Market Spotlight: Zika virus – Report

This Market Spotlight report covers the Zika virus market, comprising key pipeline therapies, clinical trials, probability of success, epidemiology, and licensing and acquisition deals.

Key Takeaways

  • The Zika virus was first reported in continental South America in Brazil in May 2015. In February 2016, between 440,000 and 1,300,000 people were infected in Brazil. In the US, about 225 Zika virus cases were reported in August 2017. In addition, 554 cases were reported in people infected through local mosquito-borne transmission. Furthermore, autochthonous Zika virus transmission was reported in 25 countries in the Americas, Africa, and Asia.
  • In 2016, it was estimated that there were between 508 and 1,778 imported cases in Europe, particularly in France, Portugal, and Italy.
  • The majority of industry-sponsored drugs in active clinical development for Zika virus are in Phase I, with just a single product in Phase II.
  • Therapies in early-to-mid-stage development for Zika virus focus on the immune system and viral antigens. Candidates comprise DNA vaccines such as the National Institutes of Health’s Zika Virus Vaccine, GeneOne’s GLS-5700, and Inovio’s INO-A002; Moderna’s mRNA vaccine; Themis Bioscience’s recombinant viral vector vaccine; Imutex’s AGS-v vaccine; Johnson & Johnson’s Ad26.ZIKV.001 vaccine; Takeda’s TAK-426 vaccine; Emergent BioSolutions’ ZIKV-IG; Valneva’s ZIKV-VLA1601; and BioCryst’s galidesivir, a broad-spectrum antiviral drug.
  • The overall likelihood of approval of a Phase I antiviral asset is 16.6%, and the average probability a drug advances from Phase III is 77.6%. Drugs, on average, take 8.8 years from Phase I to approval, compared to 9.0 years in the overall infectious disease space.
  • There have been 11 licensing and asset acquisition deals involving Zika virus drugs during 2014–19, all of which occurred in either 2016 or 2017. The exclusive 2017 agreement between Emergent BioSolutions and Valneva, worth $58.3m, for the global rights to Valneva’s Zika vaccine technology and ZIKV-VLA1601, was the largest deal during the period.
  • All clinical trials for Zika virus have been in either Phase I or Phase II, with no Phase III trials to date.
  • The US leads in terms of the number of Zika virus clinical trials globally. The largest share of industry-sponsored clinical trials are ongoing. Takeda and GeoVax have planned one trial each in the Zika virus space.
  • Inovio and Sanofi lead industry sponsors with three clinical trials each for Zika virus

 

CONTENTS

5 OVERVIEW

6 KEY TAKEAWAYS

7 DISEASE BACKGROUND

8 TREATMENT
8 Vaccines
8 Therapeutics

10 EPIDEMIOLOGY

11 PIPELINE DRUGS

17 PROBABILITY OF SUCCESS

18 LICENSING AND ASSET ACQUISITION DEALS
18 GeoVax Collaborates With Enesi Pharma On Needle-Free Vaccines
19 Bridging The Gap: Cyclenium Pharma
19 Brazil’s Oneway Diagnostica, iBio Collaborate On Virus Diagnostics

20 CLINICAL TRIAL LANDSCAPE
21 Sponsors by status
22 Sponsors by phase
23 Recent events

25 BIBLIOGRAPHY

26 APPENDIX
10 Figure 1: Recent epidemiological updates
10 Figure 2: Zika cases timeline

LIST OF FIGURES
11 Figure 3: Overview of pipeline drugs for Zika virus in the US
12 Figure 4: Pipeline drugs for Zika virus, by company
12 Figure 5: Pipeline drugs for Zika virus, by drug type
12 Figure 6: Pipeline drugs for Zika virus, by classification
17 Figure 7: Probability of success in the Zika virus pipeline
18 Figure 8: Licensing and asset acquisition deals in Zika virus, 2014–19
20 Figure 9: Clinical trials in Zika virus
20 Figure 10: Top 10 drugs for clinical trials in Zika virus
21 Figure 11: Top 10 companies for clinical trials in Zika virus
21 Figure 12: Zika virus trial locations
22 Figure 13: Zika virus trials status
23 Figure 14: Zika virus trials sponsors, by phase

