FDA Accepts Application for AbbVie's Imbruvica in Specific Blood Cancers

The drug will be used together with Roche's Gazyva

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AbbVie (ABBV, Financial) has seen its marketing application for its drug Imbruvica combined with Roche (XSWX:RO, Financial)’s Gazyva, accepted by the U.S. Food and Drug Administration for a priority review as treatment for adult patients affected with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

If the U.S. agency approves the marketing application, the combined therapy of AbbVie’s Imbruvica and Roche’s Gazyva will be the first treatment given for lymphocytic leukaemia or small lymphocytic lymphoma.

Chronic lymphocytic leukaemia starts in the bone marrow before crowding out healthy blood cells. The origin of the disease in the bone marrow centers on a specific line of white cells called lymphocytes. Since the lymphocytes don’t reach a complete maturation stage, these patients cannot easily fight off infections.

People with chronic lymphocytic leukaemia present a high white blood cell count. Usually, these patients are symptom free. In chronic lymphocytic leukaemia, in which patients have no evidence of the disease in the blood but have enlarged lymph nodes, the disease is labelled as small lymphocytic lymphoma.

The combined therapy targets the etiologic agent that determines the proliferation of undeveloped lymphocytes.

Imbruvica is the trade name under which AbbVie sells Ibrutinib. The product blocks signals that stimulate malignant B lymphocytes to grow and divide uncontrollably. Imbruvica accounts for approximately 8-10% of AbbVie’s total revenues. The Lake Bluff, Illinois-based health care company gained $850 million in revenue from the drug in the second quarter of 2018, reflecting 35.6% growth from the prior-year quarter. The annual sales turnover from Imbruvica is approximately $3 billion.

AbbVie closed at $92.27 per share on Wednesday, for a market capitalization of approximately $139.18 billion. The stock has a price-sales ratio of 4.75 and a price-earnings ratio of 22.84. The industry has medians of 3.1 for the price-sales ratio and 23.77 for the price-earnings ratio.

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AbbVie is down 6% so far this year, as is Roche Holding AG ADR, whose share price was $29.80 at close on Wednesday. Roche has a market capitalization of $204.24 billion, a price-book ratio of 7.4 versus an industry median of 2.64, a price-sales ratio of 3.63 and a price-earnings ratio of 19.46.

In addition, AbbVie grants a forward dividend yield of 4.18% and Roche of 3.52% versus an industry median of 1.66%.

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

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