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FDA Nods to Emergent's (EBS) Narcan Shelf Life Extension

Zacks Equity Research
·3 min read

Emergent BioSolutions Inc. EBS announced that the FDA has approved the extension of its Narcan (naloxone HCl) nasal spray’s shelf life from 24 months to 36 months.

Notably, Narcan is an intranasal form of naloxone approved in the United States and Canada for the emergency treatment of known or suspected opioid overdose. Following this latest regulatory nod for shelf-life expansion, the nasal spray can now be used by patients for a period of three years, stretched a year more from the earlier time frame. As a result, patients can now have longer accessibility to Narcan, which is used to temporarily reverse the effects of opioid medicines.

Shares of Emergent have skyrocketed 147.2% so far this year compared with the industry’s rise of 2.6%.

We remind investors that Narcan nasal spray was added to Emergent’s portfolio with the 2018 acquisition of Adapt Pharma, thereby solidifying the company’s presence in the public health threats market. The product contributed significantly to Emergent’s sales growth in 2019.

In the first half of 2020, Narcan nasal spray added $145 million to Emergent’s product sales, reflecting an increase of 5% year over year.

In the meantime, Emergent has been fighting hard with a patent issue on Narcan. In June 2020, a district court of New Jersey passed an unfavorable decision with respect to the company’s patent litigation of Narcan nasal spray 4mg. The court ruled in favor of the defendants, Teva Pharmaceuticals Industries Limited TEVA. Emergent plans to challenge the above decision at the Court of Appeals for the Federal Circuit. Shares of the company fell significantly back then.

Other than Narcan, Emergent has a robust vaccine portfolio, candidates of which are being evaluated in several early-mid-stage studies to address various ailments.

Emergent markets smallpox vaccine ACAM2000 and anthrax monoclonal antibody raxibacumab, both of which were acquired in 2017 from Sanofi SNY and GlaxoSmithKline GSK, respectively.

Additionally, the company markets two anthrax vaccines (BioThrax and AV7909), both of which contributed steadily to sales during the first six months of 2020. Total sales of the vaccines were reported to be $184.2 million in the period, reflecting substantial growth year over year.

Zacks Rank

Emergent currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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Click to get this free report Teva Pharmaceutical Industries Ltd. (TEVA) : Free Stock Analysis Report Sanofi (SNY) : Free Stock Analysis Report GlaxoSmithKline plc (GSK) : Free Stock Analysis Report Emergent Biosolutions Inc. (EBS) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research