LIST OF TABLES
14 Table 1: Pipeline drugs for Zika virus in the US

 

Published: 14 May 2019
Number of pages: 27
Price: $1,318
Formats: PDF, PPT
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Market Spotlight: Cervical Cancer – Report

This Market Spotlight report covers the cervical cancer market, comprising key pipeline and marketed drugs, clinical trials, upcoming events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

  • Datamonitor Healthcare estimates that in 2017, there were 564,900 incident cases of cervical cancer in females worldwide, and expects that number to increase to 618,400 incident cases by 2026.
  • Roche’s Avastin, Mylan’s biosimilar bevacizumab, Pfizer’s biosimilar bevacizumab, and Amgen’s Mvasi, which target vascular endothelial growth factor; Novartis’s Hycamtin, a topoisomerase I inhibitor; Pinnacle’s Photofrin, a photodynamic therapy; and Merck’s Keytruda, an anti-PD-1 antibody, are the marketed drugs available for cervical cancer. The majority of the marketed drugs are administered via the intravenous route.
  • The majority of the industry-sponsored drugs in active clinical development for cervical cancer are in Phase II. Therapies in mid-to-late-stage development for cervical cancer focus on a wide variety of targets. The majority of the pipeline drugs are administered via the intravenous route, with the remainder being oral, subcutaneous, intramuscular, and intranasal formulations.
  • The release of topline Phase III trial results for Libtayo is the only high-impact upcoming event in the cervical cancer space. The overall likelihood of approval of a Phase I solid tumors asset is 5.8%, and the average probability a drug advances from Phase III is 40.3%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
  • There have been 11 licensing and asset acquisition deals involving cervical cancer drugs during 2014–19. The $727.5m license agreement signed in 2015 between Inovio and MedImmune for the exclusive rights to develop and market Inovio’s INO-3112 was the largest deal.
  • The distribution of clinical trials across Phase I–IV indicates that the vast majority of trials for cervical cancer have been in the early and mid-phases of development, with 94% of trials in Phase I–II, and only 6% in Phase III–IV.
  • The US has a substantial lead in the number of cervical cancer clinical trials globally. The UK leads the major EU markets, while South Korea has the top spot in Asia.
  • Clinical trial activity in the cervical cancer space is dominated by ongoing trials. AstraZeneca has the highest number of ongoing clinical trials for cervical cancer, with 15 trials.
  • AstraZeneca leads industry sponsors with the highest number of clinical trials for cervical cancer, followed by Roche

 

CONTENTS

6 OVERVIEW

7 KEY TAKEAWAYS

8 DISEASE BACKGROUND

9 TREATMENT
9 Surgery
9 Radiotherapy
9 Chemotherapy
10 Targeted therapy

11 EPIDEMIOLOGY

14 MARKETED DRUGS

17 PIPELINE DRUGS

24 RECENT EVENTS AND ANALYST OPINION
24 Sacituzumab Govitecan for Cervical Cancer (April 29, 2019)
25 Nerlynx for Cervical Cancer (April 01, 2019)
26 Nerlynx for Cervical Cancer (March 18, 2019)
27 Axalimogene Filolisbac for Cervical Cancer (January 23, 2019)
28 Nerlynx for Cervical Cancer (January 11, 2019)
29 Axalimogene Filolisbac for Cervical Cancer (July 13, 2018)
30 Axalimogene Filolisbac for Cervical Cancer (March 9, 2018)
31 Imfinzi for Cervical Cancer (March 9, 2018)

33 KEY UPCOMING EVENTS

34 PROBABILITY OF SUCCESS

35 LICENSING AND ASSET ACQUISITION DEALS
35 US Merck Links With Tessa On Keytruda Combo For Cervical Cancer
35 Advaxis Stumbles Further As Amgen Exits Early-Stage Cancer Immunotherapy Pact

