CNS drugs take center stage: BioPharma's 2018 predictions
Editor's note: What market forces or trends will shape the biopharma industry in 2018? In this series, BioPharma Dive's editors take a stab at predicting how the year may unfold for AI, oncology and neuroscience. Read about how AI could impact pharma and coming soon: why price competition might hit oncology.
Oncology and gene therapies are enjoying the spotlight for pharma, but one of the world's biggest biotechs is betting neuroscience will be next to take center stage.
"We believe that all signs point to neuroscience as the next oncology," Mike Ehlers, head of Biogen Inc.'s R&D, predicted during a company earnings call in July.
If the last few years are any indication, Ehlers may be on to something.
Cancer — and immuno-oncology, in particular — reigns as the hottest therapeutic area around. It's also one of the most crowded, prompting some drugmakers to search for less picked over markets.
Enter neuroscience. Long thought of as too costly and risky to build a pipeline around, the diverse therapeutic area is now more attractive to manufacturers, thanks in part to breakthrough research that has improved the industry's understanding of central nervous system (CNS) disorders like Huntington's disease and ALS.
That stronger science has fueled many big pharmas and small biotechs to craft ambitious plans for developing CNS treatments, plans likely to grab the industry's attention in 2018 as companies race for new migraine drugs, advance multiple sclerosis candidates and continue a long-running bid for an Alzheimer's treatment.
Regardless of who's making the deals, neuroscience should continue to captivate over the coming years. The space encompasses many diseases with sizable patient populations and high unmet medical needs, and is poised for substantial growth. Market analysis firm Grand View Research estimates that the global CNS therapeutic market will have a compound annual growth rate of 5.9% from 2016 to 2025, ultimately reaching $129 billion.
Neuroscience isn't for everyone, though. Pfizer Inc., while not exactly a dominant player in the space, over the weekend disclosed plans to end discovery and early development efforts in the field, and instead pump more money into therapeutic areas where it has more scientific expertise.
The spotlight will also bring more attention to setbacks. Axovant Sciences Inc. just revealed its drug intepirdine failed a mid-stage study in dementia patients, and decided to scrap the program, though it still retains neuroscience assets in its pipeline. The company saw its stock plunge more than 50% on the news.
Alzheimer's in the spotlight
Considered the Holy Grail of drug development by some, Alzheimer's disease holds some promise from the clinic next year, notwithstanding a long history of failures. Data from the first piece of an advanced study evaluating vTv Therapeutics Inc.'s azeliragon are expected in March, and Roche AG estimates a November primary completion for a Phase 3 trial of gantenerumab, one of its amyloid beta inhibitors.
A terrible track record for late-stage Alzheimer's drugs doesn't quite set an uplifting tone. Yet with the world's elderly population growing and no Food and Drug Administration-approved treatments for underlying causes, Alzheimer's remains an alluring and lucrative target.
Case in point: market intelligence firm EvaluatePharma recently ranked Biogen's aducanumab as the most valuable R&D project in the global pipeline, with a projected $1.5 billion in worldwide product sales in 2022, pending approval.
Another candidate from Biogen, dubbed E2609, should garner some added attention in the coming months. Co-developed with Eisai Co. Ltd., the drug holds a spot on the short list of Alzheimer's treatments in late-stage testing. While Phase 3 investigations are still recruiting, a Phase 2 dose-finding study of Alzheimer's-related cognitive impairment and dementia is set to wrap up in April.
Parkinson's and pain
Outside of Alzheimer's, drugmakers have pumped millions of dollars into innovative therapies for pain as well as other neurodegenerative disorders.
Healthcare regulators have tasked the industry to come up with less addictive painkillers than the opioid-based drugs that aided in the rise of a national epidemic.
Several pharmas have answered the call. The FDA in October approved Flexion Therapeutics Inc.'s Zilretta (triamcinolone acetonide) a non-opioid analgesic for osteoarthritis knee pain, and has set a target action date of May 26 for Recro Pharma Inc.'s non-opioid drug for moderate to severe pain, meloxicam 30 mg.
Headaches will be another key battleground for pain.
Four companies are competing to be first-to-market with a fresh class of migraine medications called calcitonin gene-related peptide inhibitors (CGRP). So far, Amgen Inc. and Novartis AG are in the lead, securing a May 17 target FDA action date for their drug erenumab.
The peptide plays a role in how the body feels pain. Alder BioPharmaceuticals Inc., Eli Lilly & Co. and Teva Pharmaceutical Industries Ltd. all have CGRP antagonists in late-stage development too, though Alder will be last to submit an approval filing with the FDA. Adding another layer of interest to the race is that each company expects their respective drug to be a key growth driver.
While those drugmakers wait on an FDA verdict, others are working on making the most of their 2017 approvals.
Mitsubishi Tanabe Pharma brought to the U.S. market the first new drug for ALS since 1995, Radicava (edaravone); Newron Pharmaceuticals' locked down an FDA OK for the Parkinson's disease drug Xadago (safinamide) and subsequently launched it about four months later; and Teva in April got the go-ahead for Austedo (deutetrabenazin), a medicine for chorea associated with Huntington's disease that the Israeli drugmaker is banking on after years of revenue hits.
Investors will be watching to see how well those products beef up bottom lines.
For its part, Pfizer intends to keep investing in late-stage programs for its diabetic nerve pain drug Lyrica (pregabalin) and osteoarthritis pain candidate tanezumab. What's more, the big pharma will continue investigating treatments for rare neuromuscular and neurological diseases, as well as institute a neuroscience venture fund to support more research.
M&A activity was fairly muted in 2017, but dealmaking could easily pick up next year — with neuroscience being a key beneficiary.
Roche is another player to watch. In an interview with BioPharma Dive earlier this year, Tom Zioncheck, head of the global neuroscience and ophthalmology business at Genentech, said the company is committed to developing disease-modifying treatments for Alzheimer's, and is on the lookout for potential partnerships.
"So much of the focus over the last decade or two has been in oncology, but now I think pharma, and to a certain extent all of society, is more aware of this devastating disease and the impact it can have, not only on patients but their caregivers," he said, referring to Alzheimer's disease.
Takeda Pharmaceutical Co. Ltd., Boehringer Ingelheim GmBH and Otsuka Pharmaceutical Co. Ltd. are just a few other drugmakers that have also inked CNS-centric deals in the last year.
Shire plc, meanwhile, was is in the midst of figuring out next steps for its neuroscience portfolio, but earlier this week announced it would create two specific units, one for rare disease and one for neuroscience.
The Dublin-based pharma plans on continuing its review in 2018, and expects to give an update in the latter half of year about whether to spin out the neuroscience unit as a standalone company.
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