Product Development
Well defined target profile and product positioning
Efficient R&D Drug development to meet target profile
Post-Marketing Support
Maximize value
through science
Product profiling studies and life cycle
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R&D Facts and Figures
Over 1,500 people working in R&D
-
1,100+ employees and 400+ contractors
- 250+ MD/PhD/PharmDs
$850MM operating budget in FY2013
Currently, 18 Products in R&D:
- 4 in
Phase I/II (8 Trials)
- 8 in Phase III (14 Trials)
- 6 in Phase IV (8 Trials, 7 Pediatric Trials)
Managing 11 partnerships
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R&D Facts and Figures
Global R&D Organization
- 22,000+
patients, in 2,100+ sites, in 49 trials, in 21 countries in FY2012
In the last five years:
- 7 NDA/sNDA filed in 9 indications, with 6 different FDA divisions
- 6 approvals... soon to be 8
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R&D Facts and Figures
Support activities in FY2012
- Toxicology
48 Studies
- Pharmacology 40 Studies
- Clinical Pharmacology 43 Studies
- Health Economics 49 Studies
-
Publications 715 Publications
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Cardiovascular CNS Pain GI Respiratory Anti-Infectives
Bystolic
nebivolol/
valsartan
azimilide
TTP-399 Viibryd Namenda
NamendaXR
cariprazine
levomilnacipran Savella GRT-6005 Linaclotide Daliresp
aclidinium
aclidinium/ formoterol
Teflaro
ceftaroline/
avibactam
ceftazidime/
avibactam
BC3781
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Cardiovascular/Metabolic
Maximize value of
current products
Bystolic
Phase IV Support
11 Phase IV Studies
+3,700 patients
Over 600 sites
Life Cycle
FDC nebivolol/valsartan
Phase III ongoing
Filing in FY2014
Expand pipeline
- Azimilide (Antiarrhythmic in patients with ICD Phase III)
- TTP-399 (Glucokinase inhibitor in diabetes Phase II)
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Submission Plan
FY2010 FY2011 FY2012 FY2013 FY2014 FY2015 FY2016 FY2017
CY2009 CY2010 CY2011 CY2012 CY2013 CY2014 CY2015 CY2016
aclidinium NDA
aclidinium/formoterol
NDA
azimilide NDA
cariprazine NDA sNDA
ceftaroline NDA
Teflaro
ceftaroline/avibactam NDA
ceftazidime/avibactam NDA
GRT6005 NDA
levolminacipran NDA
Linaclotide NDA Canada
milnacipran
Savella
nebivolol Bystolic Canada
nebivolol/valsartan NDA
Daliresp NDA
roflumilast NDA sNDA
Vilazodone NDA Viibryd Canada
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Forest R&D Summary
Outstanding track record in product selection, drug development and life-cycle management
- A global R&D organization led by an experienced management team
Supporting the Present...
- Extensive
life-cycle and Phase IV programs to support currently marketed products
...while Building the
Future
- Effective and efficient product development
- Expanding pipeline within and outside the current therapy areas
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Sustainable
Growth Beyond
2012
Forest Laboratories, Inc.
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Building the Future
A Focus on Our Products
& Therapeutic
Categories
Forest Laboratories, Inc.
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Gavin Corcoran, MD
Executive Vice President
Research & Development,
Early and Clinical Development
Forest Research
Institute, Inc.
Cardiovascular Bystolic nebivolol/ valsartan azimilide TTP-399
CNS Viibryd Namenda Namenda XR cariprazine levomilnacipran
Pain Savella GRT-6005
GI linaclotide
Respiratory Daliresp aclidinium aclidinium/ formoterol
Anti-lnfectives Teflaro ceftaroline/ avibactam ceftazidime/ avibactam BC3781
Mood Disorders Psychosis
Anxiety Depression
Severe Depression Bipolar Depression Mania Schizophrenia
Serotonin 5HT Norepinephrine Dopamine
(SSRI & 5HT1a) Levomilnacipran (SNRI) Cariprazine (D2/D3 partial agonist)
ViibrydTM (vilazadone)
SSRI with 5HT1a
partial agonism
Indicated for MDD
Ongoing program to further define the utility of this drug for patients
- Low dose
- Relapse prevention
- Pediatrics
- General Anxiety Disorder
Levomilnacipran Pharmacology
A new SNRI
for the treatment of MDD
- Greater selectivity for the NE transporter
- More balanced increase in 5HT and NE in the brain
Relief of symptoms of depression
Potential for a positive effect on patient functionality
Levomilnacipran
Effect on Symptoms and Function
Three pivotal trials examining doses from 40-120mg/day
- MADRS change from baseline
- SDS change from baseline
Significant
effect on both scores
MD-01
MADRS LSMD (Placebo-Adjusted)
0
-1
-2
-4
-5
-6
-7
* ** ***
*P<0.05, **P<0.01, ***P<0.001 versus placebo
40mg 80mg 120mg
Levomilnacipran
Effect on Symptoms and Function
Three pivotal trials examining doses from 40-120mg/day
- MADRS change from baseline
- SDS change from baseline
Significant
effect on both scores
Dose response in study with all 3 doses (MD-01)
Lower rate of common adverse effects than most other SNRI
Slight, non dose-dependent increase in HR/BP
Figure 3. Sheehan Disability Scale: Least Squares Mean Change From Baseline to Week 8 (ITT Population, MMRM)
A. Total Score B. Work Item Social Life Item Family Life Item
0 -1 -2 -3 -4 -5 -6 -7 -8 -9 -10
0 -1 -2 -3 -4 -5
LS Mean Change From Baseline
Placebo
Levomilnacipran SD, 40 mg/day
Levomilnacipran SD,
80 mg/day
Levomilnacipran SD, 120 mg/day
*P<05 and **P<01 vs placebo
Cariprazine Pharmacology
Dopamine receptor
partial agonist