37 PARENT PATENTS

38 REVENUE OPPORTUNITY

39 CLINICAL TRIAL LANDSCAPE
40 Sponsors by status
41 Sponsors by phase

43 BIBLIOGRAPHY
43 Prescription information

44 APPENDIX

LIST OF FIGURES
13 Figure 1: Trends in incident cases of cervical cancer, 2017–26
17 Figure 2: Overview of pipeline drugs for cervical cancer in the US
17 Figure 3: Pipeline drugs for cervical cancer, by company
18 Figure 4: Pipeline drugs for cervical cancer, by drug type
18 Figure 5: Pipeline drugs for cervical cancer, by classification
27 Figure 6: Nerlynx for Cervical Cancer (March 18, 2019): Phase II – SUMMIT – w/Fulvestrant (HER2-low/HER2mut)
33 Figure 7: Key upcoming events in cervical cancer
34 Figure 8: Probability of success in the cervical cancer pipeline
35 Figure 9: Licensing and asset acquisition deals in cervical cancer, 2014–19
37 Figure 10: Parent patents in cervical cancer
39 Figure 11: Clinical trials in cervical cancer
39 Figure 12: Top 10 drugs for clinical trials in cervical cancer
40 Figure 13: Top 10 companies for clinical trials in cervical cancer
40 Figure 14: Trial locations in cervical cancer
41 Figure 15: Cervical cancer trials status
42 Figure 16: Cervical cancer trials sponsors, by phase

LIST OF TABLES
12 Table 1: Incident cases of cervical cancer, 2017–26
15 Table 2: Marketed drugs for cervical cancer
19 Table 3: Pipeline drugs for cervical cancer in the US
24 Table 4: Sacituzumab Govitecan for Cervical Cancer (April 29, 2019)
25 Table 5: Nerlynx for Cervical Cancer (April 01, 2019)
26 Table 6: Nerlynx for Cervical Cancer (March 18, 2019)
28 Table 7: Axalimogene Filolisbac for Cervical Cancer (January 23, 2019)
29 Table 8: Nerlynx for Cervical Cancer (January 11, 2019)
30 Table 9: Axalimogene Filolisbac for Cervical Cancer (July 13, 2018)
31 Table 10: Axalimogene Filolisbac for Cervical Cancer (March 9, 2018)
32 Table 11: Imfinzi for Cervical Cancer (March 9, 2018)
38 Table 12: Historical global sales, by drug ($m), 2014–18
38 Table 13: Forecasted global sales, by drug ($m), 2019–23

 

Published: 15 May 2019
Number of pages: 45
Price: $1,318
Formats: PDF, PPT

Market Spotlight: Duchenne Muscular Dystrophy (DMD) – Report

This Market Spotlight report covers the Duchenne Muscular Dystrophy market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, probability of success, recent events and analyst opinion, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

  • Datamonitor Healthcare estimates that in 2017, there were 182,100 prevalent cases of Duchenne muscular dystrophy (DMD) in males worldwide, and forecasts that number to increase to 199,100 prevalent cases by 2026.
  • Marketed drugs for DMD include the FDA-approved drugs Emflaza, a glucocorticoid with anti-inflammatory and immunosuppressant properties, and Exondys 51, a novel phosphorodiamidate morpholino oligomer designed to induce the skipping of exon 51 in the dystrophin gene. The marketed drugs also include an EU-approved drug, Translarna, which acts by targeting premature nonsense mutations. Emflaza and Translarna are administered via the oral route, while Exondys 51 is available as an intravenous formulation.
  • The largest proportion of industry-sponsored drugs in active clinical development for DMD are in Phase II, with only one drug in the NDA/BLA phase.
  • Therapies in mid- and late-stage development for DMD focus on a wide variety of targets. The largest proportion of pipeline drugs in mid- and late-stage development are administered orally, with the remainder being intravenous, intramuscular, intraarterial, and subcutaneous formulations.
  • High-impact upcoming events for drugs in the DMD space comprise topline Phase II and Phase III trial results, expected PDUFA dates for an NDA and sNDA, and a supplemental CHMP opinion.
  • The overall likelihood of approval of a Phase I single-gene disorders (non-inborn errors of metabolism) asset is 23.9%, and the average probability a drug advances from Phase III is 66.7%. Drugs, on average, take 7.2 years from Phase I to approval, compared to 8.8 years in the overall metabolic space.
  • There have been 20 licensing and asset acquisition deals involving DMD drugs during 2014–19, seven of which occurred in 2017. The $562m license and collaboration agreement between Sarepta Therapeutics and Summit Therapeutics for European rights to Summit Therapeutics’ utrophin modulator pipeline for the treatment of DMD was the largest deal.
  • The distribution of clinical trials across Phase I–IV indicates that the majority of trials for DMD have been in the early and midphases of development, with 70% of trials in Phase I–II, and only 30% in Phase III–IV.
  • The US has a substantial lead in the number of DMD clinical trials globally. The UK leads the major EU markets, while Israel has the top spot in Asia.
  • Sarepta Therapeutics has the highest number of ongoing trials for DMD, with 10 trials.
  • PTC Therapeutics leads industry sponsors with the highest number of clinical trials for DMD, followed by Sarepta Therapeutics

