AbbVie's (ABBV 0.61%) Humira will face-off against cheaper biosimilars in the coming years, and that's bad news because Humira generates about two-thirds of AbbVie's companywide sales. Fortunately, there's still time to develop blockbuster drugs that can help offset any eventual slowing in Humira demand.
Today, AbbVie and collaboration partner Roche Holdings (RHHBY -0.28%) reported new data on Venclexta that could significantly expand its use and drive its revenue higher, helping AbbVie make up for any drop in future sales.
Two titans team up
AbbVie's global Humira sales are clocking in at an annualized $18 billion annually, and that makes expanding the addressable market for drugs like Venclexta important. However, AbbVie isn't alone in facing the patent cliff. Roche Holdings also risks seeing sales decline due to the launch of biosimilars to Rituxan, a multibillion-dollar per year cancer drug. Given that both companies are hunting for new sources of revenue, it's fitting that the two are teamed up on Venclexta, a treatment that's currently only approved for use in a limited subset of late-stage chronic lymphocytic leukemia (CLL) patients with a specific genetic mutation.
Venclexta won't offset all the potential risk to these companies' top lines, but based on the data released earlier today, Venclexta could become a go-to option in second- or third-line CLL, regardless of a patient's genetic make-up.
In trials, relapsing or refractory CLL patients who were given Venclexta and Rituxan had progression-free survival (PFS) of 84.9%. For comparison, the PFS for the commonly used bendamustine chemotherapy plus Rituxan was only 36.3%. The complete response rate of 26.8% for Venclexta plus Rituxan also easily outperformed the 8.2% for bendamustine plus Rituxan.
As for safety, the percentage of patients suffering an adverse event was higher in the Venclexta-plus-Rituxan arm, but severe adverse events were about the same between the two groups.
The potential to expand Venclexta earlier in CLL treatment could provide significant revenue tailwinds for these companies. A Food and Drug Administration (FDA) approval of Venclexta in relapsing and refractory CLL could come next year. If so, analysts think Venclexta could add about $700 million in sales in 2019. Eventually, industry watchers think Venclexta's peak sales opportunity could be $3 billion if efforts allowing Venclexta's use in even more patients pans out.
That's a heady figure, but investors probably should take those forecasts with a grain of salt. After all, industry analyst's sales predictions are often wrong. Nevertheless, a multibillion dollar forecast doesn't seem too off base when you consider that Imbruvica, a J&J and AbbVie drug, is a multibillion-dollar drug and it generates most of its sales from treating CLL. Obviously, Venclexta isn't going to cure AbbVie and Roche's patent ills all on it's own, but it's a step in the right direction.