- D3 preferring, but partial agonist of D2 and D3 receptors
- Less effect on histamine, adrenergic and 5HT2c
Suitable for the treatment of a range of conditions
Initial development for 2 indications
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Schizophrenia and acute mania
3 positive trials in each indication
- Dose range from 1.5-12mg
Significant Effect in Schizophrenia
Comparative
Results for Schizophrenia (PANSS)
Mean change from baseline
RGH-MD-16 RGH-MD-04 RGH-MD-05
0 -5 Placebo -10 CAR 1.5 -15 CAR 3 -20 CAR 4.5 RIS 4
0 -5 Placebo -10 -15 CAR 3 -20 ARI 10 CAR 6 -25 -30
0 -5 Placebo -10 -15 CAR 3-6 CAR 6-9 -25 -30
0 1 2 3 4 5 6 0 1 2 3 4 5 6 0 1 2 3 4 5 6
Improvement in all active arms at week 6 were highly significant compared to placebo
Significant Effect in Acute Mania
Comparative
Results for Mania (YMRS)
Mean change from baseline
RGH-MD-31 RGH-MD-32 RGH-MD-33
0 -5 Placebo -10 CAR 3-12 -15 -20
0 -5 -10
Placebo -15 CAR 3-12
0 -5 Placebo -10 CAR 6-12 CAR 3-6 -20
0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21 0 3 6 9 12 15 18 21
Improvement in all active arms at week 3 were highly significant compared to placebo
Favorable Adverse Event Profile
Most
common adverse effects
- Insomnia, headache, constipation
Low potential for
- Clinically relevant weight gain, somnolence and EPS/EPD
Few changes on metabolic parameters
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Liver enzymes, blood lipids, prolactin, CPK
Akathisia
- Up to 14% in schizophrenia and 20% in acute mania
- Most cases were mild to moderate
- <2% of patients withdrew from studies for akathisia
Focus on Pain
Savella
- Indicated for the treatment of
fibromyalgia
GRT6005
- Novel opioid for chronic pain
- Potent activity
through the mu and OLR-1 receptors
- Currently in Phase II
Osteoarthritis, neuropathic pain, low back pain
Cancer pain (ex-US)
Linaclotide
Ongoing unmet need
- IBS-C
- Chronic constipation
Conditions characterized by
- Bowel
symptoms
Constipation
- Abdominal symptoms
Bloating, discomfort
linaclotide
Lumen
Cl
HCO3
Na
H2O
GC-C
CFTR
P
GTP
cGMP
PKGII
Serosa
Afferent
pain fibers
Linaclotide Pivotal Data
Phase III
- 2 large studies in CC and 2 in IBS-c
- 2 long term studies
Endpoints focused on demonstrating effect on bowel and abdominal symptoms
- Significant effect on all primary and secondary parameters
- Relief noted within a week of therapy
Randomized Withdrawal
CC Patients
Stool Frequency (CSBM)
CSBMs 0 1 2 3
Treatment Period
RW Period
BL 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Trial
Week
Treatment Period
290 µg
Placebo
IBS-C Patients
Stool Frequency (CSBM)
Treatment Period
RW Period
CSBMs 0 1 2 3
BL 1 2 3 4 5 6 7 8 9 10 11 12 13 14
15 16
Trial Week
Treatment Period
290 µg
Placebo
Linaclotide Phase III IBS-C Trial
Weekly Change
in Abdominal Symptoms
Treatment Groups
266 µg
Placebo
Discomfort
% Change
0 -10 -20 -30 -40 -50 -60
BL 2 4 6 8 10 12 14 16
18 20 22 24 26
Trial Week
Bloating
% Change
0 -10 -20 -30 -40 -50 -60
BL 2 4 6 8 10 12 14 16 18 20 22 24 26
Trial Week
Fullness
% Change
0 -10 -20 -30 -40 -50 -60
BL 2 4 6 8 10 12 14 16 18 20 22 24 26
Trial Week
Cramping
% Change
0 -10 -20 -30 -40 -50 -60
BL 2 4 6 8 10 12 14 16
18 20 22 24 26
Trial Week
p <0.01 for each of the 26 Weeks in the Treatment Period. Patients with main baseline score
³
3 for each respective parameter.
Cardiovascular
CNS
Pain
GI
Respiratory
Anti-Infectives
Bystolic
nebivolol/
valsartan
azimilide
TTP-399
Viibryd
Namenda
Namenda XR cariprazine levomilnacipran
Savella
GRT-6005
linaclotide
Daliresp
aclidinium
aclidinium/
formoterol
Teflaro
ceftaroline/
avibactam
ceftazidime/
avibactam
BC3781
Robust pipeline of important medicines in these 3 therapeutic areas
Cardiovascular
CNS
Pain
GI
Respiratory
Anti-Infectives
Bystolic
nebivolol/
valsartan
azimilide
TTP-399
Viibryd
Namenda Namenda XR
cariprazine levomilnacipran
Savella
GRT-6005
linaclotide
Daliresp
aclidinium
aclidinium/
formoterol
Teflaro
ceftaroline/
avibactam
ceftazidime/
avibactam
BC3781
Scientific programs that develop useful data for patients and physicians beyond required registration studies
Cardiovascular
CNS
Pain
GI
Respiratory
Anti-Infectives
Bystolic
nebivolol/
valsartan
azimilide
TTP-399
Viibryd
Namenda
Namenda XR cariprazine levomilnacipran
Savella
GRT-6005
linaclotide
Daliresp
aclidinium
aclidinium/
formoterol
Teflaro
ceftaroline/
avibactam
ceftazidime/
avibactam
BC3781
Our therapeutic focus of complimentary medicines demonstrates our commitment to change the lives of patients with significant diseases
Building the Future
A Focus on Our
Products & Therapeutic Categories
Forest Laboratories, Inc.
Harry J. Sacks, MD, FAAP
Executive Director,
Clinical Development Respiratory Forest Research Institute, Inc.
Cardiovascular CNS Pain GI Respiratory Anti-lnfectives
Bystolic
nebivolol/
valsartan
azimilide
TTP-399 Viibryd
Namenda
NamendaXR
cariprazine
levomilnacipran Savella
GRT-6005 linaclotide Daliresp
aclidinium
aclidinium/ formoterol Teflaro
ceftaroline/
avibactam
ceftazidime/
avibactam
BC3781
Improve lives of
PATIENTS WITH RESPIRATORY
DISEASES
Forest Laboratories, Inc.
Respiratory Overview
Goal: Improve lives of
patients with respiratory diseases
Robust COPD development programs underway
Product differentiation studies for all products
Investigate products in other respiratory conditions such as asthma
Seek out and invest in new treatments
Managing the Spectrum of COPD
Forest
Laboratories, Inc.