 

CONTENTS

7 OVERVIEW

8 KEY TAKEAWAYS

9 DISEASE BACKGROUND

10 TREATMENT
10 Corticosteroids
10 Genetic therapies
10 Vitamin D supplement

11 EPIDEMIOLOGY

13 MARKETED DRUGS

15 PIPELINE DRUGS

23 RECENT EVENTS AND ANALYST OPINION
23 AT702 for DMD (April 8, 2019)
24 SRP-4045 for DMD (March 28, 2019)
25 Catena for DMD (February 25, 2019)
27 SGT-001 for DMD (February 7, 2019)
29 Emflaza for DMD (January 7, 2019)
29 CAP-1002 for DMD (December 21, 2018)
30 PF-06252616 for DMD (August 30, 2018)
32 AAV1-FS344 for DMD (August 30, 2018)
34 RG6206 for DMD (August 30, 2018)
35 Ezutromid for DMD (June 27, 2018)
37 NS-065/NCNP-01 for DMD (June 27, 2018)
39 Microdystrophin Gene Therapy Program (NCH) for DMD (June 19, 2018)
41 SGT-001 for DMD (June 18, 2018)
42 SGT-001 for DMD (March 14, 2018)
43 Golodirsen for DMD (March 12, 2018)
44 Translarna for DMD (February 20, 2018)
44 Ezutromid for DMD (January 25, 2018)

47 KEY UPCOMING EVENTS

48 KEY REGULATORY EVENTS
48 Not The End For Exondys In EU, Says Sarepta
48 Sarepta Should Gain Clean Slate With CBER Review of DMD Gene Therapy
48 Sarepta Will Challenge Expected No From EMA On Exondys 51
48 Sarepta CEO Vows To Get Exondys 51 Into EU Despite CHMP Negative Trend Vote
48 Definitive Data Hopes Keep Santhera’s Duchenne Drug Alive in UK Despite EMA No

49 PROBABILITY OF SUCCESS

50 LICENSING AND ASSET ACQUISITION DEALS
50 Audentes Gains License To NCH’s DMD, DM1 Candidates
50 Santhera To Snap Up Second DMD Drug As Idorsia Climbs Aboard

