February 21, 2017
`
`Amphastar Announces the Receipt of a CRL for Intranasal Naloxone for the Emergency
`Treatment of Opioid Overdose
`
`RANCHO CUCAMONGA, Calif., Feb. 21, 2017 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ:AMPH)
`announced today that the U.S. Food and Drug Administration ("FDA") issued a Complete Response Letter ("CRL") for its
`New Drug Application ("NDA") for Naloxone Hydrochloride 2mg/0.5mL Nasal Spray ("Intranasal Naloxone"), indicated for the
`emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system
`depression.
`
`The CRL identifies issues including user human factors study, device evaluation, and other items that need to be addressed
`before the NDA can be approved.
`
`Amphastar's CEO, Dr. Jack Zhang, stated: "While we are disappointed to have not received approval at this time, we intend
`to continue to work with the FDA to address their concerns in the CRL and hope to bring Intranasal Naloxone to the market
`as soon as possible." 
`
`Deaths from prescription opioids have more than quadrupled since 1999. From 2000 to 2015 more than half a million
`people died from drug overdoses. 91 Americans die every day from an opioid overdose.
`
`Amphastar will continue to offer naloxone in pre-filled syringes while we pursue the NDA for Intranasal Naloxone.  
`
`Company Information
`
`Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and
`selling technically-challenging generic and proprietary injectable and inhalation products. In 2014, the Company also
`commenced sales of insulin active pharmaceutical ingredient products. Most of the Company's finished products are used in
`hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations
`and drug wholesalers. More information is available at the Company's website at www.amphastar.com.
`
`Forward Looking Statements
`
`All statements in this press release that are not historical are forward-looking statements, including, among other things,
`statements relating to the Company's expectations regarding sales and marketing of its products, the timing of FDA filings
`and other matters related to its pipeline of product candidates and other future events. These statements are not historical
`facts but rather are based on Amphastar's current expectations, estimates, and projections regarding Amphastar's
`business, operations, and other similar or related factors. Words such as "may," "will," "could," "would," "should,"
`"anticipate," "predict," "potential," "continue," "expects," "intends," "plans," "projects," "believes," "estimates," and other
`similar or related expressions are used to identify these forward-looking statements, although not all forward-looking
`statements contain these words. You should not place undue reliance on forward-looking statements because they involve
`known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases,
`beyond Amphastar's control. Actual results may differ materially from those in the forward-looking statements as a result of
`a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission.
`Amphastar undertakes no obligation to revise or update information in this press release to reflect events or circumstances
`in the future, even if new information becomes available.
`
`Contact Information:
`Amphastar Pharmaceuticals, Inc.
`Bill Peters
`Chief Financial Officer
`(909) 980-9484
`
`Adapt & Opiant Exhibit 2002
`Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Limited et al.
`IPR2019-00693
`Page 1
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