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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934


Date of report (Date of earliest event reported): March 8, 2011


DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)


Delaware
001-16133
06-1245881
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification Number)


810 Seventh Avenue, Suite 3505, New York, New York, 10019
(Address of principal executive offices, including zip code)

(212) 489-2100
(Registrant’s telephone number, including area code)

NONE
(Former name or former address, if changed since last report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 
 
 

 
Item 7.01. Regulation FD Disclosure.
 
A copy of Delcath Systems, Inc.’s updated investor presentation slides that the Company intends to use effective immediately is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.
 
The information disclosed under this Item 7.01, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.
 

 
 
 

 
Item 9.01.  Financial Statements and Exhibits.
 
The following exhibit is filed herewith:
 
(d) Exhibits.
 
Exhibit No.
  
Description
99.1
  
Delcath Systems, Inc. Investor Presentation Slides
 

 
 
 

 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 

 
DELCATH SYSTEMS, INC.
   
Dated: March 8, 2011
By:
/s/ Peter Graham
   
Name:
Peter Graham
   
Title:
Executive Vice President,
     
General Counsel



 
 
 

 
EXHIBIT INDEX
 
Exhibit No.
  
Description
99.1
  
Delcath Systems, Inc. Investor Presentation Slides
ex99-1.htm
 
Exhibit 99.1
 
 
Investor Presentation
March 2011
NASDAQ: DCTH
Concentrating the Power of Chemotherapy TM
 
 
 
 
 
 
 
 
2
Forward-looking Statements
This presentation contains forward-looking statements, within the meaning of federal
securities laws, related to future events and future financial performance which include
statements about our expectations, beliefs, plans, objectives, intentions, goals, strategies,
assumptions and other statements that are not historical facts. Forward-looking
statements are subject to known and unknown risks and uncertainties and are based on
potentially inaccurate assumptions, which could cause actual results to differ materially
from expected results, performance or achievements expressed or implied by statements
made herein. Our actual results could differ materially from those anticipated in forward-
looking statements for many reasons, including; our ability to address the issues raised in
the FDA’s refusal to file letter and re-submit our New Drug Application (NDA) by the end of
our third quarter; acceptance of our NDA by the FDA and approval thereof; acceptance of
our CE Mark Technical File by our Notified Body and approval thereof; our ability to
successfully commercialize the Delcath Chemosaturation System in the United States,
EEA and other foreign markets and any corresponding revenue; our ability to enter into
distribution and strategic alliances in the US and foreign markets and any corresponding
revenue; actions of regulatory authorities; our ability to obtain reimbursement coverage
for the Chemosaturation System; the progress of our research and development programs
and future clinical trials; approval of the current or future chemosaturation system for
other indications; overall economic conditions; the availability of capital; and other factors
described in the section entitled ‘‘Risk Factors’’ in our most recent Annual Report on Form
10-K and the Quarterly Reports on Form 10-Q that we file with the Securities and Exchange
Commission.
 
 
 
3
Company Highlights
§ Focused on making established chemotherapeutic drugs work better in target organs
§ Chemosaturation delivers ultra-high dose chemotherapy to the liver
§ Successful Phase III trial results reported
§ Filed CE Mark for Class III medical device, potential approval in mid-2011
§ Positioned to address potential $3.0 billion European labeled market opportunity
§ Expect to re-file 505(b)(2) NDA to FDA for orphan drug and delivery apparatus by end
 of September 2011
§ Potential $675 million US labeled market opportunity
§ Issued patents and orphan drug designations create competitive barriers
§ Deep and experienced management team
Concentrating the Power of Chemotherapy
 
 
 
4
• Seeking initial indication for
 Melanoma liver mets in USA
• Seeking general device
 indication in EU for delivery
 of melphalan to the liver
 permits physician use on a
 broad range of liver cancers
• Asia potentially requires long
 term clinical development
 pathway
• Australia- Niche opportunity
 (high melanoma incidence) -
 device approval following EU
 CE Mark
• Significant potential label
 expansion opportunity
Transparent Areas
Represent Potential
Additional Indications
13,505**
101,563
355,712
*TPM Total Potential Market
**TPM for potential U.S. labeled indications only
Potential $3.75 Billion Labeled Market Opportunity*
 
 
 