52 PARENT PATENTS

53 REVENUE OPPORTUNITY

54 CLINICAL TRIAL LANDSCAPE
55 Sponsors by status
56 Sponsors by phase
57 Recent events

59 BIBLIOGRAPHY
59 Prescription information

60 APPENDIX

LIST OF FIGURES
12 Figure 1: Trends in prevalent cases of DMD, 2017–26
15 Figure 2: Overview of pipeline drugs for DMD in the US
15 Figure 3: Pipeline drugs for DMD, by company
16 Figure 4: Pipeline drugs for DMD, by drug type
16 Figure 5: Pipeline drugs for DMD, by classification
25 Figure 6: SRP-4045 for DMD (March 28, 2019): Phase III – ESSENCE (Study 4045-301; Exon 45 & 53)
27 Figure 7: Catena for DMD (February 25, 2019): Phase III – SYROS
32 Figure 8: PF-06252616 for DMD (August 30, 2018): Phase II – PK and PD Study
37 Figure 9: Ezutromid for DMD (June 27, 2018): Phase II – PhaseOut DMD (US and EU)
39 Figure 10: NS-065/NCNP-01 for DMD (June 27, 2018): Phase II – 201
41 Figure 11: Microdystrophin gene therapy program (NCH) for DMD (June 19, 2018): Phase I/IIa – pilot study
46 Figure 12: Ezutromid for DMD (January 25, 2018): Phase II – PhaseOut DMD (US and EU)
47 Figure 13: Key upcoming events in DMD
49 Figure 14: Probability of success in the DMD pipeline
50 Figure 15: Licensing and asset acquisition deals in DMD, 2014–19
52 Figure 16: Parent patents in DMD
54 Figure 17: Clinical trials in DMD
54 Figure 18: Top 10 drugs for clinical trials in DMD
55 Figure 19: Top 10 companies for clinical trials in DMD
55 Figure 20: Trial locations in DMD
56 Figure 21: DMD trials status
57 Figure 22: DMD trials sponsors, by phase

LIST OF TABLES
11 Table 1: Prevalent cases of DMD, 2017–26
14 Table 2: Marketed drugs for DMD
17 Table 3: Pipeline drugs for DMD in the US
23 Table 4: AT702 for DMD (April 8, 2019)
24 Table 5: SRP-4045 for DMD (March 28, 2019)
26 Table 6: Catena for DMD (February 25, 2019)
28 Table 7: SGT-001 for DMD (February 7, 2019)
29 Table 8: Emflaza for DMD (January 7, 2019)
30 Table 9: CAP-1002 for DMD (December 21, 2018)
31 Table 10: PF-06252616 for DMD (August 30, 2018)
33 Table 11: AAV1-FS344 for DMD (August 30, 2018)
34 Table 12: RG6206 for DMD (August 30, 2018)
36 Table 13: Ezutromid for DMD (June 27, 2018)
37 Table 14: NS-065/NCNP-01 for DMD (June 27, 2018)
39 Table 15: Microdystrophin gene therapy program (NCH) for DMD (June 19, 2018)
41 Table 16: SGT-001 for DMD (June 18, 2018)
42 Table 17: SGT-001 for DMD (March 14, 2018)
43 Table 18: Golodirsen for DMD (March 12, 2018)
44 Table 19: Translarna for DMD (February 20, 2018)
45 Table 20: Ezutromid for DMD (January 25, 2018)
53 Table 21: Historical global sales, by drug ($m), 2014–18
53 Table 22: Forecasted global sales, by drug ($m), 2019–23

 

Published: 15 May 2019
Number of pages: 61
Price: $1,318
Formats: PDF

Market Spotlight: Pancreatic Cancer – Report

This Market Spotlight report covers the pancreatic cancer 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 incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

  • Datamonitor Healthcare estimates that in 2017, there were 453,200 incident cases of pancreatic cancer worldwide, and expects that number to increase to 495,900 incident cases by 2026.
  • The approved drugs in the pancreatic cancer space target microtubules (tubulin), DNA, DNA synthesis, topoisomerase I, dihydropyrimidine dehydrogenase, thymidylate synthase, and epidermal growth factor receptor. These are commonly administered via the intravenous route, with a few select products being available in oral and intratumoral formulations.
  • The majority of industry-sponsored drugs in active clinical development for pancreatic cancer are in Phase II. Therapies in development for pancreatic cancer focus on a wide variety of targets. The majority of pipeline drugs for pancreatic cancer are administered via the oral and intravenous routes.
  • High-impact upcoming events for drugs in the pancreatic cancer space comprise topline Phase II and Phase III trial results, and patent expirations.
  • The overall likelihood of approval of a Phase I pancreatic cancer asset is 2.2%, and the average probability a drug advances from Phase III is 13.0%. Drugs, on average, take 10.6 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
  • There have been 45 licensing and asset acquisition deals involving pancreatic cancer drugs during 2014–19. The $1,770m exclusive clinical collaboration agreement signed in 2014 between Bristol-Myers Squibb and Five Prime Therapeutics to explore the combination of Opdivo with FPA008 in six tumor types including pancreatic cancer was the largest deal.
  • The distribution of clinical trials across Phase I–IV indicates that the vast majority of trials for pancreatic cancer have been in the early and mid-phases of development, with 93% of trials in Phase I–II, and only 7% in Phase III–IV.
  • The US has a substantial lead in the number of pancreatic cancer clinical trials globally. The UK leads the major EU markets, while Japan has the top spot in Asia.
  • Clinical trial activity in the pancreatic cancer space is dominated by completed trials. Roche has the highest number of completed clinical trials for pancreatic cancer, with 93 trials.
  • Roche leads the industry sponsors with the highest number of clinical trials for pancreatic cancer, followed by Eli Lilly.

