Share in Life Healthcare Group – a South African private hospital operator – soared in trade on the Johannesburg Stock Exchange on Tuesday (8 June), after the US Food and Drugs Administration approved Biogen’s Alzheimer’s drug.
Biogen Inc’s controversial Alzheimer’s disease therapy was approved by US regulators, a landmark decision that stands to dramatically change treatment for the debilitating brain condition, Bloomberg reported.
The Food and Drug Administration granted the antibody therapy an accelerated approval, meaning that Biogen will need to conduct more research to establish its benefits for it to remain on the market.
Patient-advocacy groups have supported the drug despite scepticism from some scientists about its mixed record in clinical trials, Bloomberg said.
The FDA said in a statement on Monday that it was allowing the drug on the market because it reduces amyloid, a sticky, harmful protein that clogs the brains of Alzheimer’s patients. Amyloid’s role in Alzheimer’s is debated, but numerous other drugs that target it are being developed by pharmaceutical companies.
Some patients may have temporary swelling in areas of the brain that usually resolves over time without causing symptoms, and some may also have small spots of bleeding, according to the drug’s label. In some cases, people with brain swelling may experience headache, confusion, dizziness, vision changes, or nausea.
Bloomberg noted that Biogen plans to sell the therapy under the brand name Aduhelm, and will cost $56,000 a year.
Life Healthcare, which operates 66 healthcare facilities in Southern Africa, and with 4,000 specialist and healthcare professionals in its network, climbed nearly 7% in afternoon trade on the JSE, having welcomed the FDA’s decision to grant accelerated approval of aducanumab for the treatment of Alzheimer’s disease.
This decision, it said, is significant, given that approximately 35 million people suffer from Alzheimer’s disease globally. It said that continued approval relies on the demonstration of clinical benefit in confirmatory trials.
The group highlighted how its business stands to benefit from the FDA’s decision. “Aducanumab has been shown to reduce amyloid beta plaques in the brain which is likely to slow neurodegeneration and disease progression. It is the first drug approved to treat Alzheimer’s disease in 20 years.
“This approval marks an exciting moment in Life Molecular Imaging’s (LMI) journey from the a research and development arm within the Bayer Pharma AG’s laboratories, to the work continued by the Piramal family over the past 20 years ago,” Life Healthcare said.
LMI was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Alliance Medical Group – a member of the Life Healthcare Group. It offers an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities.
Life Healthcare said that before achieving EBITDA breakeven in 2020, over $400 million had been invested in this business to research, and develop, a pipeline of radioisotope tracers to assist with the diagnosis of various diseases.
One such tracer, LMI’s FDA-approved Beta amyloid imaging tracer NeuraCeq, is used to diagnose Alzheimer’s disease by highlighting the Beta amyloid deposits in the brain. “Aducanumab’s approval yesterday paves the way for LMI to become an integral part of the diagnostic pathway, prior to patients starting treatment for Alzheimer’s disease,” it said.
“At Life Healthcare, our purpose is making life better – for patients and our people. As we expand and grow our business into new markets, our purpose will become increasingly important to more people in more geographies. Having a part to play in improving the lives of Alzheimer’s patients and bringing hope to them and their families is significant and aligned to our purpose,” said Peter Wharton-Hood, group chief executive for Life Healthcare.
LMI has the capability to manufacturer NeuraCeq through its wholly-owned cyclotrons across Europe. In partnerships with cyclotron operators, LMI will also scale up investment to bolster its manufacturing capacity for NeuraCeq whilst also enhancing its sales, marketing and distribution capabilities, the group said.
“This is also an exciting moment for LMI’s parent company, Alliance Medical Group (AMG), one of the largest diagnostic imaging groups within Europe. AMG is well placed to assist patients undergoing diagnostic testing for Alzheimer’s disease through its network of PET-CT scanners.
“In addition, AMG can assist with the MRI scans that patients on aducanumab may need as part of the monitoring of their treatment,” it said.
At this stage, the financial impact of the FDA approval is uncertain due to a numbers of factors, Life Healthcare said.