Download January 13, 2016 Presentation to the J.P. Morgan Healthcare

Presentation to the J.P. Morgan Healthcare Conference
January 13, 2016
January 13, 2016
Forward-Looking Statements
Some of the statements in this presentation constitute forward-looking statements. Forward-looking statements relate to
expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions
concerning matters that are not historical facts. The forward looking statements contained in this presentation involve risks
and uncertainties as well as statements as to:
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availability of investment opportunities;
changes in our business strategy;
our ability to consummate an appropriate investment opportunity within given time constraints; availability of qualified
personnel;
changes in our industry, interest rates, the debt securities markets or the general economy;
changes in governmental regulations, tax rates and similar matters;
changes in generally accepted accounting principles by standard-setting bodies; and
the degree and nature of our competition.
The forward-looking statements are based on our beliefs, assumptions and expectations of our future performance, taking
into account all information currently available to us. These beliefs, assumptions and expectations can change as a result of
many possible events or factors, not all of which are known to us or are within our control. If a change occurs, our business,
financial condition, liquidity and results of operations may vary materially from those expressed in our forward-looking
statements.
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Braeburn Value Proposition
A pill-free pharma company delivering precision medicine in neuroscience
Braeburn’s novel, long-acting implants and injectables improve public health and social cost outcomes
associated with drug diversion, misuse and non-compliance
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Guaranteeing length of therapy improves both outcomes
Eight programs in three related multi-billion dollar markets
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Opioid Addiction (buprenorphine)
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Pain (buprenorphine)
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Schizophrenia (risperidone, ATI-9242)
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7 out of 8 programs are 505(b)2 programs, with potentially lower cost and regulatory risk
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First Approval: 1Q’16; at least one product launch each year thru 2019
All products are focused around neuropsychiatric indications where team expertise is strong and unmet
clinical need is high.
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Management Team
Behshad Sheldon
President & CEO
Marshall Woodworth
CFO
Frank Young, MD, PhD
EVP, Medical and Regulatory
Sonnie Kim, PharmD
VP, Clinical and Medical Affairs
Craig Brown
VP, Commercial, Project
Management & Manufacturing
Enrique Arvelo
VP, Business Analytics
Jonathan Young, JD, PhD
General Counsel & VP,
Policy/Advocacy
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 Otsuka Pharmaceuticals, SVP Global Commercial Lead and Board Member of R&D company
• Launched and led development and commercialization efforts for Abilify® for 12 years
• Otsuka/Lundbeck landmark $10B CNS deal
 Bristol-Myers Squibb / Smithkline Beecham
• Plavix®, Glucophage®, Abilify® , Bactroban
 Aerocrine AB, CFO
 Furiex Pharmaceuticals, CFO
 Xerium Technologies / Milliken and Company / Monsanto / Dow Chemical / Eli Lilly
 U.S. Food & Drug Administration, Commissioner
 Essex Woodlands, Partner
 University of Rochester, Dean of Medical School; VP, Health Affairs; Chairman Dpt. of Microbiology
• Authored over 200 scientific articles in the fields of biotechnology and microbiology
 Otsuka Pharmaceuticals. Director, Medical Affairs/Hospital Medicine
 University of Maryland Medical System. Director, Pain Clinic
 Columbia Medcom Group, Inc. VP and board member
 Otsuka Pharmaceuticals, Sr. Director, Marketing – Abilify, Brexpiprazole
 Bristol-Myers Squibb, Associate Director – Stadol NS (pain)
 Westwood Squibb – Dermatology
 Otsuka Pharmaceuticals, Sr. Director, Global Commercialization and Portfolio Management
 Bristol-Myers Squibb, Associate Director
 Procter & Gamble, Group Manager
 FoxKiser, Partner and General Counsel
 National Council on Disability, Chairman
 The Clinton White House, Executive Office of the President, Assoc. Dir. Disability Policy
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Markets Summary
Today’s
Patients
Opioid Use Disorder
Chronic Pain
Dependent
N~5M
~45M Full
Agonist
Schizophrenia
1%
Population
Diagnosed
N~2.4M
Treated
N~1,100K
Buprenorphine
N~750K
~1M Methadone
~750K
Buprenorphine
~15% on
Long Acting Formulations
Growth
Drivers
• Opioid Use Disorder (OUD) is a rising national epidemic
• Significant off-label use of buprenorphine for pain
– Less than 1 in 5 opioid dependent patients treated
• Heightened awareness of buprenorphine as an accepted
treatment modality for pain will drive physicians and
• Buprenorphine treatment is becoming the standard of care
patients towards on-label use
