Pharmaceutical Companies Terminate Multiple Pipeline Projects, Impacting Drug Development Strategies

In recent news, it has been reported that approximately 50 pipeline projects have been terminated by various pharmaceutical companies. Takeda, for instance, disclosed in their third-quarter financial report that they have experienced a significant increase in net losses due to a series of uncontrollable factors. As a result, their projected annual net profit has been downgraded by 71%. Takeda has announced the discontinuation of four pipeline projects, including a product that has already been launched, focusing on the treatment of diseases such as lung cancer and Alzheimer's disease.

Just last month, Takeda announced the voluntary withdrawal of mobocertinib (brand name: Exkivity) from the market in the United States following discussions with the FDA. Mobocertinib had received approval from the FDA and the National Medical Products Administration based on its Phase I/II second-line single-arm trial. However, Takeda did not continue its development for second-line applications and instead shifted its research focus to first-line treatment, initiating the EXCLAIM-2 trial. Unfortunately, EXCLAIM-2 was terminated as the Phase III clinical study did not meet its primary endpoint.

Takeda has also initiated the process of withdrawing approved indications in China and other countries where mobocertinib had been approved. The company is actively engaging with regulatory authorities in these regions. This year, several major multinational pharmaceutical companies have announced streamlining plans, resulting in the termination of nearly 50 pipeline projects.

Recently, Roche's third-quarter financial report revealed that they will be streamlining four product development pipelines. These pipelines cover the treatment areas of multiple myeloma, diabetic retinopathy, schizophrenia, and other diseases. The specific projects include the discontinuation of a Phase III study of Venclexta in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma due to results falling short of expectations. Additionally, two Phase II projects, including the TAAR1 agonist Ralmitaront for the treatment of schizophrenia and the Vicasinabin therapy for diabetic retinopathy, were terminated for not meeting their primary endpoints. The Phase I trial of the T-cell bispecific antibody Cibisatamab for solid tumors was also abandoned based on "overall efficacy and safety data and the evolving treatment landscape in the therapeutic area."

Six months ago, Roche had also discontinued several other drug development projects, including an ASO drug for Angelman syndrome (Rugonerse), a Phase III-stage tenecteplase therapy for stroke indications, and RG6358, a Phase II-stage gene therapy for hemophilia A.

Based on the clinical stages, out of the 48 suspended pipeline projects included in the analysis, approximately half of them were halted at the Phase II stage. This accounts for a total of 24 projects. Pfizer, for example, had at least eight clinical projects halted at this stage. These included PF-07038124, a topical PDE4 inhibitor for psoriasis and atopic dermatitis, APD418, a β3-adrenergic receptor antagonist for acute heart failure, and Temanogrel, a clinical trial for systemic sclerosis-associated microvascular obstruction and Raynaud's syndrome.

Phase II trials, also known as efficacy or clinical effectiveness trials, aim to provide preliminary evaluations of a drug's therapeutic effect and safety in patients with the target indication. During this stage, the trial population is often expanded compared to earlier phases, making it easier to identify potential safety concerns as the number of participants increases. Besides safety, if a drug does not demonstrate significant advantages over existing treatment options in terms of therapeutic effects during this stage, the corresponding pipeline project is likely to be terminated.

In the analyzed data, Phase I projects had the second-highest frequency of termination, with approximately 16 pipeline projects being discontinued at this stage. Approximately eight projects were terminated at the Phase III stage.

In terms of drug types, small molecule drugs were the most frequently affected. Bayer, for example, announced the termination of four pipeline projects, all of which were small molecule drugs. These included BDKRB1 receptor antagonists for neuropathic pain (BAY2395840), an oral soluble guanylate cyclase (sGC) stimulator for chronic kidney disease (Runcaciguat), and BAY2395840 and a P2X4 antagonist for endometriosis.

In recent years, the pharmaceutical industry has witnessed clustering of companies in popular research areas, and in some fields, dozens or even hundreds of pharmaceutical companies are involved in research and development. However, only a minority of these companies will ultimately succeed in achieving commercialization and successful market entry.

With changing market conditions, large pharmaceutical companies with global operations are increasingly focusing on terminating or divesting non-core pipeline projects, optimizing their workforce structure, reducing costs, increasing efficiency, and achieving growth.