5
Spectrum of Liver Cancer Treatments
Existing Treatments Involve Significant Limitations
Type of Treatment
 
Advantages
 
Disadvantages
 
Systemic
 
ü
 
Non
-
invasive
 
ü
 
Repeatable
 
-
 
Systemic toxicities
 
-
 
Limited efficacy in liver
 
Regional
 
(
e.g.
,
 
IHP)
 
ü
 
Therapeutic effect
 
ü
 
Targeted
 
-
 
Invasive/limited repeatability
 
-
 
Multiple treatments are
required
 
Focal
 
ü
 
Isolated
removal of tumor
 
-
 
90% unresectable
 
-
 
Invasive and/or limited
repeatability
 
 
 
 
6
Advantages of
 Chemosaturation
§ ISOLATION
 § Treats entire liver
§ SATURATION
 § Allows for ~ 100x
 effective dose
 escalation of drug
 agents at tumor site
§ FILTRATION
 § Controls systemic
 toxicities
The Delcath Chemosaturation System
Note: Image not to scale.
Converts Traumatic Open Surgery to Minimally Invasive, Repeatable Procedure
 
 
 
7
Melphalan Dosing & Background
§ Well understood, dose dependant, tumor preferential, alkylating cytotoxic agent that
 demonstrates no hepatic toxicity
§ Manageable systemic toxicities associated with Neutropenia and Cytopenia
§ Drug dosing over 10x higher than FDA-approved dose via systemic IV chemotherapy
§ Dose delivered to tumor is approximately 100x higher than that of systemic IV
 chemotherapy
A Promising Drug For Liver Cancer Therapy
Type
 
Dosing (mg/kg)
 
Multiple Myeloma (label)
 
0.25
 
Chemoembolization
 
0.6
2
 
Surgical Isolated Hepatic Perfusion (IHP)
 
1.5
0
 
Myeloablation
 
2.50
-
3.50
 
Chemosaturation
 
  (PHP)
 
3.00
 
 
 
 
8
What Chemosaturation Offers
Attractive Clinical and Economic Proposition For Patient and Providers
Patients:
 § Significant improvement in disease control in the liver compared to standard
 of care in patients with unresectable hepatic melanoma mets
 § Manageable systemic toxicities
 §Time, so that primary cancers can continue to be treated
Physicians:
 § Novel, targeted liver directed treatment to complement other cancer
 therapies
 § Repeatable, percutaneous procedure
 § Ability to treat the entire liver, including both visible and micro tumors
 § Ability to continue treating patients for extra-hepatic disease
 
 
 
 
 
9
Interventional
Radiologist
Current Patient Referral Path
Patient
Primary
Care
Medical
Oncologist
Offers systemic therapy to
treat Cancer
Surgical
Oncologist
Offers resection or other focal
therapy to treat cancer in Liver
Transferred for
chemosaturation
Diagnosis of
Cancer
Identification of liver
involvement
with no improvement
from systemic
therapy
When liver disease is
controlled, patients return to
the Medical Oncologist for
additional systemic therapy
 
 
 
 
10
Future Patient Referral Path
Interventional
Radiologist
Offers Chemosaturation
therapy
Patient
Primary
Care
Surgical
Oncologist
Diagnosis of
Cancer
Resection
Medical
Oncologist
Offers systemic therapy to
treat cancer
Identification of liver
involvement
with no improvement
from systemic
therapy
When liver disease is
controlled, patients return to
the Medical Oncologist for
additional systemic therapy
 
 
 
 
11
Summary of Phase III Results
§ Primary endpoint exceeded
§ Secondary endpoints support results
§ OS cohort analysis favorable
§ Safety profile - expected and consistent with
 currently approved labeling for melphalan
Trial Outcomes Favorable and Consistent with Special Protocol Assessment
 
 
 
 
12
Phase III Clinical Trial Design
Randomized to CS
92 patients: ocular
or cutaneous melanoma
CS/Melphalan
Treat every 4 weeks x 4 rounds
(responders can receive up to 6 rounds)
Cross-over
 Primary Trial Endpoint
 § Statistically significant difference in Hepatic
 Progression Free Survival (“hPFS”): p < 0.05
 § Over 80% of Oncologic drugs approved by FDA
 between 2005 - 2007 on endpoints other than
 overall survival
Modeled hPFS for Trial Success:
7.73 months (CS)
vs.
4 months (BAC)
Secondary Trial Endpoints
§ Hepatic response and duration of hepatic response
§ Overall response and duration of overall response
§ Overall Survival - Diluted by Cross Over
§ SAP calls for analysis of various patient cohorts
Fully Powered, 93 Patient, Randomized, Multi-Center NCI Led Study
Pre-CS (Baseline)
Post-CS (22+ Months)
Hepatic Response - Metastatic Melanoma
 
