DUBLIN–(BUSINESS WIRE)–The “Market
Spotlight: Amyotrophic Lateral Sclerosis (ALS)” report has been
added to ResearchAndMarkets.com’s offering.
This Market Spotlight report covers the Amyotrophic Lateral Sclerosis
(ALS) 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
The report estimates that in 2017, there were 47,190 incident cases of
amyotrophic lateral sclerosis (ALS) in adults aged 40 years and older
worldwide, and forecasts that number to increase to 56,070 incident
cases by 2026.
Oceania and Europe are estimated to have the highest disease incidence
(2.33 and 2.16 cases per 100,000 people, respectively), while Asia and
Africa have the lowest incidence (0.62 and 0.89 cases per 100,000
Italfarmaco’s Tiglutik, Mitsubishi Tanabe’s Radicava, Advanz’s
Rilutek, and Corestem’s Neuronata-R are the only marketed drugs
available for ALS. These drugs are administered via the intravenous
and oral routes.
The greatest proportion of industry-sponsored drugs in active clinical
development for ALS are in Phase II, with only one drug in the NDA/BLA
Therapies in mid-to-late-stage development for ALS focus on a wide
variety of targets. The most popular method of administration is the
High-impact upcoming events for drugs in the ALS space comprise
topline Phase II and Phase III trial results for a number of drugs, an
expected PDUFA date for BHV-0223, and an expected CHMP opinion for
The overall likelihood of approval of a Phase I ALS asset is 5.3%, and
the average probability a drug advances from Phase III is 33.3%.
Drugs, on average, take 7.9 years from Phase I to approval, compared
to 9.6 years in the overall neurology space.
There have been 24 licensing and asset acquisition deals involving ALS
drugs during 2014-19. The $1,225m exclusive collaboration and license
agreement signed in October 2018 between Denali and Sanofi to develop
and commercialize products containing receptor-interacting
serine/threonine-protein kinase 1 (RIPK1) inhibitors for neurological
indications such as Alzheimer’s disease, ALS, and multiple sclerosis
was the largest deal during the period.
The distribution of clinical trials across Phase I-IV indicates that
the majority of trials for ALS have been in the early and midphases of
development, with 81% of trials in Phase I-II, and only 19% in Phase
The US has a substantial lead in the number of ALS clinical trials
globally. The UK leads the major EU markets, while Japan has the top
spot in Asia.
Clinical trial activity in the ALS space is dominated by completed
trials. Otsuka/Avanir have the highest number of completed clinical
trials for ALS, with 11 trials.
Biogen leads industry sponsors with the highest number of clinical
trials for ALS.
Key Topics Covered:
RECENT EVENTS AND ANALYST OPINION
Masitinib for ALS (May 28, 2018)
NP001 for ALS (April 26, 2018)
IONIS-C9Rx for ALS (April 20, 2018)
IONIS-SOD1Rx for ALS (April 20, 2018)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
ITF Pharma Plans October US Roll-Out Of Liquid Riluzole Formulation For
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
Sanofi Stumps Up $125m To Access Denali RIPK1 Inhibitors
Celgene Options Neuro Candidates From Skyhawk, Participates In Series A
$27.5m For AliveGen Neuromuscular Candidates
Celgene Further Commits To Neuroscience With Prothena Pact
A Deal For Biogen, But Not The One Investors Are Waiting For
Deal Watch: Pfizer Begins 2018 With Two Deals, Including ALS Tie-Up With
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
For more information about this report visit https://www.researchandmarkets.com/r/yjbq3h
Laura Wood, Senior Press Manager
E.S.T. Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
For GMT Office Hours Call +353-1-416-8900
Nervous System Drugs