 

CONTENTS

6 OVERVIEW

7 KEY TAKEAWAYS

8 DISEASE BACKGROUND
8 Subtypes

10 TREATMENT
10 Surgery
10 Ablation or embolization
11 Radiation therapy
11 Chemotherapy
11 Targeted therapy
12 Immunotherapy
12 Drugs used specifically for the treatment of PNETs

13 EPIDEMIOLOGY

16 MARKETED DRUGS

19 PIPELINE DRUGS

40 RECENT EVENTS AND ANALYST OPINION
40 Sacituzumab Govitecan for Pancreatic Cancer (April 29, 2019)
41 RX-3117 for Pancreatic Cancer (April 16, 2019)
41 Abraxane for Pancreatic Cancer (March 12, 2019)
43 Abraxane for Pancreatic Cancer (February 27, 2019)
44 Lynparza for Pancreatic Cancer (February 26, 2019)
45 SM-88 for Pancreatic Cancer (January 18, 2019)
47 BL-8040 for Pancreatic Cancer (October 19, 2018)
49 AM0010 for Pancreatic Cancer (June 3, 2018)

52 KEY UPCOMING EVENTS

53 KEY REGULATORY EVENTS
53 Lutathera’s Broad Tumor Indication Aided By Expanded Access Data
54 PROBABILITY OF SUCCESS
55 LICENSING AND ASSET ACQUISITION DEALS
55 Mateon, Oncotelic Merge With Focus On Brain, Pancreatic Cancer Candidate
56 BioSense Picks Up Greater China Rights To Rexahn’s Cancer Candidate

57 PARENT PATENTS

59 REVENUE OPPORTUNITY

61 CLINICAL TRIAL LANDSCAPE
62 Sponsors by status
63 Sponsors by phase
64 Recent events

66 BIBLIOGRAPHY
66 Prescription information

68 APPENDIX

LIST OF FIGURES
15 Figure 1: Trends in incident cases of pancreatic cancer, 2017–26
19 Figure 2: Overview of pipeline drugs for pancreatic cancer in the US
19 Figure 3: Pipeline drugs for pancreatic cancer, by company
20 Figure 4: Pipeline drugs for pancreatic cancer, by drug type
20 Figure 5: Pipeline drugs for pancreatic cancer, by classification
43 Figure 6: Abraxane for Pancreatic Cancer (March 12, 2019): Phase III – APACT – w/Gemcitabine (Adjuvant)
45 Figure 7: Lynparza for Pancreatic Cancer (February 26, 2019): Phase III – POLO
47 Figure 8: SM-88 for Pancreatic Cancer (January 18, 2019): Phase II – Tyme-88-Panc (>1L)
49 Figure 9: BL-8040 for Pancreatic Cancer (October 19, 2018): Phase IIa – COMBAT/KEYNOTE-202 (w/Keytruda)
51 Figure 10: AM0010 for Pancreatic Cancer (June 3, 2018): Phase I/Ib – 001
52 Figure 11: Key upcoming events in pancreatic cancer
54 Figure 12: Probability of success in the pancreatic cancer pipeline
55 Figure 13: Licensing and asset acquisition deals in pancreatic cancer, 2014–19
57 Figure 14: Parent patents in pancreatic cancer, 2019–25
58 Figure 15: Parent patents in pancreatic cancer, 2025–29
58 Figure 16: Parent patents in pancreatic cancer, 2029–38
61 Figure 17: Clinical trials in pancreatic cancer
61 Figure 18: Top 10 drugs for clinical trials in pancreatic cancer
62 Figure 19: Top 10 companies for clinical trials in pancreatic cancer
62 Figure 20: Trial locations in pancreatic cancer
63 Figure 21: Pancreatic cancer trials status
64 Figure 22: Pancreatic cancer trials sponsors, by phase