• Patient share is increasing relative to methadone
• Long term formulations are increasingly preferred in other
therapeutic areas – pain to follow this trend
• Long acting formulations are poised to become
the gold standard treatment for Schizophrenia
• 4 companies are currently promoting long
acting formulations
• Patient demographics suit long acting solutions
• Growing sentiment that full agonist are overprescribed and
alternatives are needed
Future
Patients
(10yrs+)
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• >1.5 Million patients on buprenorphine
• Approx. 1.5 Million patients on buprenophine
• Patient penetration of long acting formulations over 20%
• Patient penetration of long acting formulations over 20%
• Approx. 2.4 Million patients on
schizophrenia therapies
• Patient penetration long acting formulations
over 25%
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Braeburn Product Launch Trajectory
2016E
2017E
2018E
2019E
Addiction Franchise
Probuphine
6 Months Buprenorphine Implant
Launch: Q1 2016
Camurus Monthly / Weekly
Buprenorphine Injectable
Launch: Q4 2017
Peak Sales: $250-300M
Peak Sales: $550-$650M
Pain Franchise
Camurus Monthly / Weekly
Buprenorphine Injectable
Launch: Q1 2018
Peak Sales: $400-$500M
Probuphine
6 Months Buprenorphine Implant
Launch: Q3 2018
Peak Sales: $200-$250M
Anti-Psychotic Franchise
2nd
Launch
1st
Launch
Total
Cumulative
Assets:
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Risperidone
Risperdal Implant
Launch: Q2 2018
ATI – 9242
Novel, Atypical Anti-Psychotic
Launch: 2019
Peak Sales: $275-$325M
Peak Sales: $300-$350M
3rd
Launch
7
4th
Launch
8
3
1
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Competitive Pipeline
Only addiction LAI on market
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Long Term Formulation Competitive Matrix
Depot Injection
Implant
(1 week, 4 weeks / Est. Launch 2H‘17)
(4 weeks / Est. Launch ‘17)
Addiction
(6 Months / Est. Launch Q1 ‘16)
(4 weeks / Est. Launch ‘18)
(4 weeks / Pre-Clin.)
(1 week, 4 weeks / Est. Launch Q1 ‘18)
(6 Months / Est. Launch Q3 ‘18)
Pain
(4 weeks / Pre-Clin.)
Schizophrenia
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(15 Days, 1Mos., 3Mos.
/ Approved)
(6 Months / Est. Launch Q2 ‘18)
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2. Addiction Market and Franchise
Opioid Addiction Market
CDC Has Declared an Opioid Epidemic in the US
• 2.4 million patients in the US with Opioid Use Disorder (heroin and illicit Rx-opioid use)
• ~$2B buprenorphine oral daily market, treating ~30% of diagnosed opioid addicted
patients1
– Suboxone® Peak Sales: $1.5B in 2012, $1.4B in 2014 2
– Suboxone® Sublingual film maintains ~70% market share despite 4 generic
tablets and two new entrants1
– New entrants Orexo/BDSI limited to daily sublingual/buccal patch 4% share2
– Relief, but with inconvenience, potential for diversion, abuse, and accidental
pediatric exposure
• Methadone Clinics
– ~330,000 patients
– “Liquid Handcuffs”
– Fogginess
• Vivitrol
– 2015 sales projected ~$200M, past 3 years growth rate >30%
– High drop out rates
– Only non opioid medical assistance treatment
• Rehab/12-step programs – Promoting abstinence
– $30-40k per month
– High relapse rates and mortality post-treatment
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2
IMS National Sales Perspective. Dollars MAT March 2015
IMS National Sales Perspective. Dollars Calendar 2014
Buprenorphine Expansion Opportunity
Buprenorphine treated patients expected to grow to ~1.6MM
by 2025
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Growing Buprenorphine patient share versus Methadone
– Less than 1 in 5 opioid dependent patients are treated
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Increasing treated population
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Opioid Use Disorders population growth
Widespread opioid use – lack of alternatives
Poor treatment compliance, complex patient population
and limited access to prescribing physicians
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Source: 1) National Institute on Drug Abuse (NIDA), 2) NSDUH , NIDA website, 3) 2013 National Survey on Drug Us and Health,
US Dept of Health and Human Services, 4) Company estimates using IMS Trx and chart audits data
Treated with Opioids for
Pain1
N=>48M
Develop Dependence2
N=5M
Diagnosed Dependence3
N= 2.4M
Treated
N=~1,100K
Treated with
buprenorphine4
N= ~750K
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US Buprenorphine Oral Market Continues to Grow
+12%
TRx MM
12
+58%
8
+19%
+16%
+13%
4
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10.8 million TRx in 2014
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TRx continued double-digit growth
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Market grew 2.7x in the past 5 years
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Very concentrated market, with >85% of
Rx’s from 5000 prescribers
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$1.9 Billion in sales in 2014
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The market continues to grow despite 4
generic competitors
0
2009
2010
2011
2012
2013
2014
$2,000
US$ MM
$1,500
$1,000
$500
