Amphastar Receives FDA Approval for Ganirelix Acetate Injection

Rhea-AI Summary

Amphastar Pharmaceuticals has received FDA approval for its Ganirelix Acetate Injection, a 250mg/0.5mL prefilled syringe, indicated for controlling premature LH surges in women undergoing ovarian hyperstimulation. This marks the company's fourth injectable peptide product approval, with plans for market launch in Q2 2022. The U.S. market for Ganirelix is valued at approximately $89 million as of the end of 2021. Amphastar's pipeline includes four ANDAs targeting a market size of $3.9 billion and several biosimilars and generics, enhancing its market position.

Positive

• FDA approval for Ganirelix Acetate Injection, expanding product portfolio.
• Projected U.S. market value of Ganirelix at approximately $89 million.
• Plans to launch Ganirelix in Q2 2022 enhances revenue potential.
• Strong pipeline with four ANDAs targeting $3.9 billion market and multiple biosimilars.

Negative

• None.

RANCHO CUCAMONGA, CA / ACCESSWIRE / April 8, 2022 / Amphastar Pharmaceuticals, Inc., (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for Ganirelix Acetate Injection, 250mg/0.5mL in a prefilled syringe. Ganirelix acetate injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation. The FDA determined Amphastar's ganirelix is bioequivalent and therapeutically equivalent to Organon Pharmaceuticals' Ganirelix Acetate Injection.

Amphastar's CEO and President, Dr. Jack Zhang, commented: "We are excited about the FDA approval of our Ganirelix Acetate Injection. Ganirelix is the Company's fourth injectable peptide product approval. It represents our capabilities in executing our pipeline while furthering the development of our diabetes product portfolio."

According to IQVIA, the U.S. brand and generic sales for ganirelix acetate injection were approximately $89 million for the 12 months ended December 31, 2021.

Amphastar plans to launch its Ganirelix Acetate Injection during the second quarter of 2022.

Pipeline Information
The Company currently has four ANDAs on file with the FDA targeting products with a market size of approximately $3.9 billion, three biosimilar products in development targeting products with a market size of approximately $13 billion, and eight generic products in development targeting products with market size of approximately $12 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2021. The Company is developing multiple proprietary products with injectable and intranasal dosage forms.

Amphastar's Chinese subsidiary, ANP, currently has 17 Drug Master Files, or DMFs, on file with the FDA and is developing several additional DMFs.

Company Information
Amphastar is a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal 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 and resources are available at www.amphastar.com.

Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar ^®, Primatene Mist ^® , Amphadase ^® , and Cortrosyn ^® , are the property of Amphastar.

Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance, backlog, sales and marketing of our products, market size and growth, product development, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, the timing and results of clinical trials, our share buyback program, the impact of the restructuring of ANP, and other future events, such as the impact of the COVID-19 pandemic including its variants and related responses of business and governments to the pandemic on our operations and personnel, and on commercial activity and demand across our business operations and results of operations. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our 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, including in our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 11, 2022 and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the SEC on November 9, 2021. In particular, the extent of COVID-19's impact on our business will depend on several factors, including the severity, duration and extent of the pandemic including its variants, as well as actions taken by governments, businesses, and consumers in response to the pandemic, all of which continue to evolve and remain uncertain at this time. You can locate these reports through our website at http://ir.amphastar.com and on the SEC's website at www.sec.gov. The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change.

Contact Information:
Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
(909) 980-9484

SOURCE: Amphastar Pharmaceuticals, Inc.

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FAQ

What is the significance of Amphastar's Ganirelix Acetate Injection FDA approval?

The FDA approval allows Amphastar to market Ganirelix for controlling LH surges in women undergoing fertility treatments, potentially generating significant revenue.

When will Amphastar launch Ganirelix Acetate Injection?

Amphastar plans to launch Ganirelix Acetate Injection in the second quarter of 2022.

What is the market potential for Ganirelix Acetate Injection?

The U.S. sales for Ganirelix acetate injection are approximately $89 million for the year ending December 31, 2021.

How many ANDAs does Amphastar have in its pipeline?

Amphastar currently has four ANDAs on file with a total market size of around $3.9 billion.

What other products is Amphastar developing?

In addition to Ganirelix, Amphastar is developing three biosimilars and eight generic products, targeting a combined market size of approximately $25 billion.