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Glaxo's (GSK) Shingles Candidate Phase III Data Positive

GlaxoSmithKline plcGSK announced positive top-line results from a phase III revaccination study on its shingles vaccine candidate, Shingrix, in older patients.

The Zoster-048 study administered Shingrix in patients aged 50 years or older who have been vaccinated against shingles with the currently available live-attenuated vaccine, Merck & Co., Inc.'s MRK Zostavax at least five years prior to being vaccinated with Shingrixas well as in previously unvaccinated patients.

The performance of the company's shares has been on par with the Zacks classified Large Cap Pharma industry so far this year. The stock and the industry, both has rallied 13.2% in that period.

The data demonstrated non-inferiority of Shingrix to Zostavax, thereby meeting the primary objective of the study. Shingrix achieved a similar immune response in both Zostavax vaccinated and unvaccinated patient cohorts. The vaccine was administered intramuscularly two months apart in older adults. The data also showed that Shingrix was well-tolerated in both patient cohorts when assessed up to a month after its second dose.

The data from the Zoster-048 study were presented to the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Shingrix is under review in the U.S., EU and Canada last year. The regulatory submission was based on data from a clinical trial program comprising two phase III studies - ZOE-50 and ZOE-70 - that evaluated the safety, efficacy and immunogenicity of the candidate in more than 37,000 individuals. Results showed that in addition to reducing the incidence of shingles, the candidate was able to reduce the overall incidence of postherpetic neuralgia.

Glaxo will submit this data that highlights the benefits of revaccination with Shingrix for protection against shingles to the FDA. Shire believes that Zostavax provides protection against shingles but that eventually wanes over time.

Shingrix is also being evaluated in immuno-compromised patient populations, including solid and hematological cancer patients, hematopoietic stem cell and renal transplant recipients and HIV-infected people.

In a separate press release, Glaxo announced that a U.S. jury has ruled in its favor in a patent infringement lawsuit covering its blood pressure drug Coreg against Teva Pharmaceutical Industries Limited TEVA .

The court has ordered Teva to pay Glaxo more than $235 million for deliberately infringing the patent by selling a generic version of Coreg with a label indicating it could be used for treating chronic heart failure. The payment includes $234.1 million in lost profits and an additional $1.4 million in royalties.

Teva is unhappy with the court's decision and is considering appealing against it.

GlaxoSmithKline PLC Price

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Zacks Rank and Stock to Consider

GlaxoSmithKline currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the healthcare sector is VIVUS, Inc. VVUS sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

VIVUS' loss per share estimates narrowed from 50 cents to 39 cents for 2017 in the last 60 days. The company delivered positive earnings surprises in all four trailing quarters with an average beat of 233.69%.

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GlaxoSmithKline PLC (GSK): Free Stock Analysis Report

Merck & Company, Inc. (MRK): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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