LIST OF TABLES

14 Table 1: Incident cases of pancreatic cancer, 2017–26
17 Table 2: Marketed drugs for pancreatic cancer
21 Table 3: Pipeline drugs for pancreatic cancer in the US
40 Table 4: Sacituzumab Govitecan for Pancreatic Cancer (April 29, 2019)
41 Table 5: RX-3117 for Pancreatic Cancer (April 16, 2019)
42 Table 6: Abraxane for Pancreatic Cancer (March 12, 2019)
43 Table 7: Abraxane for Pancreatic Cancer (February 27, 2019)
44 Table 8: Lynparza for Pancreatic Cancer (February 26, 2019)
46 Table 9: SM-88 for Pancreatic Cancer (January 18, 2019)
48 Table 10: BL-8040 for Pancreatic Cancer (October 19, 2018)
49 Table 11: AM0010 for Pancreatic Cancer (June 3, 2018)
59 Table 12: Historical global sales, by drug ($m), 2014–18
60 Table 13: Forecasted global sales, by drug ($m), 2019–23

 

Published: 15 May 2019
Number of pages: 69
Price: $1,318
Formats: PDF

Market Spotlight: Hereditary Angioedema (HAE) – Report

This Market Spotlight report covers the Hereditary Angioedema market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

  • Datamonitor Healthcare estimates that in 2017, there were approximately 402,700 prevalent cases of hereditary angioedema (HAE) worldwide, and forecasts that number to increase to 440,600 prevalent cases by 2026.
  • The approved drugs in the HAE space target complement proteins, androgen receptors, follicle-stimulating hormone, gonadotropin-releasing hormone, progesterone receptor, bradykinin B2 receptor, and the kinin-kallikrein system. These are commonly administered via the intravenous or subcutaneous routes, with one product being available in an oral formulation.
  • There are only seven drugs in active clinical development for HAE, with five drugs in Phase I and two in Phase III. Therapies in mid-to-late-stage development for HAE focus on targets such as the kinin-kallikrein system and complement proteins. These drugs are administered via the subcutaneous and oral routes.
  • High-impact upcoming events for drugs in the HAE space comprise topline Phase III trial results for BCX7353, topline Phase II trial results for KVD900, and a data exclusivity expiration for Ruconest.
  • The overall likelihood of approval of a Phase I autoimmune/immunology-other asset is 21.4%, and the average probability a drug advances from Phase III is 70.0%. Drugs, on average, take 10.0 years from Phase I to approval, compared to 8.8 years in the overall autoimmune/immunology space.
  • There have been only three licensing and asset acquisition deals involving HAE drugs during 2014–19. The $125m licensing agreement signed in 2016 between Pharming Group and Bausch Health for the acquisition of North American commercialization rights for Ruconest was the largest deal.
  • The distribution of clinical trials across Phase I–IV indicates that trials for HAE have been evenly split between the early and late phases of development, with 51% of trials in Phase III–IV, and 49% in Phase I–II.
  • The US has a substantial lead in the number of HAE clinical trials globally. The UK leads the major EU markets, while Israel has the top spot in Asia.
  • Clinical trial activity in the HAE space is dominated by completed trials. Takeda has the highest number of completed trials for HAE, with 22 trials.
  • Takeda leads industry sponsors with the highest number of clinical trials for HAE, followed by BioCryst.