$
2009
2010
2011
Indivior (formerly Reckitt Benckiser)
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Source: TRx IMS NPA; Sales IMS NSP
2012
2013
2014
All Others
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Treatment of Opioid Dependence
Braeburn intends to shift the treatment paradigm by replacing daily sublingual
products with a suite of complementary long-acting medications for patients at all
stages of recovery:
Early Stage Treatment
• Patients are required to make at least weekly visits
• Trust required, as commonly seven days worth of drug given at one time
• Some patients need the structure of more regular visits longer-term
• Braeburn Solution: CAM2038 Weekly injection
Maintenance Treatment
• Patients “graduate” to less frequent, monthly visits as they make progress in
behavior modification
• Some patients have even less frequent access/need to see their clinician
• Braeburn Solutions : CAM2038 Monthly injection and Probuphine® sixmonth implant
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Benefits of Braeburn’s Addiction
Franchise
Patient Benefit
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Freedom from burdens of daily medication
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Flexible and personalized dosing
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Increased compliance- no ability to take “drug holiday” and get high
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No daily reminders of disease or reinforcement of drug-taking behavior
by taking daily buprenorphine
Clinician Benefit
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Assurance that dose given is dose taken
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Peace of mind regarding patients diverting medication
Public Health/Payer Benefit
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•
Helps improve issues with daily buprenorphine
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Diversion, abuse
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Accidental pediatric exposure
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“Pill mills”
7-12x ROI for treatment of opioid addiction
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2. Addiction Market and Franchise
a) Probuphine Six Months Implant
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Probuphine Six-Month Implant
Licensed from Titan Pharmaceuticals in December 2012
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Implant smaller than matchstick (~1 inch or <30mm)
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Administered as four subcutaneous implants in upper arm
Enrollment of 177 patients in 4 months far outpaced typical
enrollment schedule of 6-9 months
Offers sustained release of buprenorphine for six months
Phase III studies
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Two Phase III trials demonstrated statistically significant
separation from placebo in unstable patients, FDA CRL
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Third Phase III trial conducted following agreement with FDA
about studying Probuphine® in patients stabilized on lower
doses of sublingual buprenorphine: positive results released
June 2015
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Would be first marketed long-acting buprenorphine product
Anticipated approval: Q1’ 2016
1
1/15/2016
IMS National Sales Perspective. Dollars MAT March 2015
2 IMS National Sales Perspective. Dollars Calendar 2014
Braeburn reached agreement with FDA on study protocol (2014)
Braeburn has successfully executed on an aggressive trial
schedule and NDA submission
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May 15th 2014: Final FDA advice on proposed protocol
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July 17th 2014: First patient enrolled
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June 2015: Positive topline data released
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August 2015: NDA Submission
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CAM-2038 Weekly and Monthly Injections
Monthly and Weekly injection FluidCrystal® nanotechnology
formulation. North American rights licensed from Camurus AB in
November 2014
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Option for Asian markets
Formulation attributes:
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Fast onset and long-acting duration
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Ready-to use subcutaneous administration
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Small volume, low-viscosity, subcutaneous injection
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Pre-filled syringe with very small needle
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Good local tolerability
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No refrigeration needed
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Personalized therapy – different durations and multiple dose strengths
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Began enrollment in pivotal program in 4Q 2015
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The FDA has granted Fast Track status to these two formulations.
