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Glaxo Initiates Dosing in Phase III Meningitis Vaccine Study

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GlaxoSmithKline plc (GSK - Free Report) announced that it has initiated patient dosing in a phase III program evaluating its 5-in-1 meningitis (MenABCWY) vaccine candidate. The initial clinical studies in the program will enroll approximately 3,650 participants who are aged 10-25 years and will compare the safety, tolerability and immunogenicity of new meningitis candidate with Glaxo’s licensed meningococcal vaccines, Bexsero and Menveo.

Please note that the Glaxo’s 5-in-1 meningitis vaccine targets five meningitis serotypes — A, C, W, Y and B — which account for nearly all cases of invasive meningococcal disease (“IMD”). There is currently no approved 5-in-1 combination vaccine for IMD. While Menveo vaccinates against meningococcal groups A, C, Y, and W-135, Bexsero is meningococcal group B vaccine.

Glaxo’s shares have lost 13.3% this year so far against the industry’s 1.9% increase.

Per the press release, a four-injection regimen during adolescence of FDA-approved meningitis vaccines help protect young persons against IMD. However, only a small percentage are observed to have received all four. Glaxo’s new 5-in-1 meningitis vaccine will likely reduce the number of injections and thereby improve completion rates as it has been designed to protect against all 5 vaccine-preventable serogroups with one combined product.

Invasive meningococcal disease is a rare disease with country-specific reported cases, ranging from 0.1 to 2.4 cases per 100,000 persons in 2017. However, the severity of the disease is high as it can kill the infected person in as few as 24 hours. It is estimated that 10% of patients die even after receiving proper treatment and additional 20% of patients survive with a major physical or neurological disability.

Vaccines is one of the leading therapeutic areas for Glaxo. Currently, the company has hepatitis, meningitis, shingles and influenza vaccines in its marketed portfolio, which generated 21% of total revenues in 2019. Overall, vaccines sales were nearly $4 billion in the first half of 2020. Apart from its marketed vaccines, the company has 15 vaccines under development. The company has also collaborated with other companies like Pfizer (PFE - Free Report) and Sanofi (SNY - Free Report) to develop adjuvant coronavirus vaccines.

Glaxo’s vaccine business was strengthened by the acquisition of Novartis AG’s (NVS - Free Report) non-influenza vaccines business in 2015. The meningitis vaccines, Menveo and Bexsero, added with this acquisitionhave generated more than $500 million in first half of 2020. Glaxo’s key vaccine product in the portfolio is shingles vaccine, Shingrix.

Zacks Rank

Glaxo currently has 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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