A bad week for Biogen
Biogen deserves credit for setting the bar high with its R&D aspirations, but additional pipeline setbacks over the past seven days will put its management team under more pressure to turn to M&A.
Late last week, Biogen and partner Eisai announced the termination of Phase III studies for the experimental oral BACE inhibitor elenbecestat in patients with early Alzheimer's disease due to an unfavourable risk-benefit profile.
Earlier this year, the two companies halted Phase III studies of the experimental anti-amyloid beta antibody aducanumab, which was being tested in mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia, as they were deemed unlikely to meet their primary endpoints.
Biogen and Eisai are continuing to develop the anti-amyloid beta protofibril monoclonal antibody BAN2401, including the Phase III Clarity AD trial, which was initiated in March in patients with early Alzheimer's disease.
Such are the low expectations for success, however, a number of analysts have suggested that discontinuation of BAN2401 would be viewed by investors as being a relatively positive development. Others have noted that were BAN2401 to prove successful, regulators would be highly suspicious that any observed effect could be a product of random chance, given the high number of prior failures in this field.
To compound matters, Biogen announced on Tuesday that it has stopped a Phase II study of the experimental drug BG00011 in patients with idiopathic pulmonary fibrosis (IPF) due to "safety concerns." Biogen gained BG00011 as part of a 2012 deal potentially worth more than $560 million to buy Stromedix.
Biogen's 'high risk, high reward' R&D strategy has delivered success in the form of Spinraza, a treatment for spinal muscular atrophy (SMA), though competition has recently entered the market in the form of Novartis' gene therapy Zolgensma and Roche hopes to secure approval of its oral SMA treatment risdiplam next year.
Analysts at Baird suggest that versus its large-cap biotech peers, "Biogen would have the easiest time solving questions on revenue shortfalls with an acquisition," requiring additional peak revenues of between only $1 billion and $2 billion "to move the needle for investors." A number of companies in the CNS space would represent a good fit, though they caution that Biogen increasingly runs the risk of becoming an acquisition target itself.
Lundbeck bets on Alder and eptinezumab
One potential CNS target no longer on the table is Alder BioPharmaceuticals, which Lundbeck has agreed to acquire in a deal potentially worth just shy of $2 billion.
It provides the Danish company access to eptinezumab, a potential fourth-to-market CGRP inhibitor for migraine prevention, which is due to be approved by the FDA next year. Lundbeck has described eptinezumab as a possible blockbuster, but to meet this bar, it will need to convince physicians on the merits of intravenous dosing every three months versus the typical monthly self-injectable administration of competitor drugs. Lundbeck says that eptinezumab has a faster onset of action than other CGRP inhibitors, with many patients who suffer from chronic migraines seeing an almost immediate benefit.
Investors have been clamouring for a deal to boost Lundbeck’s late-stage pipeline, but management is only likely to receive credit for acquiring Alder if commercial execution, once eptinezumab is launched, is up to scratch, said analysts.
Lots more to come says Roche
At an event held in London on Monday, Roche detailed a broad overview of its pharmaceutical business, providing further evidence that it is well positioned to outgrow biosimilar erosion of its legacy oncology franchises through improvements in R&D productivity.
Recent launches such as Ocrevus (multiple sclerosis) and Hemlibra (haemophilia) will play a key role here and showcase Roche's diversification outside of cancer care; a trend that looks poised to continue as new products emerge from the pipeline.
There is, for example, considerable excitement around risdiplam, an experimental oral treatment for spinal muscular atrophy (SMA), and HTT-ASO, a potential first disease modifying agent for Huntington's disease.
That is not to downplay the importance of oncology. Next year will be an important one in terms of data readouts - including Tecentriq in adjuvant lung cancer - and Roche confirmed this week it is accelerating two novel breast cancer drugs from Phase I to Phase III studies.
The Swiss pharma showdown gathers pace
Arguably competing with Roche for the title of pharma's most productive R&D company is its cross-town rival Novartis; an interesting by-product of which is that over the next few years, the Swiss pair will trade blows in a number of disease areas.
A particularly intriguing showdown awaits in the spinal muscular atrophy (SMA) market, where Novartis has recently launched its gene therapy Zolgensma. Next year, Roche hopes to launch an effective oral therapy in risdiplam, noting this week that serious questions remain about the long-term durability of gene therapy.
Elsewhere, Novartis is hoping to dent Roche's progress in the multiple sclerosis market, where Ocrevus has rapidly become established as a treatment of choice over the past two years. Late last week, Novartis unveiled positive data for its own anti-CD20 antibody product ofatumumab, setting up likely approval next year.
How these two agents are administered to patients could play a key role in how the market shapes out, with battle lines being drawn even before ofatumumab has been submitted to regulators.
This time next week the European Society of Medical Oncology (ESMO) congress will have kicked off in Barcelona, Spain, providing a venue for notable data updates for both targeted- and immuno-therapies.
Results from two positive pivotal-stage studies evaluating PARP inhibitors (AstraZeneca and Merck & Co.'s Lynparza and GlaxoSmithKline's Zejula) as first-line maintenance therapies for ovarian cancer will be presented. Long-awaited overall survival data for AstraZeneca's Tagrisso - in EGFRm non-small-cell lung cancer - will also be unveiled.
As will a number of key immunotherapy updates, including Roche's Tecentriq in first-line bladder cancer and Merck's Keytruda in adjuvant triple negative breast cancer.
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