Managing the Spectrum of COPD
Affects as
many as 24 million Americans1
Third leading cause of death in US2
Breathlessness is leading symptom
aclidinium / formoterol
aclidinium Daliresp
MILD MODERATE SEVERE VERY SEVERE
Source: 1 COPD Foundation Website: http://www.copdfoundation.org/COPDYOU/AboutCOPD.aspx, accessed June 18, 2012
2Centers for Disease Control (CDC) and Preventions National Center for Health Statistics (NCHS), Deaths: Preliminary Data for 2008.
http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_02.pdf. Accessed 6/18/2012.
Aclidinium Bromide: A Novel Anticholinergic Bronchodilator
Efficacy
Improved lung function 24 hour control
Symptom relief
Safety
Well tolerated Low drug interaction
Successful
FDA AdCom
Inhaler
Simple to use Patient friendly
COPD
TREATMENT OPTIONS
Forest Laboratories, Inc.
Aclidinium Bromide: A Novel Anticholinergic Bronchodilator
400
350 300 250 200
150 100
50
0
-50
-100
0
Evening administration
Aclidinium 400 ug * BID (N=29)
Tiotropium 18 ug
QD (N=28)
Placebo
(N=30)
0 1 2 4 5 6 7 8 10 11 12 13 14 16 17 18 19
20 22 23 24
Time, h
Study LAS-MD-23; presented at Feb. 23, 2012 FDA Advisory Committee
Further Studies
Planned
Forest Laboratories, Inc.
Further Studies Planned
Relative effect of
aclidinium over 24 hours
- Direct comparison to approved product
Exacerbations
- Confirm aclidinium reduces flare ups
Exercise Tolerance
- Confirm aclidinium enables patients to better tolerate physical exertion
Aclidinium + Formoterol FDC
Forest Laboratories,
Inc.
Aclidinium + Formoterol FDC
Phase III
pivotal studies currently enrolling
For moderate to severe patients requiring more symptom control than
with a single agent
- Step between monotherapy and inhaled steroids
- May delay need for steroids
Established efficacy in Phase II; well tolerated
NDA Early CY 2014
Importance of Reducing COPD Exacerbations
History of exacerbations predicts higher likelihood of future exacerbations
Reduction of exacerbations
is a key component of COPD management1
Exacerbations are associated with accelerated deterioration in
lung function and increased risk of death
Daliresp reduces the rate of exacerbations
Reference: 1Global Initiative for Chronic Obstructive Lung Disease (GOLD), Global Strategy for the Diagnosis, Management,
and Prevention of Chronic Obstructive Lung Disease, Revised 2011, http://www.goldcopd.org/uploads/users/files/GOLD_Report_2011_Feb21.pdf, Accessed 6/18/2011.
Daliresp (roflumilast, 500 mcg tablets)
Severe
and Very Severe COPD
DALIRESP is indicated as a treatment to reduce the risk of COPD exacerbations in
patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Approved February 2011
- Once daily oral treatment
- First and only approved phosphodiesterase 4 (PDE-4) inhibitor
- First new drug class in over 25 years for COPD treatment
Place in treatment: Severe COPD with a history of exacerbations in addition to bronchodilator therapy
Cardiovascular CNS Pain GI Respiratory Anti-Infectives
Bystolic
nebivolol/
valsartan
azimilide
TTP-399 Namenda
NamendaXR
cariprazine
levomilnacipran Savella GRT-6005
linaclotide Daliresp
aclidinium
aclidinium/ formoterol Teflaro
ceftaroline/
avibactam
ceftazidime/
avibactam
BC3781
Building the Future
A Focus on Our
Products & Therapeutic Categories
Forest Laboratories, Inc.
Paul C. Grint, MD
President, Cerexa, Inc.
Cardiovascular CNS Pain GI Respiratory Anti-Infectives
Bystolic
nebivolol/
valsartan
azimilide
TTP-399 Namenda Namenda XR
cariprazine
levomilnacipran Savella GRT-6005 linaclotide Daliresp
aclidinium
aclidinium/ formoterol Teflaro
ceftaroline/
avibactam
ceftazidime/
avibactam
BC3781
Bad Bugs Need Drugs
Antibiotic resistant
infections in the US
- 8 million hospital days
- $20B annual cost Public health threat
National security threat
The 10 x
'20 Initiative NewDrugs4BadBugs
- European initiative against antimicrobial resistance
GAIN Legislation - Generate Antibiotic Incentives Now
Bad Bugs
Need Drugs
10x 20
Ten new ANTIBIOTICS by 2020
10
9
8
7
6
5
4
3
2
1 ceftaroline fosamil: Forest Laboratories,
Inc.
