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AbbVie/J&J’s Imbruvica Succeeds in Combo Study with Rituxan


AbbVie Inc. ABBV and partner Janssen, Johnson & Johnson’s JNJ pharmaceuticals subsidiary, announced that a combination study evaluating their key cancer drug Imbruvica in Waldenström's macroglobulinemia (WM), a rare form of non-Hodgkin's lymphoma, met the primary endpoint.

Interim data from the phase III iNNOVATE study showed that a combination of Imbruvica and Roche’s RHHBY Rituxan led to improved progression-free survival (PFS) in treatment-naive and previously-treated patients with WM compared to Rituxan alone. Based on the early positive results, the Independent Data Monitoring Committee (IDMC) recommended an unblinded study. AbbVie and J&J plan to discuss the positive interim data with regulatory authorities

Imbruvica is already approved as a monotherapy for the treatment of WM. In fact, including WM, Imbruvica is presently approved for six distinct patient populations including mantle cell lymphoma (MCL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia (CLL), marginal zone lymphoma (MZL) and chronic graft versus host disease (GVHD).

Imbruvica was added to AbbVie’s pipeline with the May 2015 acquisition of Pharmacyclics. It has become a key revenue driver for AbbVie. In 2017, AbbVie expects to record Imbruvica global revenues of more than $2.4 billion with sales in the United States expected to cross $2 billion. In the first nine months of 2017, Imbruvica had recorded sales of $1.87 billion, representing growth of 41.2% year over year. In fact, AbbVie expects Imbruvica peak sales of more than $7 billion and revenues of about $5 billion in 2020

At present, the CLL segment is the largest revenue contributor to Imbruvica's growth while expansion into non-Hodgkin’s lymphoma (NHL) and other indications will be major growth drivers in the future.

Imbruvica has multi-billion dollar potential and AbbVie is exploring the potential to expand its label into solid tumors and autoimmune diseases. Imbruvica is in phase III studies for diffuse large B-cell lymphoma and follicular lymphoma. AbbVie is positioning Imbruvica as a “pipeline in a molecule” with the treatment featuring in several company-sponsored studies.

AbbVie’s shares have gained 52.3% so far this year, comparing favorably with a gain of only 15% recorded by the industry.

The share price surge was supported by a series of positive news in the past few months. AbbVie presented promising data from several pivotal studies, gained regulatory approvals in the United States, Europe, and Japan for its competitive HCV medicine, Mavyret; received FDA approval for the sixth indication for Imbruvicaand settled its Humira patent disputes with Amgen, Inc. AMGN.

AbbVie carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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