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Market Spotlight: Myelofibrosis

  • ID: 4421371
  • Report
  • January 2020
  • Region: Global
  • 44 Pages
  • Datamonitor Healthcare
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Myelofibrosis is a myeloproliferative neoplasm which can exist as a primary disease known as primary myelofibrosis, or can evolve to post- polycythemia vera (PV) or post-essential thrombocythemia (ET) myelofibrosis from PV or ET. It is characterized by the buildup of scar tissue (fibrosis) in bone marrow, which leads to a reduction in blood cell production.

Key Takeaways
  • The author estimates that in 2017, there were 47,000 prevalent cases of myelofibrosis in adults aged 50 years and older worldwide, and forecasts that number to increase to 58,300 prevalent cases by 2026.
  • The global prevalence of myelofibrosis is estimated to be 0.0027%. Bristol-Myers Squibb’s Inrebic and Incyte’s Jakafi are the only marketed drugs for myelofibrosis. These drugs are administered via the oral route.
  • The majority of industry-sponsored drugs in active clinical development for myelofibrosis are in Phase II. Therapies in development for myelofibrosis focus on a wide variety of targets. The majority of the pipeline drugs are administered via the oral route.
  • High-impact upcoming events for drugs in the myelofibrosis space comprise topline Phase III trial results for pacritinib and momelotinib.
  • The overall likelihood of approval of a Phase I hematologic asset is 9.9%, and the average probability a drug advances from Phase III is 59.4%. Drugs, on average, take 8.8 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
  • There have been only three licensing and asset acquisition deals involving myelofibrosis drugs during 2015-20. The largest deal was the $1,250m agreement in 2015 between Bristol-Myers Squibb and Promedior, pursuant to which Bristol-Myers Squibb was granted an exclusive right to acquire Promedior along with its lead asset PRM-151, which is in development for idiopathic pulmonary fibrosis and myelofibrosis.
  • The distribution of clinical trials across Phase I-IV indicates that the vast majority of trials for myelofibrosis have been in the early and mid-phases of development, with 86% of trials in Phase I-II, and only 14% in Phase III-IV.
  • The US has a substantial lead in the number of myelofibrosis clinical trials globally. Germany leads the major EU markets, while Israel has the top spot in Asia.
  • Novartis has the highest number of completed clinical trials for myelofibrosis, with 15 trials.
  • Novartis leads industry sponsors with the highest overall number of clinical trials for myelofibrosis, followed by Incyte
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Key Takeaways

Disease Background

  • Anemia
  • Splenomegaly
  • Curative treatment

Marketed Drugs

Pipeline Drugs

Recent Events and Analyst Opinion
  • Reblozyl for Myelofibrosis (November 6, 2019)
  • Pracinostat for Myelofibrosis (July 31, 2019)
  • CPI-0610 for Myelofibrosis (June 3, 2019)
  • Inrebic for Myelofibrosis (June 3, 2019)
Key Upcoming Events

Key Regulatory Events
  • Inrebic Approval Is A Boost For Myelofibrosis And Celgene’s Buyer Bristol
  • Celgene Takes Important Regulatory Step Ahead Of Bristol Merger With Fedratinib Filing
  • Pacritinib MAA Withdrawal
  • Patients Speak Up On Pacritinib
Probability of Success

Licensing and Asset Acquisition Deals
  • Roche Paying $390m Up Front For Fibrosis-Fighting Promedior
  • Deals Shaping The Medical Industry, January 2019
Parent Patents

Revenue Opportunity

Clinical Trial Landscape
  • Sponsors by status
  • Sponsors by phase
  • Prescription information

List of Figures
Figure 1: Trends in prevalent cases of myelofibrosis, 2017–26
Figure 2: Overview of pipeline drugs for myelofibrosis in the US
Figure 3: Pipeline drugs for myelofibrosis, by company
Figure 4: Pipeline drugs for myelofibrosis, by drug type
Figure 5: Pipeline drugs for myelofibrosis, by classification
Figure 6: Reblozyl for Myelofibrosis (November 6, 2019): Phase II - MF-001
Figure 7: CPI-0610 for Myelofibrosis (June 3, 2019): Phase I/II - MANIFEST (+/- Ruxolitinib)
Figure 8: Key upcoming events in myelofibrosis
Figure 9: Probability of success in the myelofibrosis pipeline
Figure 10: Licensing and asset acquisition deals in myelofibrosis, 2015–20
Figure 11: Parent patents in myelofibrosis
Figure 12: Clinical trials in myelofibrosis
Figure 13: Top 10 drugs for clinical trials in myelofibrosis
Figure 14: Top 10 companies for clinical trials in myelofibrosis
Figure 15: Trial locations in myelofibrosis
Figure 16: Myelofibrosis trials status
Figure 17: Myelofibrosis trials sponsors, by phase

List of Tables
Table 1: Prevalent cases of myelofibrosis, 2017–26
Table 2: Marketed drugs for myelofibrosis
Table 3: Pipeline drugs for myelofibrosis in the US
Table 4: Reblozyl for Myelofibrosis (November 6, 2019)
Table 5: Pracinostat for Myelofibrosis (July 31, 2019)
Table 6: CPI-0610 for Myelofibrosis (June 3, 2019)
Table 7: Inrebic for Myelofibrosis (June 3, 2019)
Table 8: Historical global sales, by drug ($m), 2014–18
Table 9: Forecasted global sales, by drug ($m), 2020–24
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