Approved October 29, 2010
We could potentially deliver an additional 2 to 3 of these 10
Spectrum of Activity
Resistant Gram+
Gram+
Gram
Resistant Gram
Teflaro
ceftaroline + avibactam
ceftazidime + avibactam
MRSA
MDRSP
S. pneumoniae
S. aureus
H. influenzae
E. coli
K. pneumoniae
ESBL
producing Gram
P. aeruginosa
Nabriva BC-3781
Ceftaroline Life Cycle Studies
patch®
pediatric antibiotic therapy
with ceftaroline in the hospital
Pediatric
PK studies including premature newborns
Comparative studies in children
- Community acquired bacterial pneumonia
- Complicated skin infections
- CABP at risk of
MRSA
Study designs for additional infections being evaluated
AWARE: Assessing Worldwide Antimicrobial Resistance Evaluation
In Vitro US Surveillance Program
No
trend of reduced susceptibility to ceftaroline for pathogens tested between 2008 and 2011
Expanding
program
- 70 centers in 2011
- 200 centers in 2012
% Susceptible to
ceftaroline (FDA Breakpoints)
Pathogen 2008 2009 2010 2011
S. aureus 97.0 98.4 99.2 99.0
S. pneumoniae 98.8 98.5 98.8 99.1
S. pyogenes
100.0 99.1 99.1 99.8
S. agalactiae 100.0 100.0 99.7 99.8
E. coli 90.1 84.9 84.9 83.1
K. pneumoniae 82.7 79.3 86.1 81.3
K. oxytoca 86.2
83.3 85.2 82.4
H. influenzae 100.0 100.0 99.7 99.6
Important Utility of ß-Lactam Antibiotics
ß-Lactams have been effective life saving antibiotics for five decades
ß-lactamases are threatening the utility of ß-Lactams
- ß-Lactamase-induced resistance is increasing worldwide
- No treatment available for new extended ß-lactamases
- Carbepenems are now threatened by KPC-producing organisms
Avibactam: Next Generation ß-Lactamase Inhibitor
Non ß-lactam ß-lactamase inhibitor
- Does not bind to PBPs
- No intrinsic
antibacterial activity
Inhibits a broad spectrum of clinically important ß-lactamases
- Older inhibitors do not offer coverage of important enzymes such as KPC or AmpC
Does NOT induce AmpC ß-lactamase
PK profile compatible for combination with IV cephalosporins ceftazidime and ceftaroline
Potential for combination with additional ß-lactam antibiotics
O
H2N
N
O
N
OSO3Na
Avibactam Combinations
Globally, over a million
patients a year suffer from infections known or suspected to be resistant to cephalosporins, and is expected to grow by more than 25% over the next decade
Ceftazidime Avibactam
- Phase III program
to treat serious Gram-negative bacterial infections has been initiated
Complicated Intra-Abdominal
Infections (cIAI)
Complicated Urinary Tract Infections (cUTI)
Ceftaroline Avibactam
- Phase II program completing
- Planning Phase
III study designs
BC-3781 Nabriva Therapeutics
Novel class
of antibiotics, the pleuromutilins
- Active against a wide range of Gram-positive pathogens as well as certain
Gram-negative organisms
No cross resistance
Low propensity for inducing resistance itself
Developed both intravenous and oral forms to treat patients after they are discharged from a hospital
Positive Phase II study results in 207 patients with ABSSSI
We expect to advance BC-3781 into pivotal Phase III studies in 2013
Summary
Very significant antibiotic
portfolio that covers a wide spectrum of Gram-positive and Gram-negative pathogens
Urgent medical need
for new antibiotic development
Potential to deliver an additional 2 to 3 antibiotics for the IDSA 10 x
20 Initiative
Bad Bugs Need Drugs
10x 20
Ten new ANTIBIOTICS by 2020
Building the Future
A Focus on Our Products &
Therapeutic Categories
Forest Laboratories, Inc.
|
David F. Solomon
Senior Vice President,
Corporate
Development
& Strategic Planning
Forest Laboratories, Inc.
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Forest Objective
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Forest Laboratories, Inc.
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Forest Objective
|
We will achieve long-term growth by maintaining our simple but powerful strategy
|
License or acquire new products
|
Rigorous scientific development
|
Effective marketing and sales
|
Vigorous protection of our intellectual property
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Forest Objective
|
We will enhance long-term growth by extending that strategy
|
Life cycle programs
|
New therapeutic areas
|
Earlier stage programs
|
Larger or more difficult to manufacture molecules
|
Adjacent business opportunities
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Expansion outside the United States
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Forest Business Development
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Opportunistic
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Targeted
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Engineered
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Unsolicited
|
|
|
|
|
|
|
|
|
|
|
|
|
Partnering
Meetings
|
|
Wall Street &
Venture Capital
|
|
|
Company
Focus
|
|
|
|
Therapeutic
Franchise &
Mechanism
Focus
|
|
Medical
Meetings
|
|
Companies
Looking
|
|
|
|
Scope of Business
|
Development Activity
|
350-450
|
Screened by Business Development
|
100-150
|
Reviewed Internally
|
15-25
|
Due Diligence
|
2-6
|
Transactions
|
|
Partner-Oriented Business Development
|
25 Product Partnerships And Acquisitions Since 2004
|
|
Partner-Oriented Business Development
|
Marketed / Next 9 Product Partnerships
|
|
|
|
Forest is a Partner of Choice
Reputation for treating partners fairly and with respect
Large enough to compete with the major pharma companies and small enough to focus on each product
History of success developing and launching in-licensed products
Senior level engagement across the partnership
Quick decision making
Flexible approach to deal
structure
No not invented here bias
|
|
Continued Success of Forests Partner-Oriented Strategy
Numerous repeat collaborations with our partners
Many novel and interesting product opportunities available
|
|
Forest is Growing its Global Footprint
Forest will expand where opportunities exist
In 3 years, we have grown from operating in 3 countries to 10 countries
Established in Canada
Expanding in
Europe
Interest in emerging markets
|
|
Forest Canada
Forest Canada fully established
Canadian rights to
most of the Next Nine products
NDS for Bystolic under review by Health Canada
Launch projected early CY13
NDS for Viibryd and linaclotide to be filed later this year, and NDS for levomilnacipran and cariprazine to be filed during CY13
|
|
Forest Europe
Tosara and Forest UK (OTC Business) Sales of ~$80M
Key products are Sudacrem and Infacol
Sold
directly in UK and Ireland, and exported to over 35 countries
|
|
Forest Europe
Pharma Business Sales of ~$50M
Largest
product is Colistin
Nebulized antibiotic for prevention of respiratory infections in cystic fibrosis
patients
In 2011 acquired rights to Colistin in several Central EU countries
Established affiliates in Germany, Austria, Netherlands, Belgium & Switzerland
|
|
Forest Europe
Pharma Business Sales of ~$50M
Approval for
Colobreathe in January 2012
Dry powder inhaler of the same antibiotic
Will establish affiliates in all major EU countries, Scandanavia and high value Eastern EU markets
Launch in Ireland, Germany, Austria, Netherlands & Denmark CY13; additional markets next
year
|
|
Forest Will Build Strategically in International Markets
International business must be structured to support long-term, sustainable, profitable growth
Need to be sensitive to regional differences
Business development to be globally deployed and looking for global and regional product rights
International business will become a meaningful contributor to top-line and bottom line
|
|
Building Long-Term Growth
Forest has the right strategy, based on licensing and acquiring interesting products
Forest will continue to build our therapeutic franchises and will be opportunistic in looking at new product and novel business opportunities
Forest will expand our strategy globally
|
|
The Right Strategy for Today and for the Future
|
|
Building the Future
A Focus on Our Products & Therapeutic Categories
Forest Laboratories, Inc.
|
|
Elaine Hochberg
|
Executive Vice President,
|
Sales & Marketing
|
and Chief Commercial Officer
|
Forest Laboratories, Inc.
|
A Focus On Our Commercial Philosophy & Therapeutic Areas
Forest Laboratories, Inc.