 
 
13
ASCO Presentation of Phase III Clinical Trial Results
§ Trial results exceed primary endpoint expectations; p value = 0.001
§ Treatment arm shows 5x median hPFS compared to control arm
§ CS/PHP median hPFS of 245 days compared to 49 days for BAC
§ Hazard Ratio = .301
§ Patients failed prior therapies (radiation, chemo, immuno, image guided local)
§ 90% Ocular, 10% Cutaneous - No difference in response
§ Overall PFS 186 vs. 46 days for BAC
§ 34% response rate for CS/PHP compared to 2% for BAC
§ 52% stable disease for CS/PHP compared to 27% for BAC
§ 86% overall clinical benefit (CR + PR + SD)
Strong Clinical Trial Results
 
 
 
14
ASCO Presentation of Phase III Clinical Trial (cont.)
§ Majority of BAC patients crossed over and obtained similar response from treatment
§ Total 93 patient trial - 10 months median OS vs. 4 months expected 1 (due to cross over provision, most
 patients received PHP/CS treatment)
§ OS cohort analysis - all positive trends
 a) Median survival of 298 days for treatment arm compared to 124 in non-crossover BAC patients
 b) Median survival of 398 days for BAC Cross Over patients vs. 124 non-cross over BAC patients
§ OS Secondary endpoint - No difference in Kaplan-Meier curves(due to cross over treatment response)
§ Safety profile as expected - in line with current FDA approved labeling for IV administration of Melphalan
 and Phase I CS/PHP study results
 § Treatment related Deaths: 3/40 patients (7.5%) 3/116 procedures (2.6%)
 § Neutropenic Sepsis (n=2) 5%, Hepatic Failure (n=1) 2.5% (95% tumor burden)
 § Current approved labeling for Melphalan - 3% to 10% mortality rate.
Encouraging Survival Data With Expected Safety Profile
1 Source: Unger et. al. Cancer 2001;91: 1148
 
 
 
15
Phase I/II NCI Trials – Neuroendocrine
Neuroendocrine Tumor Trial Results (n=23)*
Promising Initial Response Rate in Attractive Market
Pre-CS
(Baseline)
Post-CS #2
(+4 Months)
Post-CS #1
(+6 Weeks)
*Presentation at American Hepato-Pancreo-Biliary Association 2008 annual meeting
Number (n)
Primary Tumor Histology
Carcinoid
3
Pancreatic Islet Cell
17
Response
Not Evaluable (Toxicity, Incomplete Treatment)
Orthopic Liver Transplantation
4
Progressive Disease
1
Minor Response / Stable Disease
3
Partial Response (30.0%-99.0% Tumor Reduction)
13
Complete Response (No Evidence of Disease)
2
Objective Tumor Response
15
Objective Tumor Response Rate
79%
Duration (months)
Median Hepatic PFS
39
Overall Survival After CS
40
 
 
 
16
Regulatory Status
Europe:
§ Submitted technical file for CE Mark as Class III medical device on December 6, 2010
§ ISO 13485 certification for manufacturing facility received February 17, 2011
§ Goal remains to receive CE Mark approval by mid-2011
United States:
§ Submitted 505(b)(2) NDA to FDA on December 22, 2010
§ Refusal to file (RTF) letter received February 18, 2011
 § Manufacturing plant inspection timing
 § Product and sterilization validation
 § Additional safety data
 § Additional statistical analysis clarification
§ Currently assembling the requested information
§ Will meet with FDA to clarify our understanding of requirements to move forward
§ Current expectation is to resubmit NDA by end of September 2011
Europe Appears on Track While U.S. is Delayed by 6-9 Months
 
 
 
17
Product Development Pipeline
Robust Development Program Planned
• Melanoma liver mets
• Proprietary drug-melphalan &
apparatus
• All liver cancers - melphalan
• Class III device
• 3rd party melphalan
• Additional drugs
• Other organs
• Broaden label
• Other liver cancers - melphalan
• Apparatus improvements
Initial Opportunity
Near Term (< 5 years)
Intermediate Term (> 5 years)
• Primary liver cancer (HCC)
• Drug-melphalan & apparatus
• Proprietary melphalan drug
approval
• Apparatus improvements
• Additional drugs
• Other organs
• Broaden label
• Other liver cancers - melphalan
• Additional drugs
• Other organs
 
