The share price of U.S. drugmaker AbbVie has been on a high-altitude run, recently setting fresh record highs day after day. The pace of commercialization is picking up as the company's key drug candidates knock on the door of U.S. regulators one after another.
On the 30th (local time), AbbVie closed at $231.54 on the New York Stock Exchange, up 3.76% from the previous day.
AbbVie said that on the day it submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for its drug candidate "pivekimab sunirine (Pivekimab Sunirine, PVEK)." The company has been developing the molecule as a treatment for blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML).
BPDCN is a rare and highly aggressive blood cancer. It has characteristics of both leukemia and lymphoma, with malignant tumors invading the skin and spreading to the bone marrow, central nervous system, and lymph nodes. Current treatment involves high-intensity first-line chemotherapy followed by hematopoietic stem cell transplantation.
PVEK, developed by AbbVie, is an antibody-drug conjugate (ADC), a next-generation anticancer therapy, designed to target the CD123 (IL-3Ra) protein, which is overexpressed in BPDCN. Unlike conventional chemotherapy that affects healthy cells, ADCs precisely target only cancer cells and are called "guided missiles that hit cancer." They consist of an antibody that seeks out cancer cells, a payload drug that kills cancer cells, and a linker that connects them.
Currently approved ADC therapies by the FDA include Pfizer's Mylotarg (acute myeloid leukemia); Enhertu (metastatic breast cancer, gastric cancer, lymphoma, etc.) from Japan's Daiichi Sankyo and Britain's AstraZeneca; Datrway (non-small cell lung cancer); and AbbVie's Emrelis (non-small cell lung cancer).
Alongside ADC cancer drugs, AbbVie is also accelerating development of a Parkinson's disease treatment. On the 26th, AbbVie said it submitted a new drug application to the FDA for tavapadon, developed as a Parkinson's treatment. If the FDA approves tavapadon, AbbVie's leadership in the Parkinson's market could strengthen further. AbbVie also has Vyalev, a Parkinson's treatment approved by the FDA in Oct. last year.
The market is watching whether AbbVie's next-generation drugs will succeed commercially. The company ranked No. 1 in global prescription drug sales for 10 years through 2022 with Humira (adalimumab), a treatment for autoimmune diseases. But as Humira's patents expired and the biosimilar market opened, concerns arose over weaker results.
Multiple companies, including Samsung Bioepis and Celltrion, rolled out Humira biosimilars (biosimilar drugs), and as a result Humira sales plunged. Humira sales reached $21.237 billion (about 29 trillion won) in 2022 alone, but fell sharply to $8.993 billion (about 12 trillion won) last year.
AbbVie has invested aggressively to secure future growth to follow Humira. A prime example is its acquisition in Dec. 2023 of ImmunoGen, a developer of ADC therapies, for $10.1 billion (about 14 trillion won).
It is continuing to invest this year as well. The company said on the 30th that it began construction of an active pharmaceutical ingredient (API) manufacturing plant in North Chicago, Illinois, and plans to invest more than $10 billion (about 14 trillion won) over the next 10 years.
AbbVie's sales last year were $56.334 billion, up 3.7% from the previous year. AbbVie expanded its scale by acquiring Allergan, the company behind Botox, for $63 billion in 2019.