Amneal Announces Dihydroergotamine (DHE) Autoinjector NDA for Migraines and Cluster Headaches

Rhea-AI Summary

Amneal Pharmaceuticals (NYSE: AMRX) announced that the FDA accepted its 505(b)(2) New Drug Application for a dihydroergotamine (DHE) prefilled syringe autoinjector. A decision is expected by mid-2022, with a potential launch in the second half of 2022. This product aims to provide patients with an easy-to-use self-administration method for acute migraine and cluster headaches. DHE's current U.S. sales are around $70 million annually, indicating a significant market opportunity. Amneal's strategy includes leveraging its existing commercial infrastructure in neurology.

Positive

• FDA acceptance of the 505(b)(2) New Drug Application for DHE autoinjector.
• Projected market launch in the second half of 2022.
• Addresses a significant healthcare need for acute migraine sufferers.

Negative

• None.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the Food and Drug Administration recently accepted Amneal’s 505(b)(2) New Drug Application for a newly licensed dihydroergotamine (DHE) prefilled syringe autoinjector and the company said it anticipates a decision by the middle of 2022. If approved, Amneal anticipates a commercial launch in the second half of 2022. Amneal plans to commercialize the product solely in the U.S. market.

“The addition of the DHE autoinjector reflects our commitment to expand our Specialty portfolio by bringing impactful therapies that deliver differentiated value for patients in need,” said Joseph Todisco, Chief Commercial Officer for Amneal Specialty. “We plan to leverage our existing commercial infrastructure in Neurology and experience in the migraine and headache space to bring this product to market.”

The proposed indication for the product is acute migraine with and without aura and cluster headache in adults. DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. Currently, DHE is also available both as ampules for injection or as a nasal spray formulation for at-home use. This product would allow patients to self-administer DHE via a single-dose, ready-to-use autoinjector pen without the need for assembly.

Over 39 million Americans are living with migraine⁽¹⁾, and up to one million with cluster headache.⁽²⁾ Headache is the fourth most common reason for emergency department visits, and accounts for 3% of all ER visits in the United States.⁽³⁾

According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for all forms of DHE for the 12 months ended March 2021 were approximately $70 million.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit www.amneal.com.

Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including among other things: discussions of future operations; expected operating results and financial performance; impact of planned acquisitions and dispositions; the Company’s strategy for growth; product development; regulatory approvals; market position and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and similar words are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

Such risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic; the impact of global economic conditions; our ability to successfully develop, license, acquire and commercialize new products on a timely basis; our ability to obtain exclusive marketing rights for our products; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; our reliance on certain licenses to proprietary technologies from time to time; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our dependence on third-party agreements for a portion of our product offerings; our ability to identify and make acquisitions of or investments in complementary businesses and products on advantageous terms; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the significant amount of resources we expend on research and development; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

(1)		https://migraineresearchfoundation.org/about-migraine/migraine-facts/
(2)		https://americanmigrainefoundation.org/resource-library/cluster-headache-2/
(3)		Zodda D, Procopio G, Gupta A. Evaluation and management of life-threatening headaches in the emergency department. Emerg Med Pract. 2019 Feb;21(2):1-20. Epub 2019 Feb 1. PMID: 30676714. https://pubmed.ncbi.nlm.nih.gov/30676714/

 

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FAQ

What did Amneal Pharmaceuticals announce regarding the DHE autoinjector?

Amneal announced that the FDA accepted its New Drug Application for a DHE prefilled syringe autoinjector, with a decision expected by mid-2022.

When is Amneal planning to launch the DHE autoinjector?

Amneal anticipates a commercial launch of the DHE autoinjector in the second half of 2022.

What is the market potential for the DHE autoinjector?

Current U.S. sales for all forms of DHE are approximately $70 million annually, indicating strong market potential for the new autoinjector.

What conditions does the DHE autoinjector target?

The proposed indication for the DHE autoinjector is for treating acute migraine and cluster headaches in adults.

How does Amneal plan to commercialize the DHE autoinjector?

Amneal plans to leverage its existing commercial infrastructure in neurology to bring the DHE autoinjector to market.