👀 Ones to watch: Undervalued stocks to buy before they report Q3 earningsSee Undervalued Stocks

Merck's Pneumococcal Vaccine Gets Breakthrough Therapy Status

Published 01/31/2019, 12:06 AM
Updated 07/09/2023, 06:31 AM
MRK
-
PFE
-
SNY
-
GSK
-

Merck & Co., Inc. (NYSE:MRK) announced that the FDA has granted Breakthrough Therapy designation to its 15-valent pneumococcal conjugate vaccine candidate, V114. The candidate is being developed as a preventive treatment for invasive pneumococcal disease (“IPD”) in pediatric patients.

The Breakthrough Therapy designation is granted to speed up the development and review of drugs that target serious or life-threatening conditions. The FDA also indicated that the candidate can be eligible for Accelerated Approval and Priority Review depending upon certain criteria.

The designation was granted on the basis of positive immunogenicity data from two clinical studies – phase I/II Study 005 and phase II Study 008 – of the multivalent pneumococcal conjugate vaccine in children aged 6 weeks to 18 years. Data from the studies showed that the vaccine induced an immune response for two disease-causing serotypes (22F and 33F), which are not provided by the currently available 13-valent pneumococcal conjugate vaccine. The candidate demonstrated non-inferiority for the other serotypes contained in both the vaccines.

The candidate is also being developed for prevention of IPD in adult patients. V114 is also currently being evaluated in two phase III studies in patients aged 50 years and above or adult HIV patients.

We remind investors that Pfizer (NYSE:PFE) is developing a 20-valent pneumococcal conjugate vaccine for a similar indication in a late-stage study.

Merck’s stock has outperformed the industry in the past six months. Merck’s shares have risen 12% against the industry’s decrease of 1.7%.

Merckhas a strong vaccine portfolio led by its human papillomavirus (“HPV”) vaccine, Gardasil. Total vaccine portfolio generated sales of $2.2 billion in the third quarter of 2018. The company’s approved pneumococcal vaccine, Pneumovax 23 alone generated sales of $214 million in the quarter. However, the portfolio is being unfavorably impacted by major decline in sales of shingles vaccine, Zostavax, which faces strong competition from Glaxo’s (NYSE:GSK) shingles vaccine, Shingrix.

Merck also has a strong vaccine pipeline. In December, the company received approval for its Hepatitis B vaccine, Vaxelis, which was developed in collaboration with Sanofi (NASDAQ:SNY) . Apart from this, the company has two late-stage vaccine candidates for shingles and Ebola. These developments are likely to maintain the double-digit growth rate for the vaccines portfolio.

Zacks Rank

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

Looking for Stocks with Skyrocketing Upside?

Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.

Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.

See the pot trades we're targeting>>



Sanofi (SNY): Free Stock Analysis Report

GlaxoSmithKline plc (GSK): Get Free Report

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

Pfizer Inc. (PFE): Free Stock Analysis Report

Original post

Zacks Investment Research

Latest comments

Loading next article…
Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.