Forests Rich Commercial History
Past 15 Years
Total revenue from $300MM to
$4B
14 launches
- 14 products
- 17 indications
Significant Product Launches
Celexa
citalopram HBr
Benicar TABLETS
Lexapro
Bystolic
Namenda
The Forest Way
Ability to right-size
and deploy commercial effort to create value
Commercial Operations
Forest Laboratories, Inc.
Commercial Operations 2012
ELAINE HOCHBERG
Executive Vice President &
Chief Commercial Officer
Global Commercial & U.S. Marketing
Office Based Sales
Managed Markets, Government & Policy
Product
Management
Global Commercialization
Marketing Services
Digital Marketing &
Marketing Communications
4 Primary Care Sales Forces
2 Speciality Sales Forces
Institutional Sales
Hospital & LTC Sales
Force
National / Regional Account Managers
Government Sales & Long Term Care Account Managers Trade Sales
Wholesaler & Retail Chain Account Managers
Global Market Research
Marketing Practices &
Production
Contract Sales Organization
Contract Sales Organization
Public Policy & Government Affairs
Global
Commercial Assessments
Sales Administration & Sales Training
Forests Advantage: Field Force Strength
RANKED 1st on Selling Power magazines
50 Best Companies to Sell For
in
20111
We Target per Year:
~ 250,000 physicians
~ 3,000
hospitals and clinics
~ 500 senior care pharmacies
Productivity2
1st Forest
2nd AstraZeneca
3rd Pfizer
4th Takeda
5th Novartis
6th GSK
7th Lilly
8th Merck
9th Boehringer I.
10th Abbott
Call Quality3
1st Pfizer
2nd Lilly
3rd Abbott
4th Boehringer I.
5th Novartis
6th Forest
7th Takeda
8th Merck
9th AstraZeneca
10th GSK
12011 survey by Selling Power magazine.
2Productivity measures in terms of calls per sales representation.
Companies were assessed if ranked within the top 10 based on total number of Calls
3Source of Calls: IMS IPS, 12 months ending January 2012;
Source for sales reps: SDIs Sales Force Structure & Strategies Report 4Q 2011 (includes contract and part-time
reps)
Forest rep count used to calculation is internal data and not based on SDIs report
Call Quality measured as Minutes per Detail (sample drops are excluded)
Companies were assessed if ranked within the top 10 based on total number of Details
|
|
|
Primary Care
Forest Laboratories, Inc.
|
Forest Reps Consistently Reach More Than 80% of Primary Care Physicians*
More Than Twice Per Month
Reach
90%
85%
80%
75%
70%
65%
60%
Reach and Frequency to 98,000 Decile 310 PCPs
Reach Call Frequency
81.2% 82.5% 81.8% 83.7%
2.55 2.55 2.65 2.78
2008 2009 2010 2011
3.2
3.1
2.9
2.8
2.7
2.5
2.4
2.3
2.1
2.0
Monthly Call Frequency
*98,000 (Decile 310) Primary Care Physicians Internal Call Data
Forest Position with PCPs is Strong and Growing Stronger
Company Details Primary Care Physicians
Details (thousands)
5,000
4,000
3,000
2,000
1,000
0
CY2007
CY2008 CY2009
Forest Merck
AstraZeneca Lilly
Novartis Takeda
Abbott Sanofi Aventis
CY2010
Pfizer
GSK
Boehringer
CY2011
Source: IMS IPS, Office-based Details
|
Commercial Philosophy
Forest Laboratories, Inc.
|
|
Forests Commercial Philosophy
Primarily Primary Care-Centric (with appropriate specialty overlays)
Therapeutically Agnostic
Differentiated Products
Professionally Driven
Sensibly Priced
Diversifying Geographically
|
|
Primary Care Professionals Generate >65% of TRxs
% of TRx
Decile 3-10 MDs
Anti-Depressants
(SRI)
Beta Blockers
COPD
Primary Care Professionals
(Includes NPs & PAs)
69%
73%
71%
Specialists
23%
22%
21%
Others
8%
5%
8%
Total
100%
100%
100%
IMS Xponent 12 months, Ending April
2012
|
|
Greater Than One-half of Naïve and New to Brand Patients are Treated by Primary care
Physicians
Percent of Patients Treated by PCPs
Naïve to Market
New to Brand
100%
80%
60%
40%
20%
0%
68%
64%
56%
54%
60%
60%
62%
61%
HTN
Depression
Alzheimer
COPD
Source: IMS Custom Patient Study,
2012
|
|
Forest Competes in Major Primary Care Markets
Ranking of Therapeutic Classes Based on Primary Care TRx Volume
Total Prescriptions (000)
500,000
450,000
400,000
350,000
300,000
250,000
200,000
150,000
100,000
50,000
0
Cardiovascular
Psychotherapeutics
Antihyperlipidemic
Analgesics
Diabetes
Anti-Infectives
Gastrointestinal
Respiratory
Cardiovascular agents include ACEs,
ARBs, Beta Blockers, Diuretics; Psychotherapeutics include Antidepressants, Antipsychotics, Anti-Anxiety, Analeptics
Source: IMS National Prescription Audit, Total Prescriptions, 12 months ending March 2012
|
|
SUCCESS WITH PRODUCTS
Forest Laboratories, Inc.
