Source: Instrument House, it may not be reproduced without authorization, and it can only be reproduced after 24 hours.
On March 20, Bayer and Thermo Fisher Scientific announced a collaboration to jointly develop a companion diagnostic test (CDx) based on next-generation sequencing (NGS) for Bayer's growing portfolio of precision oncology.
On the same day, Bayer announced that it would halve the management team of its pharmaceutical division.
Currently, the German pharmaceutical giant has too few new drugs to make up for the billions of sales lost due to the expiration of important patents. The company's most important drugs, Xarelto (anticoagulants) and Eylea, which account for 40% of total pharmaceutical sales, account for 40% of total pharmaceutical sales. As of December 31, 2023, Bayer's net financial debt was 34.498 billion euros (about 269.530 billion yuan).
Bayer is now looking for a new business breakthrough.
Bayer has been involved in the medical device field several times in recent years, and signed a cooperation agreement with CrossBay Medical in November last year to jointly develop a new intrauterine contraceptive device. In September, Bayer Pharmaceuticals Beijing Supply Center opened a ceremony for the opening of the imaging diagnostic medical device plant in Beijing Economic Development Zone, marking the imminent local production of Bayer's imaging diagnostic equipment in China.
01
Focus on precision treatment
Companion diagnostics (CDx) are important for the safety and efficacy of their concomitant drugs, which are used to detect patient-specific biomarkers and identify which patients can clearly benefit from drug therapy or are at increased risk of side effects.
In cancer treatment, the addition of companion diagnostics, that is, genetic testing of patients before medication is carried out to determine the sensitivity of patients to specific targeted drugs, so that patients can truly obtain accurate and effective treatment.
The companion diagnostics industry started first and developed the most mature in the United States. The U.S. FDA encourages companion diagnostics companies to work closely with drug development companies to achieve co-approval of companion diagnostics and their companion drugs in a more cost-effective way.
The CDx developed by Bayer and Thermo Fisher will be developed using the Oncomine Dx Express Test Kit (ODxET) on the Thermo Fisher Fisher Ion Torrent™ Genexus™ Dx sequencing platform.
High-throughput sequencing (NGS) is fast becoming the recommended technology path for molecular testing of oncology worldwide due to its throughput and detection advantages, but at the same time, its long turnaround time significantly limits the application of clinical outcomes.
Ion Torrent™ Genexus™ Dx is a fully automated next-generation sequencing (NGS) platform with a very fast turnaround time, delivering results from samples in as little as one day.
The Ion Torrent™ Genexus™ Dx Integrated Sequencer fully automates the application of DNA, RNA, and cfTNA samples, from NGS library preparation, template preparation, sequencing, and raw data analysis to variant annotation and reporting.
The Thermo Fisher Scientific Pan-Cancer Assay ODxET is a Genexus integrated NGS platform based on Thermo Fisher Fisher's all-in-one NGS platform. ODxET uses targeted NGS technology to provide clinically relevant tumor mutation analysis in as little as 24 hours, covering deletions, insertions, substitutions, and copy number increases in 42 genes of DNA and RNA in solid tumor FFPE tissue samples, as well as fusion or splice variants in 18 genes. It can also be applied to deletions, insertions, substitutions, and fusion or splice variants of 7 genes in cfTNA in plasma samples from non-small cell lung cancer (NSCLC).
Christine Roth, Member of the Executive Committee of Bayer Pharmaceuticals and Head of Bayer's Strategic Oncology Business Unit, said: "We are committed to developing new treatment options for patients with unmet medical needs and reducing treatments that offer less benefit or unnecessary side effects. "The collaboration with Thermo Fisher Scientific perfectly complements Bayer's precision medicine strategy and aligns with our ambition to further advance oncology genomic testing and personalized treatment to deliver the right treatment to the right patient at the right time."
Garret Hampton, President, Clinical Next-Generation Sequencing and Oncology, Thermo Fisher Scientific, said, "We are committed to providing a simple, rapid next-generation sequencing-based solution using tumor and liquid biopsy samples to support patient access to targeted therapies and improve patient outcomes. Our experience in developing CDx assays combined with the game-changing turnaround time provided by the Genexus Dx system enables rapid collection of results to better understand the impact of therapies. Combined with Bayer's growing portfolio of precision oncology, we are well-positioned to help patients get the right treatment quickly." ”
Financial terms of the partnership were not disclosed.
02
Radical change
In recent years, Bayer, one of the world's largest pharmaceutical companies, has faced multiple difficulties.
First, Bayer's best-selling core drug is currently facing the impact of the patent cliff. The oral anticoagulant Xarelto (rivaroxaban) jointly developed by Bayer and Johnson & Johnson, and the ophthalmic drug Eylea (aflibercept), jointly developed by Regeneron, contributed the majority of Bayer's revenue, contributing 4.516 billion euros and 3.213 billion euros in sales in 2022, respectively.
