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               Pancreatic Cancer:
              Disease and Pipeline
                    Analysis




Info@ISRreports.com 		   ©2013 Industry Standard Research   www.ISRreports.com
act with confidence



Report Overview


T
       he pancreas is the 10th most common site of new cancers but is the 4th leading cause of cancer
       death, largely due the difficulties associated with diagnosing the disease in its early stages. As a
       consequence, over 80% of patients present with regional spread or distant disease at the time of
diagnosis (Stage III or Stage IV) and are unsuitable for surgical resection. Survival rates from the disease are
among the lowest for any type of cancer with a median survival time of 4-6 months from diagnosis, a 1-year
survival rate of 26% and a 5-year survival rate of only 6%. Following curative resection, median survival time
increases to between 12 and 19 months.

In a market with few available therapies that exhibit limited effectiveness and a disease class still classified as
“rare”, poor survival rates and lack of viable treatment options remain compelling reasons to develop new
“Orphan” therapies to address this large unmet need.




              67 pages
                                         38
                                      charts and graphs
                                                                               Q2
                                                                          2013 publication date



   What you will learn in this report:                          How you can use this report:
   •	   Information on over sixty potential new                 •	    Optimize your product’s global development
        therapies in active development                               and commercial strategies
   •	   Incidence rate of pancreatic cancer for each of         •	    Benchmark trial length and number of patients
        the major and emerging global markets                         (by Phase)
   •	   Drug approval dynamics by country                       •	    Identify drug candidates for partnering
                                                                      strategies
        •	   Trial and Recruitment environment
                                                                •	    Evaluate your pipeline against products
        •	   Regulatory environment
                                                                      currently in development
        •	   Competitive product landscape
                                                                •	    Identify the most effectives market entry
        •	   Pricing and reimbursement environment                    strategies




Major Sections                                                    Valuable for:
1.	 Pancreatic Cancer Overview                                    1.	 Brand Managers
2.	 Commercial Rationale                                          2.	 Medical Directors
3.	 Environmental Analysis                                        3.	 Portfolio Managers
4.	 Clinical Development Pipeline                                 4.	 Executive Suite
5.	 Clinical Trial Environment




                                         www.ISRreports.com ©2013 | Preview of: Pancreatic Cancer: Disease and Pipeline Analysis   2
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Table of Contents
  Full Table of Contents, list of figures, and list of tables, are available in the report preview, free on our website:


  http://www.isrreports.com/industry-reports/preview/pancreatic-cancer-disease-and-pipe-
  line-analysis




                                             www.ISRreports.com ©2013 | Preview of: Pancreatic Cancer: Disease and Pipeline Analysis   3
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Sample Page


                 act with confidence




                 Figure 2. Global Map of per Capita Adult Alcohol Consumption (Pure Alcohol, litres)




                                                                                 Source: World Health Organization [3]



                 The association between pancreatic cancer and diet, alcohol consumption and
                 smoking are discussed further in Chapter 3.



                                               Orphan Disease Status
                 Due to the relatively low number of people affected by pancreatic cancer it is classified
                 as an orphan or rare disease. This is defined in the US as a disease which affects fewer
                 than 200,000 individuals, in Japan as one which affects less than 50,000 people and in
                 the EU as affecting less than 1 in 2,000 individuals at any given time.
                 Orphan disease status can result in potential therapies for the treatment of pancreatic
                 cancer being eligible for Orphan Drug Designation. This designation allows the
                 developing company to receive tax breaks and market exclusivity on approval of the
                 therapy. In the US, under the terms of the Orphan Drug Act, the new therapy may
                 receive 7 years market exclusivity and is not subject to discounting under the new
                 healthcare law. In addition the therapy is not subject to prescription drug user fee act
                 (PDUFA) fees unless the application includes a non-orphan disease.
                 In addition to favourable market conditions, as the treatment options for the disease are
                 so limited, a single pivotal phase III trial is all that is usually required for the development
                 plan, thereby potentially significantly decreasing drug development costs.