 
 
18
• US - largest opportunity for Melanoma
• China - largest opportunity for HCC
• CRC - largest opportunity worldwide
Market Opportunity* by Disease (patients)
*TPM Total Potential Market
 
 
 
19
§ CE Mark approval covers European Economic Area (EEA)
§ EEA includes 32 countries
§ 14 countries currently have Melphalan for injection
 commercially available
 § Belgium (BE), Czech Republic (CZ), Germany (DE), Estonia (EE), Spain (ES), France (FR),
 Ireland (IE), Italy (IT), Lithuania (LT), Luxembourg (LU), Netherlands (NL), Sweden (SE), Slovakia
 (SK), United Kingdom (UK).
§ 6 initial target countries (DE, UK, FR, IT, SP, NL) represent
 85%-90% of total potential market
Large European Market Opportunity Concentrated in Six Countries
EU – Landscape
 
 
 
20
Germany
(Direct)
UK
(Direct)
France
(Indirect)
Italy
(Indirect)
Spain
(Indirect)
Netherlands
(Direct)
Total Potential
(patients)
Potential Market
($ millions)1,2,3
Total Potential Market #Patients
Ocular Melanoma
403
296
294
284
197
79
1,553
$46.6
Cutaneous Melanoma
2,834
1,735
1,314
1,398
628
662
8.571
$257.1
CRC
18,978
10,155
10,490
13,952
7,694
3,151
64,420
$1,932.6
HCC (Primary)
3,941
1,734
3,645
6,253
2,616
197
18,386
$551.6
NET
2,168
1,624
1,645
1,579
1,185
438
8,639
$259.2
TOTAL
25,087
13,513
15,780
21,784
11,495
3,786
91,445
$3,047.1
Europe is Potential $3.0 Billion Market Opportunity for Device Only
1. Assumes 2.5 treatments per patient
2. Assumes ASP of $12K (device only)
3. Assumes mix of direct sales and distributors
Market by Disease – EU Device Only
Initial Target Markets (DE, UK, FR, IT, SP, NL)
 
 
 
 
21
Germany
(Direct)
UK
(Direct)
France
(Indirect)
Italy
(Indirect)
Spain
(Indirect)
Netherlands
(Direct)
Total Potential
(patients)
Potential Market
($ millions)1,2,3
Total Potential Market #Patients
Ocular Melanoma
403
296
294
284
197
79
1,553
$62.1
Cutaneous Melanoma
2,834
1,735
1,314
1,398
628
662
8.571
$342.8
CRC
18,978
10,155
10,490
13,952
7,694
3,151
64,420
$2,576.8
HCC (Primary)
3,941
1,734
3,645
6,253
2,616
197
18,386
$735.5
NET
2,168
1,624
1,645
1,579
1,185
438
8,639
$345.6
TOTAL
25,087
13,513
15,780
21,784
11,495
3,786
91,445
$4,062.8
1. Assumes 2.5 treatments per patient
2. Assumes ASP of $16K, when Delcath branded melphalan is available
3. Assumes mix of direct sales and distributors
Europe Represents Potential $4.1 Billion Market Opportunity for Drug & Device
Market by Disease - EU Including Drug
Initial Target Markets (DE, UK, FR, IT, SP, NL)
 
 
 
 
22
Liver Metastasis
Potential Market
# Patients
Potential Market
# Procedures
(Avg 2.5/patient)
Potential Market ($MM)
$20K ASP **
Ocular
Melanoma

1,622

4,055
$81.1
Cutaneous
Melanoma

11,883

29,708
$594.2
TOTAL MELANOMA
(Initial Expected Label)

13,505

33,763
$675.3
CRC

38,423

96,057
$1,921.1
HCC (Primary)

12,386

30,964
$619.3

9,986

24,965
$499.3
TOTAL OTHER
(Potential Label Expansion)

60,794

151,985
$3,039.7
*TPM Total Potential Market
** Estimated ASP
Market by Disease - USA
 
 
 
