Gilead Sciences is acquiring the maker of an antibody-drug conjugate for breast cancer that won accelerated Food and Drug Administration approval earlier this year, the biotech drugmaker said over the weekend.
Foster City, California-based Gilead said Sunday it would acquire Morris Plains, New Jersey-based Immunomedics for $21 billion, or $88 per share, in a deal approved by both companies’ boards and that is expected to close during the fourth quarter.
Shares of Immunomedics were up 105.7% in pre-market trading on the Nasdaq Monday morning. Shares of Gilead were down 1.7% pre-market.
The crown jewel of the deal is Trodelvy (sacituzumab govitecan-hziy), an antibody-drug conjugate targeted at Trop-2 that the FDA granted accelerated approval in April for metastatic triple-negative breast cancer who have received at least two prior therapies. Immunomedics plans to submit an application seeking full approval of the drug in the fourth quarter and expects to get approval from the European Medicines Agency in the first half of next year. The company is also running a Phase III trial of the drug in HR-positive/HER2-negative breast cancer and a Phase II trial in bladder cancer.
“This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio,” Gilead CEO Daniel O’Day said in a statement. “Trodelvy is an approved, transformational medicine for a form of cancer that is particularly challenging to treat.”
Immunomedics is also developing Trodelvy for urothelial carcinoma, non-small cell lung cancer and others. Additional candidates in its pipeline include the Phase II IMMU-130, for colorectal cancer, and the preclinical IMMU-140, for hematological cancers.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Still, not all analysts were impressed with the deal.
“While Immunomedics’ lead asset, Trodelvy, should give Gilead a nice addition to cement the foothold it has been looking to form for years, we are less than thrilled about the price here,” wrote Baird analyst Brian Skorney in a note Sunday evening. “While Trodelvy looks like a fine product, we think this deal looks more like Kite than Pharmasset and see it being an uphill climb to reach a positive ROI.”
Gilead acquired Pharmasset – the developer of what eventually became the oral hepatitis C drug Sovaldi (sofosbuvir) in 2011 for $11 billion. It acquired Kite Pharma, the maker of the CAR-T cell therapy Yescarta (axicabtagene ciloleucel) in 2017 for $11.9 billion. While Sovaldi achieved sales of $10.3 billion in 2014, global sales of Yescarta have stayed in the hundreds of millions.
Cowen analyst Phil Nadeau noted that the Immunomedics deal is the 13th oncology transaction Gilead has done over the past couple of years. Trodelvy is expected to have $4 billion in peak sales, he wrote.
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