Bayer cuts swathe through pipeline

Bayer has dropped 20 development projects, but another 50 potential new drugs have been judged to have made the grade and their development will continue. Of those, 14 are in Phase I, 17 in Phase II and 19 in Phase III. A further nine projects have already been submitted for marketing authorisation. Bayer's acquisition of Schering was originally announced back in March 2006, and a spokesperson for Bayer first revealed to DrugResearcher.com that there would be significant pipeline cuts over four months ago​, when the company announced research job cuts. However, with industry insiders keen to find out more, it is only now that Bayer has confirmed how the amalgamation of the two companies will definitely affect its prospective pipelines; although Bayer claims that the integration process is going faster than it thought it would. The dropped projects were rejected "due to strategic reasons or low prospects for success"​, said Bayer. These include Leukine (sargramostim) against Crohn's disease. The drug is already approved to reduce infections picked up following chemotherapy. It is a recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) designed to reduce the amount of time neutrophil white blood cell counts take to recover from low levels induced by intensive cancer treatment. A number of other projects have been deprioritised, with Bayer's head of global drug discovery, Andreas Busch, explaining that some will be terminated, while others will be available for an outlicensing deal. This latter group includes a CETP Inhibitor, a protein in the liver that transfers cholesterol. This is the same drug class as Pfizer's torcetrapib, which failed a pivotal trial last December​. Among the other scraps for rival drug developers to pick up are MS-275, a histone deacetylase (HDAC) inhibitor, the cancer drug PTK/ZK and asoprisnil to combat benign uterine tumours. PTK/ZK is a multi-VEGF (vascular endothelial growth factor) receptor tyrosine kinase inhibitor, which blocks tumour angiogenesis and lymph angiogenesis by inhibiting all known VEGF receptors. The drug was co-developed by Schering and Novartis but little has been heard of it since it failed two Phase III clinical trials in 2005 and Bayer's decision to try and offload it is unlikely to come as a surprise to many. Asoprisnil is a selective steroid receptor modulator and represents a new class of progesterone receptor (PR) ligands that exhibit partial agonist and antagonist activities in vivo​. What is left after the reshuffle is a fairly strong pipeline, with a fair proportion of innovative drugs. 25 of the 59 drugs are New Molecular Entities (NMEs), a good measure of whether a drug can be seen as truly innovative, rather than simply a so-called 'me-too' effort. Most of those 29 are, unsurprisingly, in early clinical development but 5 are in Phase III or already submitted to regulatory authorities. Also, eight of the 25 are New Biological Entities (NBEs), which highlights Bayer's commitment to biological drug development as well as small molecules. More generally, Busch outlined plans to reduce the number of therapeutic areas the company will concentrate on. Bayer's haematology programmes look to have lost out, along with Schering's dermatology, immunology and men's health (andrology) projects. Instead, Bayer will focus on just four therapeutic areas. It will continue to focus on Oncology and Cardiology, incorporating matching research from Schering. The acquired company's diagnostic imaging and women's health programmes will be kept, although the latter will be refocused towards gynaecological therapies. "We are adjusting our pharmaceutical research and development budget for this year and in 2008 to about 15 percent of the division's sales. We expect that the budget will be between 15 and 17 percent in the years thereafter,"​ said Arthur Higgins, Chairman of Bayer HealthCare. A new 'proof of concept' process has been established by the company to try and speed up the process of deciding which new drugs are effective. "A key factor in our R&D strategy was to increase productivity and strengthen our innovation capability,"​ said Higgins. Bayer has also agreed to renew and extend its license agreement with Ariadne Genomics, which will allow it to use the company's Pathway Studio software until 2010. The systems biology software is used to analyse pathways, signalling networks, and microarray data interpretation. It is powered by Ariadne's MedScan technology and can be used to automatically extract pathway-related information from biomedical literature.