We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pfizer: FDA Approves Eczema Ointment; Xtandi Fails Study
Read MoreHide Full Article
Pfizer, Inc. (PFE - Free Report) announced that it received FDA approval for crisaborole topical ointment to treat mild-to-moderate eczema, or atopic dermatitis, in patients two years and older. The ointment will be sold under the brand name Eucrisa.
Pfizer shares have risen 2.1% this month so far, lower than the gain of 3.0% for the Zacks classified Large-Cap Pharma industry.
Coming back to the latest release, Pfizer added crisaborole to its pipeline with the Anacor acquisition in June.
The approval of Eucrisa, a PDE-4 inhibitor, is based on data from two pivotal phase III studies. Detailed data from the studies presented in July showed that crisaborole achieved statistical significance on both primary and secondary endpoints in the treatment of atopic dermatitis in children (aged two years and above) and adults, compared to vehicle ointment (non-medicated ointment) alone. Adverse events related to the treatment were infrequent, mild-to-moderate in severity and similar to vehicle ointment.
Eczema affects nearly 18 million children and adults in the U.S. with approximately 90% of patients suffering from the mild-to-moderate form of the disease. Eucrisa has the potential to be a significant first-in-class treatment and address its lucrative market.
Eucrisa adds a much-needed new product to Pfizer’s inflammation/immunology portfolio which includes rheumatoid arthritis drugs like Enbrel and Xeljanz. Sales of Enbrel were hit lately by biosimilar competition in European markets. Pfizer has exclusive rights to market Enbrel outside the U.S. and Canada. It is marketed in the U.S. by Amgen, Inc. (AMGN - Free Report) . Moreover, further competition for Enbrel looms large. In August, Sandoz (Novartis AG’s (NVS - Free Report) generic arm) received FDA approval for its biosimilar version of Enbrel, Erelzi. In the U.S., sales of Enbrel will be threatened by Erelzi once it is launched.
Moreover, on the third-quarter conference call, Amgen management mentioned that in order to protect its formulary position, it expects minimal net price growth for Enbrel in 2017. We believe this can hurt sales further.
Meanwhile, in a separate press release, Pfizer and partner Astellas announced that a phase IV study evaluating the efficacy and safety of continued treatment with its prostate cancer drug Xtandi did not meet the primary endpoint.
Xtandi is presently approved for the treatment of metastatic castration-resistant prostate cancer (CRPC) in patients who have previously received docetaxel. Xtandi was added to Pfizer’s portfolio with the acquisition of Medivation in September.
The PLATO study evaluated Xtandi plus Johnson & Johnson’s (JNJ - Free Report) Zytiga and prednisone as compared to Zytiga and prednisone alone. The primary endpoint was improvement in progression-free survival (PFS) in chemo-naïve metastatic prostate cancer patients whose disease has progressed following treatment with Xtandi.
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Pfizer: FDA Approves Eczema Ointment; Xtandi Fails Study
Pfizer, Inc. (PFE - Free Report) announced that it received FDA approval for crisaborole topical ointment to treat mild-to-moderate eczema, or atopic dermatitis, in patients two years and older. The ointment will be sold under the brand name Eucrisa.
Pfizer shares have risen 2.1% this month so far, lower than the gain of 3.0% for the Zacks classified Large-Cap Pharma industry.
Coming back to the latest release, Pfizer added crisaborole to its pipeline with the Anacor acquisition in June.
The approval of Eucrisa, a PDE-4 inhibitor, is based on data from two pivotal phase III studies. Detailed data from the studies presented in July showed that crisaborole achieved statistical significance on both primary and secondary endpoints in the treatment of atopic dermatitis in children (aged two years and above) and adults, compared to vehicle ointment (non-medicated ointment) alone. Adverse events related to the treatment were infrequent, mild-to-moderate in severity and similar to vehicle ointment.
Eczema affects nearly 18 million children and adults in the U.S. with approximately 90% of patients suffering from the mild-to-moderate form of the disease. Eucrisa has the potential to be a significant first-in-class treatment and address its lucrative market.
Eucrisa adds a much-needed new product to Pfizer’s inflammation/immunology portfolio which includes rheumatoid arthritis drugs like Enbrel and Xeljanz. Sales of Enbrel were hit lately by biosimilar competition in European markets. Pfizer has exclusive rights to market Enbrel outside the U.S. and Canada. It is marketed in the U.S. by Amgen, Inc. (AMGN - Free Report) . Moreover, further competition for Enbrel looms large. In August, Sandoz (Novartis AG’s (NVS - Free Report) generic arm) received FDA approval for its biosimilar version of Enbrel, Erelzi. In the U.S., sales of Enbrel will be threatened by Erelzi once it is launched.
Moreover, on the third-quarter conference call, Amgen management mentioned that in order to protect its formulary position, it expects minimal net price growth for Enbrel in 2017. We believe this can hurt sales further.
Meanwhile, in a separate press release, Pfizer and partner Astellas announced that a phase IV study evaluating the efficacy and safety of continued treatment with its prostate cancer drug Xtandi did not meet the primary endpoint.
Xtandi is presently approved for the treatment of metastatic castration-resistant prostate cancer (CRPC) in patients who have previously received docetaxel. Xtandi was added to Pfizer’s portfolio with the acquisition of Medivation in September.
The PLATO study evaluated Xtandi plus Johnson & Johnson’s (JNJ - Free Report) Zytiga and prednisone as compared to Zytiga and prednisone alone. The primary endpoint was improvement in progression-free survival (PFS) in chemo-naïve metastatic prostate cancer patients whose disease has progressed following treatment with Xtandi.
Pfizer carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>