Merck & Co., Inc. MRK announced that the European Commission has granted conditional marketing approval to its investigational vaccine for Ebola Zaire disease, V920. The vaccine, which has been approved for active immunization of individuals 18 years of age or older, will be marketed by the trade name of Ervebo.
With the approval, Merck can initiate manufacturing of licensed doses in Germany. These doses are expected to be available in the third quarter of 2020
Merck’s shares have risen 9% this year so far compared with the industry’s increase of 3.6%.
The European Commission’s conditional approval was expected as last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion, recommending conditional marketing approval of Ervebo. Ervebo is under priority review in the United States with a FDA decision expected on Mar 14 next year.
Some other companies like Inovio Pharmaceuticals’ INO and Regeneron REGN are also currently evaluating Ebola vaccine candidates. Regeneron has four investigational therapies for Ebola virus infection in its pipeline. In August, Glaxo GSK granted exclusive technology license of its Ebola vaccine candidates to Sabin Vaccine Institute, which now takes care of development of the prophylactic candidate vaccines against the deadly Ebola Zaire, Ebola Sudan and Marburg virus.
Vaccine is an important therapeutic area for Merck. The company has several marketed vaccines in its portfolio like Gardasil/Gardasil 9, ProQuad/M-M-R II/Varivax, RotaTeq, Pneumovax 23 and Zostavax. Among these, human papillomavirus vaccine, Gardasil/Gardasil 9 is a key top-line driver of the company, recording sales of more than $3 billion in the first nine months of 2019.
Apart from the Ebola vaccine candidate, Merck is studying an investigational 15-valent pneumococcal conjugate vaccine candidate, V114, in late-stage studies. The candidate is being developed as a preventive treatment for invasive pneumococcal disease in pediatric as well as adult patients.
Merck currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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