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Frankfurt: Bayer 's pioneering cell and gene therapies for Parkinson's disease are at the forefront of an exciting but risky test of CEO Bill Anderson's development credentials as patent expiries on blockbuster drugs threaten the group's long-term growth projects. Rivals in cell and gene therapy technologies are already generating revenue from treating cancer or rare hereditary diseases, but Bayer is entering new territory through subsidiary BlueRock's bemdaneprocel, an experimental Parkinson's disease treatment designed to replace dopamine-producing brain cells killed by the disease. BlueRock reached a milestone on Monday, becoming the first to take a cell therapy against Parkinson's to the third phase of testing, but the path to regulatory approval is long and the outcome uncertain. Pharma division head Stefan Oelrich expects results in 2028 or 2029. PIPELINE CHALLENGES FOR CEO Former Roche executive Anderson, meanwhile, is coming under increasing scrutiny over Bayer's pharmaceuticals pipeline after the revenue hit it has taken from the expiry of patents on its anticoagulant Xarelto and eye medicine Eylea. That leaves cell and gene therapies accounting for about 20% of a pharma pipeline Anderson identified as one of the biggest challenges facing the German conglomerate when he took the helm in June 2023. "Anderson's background is in the pharmaceutical business. After more than two years, it's about time he started to deliver in his strongest domain," said Ingo Speich, at mutual funds company Deka Investment. "Bayer urgently needs success in the pharmaceutical sector to overcome past disappointments and rebuild trust in the capital market." Markus Manns at Union Investment also emphasised the risk element. "Bayer's cell and gene therapies do not currently play a role in the valuation of the group due to the high development risk," he said, citing the complexity of transplanting cells into the brain and the immune suppression patients will require. The development line-up took a big hit in 2023, when a once-promising blood thinner flopped in a trial, though cancer drug Nubeqa and kidney disease medicine Kerendia are compensating for lost Xarelto sales. SHARES DOWN 70% SINCE MONSANTO DEAL Bayer's problems run deeper, however, with its shares down more than 70% since the 2018 takeover of Monsanto. U.S. litigation over disputed claims that its weedkiller glyphosate causes cancer has cost it billions of dollars, with billions more at stake as further settlements loom. The group's heavy debt burden, meanwhile, has led it to consider a capital increase in the medium term. Much rests on the cell and gene therapies, therefore. Despite bemdaneprocel being years from market launch, Bayer is working on a manufacturing network for cell and gene therapy products, including a $250 million facility in California. "The manufacture of cell and gene therapy products is not just a science, it is a very special kind of expertise," says Bayer's Oelrich. "That's why we use the term 'the process is the product' in cell and gene therapies." Though there is no analyst consensus yet on future sales potential and Bayer has not issued estimates on sales or costs, the rewards could be considerable. "We believe that our treatments can stop the progression of the disease and possibly reverse it," said Christian Rommel, Bayer's head of pharmaceutical research and development. Parkinson's disease and its progressive brain damage affect more than 10 million people worldwide, with the number projected to more than double by 2050. Symptoms include loss of muscle control, tremors and dementia in some patients. Christie Wong, neurology expert at market researcher GlobalData, said that treatment of the causes rather than the symptoms of the disease would be in high demand. "The need for disease-modifying therapies is one of the greatest unmet needs in this area," she said. WIDE FIELD OF RIVAL PROJECTS The hunt for Parkinson's treatments has suffered many setbacks over the years, but there has been something of a revival of late. Market researchers at GlobalData told Reuters that Bayer's BlueRock is the most advanced in a race of 17 projects testing cell therapies against Parkinson's. They also estimate that the overall Parkinson's therapy market will reach $7 billion in the world's seven largest markets by 2033, almost doubling from 2023, on new therapy launches and growing patient numbers. Bayer's rivals in the field include Japan's Sumitomo Pharma in partnership with Kyoto University Hospital, a collaboration between Lund University and Cambridge University as well as U.S. biotech company Aspen Neuroscience. Among Bayer's other cell and gene therapy projects, its AskBio operation is in separate Phase II testing of new gene therapies for Parkinson's disease and heart failure. The broader cell and gene therapy sector is expected to climb from $8.3 billion in 2024 to $71.7 billion in 2030, GlobalData says. (Reporting by Patricia Weiss Writing by Ludwig Burger Editing by David Goodman)

SAN SEBASTIAN, Spain: Bayer has started the third phase of human testing of an experimental stem cell therapy for Parkinson's disease, with future results potentially underpinning a request for regulatory approval, the company said on Monday. Despite still being years from market launch, Bayer, which spent about $250 million on a new facility for cell therapies in California in 2023, said it is already working on a manufacturing network for the cell-replacement therapy. The cell and gene therapy push has been seen by investors as an uncertain longer-term attempt to revive its drug development pipeline while it seeks to reduce financial debt and fight litigation that could cost it billions of dollars. COMPETING CELL THERAPIES FOR PARKINSON'S DISEASE Over the near term, Bayer's pharmaceutical unit is banking on revenue from products such as new prostate cancer drug Nubeqa, kidney treatment Kerendia and a menopause relief drug to offset expiring patents for bestsellers like stroke prevention drug Xarelto and an older version of eye medication Eylea. The experimental Parkinson's therapy, developed by Bayer's BlueRock subsidiary, was previously shown to be well-tolerated, and the transplanted cells have grown as intended in patients' brains. Bayer's Asklepios Biopharmaceutical unit, also known as AskBio, is separately in Phase II of testing a new gene therapy for Parkinson's disease. The hunt for Parkinson's treatments has seen many setbacks over the past decades. But a number of research teams have said they are working on a similar approach that transplants modified cells to restore parts of the brain that normally produce dopamine. They include Japan's Sumitomo Pharma, a team at Lund University and Cambridge University, U.S. biotech firm Aspen Neuroscience, and a team at hospital network Mass General Brigham in Boston. For BlueRock's procedure, researchers take human stem cells and transform them into dopamine-producing nerve cells. When surgically implanted into the brain of a person with Parkinson's disease, the therapeutic cells are designed to restore neural networks destroyed by the disease. There is currently no cure for Parkinson's disease, which causes progressive brain damage and affects more than 10 million people worldwide. Common symptoms are loss of muscle control, tremors, muscle rigidity and slowness of movement with dementia seen in some patients. (Reporting by Patricia Weiss; Writing by Ludwig Burger; Editing by Joe Bavier)