Merck & Co., Inc. 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 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 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 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.
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