|
|
Bystolic A Case Study
TRx (Absolute Numbers)
Bystolic
Prilosec
Januvia
Symbicort
Vyvanse
Bexilant
Pradaxa
Janumet
3,000,000
2,250,000
1,500,000
750,000
Bystolic
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Quarters
Source: IMS, NPA, May 12
Note: Dexilant was
originally marketed as Kapldex
|
|
PCP Response to Bystolic Detailing:
Launches Take Two Years
Bystolic TRx per MD
35
30
25
20
15
10
5
0
0 6 12 18 24 30 36 42
Bystolic Calls per
MD
Source: Internal Data, 75,970 physicians were analyzed
Rx Data- IMS Xponant
Year 2
Year 1
|
|
Strong Growth Performance for in its 4th Year with Broad Coverage by Managed Care
% Unrestricted T2/T3 Access
Bystolic TRx
100%
80%
60%
40%
20%
0%
73%
82%
83%
84%
1,600
1,400
1,200
1,000
800
600
400
200
0
Total Rx (000)
1Q 08
2Q 08
3Q 08
4Q 08
1Q 09
2Q 09
3Q 09
4Q 09
1Q 10
2Q 10
3Q 10
4Q 10
1Q 11
2Q 11
3Q 11
4Q 11
1Q 12
Source: IMS National Prescription Audit, Total Prescriptions March 2012
MediMedia Technologies, LLC Formulary Compass TM; Access includes Commercial & Medicare
|
|
Forest Pipeline
FY2013
aclidinium (COPD)
linaclotide (CC/IBSc)
FY2014
Namenda XR (Alzheimers
Disease)
levomilnacipran (MDD)
cariprazine (schizophrenia and mania)
FY15 and
Beyond
Bystolic / valsartan (Hypertension)
aclidinium / formoterol (COPD)
Viibryd (GAD)
cariprazine (Depression &
Bipolar Disorder)
GRT-6005 (Chronic Pain)
azimilide (Anti-Arrhythmic)
TTP-399 (Diabetes)
|
|
Sales Rep High Driver of MD Adoption
Stated and Implied Importance in Making a Prescribing
Decision at Launch for Physicians
DTC Advertising
Sales Reps
Samples
Perceived Unmet Need
Coverage
Out-of-Pocket Cost
Pre-launch Awareness
Guidelines at
Launch
Novel MOA
Expert Advocacy
Dosing
Manufacturer Credibility
Low implied importance
High implied
importance
Low stated importance
High stated importance
Note: Coverage
refers to whether a drug is covered by payers and restrictions placed on reimbursement; Out-of-pocket cost refers to the co-pay cost to the patient
Note: At launch refers to the influence each factor would have on a physicians decision to adopt a drug immediately following its availability. The period of evaluation
varies by respondent due to differences in adoption timing, but generally encompasses the first 3-12 months following launch ZS Associates 2012
|
|
What Do Doctors Really Want?
Practical Help, Survey Finds
Doctors
also see a greater practical benefit
in meeting with sales reps
who are trained beyond their own product, and prepared for a serious discussion of multiple therapeutic
options.
Source: What Physicians Want Survey by Publics Touchpoint Solutions and
Sermo
|
|
Forests Value is in the Mix
Industry PCP Total Prescriptions by Therapeutic Area
Anti-Infectives 5%
Respiratory 5%
GI 5%
Pain 7%
CNS 11%
Other 39%
Cardiovascular 28%
Forest Product Line
Cardiovascular (3)
Bystolic
nebivolol/valsartan
azimilide
CNS (4)
Viibryd
Namenda/Namenda XR
Cariprazine
Levomilnacipran
Pain (2)
Savella
GRT-6005
GI (1)
linaclotide
Respiratory (3)
Daliresp
aclidinium
aclidinium/formoteral
Anti-Infectives
(4)
Teflaro
ceftaroline/avibactam
ceftazidime/avibactam
BC3781
Source: IMS National Prescription Audit, 12
months ending March 2012
|
|
Significant Overlap Among PCPs in Different Therapeutic Areas
SSRI
55% 3 Products
80% 2 Products
87% linaclotide
COPD
Beta blocker
IMS Xponent 12 months, Ending April 2012
|
|
Forest - Diversifying Geographically
Ex US
Canada
Europe
Latin America
other
US Institutions
Anti-infectives
Respiratory
Alzheimers
Other
|
|
Average Uptake for Hospital INJ Antibiotics:
Slower Ramp and Longer Period
Avg Retail Uptake
Avg Hospital INJ Antibiotics
Uptake
Percent of Peak Volume
0%
25%
50%
75%
100%
Months Post-Launch
M1
M12
M23
M34
M45
M56
M67
M78
M89
M100
Source: IMS NPA Prescriptions
IMS National Sales Perspectives
|
|
Forests Commercial Philosophy
Look for efficiencies to build long term value
Forest Laboratories, Inc.
|
Building the Future
A Focus On Our Products
& Therapeutic Categories
Forest Laboratories, Inc.
William Meury
Senior Vice President,
Global Commercial & US Marketing
Forest Laboratories, Inc.
Building the Future
A Focus on Our Products
& Therapeutic Categories
Forest Laboratories, Inc.
Cardiovascular
Bystolic
nebivolol/
valsartan
Azimilide
TTP-399 CNS
Viibryd Namenda
Namenda
XR cariprazine levomilnacipran pain Savella GRT-6005 GI linaclotide Respiratory Daliresp aclidinium aclidinium/ formoterol
Anti-Infectives Teflaro ceftaroline/avibactam ceftazidime/avibactam BC3781
User Trends and Prescriptions
Are Strong
Cumulative Bystolic Prescribers
300,000 225,000 150,000, 75,000,
0
264,057
1/4/08
10/9/09
6/13/08
11/21/08
5/1/09
3/19/10
8/27/10
2/4/11
7/15/11
12/23/11
5/25/12
Over 5 Million Prescriptions
Prescriptions up 20% in 1st calendar quarter vs. prior year
550 530 510 490 470 450 430 410 390 370 350
Apr
-11 May-11 June-11 Aug-11 Sep-11 Oct-11 Nov-11, Dec-11Jan-12 Feb-12 Mar-12 Apr-12 May 12
IMS NGps & IMS Xponent, updated through May 2012
Market for 1st /2nd Line is Larger
Patients
receiving 3 or 4 anti-hypertensives of control BP
Position Bystolic Here!
26% 74%
Patients received 1 or 2 anti-hypertensives to control BP
Sources: Decision Resources (Pharamacor 2009); IMS/SDI (Custom) Hypertension Monthly Report, January 2012.
