Merck & Co., Inc. MRK announced that two phase III studies evaluating V114, its investigational 15-valent pneumococcal conjugate vaccine candidate in adults met its primary immunogenicity objectives.
In the PNEU-WAY study, 302 adults 18 years of age or older living with HIV were administered either V114, followed by Merck’s pneumococcal vaccine Pneumovax 23 or the currently available 13-valent pneumococcal conjugate vaccine (PCV13) plus Pneumovax 23. In this study, V114 demonstrated an immune response to all 15 serotypes included in the vaccine, including serotypes 22F and 33F, which are not contained in PCV13
In the PNEU-FLU study, V114 was administered concomitantly or non-concomitantly with the influenza vaccine in healthy adults 50 years of age or older. The data from this study showed that V114 can be given concomitantly with the quadrivalent influenza vaccine
Merck’s development program on V114 comprises 16 studies evaluating safety, tolerability and immunogenicity of V114 on various patient populations including adults as well pediatric patients who are at an increased risk of pneumococcal disease.
Please note that Pfizer PFE is also developing a 20-valent pneumococcal conjugate vaccine in late-stage studies and expects to file a new drug application for the same this year.
Merck’s shares have lost 15.5% this year so far compared with the industry’s 1.8% decline.
Merck has a strong vaccine portfolio led by its human papillomavirus (“HPV”) vaccine, Gardasil. Total vaccine sales rose 14% in the first quarter of 2020 to $2.2 billion. Gardasil recorded sales of more than $1.1 billion in the first quarter of 2020, up 30% year over year. Apart from Gardasil, the company has several marketed vaccines in its portfolio like ProQuad/M-M-R II/Varivax, RotaTeq, Pneumovax 23 and Zostavax. Pneumovax 23 generated sales of $256 million in the quarter. The company received approval for an Ebola vaccine, Ervebo, in December last year. However, sales of shingles vaccine, Zostavax, are declining rapidly due to strong competition from Glaxo’s GSK Shingrix.
In a separate press release, Merck announced that Keytruda was granted approval in China for second-line treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1. The approval was based on overall survival data from the KEYNOTE-181 study including data from an extended arm of the study in Chinese patients. Keytruda was approved for a similar indication in the United States in July last year. With the latest approval, Keytruda is now approved for five indications across three different types of cancer in China.
Merck currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked large-cap pharma stock is Eli Lilly & Company LLY, which has a Zacks Rank #1.
Lilly’s shares have risen 22.1% this year so far. Its earnings estimates for 2020 and 2021 have risen 0.6% and 0.5%, respectively over the past 60 days.
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