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Janssen, AbbVie"s Imbruvica Achieves PFS in Innovate Study

- By Alberto Abaterusso

The progression-free survival (or PFS) primary endpoint was successfully met by researchers of Janssen - a unit of Johnson & Johnson"s (JNJ) Pharmaceutical Research and Development - at the end of Phase 3 of a clinical trial, called Innovate, Janssen reported yesterday Dec. 5.

During the study, Imbruvica (ibrutinib) was evaluated by Janssen on patients affected with relapsed/refractory Waldenstrom"s macroglobulinemia, which is a rare form of non-Hodgkin lymphoma.


Imbruvica , which is developed and commercialized by Janssen Biotech Inc., together with AbbVie"s (ABBV) Pharmacyclics LLC, was evaluated on patients in a combined therapy with Rituxan. The latter is the brand name under which Roche Group"s (RHHBY) Genentech and Biogen Inc. (BIIB), jointly marketed rituximab, a medication used for the treatment of certain types of cancer and autoimmune diseases.

The patients who were enrolled in the study had never undergone any kind of treatment for Waldenstrom"s macroglobulinemia .

Janssen is working with AbbVie"s Pharmacyclics to globally share the results of the trial with health authorities.

In January 2015, Imbruvica was approved by the Food and Drug Administration for its commercialization in the U.S. as a treatment for patients with Waldenstrom"s macroglobulinemia .

Waldenstrom"s macroglobulinemia is a cancer cells and non-Hodgkin lymphoma"s (NHL) type, which produces abnormal levels of a certain type of antibody (immunoglobulin M, or IgM) - a protein that is known as macroglobulin - leading to several problems of excess bleeding, vision problems, plus problems to the nervous system.

This form of non-Hodgkin lymphoma also leads to problems of anaemia or a low count of red blood cells and to problems for the organism to successfully fight infections because the cancer causes a drop in the blood of white cells.

Imbruvica is a drug that inhibits Bruton"s tyrosine kinase, a protein that plays a key role in the maturation of B-Cells. Since specific cancer cells such as WM cells use this protein to metastasise, its inhibition prevents them to persist and disseminate in the body.

The company says that "Worldwide, IMBRUVICA was used to treat more than 90,000 patients to date".

Johnson & Johnson is trading at $139.67 per share on the New York Stock Exchange, with a market capitalization of $ 375.23 billion, a price to book (P/B) ratio of 5.09 versus an industry median of 2.86, a price to earnings (P/E) ratio of 24.24 versus an industry median of 25.41 and a price to sales (P/S) ratio of 5.18 versus an industry median of 2.79.

AbbVie Inc. is trading at $95.41 per share on the New York Stock Exchange, with a market capitalization of $152.32 billion, a price to book (P/B) ratio of 22.75 versus an industry median of 2.86, a price to earnings (P/E) ratio of 23.22 versus an industry median of 25.41 and a price to sales (P/S) ratio of 5.63 versus an industry median of 2.79.

Disclosure: no positions in any stock mentioned in this article.

This article first appeared on GuruFocus.