Bystolic is Being Used 1st or 2nd Line
Bystolic
Line of Therapy
Difference in 1st and 2nd Line
4th Line 15%
3rd Line 27%
1st & 2nd Line 58%
Bystolic 4%
-1%
5% 4% 3% 2% 0% (1%) (2%)
Beta Blocker Market
Source: IMS Study Drug Order as Written, First Filled
11 Bystolic Clinical Studies
Over 4 Years
Study
Conclusion
9
10
11
Weiss/Greathouse
Lacourciere
Weiss
Neutel
Lacourciere
Weber
Saunders
Punzi
Registration
Registration
Lukic
Monotherapy
Monotherapy
Monotherapy Stage 2
Add on to ACE, ARB, HCTZ
Initial combination with ACE
Black patients
Hispanic patients
Younger and Older (+65)
Male and Female
<55 Years of Age Monotherapy
Cardiovascular
Bystolic
nebivolo
valsartan
azimilide
TTP-399
CNS
Viibryd
Namenda
Namenda XR
cariprazine
levomilnacipran
Pain
Savella
GRT-6005
GI
linaclotied
Respiratory
Daliresp
aclidinium
aclidinium/formoterol
Anti-Infectives
Teflaro
ceftaroline/
avibactam
ceftazidime/avibactam
BC3781
Bystolic + valsartan
54.2MM Prescriptions
ARB + BB ARB + BB + HCT ARB + HCT
10MM Rx 15.9MM Rx 28.3MM Rx
$3.3B Annual Sales
Cardiovascular
Bystolic nebivolol/valsartan
azimilide TTP-399
CNS
Viibryd Namenda Namenda XR cariprazine levomilnacipran
Pain
Savella
GRT-6005
GI
Linclotide
Respiratory
Daliresp
Aclidinium
Aclidinium/formoterol
Anti-Infectives
Teflaro
Ceftaroline/avibactam
Ceftazidime/avibactam
BC3781
Namenda
Large User Base
173,000
129,750
86,500
43,250
0
173,000
MD Users
High Satisfaction Rate
7.0
6.0
5.0
4.0
3.0
2.0
1.0
0
5.1
5.1
5.0
Basic ADLs
Cognitive Decline
Quality of Life
Source: IMS XPO & Market Research
Once-Daily
NamendaXR
(memantine HCL) extended release capsules
TM
Once-Daliy
Namenda XR
(Memantine HCI)extended release capsules
Demonstrated effective with all ACHEI
Improvement
in cognition, function, and behavior
AE consistent with Namenda
Once a day high dose formulation
TM
Viibryd is off to a Strong Start
Prescriptions
Market Share %
0
0.05
0.10
0.15
0.20
0.25
0.30
0.35
0.40
0.45
0.50
Jul-11
Sep-11
Nov-11
Jan-12
Mar-12
TM
May-12
0
10
20
30
40
50
60
70
80
90
100
Total Prescription Volume (000s)
TRx
Mkt Share
Overall volume up 20% since start of 2012
Source: IMS NGPS NPA, May 2012
Viibryd Prescribers are on the Rise
Prescribers
Since Launch
Prescribers Since Launch
60,000 45,000 30,000 15,000 0
6/17/11 7/29/11
9/9/11 10/21/11 12/2/11 1/13/12 2/24/12 4/6/12 5/18/12
1,000 added/week
50,516
Source: IMS Xponent, Week ending 5/18/2012
Viibryd is off to a Strong Start
Physician
Reported Use of Viibryd
4+ Line 17% 3rd Line 28% 1st Line 29% 2nd Line 26%
Source: Market Research
TM
Viibryd TM
LEVOMILNACIPRAN
Forest Laboratories, Inc.
Levomilnacipran
Dual Reuptake Inhibitor for Major
Depressive Disorder (MDD)
200 million prescriptions written
Sales for antidepressants approximately $18B
Only 3040% of patients on any achieve remission
Source: STAR-D and GYK, 2008
Levomilnacipran
Dual Reuptake Inhibitor for Major
Depression Disorder (MDD)
Strong effect on the MADRAS
Significant effect on function
Acceptable adverse event profile
Source: STAR D
and GIK, 2008
Market Positions for Levomilnacipran
1st line
2nd line
3rd line
Treatment Resistant
SSRIs
SNRIs Wellbutrin
Anti-psychotics
Viibryd levomilnacipram
CARIPARAZINE
Forest Laboratories, Inc.
Cariprazine: A Novel Next Step
D2/5HT
Antagonists
D2 Partial
Agonist
New D3/D2
Partial Agonist
Risperdal
Zyprexa
Seroquel
Geodon
Clozaril
Invega
Saphris
Fanapt
Latuda
Abilify
Cariprazine
Recent Launch Performance
Total Rx (000s)
Latuda #10
Saphris #8
Fanapt #9
40
30
20
10
0
M1 M3 M5 M7 M9 M11 M13 M15 M17 M19 M21 M23
Source: IMS NPA TRx, March 2012
Bipolar Depression and MDD Markets
Abilify
$5.3B 22% 26% 39% 13% Source: IMS NSP, MAT April 2012; NDTI, MAT April 2012
Note: Others includes
Psychoses unspecified, autism, anxiety, OCD, domestic
Schizophrenia
Bipolar Disorder
Depression
Others
Seroquel/XR $5.5B
29% 17% 41% 14%
Cardiovascular
CNS
Pain
GI
Respiratory
Anti-Infectives
Bystolic
nebivolol/
valsartan
azimilide
TTP-399
Viibryd
Namenda
Namenda XR
cariprazine
levomilnacipran
Savella
GRT-6005
linaclotide
Daliresp
aclidinium
aclidinium/
formoterol
Teflaro
ceftaroline/
avibactam
ceftazidime/
avibactam
BC3781
CURRENT TREATMENTS
Forest Laboratories, Inc.