Expected approval: 4Q18
(both weekly and monthly injections)
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High Physician Interest in Long-Acting Products
Target Product Profile (“TPP”) shown to 150 buprenorphine prescribing physicians
Intent to Inject Once-monthly
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Intent to Implant Probuphine
Likelihood to Inject
% of Doctors
Patient Share
Likelihood to Implant
% of Doctors
Patient Share
Definitely Would
24%
57%
Definitely Would
11%
33%
Probably Would
27%
41%
Probably Would
24%
23%
Possibly Would
26%
28%
Possibly Would
36%
19%
Total
77%
32.1%
Total
71%
15.7%
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3. Pain
Significant Upside for Long-Acting Buprenorphine in Pain
Braeburn to pursue pain solutions using Probuphine and both the weekly and monthly CAM-2038 injectable
formulations
Large market opportunity: over 100 million people suffer from chronic pain (48+ million treated with opioids)
Buprenorphine has been shown to be effective in pain
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Buprenex, first ever buprenorphine approved product in 1981, is an injection for acute pain
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Butrans® (Purdue): 7-day buprenorphine patch approved for pain in 2010
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BEMA buprenorphine (BioDelivery/Endo): FDA approved 2015
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~50% of buprenorphine oral is being used off label to treat pain
Long-acting formulations of buprenorphine may benefit patients by:
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Limiting peaks and troughs of daily medications
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Breaking the cycle of pain and minimizing anticipatory worsening of pain
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Minimizes potential for pill-mills, diversion and abuse
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Simplifying drug regimen vs daily medication
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Buprenorphine – Mechanism of Action (Pain)
Buprenorphine may have additional mechanistic advantages vs full mu receptor agonists
(oxycodone, hydrocodone, morphine, etc.)
Mu
1/15/2016
Kappa
(analgesia, euphoria,
respiratory depression)
(dysphoria,
hyperalgesia,
antinorciceptive)
Delta
ORL1
(minor analgesia)
(spinal analgesia)
Buprenorphine
Partial agonist
Strong affinity
Antagonist
Strong affinity
Antagonist
Moderate affinity
Agonist
Morphine
Full agonist
Moderate affinity
Weak agonist
Very Low affinity
Weak agonist
Very low affinity
N/A
Naltrexone
Antagonist
Strong affinity
Antagonist
Moderate affinity
Antagonist
Very Low affinity
Antagonist
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Buprenorphine’s Potential
Advantages vs. Full Agonists
• Reduced hyperalgesia (higher opioid dose =
worsening of pain)
• Due to ceiling effect, virtually no potential for adults
to overdose on buprenorphine alone (unlike
OxyContin or Morphine)
• Potential for lower side effects (cognitive
dysfunction, constipation, etc.)
• Much lower risk of respiratory depression compared
to full mu agonists
• Potential anti-depressant effect due to Kappa
antagonist activity
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4. Schizophrenia
Schizophrenia
Huge Opportunity for LAIs
• 2.4 million adults with Schizophrenia
• $4-5B market opportunity in US only
• Latuda®, approved in 2010, reached >$1.0B in year
4 (fast uptake) depsite availability of 4 good generic
molecules
• Long-acting injectable (“LAI”) market reached $1.7B
in 2014
• 13% growth y-o-y for past two years, with
expected CAGR of 10-12% over next 5 years
• Currently ~18% patient share
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Risperidone six-month implant
• Risperdal well known and trusted product for schizophrenia
• 30% current patient share
• >$5B at peak (all indications)
• Key Opinion Leaders, patients and caregivers receptive to the concept of six-month implant
• Compliance is critical due to patient lack of insight
• “Game-changing”
• Long-acting risperidone family successfully penetrated oral market
• Consta (risperidone, every two weeks)/Sustenna paliperidone, (monthly) protected, priced at ~$1300 per
month, with sales of ~$1.4B
• J&J launched 3-month Sustenna in 2015
• Anticipated launch: 1H’18
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Novel, Atypical Antipsychotic
ATI-9242 is only non 505(b)2, however active IND and early
human dosing already available
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Designed to emulate best-in-class efficacy profile of
clozapine, while significantly limiting side effects
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Has performed well in industry validated animal models
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45 min half-life in humans, resolvable with long-acting
formulation
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Attractive deal economics, single digit royalties
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Significant market potential
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Other MedLaunch® Applications/Collaborations
• Tizanidine for MS spasticity targeted for Ph I/II in mid-2016
• Out-licensing discussions underway for anastrozole twelve-month implant for Breast Cancer with public largepharma company
• Research collaboration with large-pharma company around two NCEs
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