 

CONTENTS

6 OVERVIEW

7 KEY TAKEAWAYS

8 DISEASE BACKGROUND
8 Subtypes

9 TREATMENT
9 C1-INH concentrates
9 Plasma-derived C1-INH (pdC1-INH)
9 Recombinant C1-INH (rhC1-INH)
9 Kallikrein inhibitor
9 Bradykinin receptor antagonist

11 EPIDEMIOLOGY

15 MARKETED DRUGS

18 PIPELINE DRUGS

22 RECENT EVENTS AND ANALYST OPINION
22 BCX7353 for HAE (September 4, 2018)

24 KEY UPCOMING EVENTS

25 KEY REGULATORY EVENTS
25 Anticancers, Orphans & The First CAR-Ts: New EU Drug Approvals In 2018
25 Takhzyro Among Hopefuls For EU Approval Recommendation
25 Takhzyro Approved For HAE Attacks With Nearly Spotless Label
25 With Takhzyro Approval, Shire Could Reclaim HAE Prophylaxis Market From CSL Behring

26 PROBABILITY OF SUCCESS

27 LICENSING AND ASSET ACQUISITION DEALS

27 BioCryst Changes Mind On Idera Merger

28 PARENT PATENTS

29 REVENUE OPPORTUNITY

30 CLINICAL TRIAL LANDSCAPE
31 Sponsors by status
32 Sponsors by phase
32 Recent events

34 BIBLIOGRAPHY
34 Prescription information

36 APPENDIX

LIST OF FIGURES
14 Figure 1: Trends in prevalent cases of HAE, 2017–26
18 Figure 2: Overview of pipeline drugs for HAE in the US
18 Figure 3: Pipeline drugs for HAE, by company
19 Figure 4: Pipeline drugs for HAE, by drug type
19 Figure 5: Pipeline drugs for HAE, by classification
23 Figure 6: BCX7353 for HAE (September 4, 2018): Phase II – ZENITH-1
24 Figure 7: Key upcoming events in HAE
26 Figure 8: Probability of success in the HAE pipeline
27 Figure 9: Licensing and asset acquisition deals in HAE, 2014–19
28 Figure 10: Parent patents in HAE
30 Figure 11: Clinical trials in HAE
30 Figure 12: Top 10 drugs for clinical trials in HAE
31 Figure 13: Top 10 companies for clinical trials in HAE
31 Figure 14: Trial locations in HAE
32 Figure 15: HAE trials status
32 Figure 16: HAE trials sponsors, by phase

LIST OF TABLES
12 Table 1: Prevalent cases of HAE, 2017–26
16 Table 2: Marketed drugs for HAE
20 Table 3: Pipeline drugs for HAE in the US
22 Table 4: BCX7353 for HAE (September 4, 2018)
29 Table 5: Historical global sales, by drug ($m), 2014–18
29 Table 6: Forecasted global sales, by drug ($m), 2019–23

 

Published: 16 May 2019
Price: $1,318
Number of pages: 37
Formats: PDF

Non-Alcoholic Steatohepatitis (NASH) KOL Interview – US, Reimbursement – Report

Overview

This interview with a French key opinion leader (KOL) provides insight into pipeline therapies for non-alcoholic steatohepatitis (NASH), as well as pricing strategies and future treatment rates for the different fibrosis stages of NASH. Key pipeline assets highlighted include Ocaliva, elafibranor, cenicriviroc, and firsocostat.

Highlights

  • I think the barriers are that we do not necessarily know exactly how big the population is going to be because we have not really had treatments to date. So, we do not know if there are patients that are being warehoused, or patients that are not diagnosed that will be diagnosed once there are treatments. So, the price has to correlate to the size of the population being treated, you cannot come up with a high drug price and have a large-sized population.
  • I think that there are going to be barriers [to adopting a combination treatment], so these patients have other co-morbid conditions and are going to be taking other medications, and now you are going to be adding at least one drug for NASH, if not a combination, these are going to be drugs that have a high cost associated with them, and so it is going to be not only burdensome to just be taking more drugs, but it is going to be a financial burden for the increased out of pocket that is going to be needed for these patients.
  • I think that they [the company with the first approved NASH therapy] will be smarter if they price it in that $400–$500 range to keep it off the specialty tier, make it less of a financial burden for patients, and therefore the broader population might have better access to it, because once they price it over that, it is going into a specialty tier, patients are going to pay co-insurance, it will get prior authorized, it will be a high out of pocket for patients.

 

Published: 20 May 2019
Price: $599
Number of pages: 12
Formats: PDF

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