Linaclotide Provides Multi-symptom Relief
Linaclotide addresses constellation of symptoms in CC/IBSc
Relieve pain Relieve bloating and discomfort Improve bowel function
Two Important Sources of Business
Convert Rx and
OTC markets
Prescription Market 24%
$2.2B
$7.0B
76% OTC Market (@ branded RX pricing)
Source: Market Research & IMS
Linaclotide for CC and IBSc
(MM)
CC
IBS-C
Total
Prevalence
26.0
13.2
39.2
Patients Seeking Care
7.9
7.6
15.5
Dissatisfied Patients (62-68%)
4.9
5.2
10.1
Satisfaction with current therapies is low
60-70% of patients seeking care are dissatisfied with current therapy
Lieborman Study, 2010
OTC Conversion Rates
40% 30% 20% 10% 0%
20% NSAIDs to Cox-2s
23% H2s to PPls
37% Sedating to Non-Sedating
Antihistamines
Source: Kline OTC Sales Date
Linaclotide Post-launch
Promotional Effort
- +1,500 representatives
- 90,000 physicians
Major educational campaign
directed to patients
Cardiovascular
Bystolic
Nebivolol/
Valsartan
Azimilide
TTP-399
CNS
Viibryd
Namenda
Namenda XR
Cariprazine
Levomilnacipran
Pain
Savella
GRT-6005
GI
Linaclotide
Respiratory
Daliresp
Aclidinium
Aclidinium/
Formoterol
Anti-infectives
Teflaro
Ceftaroline/
Avibactam
Ceftazidime/
Avibactam
BC3781
COPD Product Line
Aclildinium
LAMA
Acilidinium
/formoterol
LAMA/LABA
Daliresp
PDEIV Inhibitor
Efficacy
Moderate COPD
Severe COPD
Need for New Therapies
Patients are Still
Experiencing Symptoms Despite Treatment
Overall PUD PCP
70% 53% 35% 18% 0% 55% 64% 46% 41% 52% 28%
Experiencing symptoms with monotherapy
Experiencing symptoms with combination Spiriva + ICS/LABA
Source: Forest Physician COPD Research GfK COPD Study, 2008
Percentage of Patients Requiring Treatment in the ED
30% 23% 15% 8% 0% 21% 27% 20%
AII MDs PUDs PCPs
Daliresp off to a Strong Start with Pulmonologists Overall volume up 42% since start of 2012
7,000 6,000 5,000 4,000 3,000 2,000 1,000 PUD Share 2.6% 2.1% 1.6% 1.1% 0.6% 0.1%-0.4%
PUD Market Share TRx
0 5/27/11 7/8/11 8/19/11
9/30/11 11/11/11 12/23/11 2/3/2012 3/16/12 4/27/12
Updated Weekly Data Week Ending May 2012
Daliresp off to a Strong Start
With
Pulmonologists
Total PUD Users
5,000 3,750 2,500 1,250
0
504 1,070 1,580 1,990 2,369 2,715 3,033 3,306 3,577 3,811 4,031
Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May
Source: IMS Xponent, Week ending 5/25/2012
PCP DEVELOPMENT
Forest Laboratories, Inc.
PCP USAGE DOUBLES:
20,000 TO 40,000
Forest Laboratories,Inc.
44% Increase in Hospital
Using Daliresp
Hospitals Purchasing
1,800
1,575
1,350
1,125
900
675
450
225
0
1,198
+531 Hospitals
1,729
Before Hospital Launch
After Hospital Launch
Updated Weekly Data Week Ending May 11
ACLIDINIUM
Forest Laboratories, Inc.
Aclidinium
Long acting inhaled anti-cholinergic
bronchodilator
Long residence time at M3 receptors and shorter residence time at the M2 receptors
Novel, multi-dose device, Genuair
Rapid effect on FEV1
Low incidence of side
effects
Novel, easy to use inhaler
Aclidinium Promotional Effort
1,500
representatives
90,000 physicians
Sampling
Advertising
Peer to peer promotional programs
ACLIDINIUM-FORMOTEROL
Forest Laboratories, Inc.
Cardiovascular
Bystolic
Nebivolol/
Valsartan
Azimilide
TTP-399
CNS
Viibryd
Namenda
Namenda XR
Cariprazine
levomilnacipran
Pain
Savella
GRT-6005
GI
Linaclotide
Respiratory
Daliresp
aclidinium
aclidinium/
formoterol
Anti-infectives
Teflaro
ceftaroline/
avibactam
ceftazidime/
avibactam
BC3781
Teflaro
Purchasing Hospitals
Above Cubicin
Tygacil
Zyvox
TEFLARO
Doribax
Cubicin
Vibativ
Weekly Accounts Purchasing
1,500
1,125
750
375
0
W1
W6
W11
W16
W21
W26
W31
W36
W41
W46
W51
W56
W61
W66
W71
Weeks Post-Launch
IMS, Hospital Report, 2012
Teflaro
20,000
15,000
10,000
5,000
Weekly DOT
Days of Therapy
Above to Zyvox
0
W1
W6
W11
W16
W21
W26
W31
W36
W41
W46
W51
W56
W61
W66
W71
Tygacil
Cubicin
Doribax
TEFLARO
Zyvox
Vibativ
Weeks post-Launch
Ims, Hospital Report, 2012
Teflaro
Has Demonstrated High Efficacy Rates in
CABP & ABSSSI
Day 4 CABP
TEFLARO 69.5% CABP
Ceftriaxone 59.4%
0% 20% 40% 60% 80% 100%
S. pneumoniae
100% 80% 60% 40% 20% 0%
85.7% 69.5%
TEFLARO Ceftriaxone
Day 3 ABSSSI
TEFLARO 74.0% ABSSSI
Vanco/Aztreonam 66.2%
0% 20% 40% 60% 80% 100%
MRSA 100% 80% 60% 40% 20% 0%
93.4% 94.3%
TEFLARO Vanco/Aztreonam
Usage Patterns
40% 25%
30% 33%
20%
10%
0%
Percentage of 1st line Use
Emergency Department
Use
100% 88%
75%
50%
25%
0%
Satisfaction
Source: Market Research
Teflaro Prescribing Intentions are High
Future Prescribing Expectation IDs and Internists
100% 2% 5%
75%
50% 98% 95%
25%
0%
Plan to initiate use of Teflaro for cSSSI
(n=43) Plan to initiate use of Teflaro for CABP (n=43)
Source: Market Research
Forest Antibiotic Franchise
First Line
Empiric Therapy
Teflaro
ceftaroline/avibactam
ceftazidime/avibactam
Workhorse antibiotic
for cSSSI and CAP
Ceftaroline with ESBL
Coverage will expand use
of ceftaroline for more
severe infections
Excellent activity against
Gram- pathogens such
as pseudomonas
Gram-negative U.S. Market Share
Days of Therapy
(non-retail)
Carbapenems
14%
Cephalosporins
13%
IV Quinolones
34%
Piperacillin/tazobactam
39%
IV Quinolones
Piperacillin/tazobactam
Cephalosporins
Carbapenems
Data Source: IMS NSP Non-retail grams (MAT April 2012) converted to days of therapy using AMR grams/DOT (MAT June 2011)
Defined market includes:
Piperacillin/tazobactam; IV Quinolones; Ciprofloxacin iv, levofloxacin iv; carbapenems; meropenem; imipenem/cilastatin, doripenem; cephalosporins: cefepime and ceftazidime
Cardiovascular CNS Pain GI Respiratory Anti-Infectives
Bystolic nebivolol/valsartan azimilide TTP-399
Viibryd Namenda Namenda XR cariprazine levomilnacipran
Savella GRT-6005
Linaclotide
Daliresp aclidinium
aclidinium/formoterol
Teflaro ceftaroline/avibactam ceftazidime/avibactam BC3781
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