One of the most important subsidiaries for the pharmaceutical and agrochemical group Bayer is the American biotechnology start-up Bluerock Therapeutics, which is working on novel cell and gene therapies. Bluerock was valued at a good one billion dollars in 2019 when the Dax group from Leverkusen took over the company completely. Bayer has now announced the first important intermediate step in the development of a Parkinson’s therapy.
The 12 patients in the first phase 1 clinical trial tolerated the treatment well, Bayer announced on Wednesday. The subjects are end-stage Parkinson’s disease patients who have live cell material injected into their brains, which is an irreversible procedure. This is not yet allowed in Germany, which is why such studies are taking place in the United States. In therapy, the transplanted cells are intended to compensate for the damage to nerve cells caused by Parkinson’s disease. The brain produces too little of the messenger substance dopamine, the treatment is intended to restore brain functions – and thus possibly prevent the disease from spreading. So far, there are only treatment methods that temporarily relieve symptoms, a healing drug would probably bring the company billions in sales.
There are over 10 million patients worldwide
However, there is still a long way to go until then, and new drugs in cell and gene therapy could not come onto the market until the end of the decade at the earliest. However, the first study showed that all patients would have tolerated the active substance “for one year without major safety problems,” as Bayer announced. Starting next year, patients are to be recruited for a phase 2 study with more subjects. There are around 400,000 Parkinson’s patients in Germany and a good 10 million worldwide. The disease is the most common neurodegenerative movement disorder, Parkinson’s patients suffer from a decrease in motor skills and muscle stiffness.
Bluerock Therapeutics is headquartered in Boston on the east coast of the United States, and Bayer also opened a research center for its pharmaceuticals division there last year. In the summer of last year, however, the subsidiary also opened a branch on the company’s Berlin campus, where cell therapies are also being researched. Despite being part of Bayer, Bluerock is still an independent company. In Leverkusen they call it the “arm’s length” principle.
Bayer invests more than 3 billion euros a year in the research and development pipeline of its pharmaceuticals division. The entire pharmaceutical industry is faced with the challenge of refinancing its high investments with new substances, years of development are risky: Even in the last clinical phase, there can still be difficulties that sink billions in investments. Even approved medicines can still be expensive for manufacturers, as numerous court cases show. Bayer hopes that cell and gene therapy will provide more treatment methods based on the same foundation of gene sequencing or stem cells that can be transplanted.
Sales potential of 12 billion euros
On Wednesday, the Dax group also presented its investors with an interim status on the research pipeline in the pharmaceuticals division. “The vast majority of our new development candidates already offer the potential to become the first or best product in their class,” said Christian Rommel, who heads up research and development at Bayer. The company is currently focusing on four areas, in addition to cell and gene therapy, these are primarily active ingredients for cardiovascular diseases, in oncology and immunology. In the short term, Bayer is betting that its four drugs, which are in the late clinical phase or are already being approved, could achieve a peak sales potential of 12 billion euros. “In the short to medium term, these will more than compensate for the effects of the loss of market exclusivity,” said Stefan Oelrich, board member for pharmaceuticals, on Wednesday.
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So far, the pharmaceuticals division has been earning reliable billions in sales quarter after quarter, primarily with the oral anticoagulant Xarelto and the eye syringe Eylea. However, the patents for both products will gradually expire in the middle of the decade. Once imitation products are on the market, sales usually plummet.