RANCHO CUCAMONGA, Calif., Jan. 03, 2019 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that Primatene® MIST has been launched. Primatene® MIST is an epinephrine inhalation aerosol bronchodilator suspension, which is the only FDA-approved metered dose inhaler (MDI) for asthma in the over-the-counter (OTC) market in the United States. Primatene® MIST is now available nationwide at Walgreens stores and online at Walgreens and CVS. It will also be available nationwide at CVS stores by mid-January. The Company is currently building additional inventory to provide Primatene® MIST to more pharmacy chains and big box retail stores in the coming months.
Pipeline Information
The Company currently has four abbreviated new drug applications (“ANDAs”) filed with the FDA, which are targeting products with a market size of approximately $0.7 billion, three biosimilar products in development targeting products with a market size of approximately $14.0 billion, and 11 generic products in development targeting products with a market size of approximately $12.0 billion. This market information is based on IQVIA data for the 12 months ended September 30, 2018. The Company’s proprietary pipeline includes an NDA for intranasal naloxone. The Company is currently developing four other proprietary products, which include injectable, inhalation and intranasal dosage forms.
Company Information
Amphastar is a specialty pharmaceutical company that focuses on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation and intra-nasal products. Additionally, the Company sells insulin API 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.
Amphastar’s logo and other trademarks or service marks of Amphastar Pharmaceuticals, Inc., including, but not limited to Primatene®, Amphadase® and Cortrosyn®, are the property of Amphastar Pharmaceuticals, Inc.
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 future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, including DMFs, the timing of product launches and the timing of products becoming available on the market, acquisitions and other matters related to its current products, pipeline of product candidates and other future events. These statements are not historical facts but rather are based on Amphastar’s historical performance and its current expectations, estimates, and projections regarding Amphastar’s business, operations, and other similar or related factors. Words such as “may,” “might,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” 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. You can locate these reports through the Company’s website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov. 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 or if subsequent events cause Amphastar’s expectations to change.
Investor Contact:
Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
(909) 980-9484
Noted products are trademarks or registered trademarks of their respective owners.
