The FDA granted accelerated approval to Elahere in November 2022 for adults with folate receptor-alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
AbbVie has completed its acquisition of ImmunoGen in a deal that was announced in November 2023, which bolsters the company’s pipeline of antibody drug conjugates (ADCs).1 As part of the transaction, AbbVie acquired in cash all outstanding shares of ImmunoGen for $31.26 per share, valuing ImmunoGen at a total equity value of approximately $10.1 billion.2
"Together with ImmunoGen, we have the potential to continue redefining the standard of care for those living with cancer," AbbVie President and Chief Operating Officer Robert A. Michael, said in a press release. "The addition of ImmunoGen's treatment for ovarian cancer will accelerate our ability to help patients today, expand our oncology pipeline and drive long-term revenue growth well into the next decade. I want to thank ImmunoGen for their efforts to advance science for patients and we look forward to welcoming our new colleagues to AbbVie."1
As part of the transaction, AbbVie gains ImmunoGen's flagship ADC Elahere (mirvetuximab soravtansine-gynx). The FDA granted accelerated approval to Elahere in November 2022 for adults with folate receptor-alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer previously administered one of three systemic treatment regimens that included bevacizumab (Avastin).3
In clinical trials, Elahere demonstrated impressive anti-tumor activity, durability of response, and overall tolerability. The SORAYA trial’s primary endpoint of confirmed objective response rate was met by 31.7% of patients administered the ADC, which makes Elahere the first targeted therapy to produce a meaningful survival benefit in this patient population. Results from the Phase III MIRASOL confirmatory trial will be used to support the submission of a supplemental Biologic License Application to the FDA to gain full approval for Elahere, as well as a Marketing Authorization Application to the European Union.
Beyond Elahere, ImmunoGen's Phase I next-generation anti-FRα ADC, IMGN-151, is being evaluated for the treatment of ovarian cancer with the potential to expand into other solid tumor types. A Phase II anti-CD123 ADC, pivekimab sunirine, treats the rare blood cancer blastic plasmacytoid dendritic cell neoplasm (BPDCN). The FDA granted pivekimab sunirine with Breakthrough Therapy Designation for relapsed/refractory BPDCN.
AbbVie stated that ImmunoGen's entire oncology portfolio could drive long-term revenue growth, giving the company a potential multi-billion dollar drug that is already on the market. Additionally, the ongoing clinical development programs for Elahere may expand its use into earlier lines of therapy, with entry into large segments of patients in the ovarian cancer market over the next decade, according to AbbVie.
In the press release, AbbVie reaffirmed its previously issued 2024 full-year adjusted diluted EPS guidance range of $11.05-$11.25, including a $0.42 per share dilutive impact related to its acquisition of ImmunoGen and the pending acquisition of Cerevel Therapeutics.
AbbVie also updated its previously issued 2024 first quarter adjusted diluted EPS guidance range from $2.30-$2.34 to $2.26-$2.30 to include a $0.04 per share dilutive impact from acquiring ImmunoGen.
Trading of ImmunoGen common stock on the NASDAQ stock exchange stopped before the market opened today. AbbVie said the acquisition of ImmunoGen will be accretive to the company’s diluted EPS starting in 2027 and significantly accretive over the long-term.
References
1. AbbVie Completes Acquisition of ImmunoGen. AbbVie. News release. February 12, 2024. Accessed February 12, 2024. https://news.abbvie.com/2024-02-12-AbbVie-Completes-Acquisition-of-ImmunoGen
2. AbbVie to Acquire ImmunoGen, including its Flagship Cancer Therapy ELAHERE® (mirvetuximab soravtansine-gynx), Expanding Solid Tumor Portfolio. AbbVie. News release. November 30, 2023. Accessed February 12, 2024. https://news.abbvie.com/2023-11-30-AbbVie-to-Acquire-ImmunoGen,-including-its-Flagship-Cancer-Therapy-ELAHERE-R-mirvetuximab-soravtansine-gynx-,-Expanding-Solid-Tumor-Portfolio
3. ImmunoGen. ImmunoGen Announces FDA Accelerated Approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian. News Release. November 15, 2022. Accsessed November 30, 2023. Accessed February 12, 2024. https://www.businesswire.com/news/home/20221104005657/en
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