At the ninth International Workshop on Waldenström’s Macroglobulinemia and Symposium on Advances in Multiple Myeloma (IWWM-9) that took place in Amsterdam, the first clinical data was presented from an ongoing phase one study of BTK inhibitor BGB-3111 in WM patients. According to BeiGene Ltd. (BGNE, Financial), the biopharmaceutical company engaged in the development of the molecule, the molecule shows “higher selectivity against BTK and higher exposure than ibrutinib, the only BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency.” (BeiGene’s PR).
Waldenström's macroglobulinemia (WM) is a type of cancer affecting a type of leucocytes (WBC), the B cells causing them to proliferate. It is a monoclonal neoplasia which shares clinical characteristics with the non-Hodgkin lymphomas.
Every year there approximately 1,500 new cases of WM in the U.S., therefore, this blood disorder is classified by the World Health Organization as a 'rare disease'.
As a treatment of this rare pathology and others - mantle cell lymphoma, chronic lymphocytic leukemia and chronic lymphocytic leukemia with 17p deletion - AbbVie Inc. (ABBV, Financial) produces and commercializes, through a business combination with the biopharmaceutical company, Pharmacyclics, IMBRUVICA (ibrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor, targeting B-cell malignancies.
In the U.S., IMBRUVICA is commercialized in a collaboration with Janssen Biotech Inc., one of the Janssen Pharmaceutical companies of Johnson & Johnson (JNJ, Financial), with AbbVie being the principal in the end customer product sales.
Janssen is responsible for and has exclusive rights to commercialize IMBRUVICA outside the U.S. The amounts payable by Janssen to AbbVie for the sale of IMBRUVICA outside the U.S. are included in total net revenues – collaboration revenues - that in first half 2016 were $12,410 million (+18.02% year-over-year). The revenues from the sale of IMBRUVICA were $802 million, approximately 6.6% of total net revenues and +382.4% year-over-year.
In the meantime, the company is putting a lot of effort into Imbruvica. Recently, the FDA updated the Imbruvica (ibrutinib) prescribing information (PI) to include new data from two phase three trials supporting its expanded use in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
A few days ago, AbbVie submitted a supplemental New Drug Application (sNDA) to the FDA for treatment of marginal zone lymphoma. If approved, it will be the fifth new treatment indication for the medication.
AbbVie's main product is Humira, which accounted for approximately 61% of the company's total net revenues in 2015.
AbbVie’s portfolio of medicines also includes AndroGel, Creon, Duodopa and Duopa, Kaletra, Lupron, Niaspan, Norvir, Sevoflurane, Synagis, Synthroid, TriCor and Trilipix, Viekira and Zemplar.
At the moment, AbbVie is trading at $62.79 per share on the New York Stock Exchange. The trailing price-earnings (P/E) is 18.09, the price-book (P/B) (mrq) is 18.13 and return on equity (ttm) is 116.28%.
Disclosure: I have no positions in any stock mentioned in this article.
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