Amphastar Licenses New Synthetic ACTH Drug for Inflammatory Diseases in US and Canada

Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) today announced that it has entered into an exclusive license agreement (the "Agreement") with Nanjing Hanxin Pharmaceutical Technology Co., Ltd. ("Hanxin") for the development, and commercialization of a fully synthetic and highly purified human adrenocorticotropic hormone (ACTH) analogs (also termed corticotropin), now designated AMP-110, in the United States and Canada. AMP-110 is designed to address inflammatory and autoimmune conditions with a potentially improved safety profile compared to porcine-derived ACTH products.

"AMP-110 represents a strategically important addition to our growing proprietary peptide portfolio," said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer. "This asset aligns with our long-term vision to develop innovative proprietary products. The fully synthetic nature of AMP-110 offers a potential for a differentiated safety profile, and we believe this program positions us well in a meaningful and growing therapeutic category."

Under the terms of the Agreement, Hanxin is granting Amphastar an exclusive license to certain intellectual property related to AMP-110 in the United States and Canada. Additionally, Hanxin will receive a non-exclusive license from Amphastar for certain intellectual property to develop and commercialize the compound in all other territories.

As part of the Agreement, Amphastar made an upfront payment of $2 million to Hanxin upon signing, with additional payments to Hanxin consisting of up to $14 million in development milestone payments and up to $75 million in sales milestone payments. In addition, Amphastar will pay Hanxin royalty payments, which are not to exceed $7.5 million each calendar year and a maximum accumulated amount of $60 million. Hanxin will also pay Amphastar a royalty payment of net sales that are based on any patents licensed by Amphastar to Hanxin under the agreement.

AMP-110 is currently in early-phase human clinical development with early human studies demonstrating a promising safety profile. According to data from manufacturers in the market, in 2024, the U.S ACTH market exceeds $684 million annually, with indications including for the treatment of acute exacerbations of multiple sclerosis, rheumatoid arthritis, gouty arthritis, systemic lupus erythematosus, ophthalmic inflammatory conditions, and infantile spasms.