23
China
(Drug)
S. Korea
(Drug)
Japan
(Device)
Taiwan
(Drug)
Australia
(Device)
Total Potential
(patients)
Potential Market
1,2,3,4
Total Potential Market # Patients
HCC (Primary)
197,082
7,486
7,625
4,945
604
217,742
$4,899.2
CRC
59,644
6,219
27,396
2,762
3,891
99,912
$2,248.0
NET
35,503
1,275
3,355
608
562
41,303
$929.3
Ocular Melanoma
1,760
66
175
31
96
2,128
$47.9
Cutaneous
Melanoma
667
74
238
429
1,996
3,404
$76.6
OTHER TOTAL
292,229
14,980
38,376
8,315
5,057
358,957
$8,201.0
1. Assumes 2.5 treatments per patient
2. Assumes ASP of $9K
3. Assumes mix of systems with and without Delcath branded melphalan
4. Assumes sales by distributors
Asia Represents Potential $8.2 Billion Market Opportunity
Market by Disease – Asia
Initial Target Markets (China, Japan, S. Korea, Taiwan, Australia)
 
 
 
24
Reimbursement Strategy
Reimbursement is a Multi-Faceted Work in Progress
United States:
 § Have retained leading reimbursement experts
 § Seek chemosaturation specific codes:
 Physician:
 § While undergoing FDA review, apply for CPT Category III code
 § Convert the Category III code to Category I following FDA approval
 Hospital:
 § Apply for new ICD-9/10 procedure code to capture full procedure of hepatic isolation and chemosaturation
 § Request new DRG based on costs above those of existing DRGs and clinical dissimilarity to other hepatic
 procedures in current DRGs
Europe:
 § Have retained leading reimbursement experts
 § No centralized EU reimbursement body
 § Nationalized healthcare systems in each geography dictate a country by country effort
 § Focused on highlighting clinical value proposition and demonstrating cost effectiveness
 
 
 
25
Three-Pronged Business Strategy
Commercialization
§ Gain regulatory approval
 § Goal: receive CE Mark approval for Class III medical device by mid-2011
 § Goal: re-file NDA by end of September 2011
 § Goal: receive FDA approval of NDA in 2012
 § Goal: receive EU approval for proprietary drug 2014
§ Direct and distribution partners OUS
§ Build out direct specialty sales force for U.S.
Pursue Asian Strategic Alliances
§ Chi-Fu Trading Company Ltd. signed 2/9/2010 for Taiwan
§ Proprietary drug and delivery apparatus approval for HCC
Establish U.S. and EU Pharma Alliances
§ Co-develop and fund additional indications for Delcath Chemosaturation System
Combination of Direct Sales Model, Partnerships & Distributors
 
 
 
26
2011 European Commercialization
§ Initially target 6 markets accounting for 85%-90% of patients
 § 7 Direct sales territories initially to cover UK, Germany, Netherlands (Sales and Medical
 Science Liaisons)
 § Distributors in Spain, Italy, & France
 § 5 Clinical Specialists to support site initiations and training
§ Establish EU Centers of Excellence and KOLs for training and support
§ Establish European website to facilitate patient education & awareness
§ Test market for 3-6 months to validate assumptions and finalize model
§ Full commercialization in late 2011
Direct Sales Model in Northern Europe & Distributors in Southern Europe
 
 
 
27
US Commercialization in 2012
§ Initial focus on top 50 cancer centers and referring community
 hospitals
§ 12 Sales & Medical Science Liaison territories ultimately
 expanding to as many as 60 territories as revenues ramp
§ 5 Clinical Specialists to support site initiation and training
§ Utilize top centers from Phase III trial as Centers of Excellence
 for training and support
Direct Sales Model in the United States Focused on Leading Cancer Centers
 
 
 
28
Intellectual Property
Patent Protection
§ 7 issued U.S. patents, 10 foreign patents issued and 4 pending
§ Primary device patent set to expire August 2016
§ Post FDA approval up to 5 years of patent extension possible
FDA Protection
§ Orphan Drug Designation granted for melphalan in the treatment of ocular
 melanoma, cutaneous melanoma and metastatic neuroendocrine tumors, as well as
 for doxorubicin in the treatment of HCC
§ Additional Orphan Drug applications to be filed for other drugs and indications,
 including HCC and CRC
Multiple Levels of Protection
 
 
 
