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Emergent Begins Phase III Study on Anthrax Vaccine AV7909

Zacks Equity Research

Emergent BioSolutions Inc. EBS announced that it has initiated a phase III study to evaluate AV7909 for the post-exposure prophylaxis of anthrax disease. The phase III program will evaluate the lot consistency, immunogenicity and safety of AV7909 (anthrax vaccine adsorbed with CPG 7909 adjuvant) following a two-dose schedule, administered intramuscularly in healthy adult patients.

AV7909 is currently being developed for post-exposure prophylaxis of anthrax disease, resulting from a suspected Bacillus anthracis exposure. The candidate is designed to lead to a faster immune response in patients as compared to the currently available anthrax vaccine.

The phase III program will enroll 3,850 patients and be conducted at various sites in the United States. The development and delivery of AV7909 is being funded by the Biomedical Advanced Research and Development Authority (BARDA).

We would like to remind investors that last December, Emergent submitted an application to the FDA for the emergency use authorization of its next-generation anthrax vaccine candidate, NuThrax, following a public health emergency involving Bacillus anthracis.

The company is developing NuThrax for the post-exposure prophylaxis of anthrax disease. The vaccine is in advanced stages of development with several phase I/II investigations already having evaluated its safety, efficacy and stability profile. The company currently anticipates that the FDA could authorize NuThrax for emergency use in the first half of 2019.

Notably, in September 2016, Emergent secured a multi-year contract worth about $1.6 billion with the BARDA for the advanced development and delivery of NuThrax.

Emergent’s key Biodefense product, BioThrax, is the sole vaccine to be marketed for the general use of both pre-exposure prophylaxis and post-exposure prophylaxis of anthrax disease. The U.S. government is the primary purchaser of the company’s Biodefense products.

The company also markets smallpox vaccine, ACAM2000, and anthrax monoclonal antibody, Raxibacumab. Both were acquired in the fourth quarter of 2017 from Sanofi SNY and GlaxoSmithKline GSK, respectively.

Shares of Emergent have decreased 17.1% so far this year against the industry’s increase of 15.8%.

Zacks Rank & Key Pick

Emergent currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Celgene Corporation CELG, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Celgene’s earnings estimates have moved 3.5% north for 2019 and 3.3% for 2020 over the past 60 days. The stock has surged 39% so far this year.

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