Lilly Pharmaceuticals continues to increase its focus on inflammatory bowel disease (IBD). On July 8th local time in the United States, Lilly Pharmaceuticals announced that it will acquire Morphic, an American biopharmaceutical company. The total amount of this acquisition is approximately 3.2 billion US dollars. After the acquisition, Lilly Pharmaceuticals will acquire Morphic's main project for treating inflammatory bowel disease, as well as other preclinical pipelines for treating autoimmune diseases, pulmonary hypertension, fibrosis, and cancer.
The acquisition is expected to be completed in the third quarter of 2024.
MORF-057 is Morphic's first pipeline, which is an oral alpha 4 β 7 specific integrin inhibitor. The drug is currently in phase 2 clinical stage and is used to treat inflammatory bowel disease, with the potential to improve the treatment effect of the disease and increase patient treatment options.
"Oral therapy can open up new possibilities for early intervention in diseases such as ulcerative colitis, while also providing the potential for combination therapy to help patients with more severe conditions," said Dr. Daniel Skovronsky, Chief Scientific Officer and President of Lilly Research Laboratories and President of Lilly Immunology
Wei Zhe (pseudonym), a senior practitioner in the medical industry, told Time Finance, "Integrin is an integrated protein with bidirectional signal transduction ability in living organisms, which can almost affect every aspect of the organism's homeostasis. Therefore, the imbalance of the integrin signaling pathway is related to many diseases, including autoimmune diseases, cardiovascular diseases, metabolism, fibrosis, cancer, etc. So far, multiple injectable drugs targeting integrin have been approved for the treatment of self reliant diseases, cardiovascular diseases, etc. However, for patients with such chronic diseases, the convenience of oral drugs is undoubtedly more advantageous than injection, which can increase patients' medication compliance."
"MORF-057 has achieved the clinical stages of ulcerative colitis (UC) phase 2 and Crohn's disease (CD) phase 2, and is expected to become the first in class oral integrin drug in the field of IBD treatment (FIC). The future clinical and market prospects are worth looking forward to," Wei Zhe explained to Time Finance.
Inflammatory bowel disease is an autoimmune disease that includes ulcerative colitis and Crohn's disease, characterized by inflammation of the intestinal mucosa, leading to abdominal pain, diarrhea, and bloody stools. In most cases, patients may experience relief through medication, but ultimately relapse, leading to an overall decline in quality of life. At present, the pathogenesis of inflammatory bowel disease is still unclear.
In recent years, autoimmune diseases have become the second largest disease market globally, with broad market space and potential. According to the industry media arterial network, the global market size for self immune diseases was approximately $131.7 billion in 2022, while the market size for self immune disease drugs in China was approximately $3.6 billion that year. According to research firm Frost Sullivan, the global market size for self immune drugs is expected to reach $176 billion by 2030, with the Chinese market expected to reach nearly $25 billion, a tenfold increase from 2020.
According to industry media "Medical Notes", in the past few years, the self exemption track has been exceptionally lively in the US stock market. From 2020 to 2024, there were over 30 trading events in the self exemption field, with trading amounts ranging from billions of dollars to tens of billions of dollars.
The drug development and trading of inflammatory bowel disease are particularly hot in the field of self immunity. Among them, the large single product Entyvio has strong sales momentum, with global sales exceeding 5 billion US dollars in 2022 and 2023.
Vedrizumab is a biologic developed by Takeda Pharmaceuticals for the treatment of inflammatory bowel disease. Its intravenous (IV) formulation was first approved in May 2014, while the subcutaneous (SC) formulation was first approved for sale in April 2020. In China, Vedrizumab (trade name: Anjiyou) was approved for marketing by the National Medical Products Administration (NMPA) in March 2020 for the treatment of moderate to severe active adult Crohn's disease and ulcerative colitis patients who have insufficient, unresponsive, or intolerant response to traditional therapy or tumor necrosis factor alpha (TNF alpha) inhibitors. At present, the intravenous and subcutaneous injection preparations of this product have been approved for marketing in multiple countries and regions.
The acquisition of Morphic by Lilly Pharmaceuticals this time is not the first large-scale transaction in the inflammatory bowel disease track and the entire field of autoimmune diseases. Last June, Lilly Pharmaceuticals acquired DICE Therapeutics for approximately $2.4 billion. The main candidate therapeutic drugs for DICE Therapeutics are IL-17 oral inhibitors. In addition, they are also developing oral candidate therapeutic drugs targeting integrin alpha 47 for the treatment of inflammatory bowel disease.
At the end of June this year, Ensho Therapeutics also reached a cooperation agreement with EA Pharma, a subsidiary of Weicai. According to the licensing terms of the agreement, Ensho Therapeutics will collaborate with EA Pharma to conduct global clinical research on EA1080. EA1080 is a novel oral inflammatory bowel disease treatment drug, and EA Pharma will receive payments from Ensho Therapeutics to achieve certain development, regulatory, and commercial milestones, as well as graded royalty fees up to a double-digit percentage of EA1080's net sales. Ensho Therapeutics has the right to develop, manufacture, and commercialize combinations of EA1080 and other oral selective alpha 4 β 7 integrin antagonists, targeting global markets outside of Japan, China, South Korea, and ASEAN.
In China, the development of the inflammatory bowel disease track is relatively slow. According to a set of data provided by the industry data platform Yaodu in 2023, new drugs for inflammatory bowel disease in China can be divided into four categories, namely biological preparations, small molecules, mesenchymal stem cells, and traditional Chinese medicine. Enterprises that develop related drugs include Kangneide Biotechnology, Kangfang Biotechnology, Quanxin Biotechnology, Ruishi Biotechnology, etc. However, the development progress of most drugs is still in the stage of clinical implied permission or Phase I and II.
Despite the global increase in trading for inflammatory bowel disease, there are still many challenges in developing an effective patent medicine.
Wei Zhe takes the study of integrin, one of the drugs that may be used for inflammatory bowel disease, as an example. "The study of integrin originated in the 1980s. Due to the dysregulation of the integrin signaling pathway and its association with many diseases, many pharmaceutical companies are competing to develop new drugs in this field. However, due to the complex characteristics and regulatory mechanisms of integrin action, the development process of integrin targeted drugs is not ideal. So far, only single digit integrin targeted drugs have been successfully launched, such as drugs targeting α IIb β 3, α 4 β 7, α 4 β 1, and α L β 2 integrin."