Merck Starts Rolling BLA Submission for Ebola Vaccine V920

Merck & Co., Inc. MRK announced that it has initiated the rolling submission of a biologics license application (BLA) to the FDA for its Ebola vaccine candidate V920. The investigational candidate is being developed for the treatment of the deadly Ebola Zaire disease.

The rolling submission comes in accordance with the FDA’s Breakthrough Therapy Designation, which was granted to the candidate in July 2016. The designation from the regulatory body is intended to expedite the development and review of drugs with an early evidence of substantial potential clinical benefit to patients or benefit patients without current treatment options.

Merck expects to complete the rolling submission of the BLA in 2019.

We would like to remind investors that another biotech company Inovio Pharmaceuticals INO is also currently evaluating its Ebola vaccine candidate — INO-4212 — in a preclinical study. In October 2018, the company announced that INO-4212 provided 100% protection following a lethal dose of the Ebola virus in the study. The vaccine prompted long-term immune responses in monkeys.

Shares of Merck have rallied 32.6% so far this year, outperforming the industry’s increase of 8%.

Merck has several marketed vaccines in its portfolio like Gardasil/Gardasil 9, ProQuad/M-M-R II/Varivax, RotaTeq, Pneumovax 23 and Zostavax.

In the last reported quarter, total vaccine sales were $2.2 billion, a 13% increase year over year. In vaccines, Gardasil/Gardasil 9 sales soared 55% to $1.05 billion, gaining from easy year-over-year comparisons, the ongoing commercial launch in China and strong growth in Europe. In the United States too, demand trends remain strong. In the third quarter, Merck received an FDA approval for Gardasil 9 in an expanded patient population (women and men aged from 27 to 45), which can fetch in additional sales in the future quarters.

Proquad, M-M-R II and Varivax vaccines recorded combined sales of $525 million in the reported quarter.

Apart from the Ebola vaccine candidate, Merck is studying an investigational polyvalent conjugate vaccine, V114. The candidate is currently being evaluated in several phase III studies for the treatment of pneumococcal disease.

Merck & Co., Inc. Price and Consensus

Merck & Co., Inc. Price and Consensus | Merck & Co., Inc. Quote

Zacks Rank & Other Stocks to Consider

Merck currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the pharma include Bristol-Myers Squibb Company BMY and Eli Lilly and Company LLY. While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), Eli Lilly carries a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings estimates have been revised 6.1% upward for 2018 and 6.5% for 2019 over the past 60 days.

Eli Lilly’s earnings estimates have moved 0.7% north for 2018 and 1.2% for 2019 over the past 60 days. The stock has surged 33.1% so far this year.

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