                                                    www.ISRreports.com ©2013 | Pancreatic Cancer: Disease and Pipeline Analysis   17



                                         www.ISRreports.com ©2013 | Preview of: Pancreatic Cancer: Disease and Pipeline Analysis       4
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Ordering Information
  Ordering information and additional sample pages are available in the full preview, free on our website:


  http://www.isrreports.com/industry-reports/preview/pancreatic-cancer-disease-and-pipe-
  line-analysis




                                          www.ISRreports.com ©2013 | Preview of: Pancreatic Cancer: Disease and Pipeline Analysis   5

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Pancreatic Cancer: Disease and Pipeline Analysis

  • 1. I EW EV PR Pancreatic Cancer: Disease and Pipeline Analysis Info@ISRreports.com ©2013 Industry Standard Research www.ISRreports.com
  • 2. act with confidence Report Overview T he pancreas is the 10th most common site of new cancers but is the 4th leading cause of cancer death, largely due the difficulties associated with diagnosing the disease in its early stages. As a consequence, over 80% of patients present with regional spread or distant disease at the time of diagnosis (Stage III or Stage IV) and are unsuitable for surgical resection. Survival rates from the disease are among the lowest for any type of cancer with a median survival time of 4-6 months from diagnosis, a 1-year survival rate of 26% and a 5-year survival rate of only 6%. Following curative resection, median survival time increases to between 12 and 19 months. In a market with few available therapies that exhibit limited effectiveness and a disease class still classified as “rare”, poor survival rates and lack of viable treatment options remain compelling reasons to develop new “Orphan” therapies to address this large unmet need. 67 pages 38 charts and graphs Q2 2013 publication date What you will learn in this report: How you can use this report: • Information on over sixty potential new • Optimize your product’s global development therapies in active development and commercial strategies • Incidence rate of pancreatic cancer for each of • Benchmark trial length and number of patients the major and emerging global markets (by Phase) • Drug approval dynamics by country • Identify drug candidates for partnering strategies • Trial and Recruitment environment • Evaluate your pipeline against products • Regulatory environment currently in development • Competitive product landscape • Identify the most effectives market entry • Pricing and reimbursement environment strategies Major Sections Valuable for: 1. Pancreatic Cancer Overview 1. Brand Managers 2. Commercial Rationale 2. Medical Directors 3. Environmental Analysis 3. Portfolio Managers 4. Clinical Development Pipeline 4. Executive Suite 5. Clinical Trial Environment www.ISRreports.com ©2013 | Preview of: Pancreatic Cancer: Disease and Pipeline Analysis 2
  • 3. act with confidence Table of Contents Full Table of Contents, list of figures, and list of tables, are available in the report preview, free on our website: http://www.isrreports.com/industry-reports/preview/pancreatic-cancer-disease-and-pipe- line-analysis www.ISRreports.com ©2013 | Preview of: Pancreatic Cancer: Disease and Pipeline Analysis 3
  • 4. act with confidence Sample Page act with confidence Figure 2. Global Map of per Capita Adult Alcohol Consumption (Pure Alcohol, litres) Source: World Health Organization [3] The association between pancreatic cancer and diet, alcohol consumption and smoking are discussed further in Chapter 3. Orphan Disease Status Due to the relatively low number of people affected by pancreatic cancer it is classified as an orphan or rare disease. This is defined in the US as a disease which affects fewer than 200,000 individuals, in Japan as one which affects less than 50,000 people and in the EU as affecting less than 1 in 2,000 individuals at any given time. Orphan disease status can result in potential therapies for the treatment of pancreatic cancer being eligible for Orphan Drug Designation. This designation allows the developing company to receive tax breaks and market exclusivity on approval of the therapy. In the US, under the terms of the Orphan Drug Act, the new therapy may receive 7 years market exclusivity and is not subject to discounting under the new healthcare law. In addition the therapy is not subject to prescription drug user fee act (PDUFA) fees unless the application includes a non-orphan disease. In addition to favourable market conditions, as the treatment options for the disease are so limited, a single pivotal phase III trial is all that is usually required for the development plan, thereby potentially significantly decreasing drug development costs. www.ISRreports.com ©2013 | Pancreatic Cancer: Disease and Pipeline Analysis 17 www.ISRreports.com ©2013 | Preview of: Pancreatic Cancer: Disease and Pipeline Analysis 4
  • 5. act with confidence Ordering Information Ordering information and additional sample pages are available in the full preview, free on our website: http://www.isrreports.com/industry-reports/preview/pancreatic-cancer-disease-and-pipe- line-analysis www.ISRreports.com ©2013 | Preview of: Pancreatic Cancer: Disease and Pipeline Analysis 5