Monopar Therapeutics Enters into License Agreement with Alexion Pharmaceuticals for Development of ALXN-1840 for Wilson Disease

Monopar Therapeutics Inc. (NASDAQ: MNPR) announced on October 23, 2024, the execution of a License Agreement with Alexion Pharmaceuticals, Inc. granting Monopar an exclusive worldwide license for the development and commercialization of ALXN-1840. ALXN-1840 is a drug candidate for Wilson disease that has recently successfully completed a Phase 3 clinical trial meeting its primary endpoint.

As part of the agreement, Alexion will receive 387,329 shares of Monopar’s common stock and an upfront cash payment of $4.0 million. Monopar will pay this amount in two installments, with $1.0 million due at signing and the remaining $3.0 million within ninety days. Additionally, Alexion stands to earn milestone payments totaling up to $94.0 million, along with tiered royalties based on net sales of the product.

Monopar will focus on the development and commercialization of ALXN-1840 to address Wilson disease, a rare genetic condition that affects the body’s ability to remove excess copper. The drug, an investigational oral medicine, has shown promise in the Phase 3 trial by achieving significant copper mobilization from tissues compared to standard care.

While the initial cash outlay is covered by Monopar’s existing funds, the company acknowledges the need for additional capital to support its clinical and preclinical programs, including further development of ALXN-1840. Consequently, Monopar anticipates seeking additional funding through various avenues, such as equity offerings or strategic partnerships.

Future regulatory approvals and market acceptance present potential challenges for the company. Monopar plans to engage with the FDA for regulatory discussions and will closely monitor the progress of ALXN-1840 towards approval. Furthermore, the company is mindful of ensuring comprehensive patent protection to safeguard its intellectual property rights.

Despite the achievements in the Phase 3 trial and the optimistic outlook for ALXN-1840, Monopar recognizes the uncertainties and risks associated with the development and commercialization of pharmaceutical products. The company aims to remain proactive in managing these challenges while staying focused on advancing its pipeline for the benefit of patients with unmet medical needs.

The full terms and conditions of the License Agreement and related agreements are detailed in the official SEC filing by Monopar Therapeutics Inc.

For further detailed information, including the press release and financial statements, please refer to the complete filing on the Securities and Exchange Commission website.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Monopar Therapeutics’s 8K filing here.

About Monopar Therapeutics

Monopar Therapeutics Inc, a clinical-stage biopharmaceutical company, engages in developing therapeutics for the treatment of cancer in the United States. Its lead product candidate in development is Validive, a clonidine hydrochloride mucobuccal tablet that is in Phase 2b/3 clinical trial for the prevention of chemoradiotherapy induced severe oral mucositis in patients with oropharyngeal cancer.