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Emergent (EBS) OTC Narcan Filing Gets FDA Priority Review Tag
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Emergent BioSolutions, Inc. (EBS - Free Report) announced that the FDA accepted its supplemental New Drug Application (sNDA) seeking a prescription-to-over-the-counter switch for its opioid overdose reversal drug Narcan (naxolone) nasal spray (“Narcan”).
The FDA also granted priority review to the sNDA filing. A final decision is expected by Mar 29, 2023.
Shares of Emergent were up 3.4% following the announcement. Per management, the company’s sNDA filing is the first prescription-to-over-the-counter switch application to be granted priority review by the FDA. If approved, the drug will be available without a prescription throughout the U.S.
In the year so far, Emergent’s stock has plunged 72.0% compared with the industry’s 17.8% decline.
Image Source: Zacks Investment Research
The sNDA filing is supported by five-year post-marketing data generated by Emergent and human factor studies conducted by management, which have exhibited the safety and efficacy of Narcan.
Currently, the escalating use of synthetic opioids, like fentanyl, has become a major public health issue in the country. Per CDC estimates, more than 71000 people died from opioids containing fentanyl.
The sNDA filing was made a month after the FDA’s issuance of a notice encouraging drug-makers to apply for OTC naxolone products. Per the regulatory body, naxolone can counter opioid overdose effects, thereby reducing deaths pertaining to opioid overdose when administered within moments of the first sign of the same. The final decision for OTC conversion by the FDA will depend upon non-prescription user interface design, which includes packaging and labeling.
During the first nine months of 2022, Emergent recorded $282.6 million from Narcan products sales, down 10% year over year. The decline in sales can be attributed to erosion in sales following the launch of generic versions of Narcan by Teva Pharmaceuticals (TEVA - Free Report) and Novartis’ (NVS - Free Report) generic arm, Sandoz, in December 2021.
In June 2020, Emergent received an unfavorable decision from a district court on a patent for Narcan nasal spray. The district court, in its decision, favored defendant Teva Pharmaceuticals to launch its own Narcan generic. Teva commercially launched its generic version last year in December. Emergent granted a license to the Novartis’ Sandoz in December 2021 to commercialize an authorized generic of Narcan. Moreover, there are several other branded nasal spray products, which also compete in the same segment as Narcan. Teva Pharmaceuticals and Novartis launched their respective generic versions of Narcan on the same day (Dec 22, 2022) in the U.S.
Emergent currently carries a Zacks Rank #4 (Sell). A better-ranked stock in the overall healthcare sector is Kamada , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Kamada’s 2022 loss per share have narrowed from 14 cents to 7 cents. During the same period, the earnings estimates per share for 2023 have risen from 26 cents to 42 cents. Shares of Kamada have declined 30.4% in the year-to-date period.
Earnings of Kamada beat estimates in two of the last four quarters and missed the mark twice, witnessing a negative earnings surprise of 62.50%, on average. In the last reported quarter, Kamada’s earnings beat estimates by 433.33%.
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Emergent (EBS) OTC Narcan Filing Gets FDA Priority Review Tag
Emergent BioSolutions, Inc. (EBS - Free Report) announced that the FDA accepted its supplemental New Drug Application (sNDA) seeking a prescription-to-over-the-counter switch for its opioid overdose reversal drug Narcan (naxolone) nasal spray (“Narcan”).
The FDA also granted priority review to the sNDA filing. A final decision is expected by Mar 29, 2023.
Shares of Emergent were up 3.4% following the announcement. Per management, the company’s sNDA filing is the first prescription-to-over-the-counter switch application to be granted priority review by the FDA. If approved, the drug will be available without a prescription throughout the U.S.
In the year so far, Emergent’s stock has plunged 72.0% compared with the industry’s 17.8% decline.
Image Source: Zacks Investment Research
The sNDA filing is supported by five-year post-marketing data generated by Emergent and human factor studies conducted by management, which have exhibited the safety and efficacy of Narcan.
Currently, the escalating use of synthetic opioids, like fentanyl, has become a major public health issue in the country. Per CDC estimates, more than 71000 people died from opioids containing fentanyl.
The sNDA filing was made a month after the FDA’s issuance of a notice encouraging drug-makers to apply for OTC naxolone products. Per the regulatory body, naxolone can counter opioid overdose effects, thereby reducing deaths pertaining to opioid overdose when administered within moments of the first sign of the same. The final decision for OTC conversion by the FDA will depend upon non-prescription user interface design, which includes packaging and labeling.
During the first nine months of 2022, Emergent recorded $282.6 million from Narcan products sales, down 10% year over year. The decline in sales can be attributed to erosion in sales following the launch of generic versions of Narcan by Teva Pharmaceuticals (TEVA - Free Report) and Novartis’ (NVS - Free Report) generic arm, Sandoz, in December 2021.
In June 2020, Emergent received an unfavorable decision from a district court on a patent for Narcan nasal spray. The district court, in its decision, favored defendant Teva Pharmaceuticals to launch its own Narcan generic. Teva commercially launched its generic version last year in December. Emergent granted a license to the Novartis’ Sandoz in December 2021 to commercialize an authorized generic of Narcan. Moreover, there are several other branded nasal spray products, which also compete in the same segment as Narcan. Teva Pharmaceuticals and Novartis launched their respective generic versions of Narcan on the same day (Dec 22, 2022) in the U.S.
Emergent Biosolutions Inc. Price
Emergent Biosolutions Inc. price | Emergent Biosolutions Inc. Quote
Zacks Rank & Stocks to Consider
Emergent currently carries a Zacks Rank #4 (Sell). A better-ranked stock in the overall healthcare sector is Kamada , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Kamada’s 2022 loss per share have narrowed from 14 cents to 7 cents. During the same period, the earnings estimates per share for 2023 have risen from 26 cents to 42 cents. Shares of Kamada have declined 30.4% in the year-to-date period.
Earnings of Kamada beat estimates in two of the last four quarters and missed the mark twice, witnessing a negative earnings surprise of 62.50%, on average. In the last reported quarter, Kamada’s earnings beat estimates by 433.33%.