However, in 2020, rivaroxaban's patents expired in China, and from 2023, rivaroxaban's patents in EU countries, the United States, and Japan will also expire one after another. The Eylea patent will also expire in 2025.
On November 19, 2023, due to poor efficacy, Bayer terminated the phase III clinical trial of Asundexian, a new anticoagulant drug for stroke prevention, ahead of schedule, which dealt another blow to Bayer, which lacked new drugs, and the company's stock price fell 19% the next day, the largest decline in history.
In addition, Bayer's acquisition of Monsanto's pesticide business was costly to the company.
In 2018, Bayer spent $63 billion to acquire Monsanto, the maker of herbicide brand Roundup, while taking on a large number of lawsuits for Roundup's alleged carcinogenesis, resulting in a sharp increase in the group's net debt, not counting the group's commitment to pay another 16 billion euros to discharge the lawsuit.
On 11/17/23, Bayer lost the glyphosate lawsuit in the United States for the fourth time in a row, and Bayer was required to pay $1.56 billion in damages to four defendants due to the carcinogenicity of the herbicide Roundup. Since the acquisition, Bayer has paid more than $10 billion to settle claims related to the herbicide.
At the same time, Bayer's current performance is not optimistic, Bayer covers three major segments: Crop Science, Pharmaceuticals and Consumer Health, which generated revenues of 17.640 billion euros (-10%), 13.502 billion euros (-6.2%) and 4.449 billion euros (-2.3%) in the first nine months of 2023, respectively.
In the face of multiple crises, Bayer is in urgent need of reform.
At the same time as the release of its third quarterly results, Bayer announced that it would spin off and reorganize, evaluate the spin-off of its consumer health or crop science divisions, while significantly reducing management positions. Bayer CEO Bill Anderson announced that he expects to save 2 billion euros per year in organizational costs from 2026 onwards by improving the company's efficiency through internal integration.
03
The era of precision is coming
The treatment of tumors has entered the era of companion diagnosis and precision therapy, and the characteristics of drugs in the era of precision medicine are that the drug is guided according to the individual differences of the genome, which can greatly improve the survival rate of cancer patients.
The co-development of drugs developed by pharmaceutical companies and companion diagnostics CDx can give full play to the synergistic advantages of drugs and diagnostics, increase the probability of drug approval, better study the drug targets of the target group, improve the efficacy and safety of drugs, reduce the necessity of drug treatment, and provide patients with better treatment options.
In fact, many drugs in the clinical stage have begun to carry out the research and development of supporting companion diagnostic products, and they are simultaneously incorporated into the clinic. The combination of companion diagnostics and new drug development not only optimizes the efficiency of companion diagnostic reagent development, but also reduces the risk of clinical trials of new drugs to a certain extent.
Recently, there have been frequent cooperative research and development of companion diagnostics at home and abroad.
In January, Agilent announced a partnership with drug manufacturer Incyte to develop companion diagnostics. The companies plan to focus on Incyte's hematology and oncology portfolio.
In the same month, Predicine, Inc., a molecular diagnostics company, announced a CDx companion diagnostic collaboration with Johnson & Johnson's Janssen Pharmaceuticals to identify™ patients with localized bladder cancer with specific genetic variants who may benefit from targeted therapies.
On October 25, 2023, at the 2023 Boehringer Ingelheim China R&D Day, Boehringer Ingelheim announced that it has officially entered into a strategic cooperation with Burning Rock Dx in the field of companion diagnostics for oncology products, which will focus on the advancement of relevant clinical trials of Brigimadlin (BI 907828), an MDM2-p53 antagonist developed by Boehringer Ingelheim, in China and the development of companion diagnostic products.
On November 29, 2023, Tianjin Yunjian Medical Laboratory Co., Ltd. (hereinafter referred to as "Yunjian Medical") and Hangzhou Baikai Biopharmaceutical Co., Ltd. (hereinafter referred to as "Baikai Biopharmaceutical") jointly announced that the two parties have reached a cooperation agreement on the joint development of innovative drug protein biomarkers and companion diagnostics.
According to statistics, the total value of the global companion diagnostics market in 2020 was about $3.5 billion, and it is estimated to reach a market size of $6.8 billion in 2025, with a compound annual growth rate of about 12.9%. It is expected that the market will continue to expand in the future with the discovery of new tumor mutations, the acceleration of targeted drug research and development, and the discovery of new biomarkers.
The cooperation between Bayer and Thermo Fisher Scientific is also a reflection of focusing on the main business and conforming to the trend.