Market Spotlight: Myelofibrosis
Market Spotlight: Myelofibrosis
This Market Spotlight report covers the Myelofibrosis market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
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.
- Datamonitor Healthcare 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
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
10 Curative treatment
15 MARKETED DRUGS
17 PIPELINE DRUGS
24 RECENT EVENTS AND ANALYST OPINION
24 Reblozyl for Myelofibrosis (November 6, 2019)
25 Pracinostat for Myelofibrosis (July 31, 2019)
26 CPI-0610 for Myelofibrosis (June 3, 2019)
28 Inrebic for Myelofibrosis (June 3, 2019)
30 KEY UPCOMING EVENTS
31 KEY REGULATORY EVENTS
31 Inrebic Approval Is A Boost For Myelofibrosis And Celgene’s Buyer Bristol
31 Celgene Takes Important Regulatory Step Ahead Of Bristol Merger With Fedratinib Filing
31 Pacritinib MAA Withdrawal
31 Patients Speak Up On Pacritinib
33 PROBABILITY OF SUCCESS
34 LICENSING AND ASSET ACQUISITION DEALS
34 Roche Paying $390m Up Front For Fibrosis-Fighting Promedior
34 Deals Shaping The Medical Industry, January 2019
36 PARENT PATENTS
37 REVENUE OPPORTUNITY
38 CLINICAL TRIAL LANDSCAPE
39 Sponsors by status
40 Sponsors by phase
42 Prescription information
LIST OF FIGURES
14 Figure 1: Trends in prevalent cases of myelofibrosis, 2017–26
17 Figure 2: Overview of pipeline drugs for myelofibrosis in the US
18 Figure 3: Pipeline drugs for myelofibrosis, by company
18 Figure 4: Pipeline drugs for myelofibrosis, by drug type
18 Figure 5: Pipeline drugs for myelofibrosis, by classification
25 Figure 6: Reblozyl for Myelofibrosis (November 6, 2019): Phase II – MF-001
28 Figure 7: CPI-0610 for Myelofibrosis (June 3, 2019): Phase I/II – MANIFEST (+/- Ruxolitinib)
30 Figure 8: Key upcoming events in myelofibrosis
33 Figure 9: Probability of success in the myelofibrosis pipeline
34 Figure 10: Licensing and asset acquisition deals in myelofibrosis, 2015–20
36 Figure 11: Parent patents in myelofibrosis
38 Figure 12: Clinical trials in myelofibrosis
38 Figure 13: Top 10 drugs for clinical trials in myelofibrosis
39 Figure 14: Top 10 companies for clinical trials in myelofibrosis
39 Figure 15: Trial locations in myelofibrosis
40 Figure 16: Myelofibrosis trials status
41 Figure 17: Myelofibrosis trials sponsors, by phase
LIST OF TABLES
13 Table 1: Prevalent cases of myelofibrosis, 2017–26
16 Table 2: Marketed drugs for myelofibrosis
20 Table 3: Pipeline drugs for myelofibrosis in the US
24 Table 4: Reblozyl for Myelofibrosis (November 6, 2019)
26 Table 5: Pracinostat for Myelofibrosis (July 31, 2019)
27 Table 6: CPI-0610 for Myelofibrosis (June 3, 2019)
29 Table 7: Inrebic for Myelofibrosis (June 3, 2019)
37 Table 8: Historical global sales, by drug ($m), 2014–18
37 Table 9: Forecasted global sales, by drug ($m), 2020–24
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