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AbbVie/J&J's Imbruvica Label Expansion Filing Accepted by FDA
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AbbVie Inc. (ABBV - Free Report) and partner Janssen, Johnson & Johnson’s (JNJ - Free Report) pharmaceuticals subsidiary, announced that a supplemental new drug application (sNDA) for their cancer drug Imbruvica has been accepted for review by the FDA. AbbVie is looking to get Imbruvica approved for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after the failure of one or more lines of systemic therapy.
So far this year, AbbVie’s share price has increased 4%, comparing unfavorably with a gain of 6.1% recorded by the Zacks classified Large-Cap Pharma industry.
Imbruvica is presently approved for five indications. The drug is currently approved in the U.S. for the treatment of mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) in patients, who have received at least one previous therapy and for CLL patients with deletion 17p. It is also approved for the treatment of Waldenstrom's macroglobulinemia and relapsed/refractory marginal zone lymphoma.
If approved for cGVHD, Imbruvica will be the first medicine approved for the treatment of this disease, which is a serious and debilitating potential consequence of stem cell or bone marrow transplant. Meanwhile, it is also the first potential indication for Imbruvica outside of hematological malignancies. Imbruvica had orphan drug status as well as breakthrough therapy designation in the U.S. for this indication.
We remind investors that a registrational study for cGVHD showed positive results in Dec 2016 and formed the basis of the sNDA application.
Imbruvica was added to AbbVie’s pipeline with the May 2015 acquisition of Pharmacyclics. It has become a key revenue driver for AbbVie and accounted for 7% of the company’s sales in 2016. In 2017, AbbVie expects to record Imbruvica global revenues of more than $2.4 billion with sales in the U.S. expected to cross $2 billion. 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.
Shares of Roche have risen 12.6% this year so far while earnings estimates for 2017 went up almost 12% in the past 30 days.
Shares of Lilly have risen 17% this year so far.
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AbbVie/J&J's Imbruvica Label Expansion Filing Accepted by FDA
AbbVie Inc. (ABBV - Free Report) and partner Janssen, Johnson & Johnson’s (JNJ - Free Report) pharmaceuticals subsidiary, announced that a supplemental new drug application (sNDA) for their cancer drug Imbruvica has been accepted for review by the FDA. AbbVie is looking to get Imbruvica approved for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after the failure of one or more lines of systemic therapy.
So far this year, AbbVie’s share price has increased 4%, comparing unfavorably with a gain of 6.1% recorded by the Zacks classified Large-Cap Pharma industry.
Imbruvica is presently approved for five indications. The drug is currently approved in the U.S. for the treatment of mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) in patients, who have received at least one previous therapy and for CLL patients with deletion 17p. It is also approved for the treatment of Waldenstrom's macroglobulinemia and relapsed/refractory marginal zone lymphoma.
If approved for cGVHD, Imbruvica will be the first medicine approved for the treatment of this disease, which is a serious and debilitating potential consequence of stem cell or bone marrow transplant. Meanwhile, it is also the first potential indication for Imbruvica outside of hematological malignancies. Imbruvica had orphan drug status as well as breakthrough therapy designation in the U.S. for this indication.
We remind investors that a registrational study for cGVHD showed positive results in Dec 2016 and formed the basis of the sNDA application.
Imbruvica was added to AbbVie’s pipeline with the May 2015 acquisition of Pharmacyclics. It has become a key revenue driver for AbbVie and accounted for 7% of the company’s sales in 2016. In 2017, AbbVie expects to record Imbruvica global revenues of more than $2.4 billion with sales in the U.S. expected to cross $2 billion. 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 has a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Eli Lilly & Company (LLY - Free Report) and Roche Holding AG (RHHBY - Free Report) . While Roche enjoys a Zacks Rank #1 (Strong Buy), Lilly has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Shares of Roche have risen 12.6% this year so far while earnings estimates for 2017 went up almost 12% in the past 30 days.
Shares of Lilly have risen 17% this year so far.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>