29
Significant Combination Product Approval and Commercialization Experience
Deep and Experienced Management Team
 
Executive
Title
Prior Affiliation(s)
Years of
Experience
Eamonn Hobbs
President and CEO
AngioDynamics, E-Z-EM
30
David McDonald
CFO
AngioDynamics, RBC Capital Markets
28
Krishna Kandarpa, M.D., Ph.D.
CMO and EVP, R&D
Harvard, MIT, Cornell, UMass
37
Agustin Gago
EVP, Global Sales &
Marketing
AngioDynamics, E-Z-EM
29
Peter Graham, J.D.
EVP & General Counsel
Bracco, E-Z-EM
16
John Purpura
EVP, Regulatory Affairs &
Quality Assurance
E-Z-EM, Sanofi-Aventis
27
Bill Appling
SVP Operations & Medical
Device R&D
AngioDynamics
25
Bernie Tyrrell
SVP N. American Sales &
Marketing
Epicept, Otsuka, Asta Zeneca
Johnson & Johnson, Eli Lilly
33
Dan Johnston, Ph.D.
VP, Pharma R&D
Pfizer, Wyeth
10
 
 
 
30
Financials

 
 
 
31
Financial Summary
Financial & Operating Overview
§ Follow On Offerings: Raised ~ $70 million since November 2009
§ Burn Rate: Approximately $2.2 million per month
§ Cash: ~ $47 million at December 31, 2010
§ Debt: None
§ Shares Out: 43.0 million (49.3 million fully diluted*)
§ Institutional Ownership: ~ 23% at December 31, 2010
§ Market Capitalization: ~ $281 million as of February 28, 2011
§ Avg. Daily Volume (3 mos) ~ 1.05 million
*  As of February 28, 2011 fully diluted includes an additional 3.7 million options at $4.91, 2.5 million warrants at $3.51, and 67,590 unvested restricted shares.
Capital Structure Strengthened Significantly in 2010
 
 
 
32
Company Highlights
§ Focused on making established chemotherapeutic drugs work better in target organs
§ Chemosaturation delivers ultra-high dose chemotherapy to the liver
§ Successful Phase III trial results reported
§ Filed CE Mark for Class III medical device, potential approval in mid-2011
§ Positioned to address potential $3.0 billion European labeled market opportunity
§ Expect to re-file 505(b)(2) NDA to FDA for orphan drug and delivery apparatus by end
 of September 2011
§ Potential $675 million US labeled market opportunity
§ Issued patents and orphan drug designations create competitive barriers
§ Deep and experienced management team
Concentrating the Power of Chemotherapy
 
 
 
33
Appendix I. – Delcath Sources for Market Estimates
American Cancer Society. Cancer Facts & Figures 2010. Atlanta: American Cancer Society; 2010.
 
Alexander, Richard H., David L. Bartlett, and Steven K. Libutti. "Current Status of Isolated Hepatic Perfusion With or Without Tumor
Necrosis Factor for the Treatment of Unresectable Cancers Confined to the Liver." The Oncologist 5 (2000): 416-24.
 
Blake, Simon P., Karen Weisinger, Michael B. Atkins, and Vassilios Raptopoulos. "Liver Metastases from Melanoma: Detection with
Multiphasic Contrast Enhanced CT." Radiology 213 (1999): 92-96. Print
Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM.
GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet].
Lyon, France: International Agency for Research on Cancer; 2010. Available from: http://globocan.iarc.fr
 
Nawaz Khan, Ali, Sumaira MacDonald, Ajay Pankhania and David Sherlock. "Liver, Metastases: [Print] - EMedicine Radiology."
Liver, Metastases. EMedicine - Medical Reference, 10 Feb. 2009. Web. <http://emedicine.medscape.com/article/369936-print>.
 
Neuroendocrine Tumors. Practice Guidelines in Oncology- v.2.2009. National Comprehensive Cancer Network (NCCN). 2009.
 
Pawlik, Timothy M., Daria Zorzi, Eddie K. Abdalla, Bryan M. Clary, Jeffrey E. Gershenwald, Merrick I. Ross, Thomas A. Aloia,
Steven A. Curley, Luis H. Camacho, Lorenzo Capussotti, Dominique Elias, and Jean-Nicolas Vauthey. "Hepatic Resection for
Metastatic Melanoma: Distinct Patterns of Recurrence and Prognosis for Ocular Versus Cutaneous Disease." Annals of Surgical
Oncology 13.5 (2006): 712-20.