At last week’s J.P. Morgan Healthcare Conference held in San Francisco, Chicago-based AbbVie (ABBV)’s chief executive officer, Richard Gonazalez, presented data in support of the company’s pipeline. The Motley Fool points out that many analysts believe the company depends too much on its anti-inflammatory drug, Humira. Gonzalez’s talk was an effort to show the company has much more diversity.


In what The Motley Fool’s Sean Williams dubs AbbVie’s “three amigos,” the company’s top three products are Humira in immunology, Imbruvica in oncology, and Viekira Pak in virology, specifically Hepatitis C. AbbVie projects combined sales of the three drugs by 2020 of $26 billion, $18 billion for Humira, $5 billion for Imbruvica, and $3 billion for Viekira Pak.

In his presentation, Gonzalez predicted overall company sales of $37 billion by 2020, with those three drugs accountable for approximately 70 percent of sales.

Williams expresses some concerns about Humira. Gonzalez suggested that in the next five years, Humira sales would increase by almost $5 billion, but Williams wonders about how it will hold up if and when biosimilars are released for Humira. “In November,” he writes, “Amgen (AMGN) submitted its first biosimilar application to the Food and Drug Administration for ABP 501, a biosimilar of Humira. Amgen anticipates launching the drug not too far after it’s approved (if it’s approved), so things could get very interesting for both companies in the not-too-distant future.”

However, AbbVie’s outlook for blood cancer and solid tumor treatments looks good. Imbruvica was developed by Pharmacyclics (PCYC) and Johnson & Johnson (JNJ). Williams writes, “Label expansion opportunities into the frontline setting will be key for Imbruvica, with AbbVie suggesting peak annual sales for it could hit $7 billion from Imbruvica. It remains an exciting product for AbbVie’s and Johnson & Johnson’s shareholders.”

In many ways, AbbVie’s Viekira Pak is a more complicated issue. AbbVie and Foster City, Calif.-based Gilead Sciences, Inc. (GILD) have been trading lawsuits over a drug combination marketed as Harvoni. Gilead’s portfolio of hepatitis C virus (HCV) treatments include blockbuster drugs Sovaldi and Harvoni. Harvoni is a combination of ledipasvir and sofosbuvir. Sovaldi was approved in December 2013 and sold $9 billion in sales by September 2014.

 
AbbVie has five U.S. patents for the use of sofosbuvir and ledipasvir. Gilead doesn’t have patents for the two drugs used in the Harvoni combination, although it filed an application in September 2011, a month before AbbVie’s first application. Litigation, which primarily revolves around the nature of the patented technologies and computer models used to develop the combinations, are likely to go on for some time.

The two companies have also been engaged in a price war through 2015, with each company trying to arrange exclusive distribution deals with insurers and pharmacy management companies. Gilead signed an agreement with health insurance company Anthem, Inc. to make Harvoni the primary treatment for genotype 1 hepatitis C. It also inked an exclusive rights deal with CVS Health Corp for Harvoni and Sovaldi. AbbVie signed an exclusive deal with Express Scripts, the largest pharmacy benefit manager in the U.S., agreeing that it would only cover Sovaldi and Harvoni.

Gonzalez brought up a drug AbbVie is working on that would be taken once a day to compete with Harvoni and Sovaldi. Williams writes, “AbbVie believes it’ll soon have a pan-genomic, once-daily formulation that could achieve 90%+ HCV clearance in as little as eight weeks. The plan would be to launch its next-generation HCV therapy in 2017.”

Gonzalez also mentioned several other promising pipeline products, including ABT-494 in immunology, venetoclax in cancer, and the above-mentioned HCV product. ABT-494 is a JAK-1 inhibitor in Phase III trials for rheumatoid arthritis. It also has venetoclax, a BCL2 inhibitor being studied as a monotherapy and in combination with Rituxan for relapsed and refractory (R/R) chronic lymphocytic leukemia (CLL).

Overall, Williams writes that he feels more optimistic about AbbVie after Gonzalez’s talk. “That doesn’t mean it isn’t without possible shortcomings, including the entrance of biosimilars for Humira, its heavy reliance on Humira, which will hurt once generics do enter the marketplace, and uncertainties surrounding Viekira Pak’s future and whether or not it’ll be able to effectively compete with Gilead and other potential entrants.”

 
 
 
AbbVie's CEO Argues Value of Company's Pipeline, Piques Analysts Interest
January 20, 2016
By Mark Terry, BioSpace.com Breaking News Staff
 
 
SOURCE: BioSpace