UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
Proxy Statement Pursuant to Section 14(a) of the
Securities Exchange Act of 1934
(Amendment No. )
Filed by the Registrant x Filed by a Party other than the Registrant ¨
Check the appropriate box:
| ¨ | Preliminary Proxy Statement | |||
| ¨ | Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) | |||
| ¨ | Definitive Proxy Statement | |||
| x | Definitive Additional Materials | |||
| ¨ | Soliciting Material Pursuant to § 240.14a-12 | |||
| FOREST LABORATORIES, INC. | ||||
| (Name of Registrant as Specified in Its Charter) | ||||
| (Name of person(s) filing proxy statement, if other than the registrant) | ||||
| Payment of Filing Fee (Check the appropriate box): | ||||
| x | No fee required. | |||
| ¨ | Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. | |||
| (1) | Title of each class of securities to which transaction applies:
| |||
|
| ||||
| (2) | Aggregate number of securities to which transaction applies:
| |||
|
| ||||
| (3) | Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined):
| |||
|
| ||||
| (4) | Proposed maximum aggregate value of transaction:
| |||
|
| ||||
| (5) | Total fee paid: | |||
|
| ||||
| ¨ | Fee paid previously with preliminary materials. | |||
| ¨ | Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. | |||
| (1) | Amount Previously Paid:
| |||
|
| ||||
| (2) | Form, Schedule or Registration Statement No.:
| |||
|
| ||||
| (3) | Filing Party:
| |||
|
| ||||
| (4) | Date Filed:
| |||
|
| ||||
| Building the Future A Focus on Our Products & Therapeutic Categories Forest Laboratories, Inc. |
| Francis I. Perier, Jr. Executive Vice President, Finance & Administration and Chief Financial Officer Forest Laboratories, Inc. |
| 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. |
| Building the Future A Focus on Our Products & Therapeutic Categories Forest Laboratories, Inc. |
| Howard Solomon Chairman and Chief Executive Officer Forest Laboratories, Inc. |
| Building the Future A Focus on Our Products & Therapeutic Categories Forest Laboratories, Inc. |
| Marco Taglietti, MD President and Chief Medical Officer, Forest Research Institute, Inc. Senior Vice President, Research & Development, Forest Laboratories, Inc. |
| Sustainable Growth Beyond 2012 Forest Laboratories, Inc. |
| 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! |
| 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! |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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)
| 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 |
| 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 |
| Sustainable Growth Beyond 2012 Forest Laboratories, Inc. |
| Building the Future A Focus on Our Products & Therapeutic Categories Forest Laboratories, Inc. |
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
- 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
- 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 Prevention’s 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. |
| Forest Objective |
||
| Forest Laboratories, Inc. |
| 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 |
| 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 |
| Expansion outside the United States |
| Forest Business Development |
||||||||||
| Opportunistic |
|
Targeted |
| |||||||
| Engineered |
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 Forest’s 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 CY’13 NDS for Viibryd and linaclotide to be filed later this year, and NDS for levomilnacipran and cariprazine to be filed during CY’13 |
| 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 CY’13; 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.
|
Forest’s 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
Forest’s Advantage: Field Force Strength
RANKED 1st on Selling Power magazine’s
“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: SDI’s 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 SDI’s 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 3–10 PCP’s
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 3–10) 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. |
| Forest’s 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 TRx’s % 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 (Alzheimer’s 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 physician’s 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 Public’s Touchpoint Solutions and Sermo |
| Forest’s 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 Alzheimer’s 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 |
| Forest’s 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
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 8 |
|
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 30–40% 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
Building the Future
A Focus on Our Products
&Therapeutic Categories
Forest Laboratories, Inc.