AnnJi Pharmaceutical Announced A Licensing Agreement With Avenue Therapeutics To Develop And Commercialize AJ201, A First-In-Class Clinical Asset For The Treatment Of Kennedy's Disease

Rhea-AI Summary

AnnJi Pharmaceutical has entered an exclusive licensing agreement with Avenue Therapeutics (ATXI) to develop AJ201 for spinal and bulbar muscular atrophy (SBMA) in multiple regions, including the U.S., Canada, EU, Great Britain, and Israel. The deal includes an upfront payment of $3 million and potential milestone payments of up to $250 million, plus royalties from net sales. Avenue will issue shares worth 19.99% of its outstanding stock to AnnJi. AJ201 has Orphan Drug Designation from the U.S. FDA and the European Medicines Agency, with safety demonstrated in Phase 1 trials. It is currently undergoing clinical evaluation for Kennedy's Disease.

Positive

• Exclusive licensing agreement with Avenue Therapeutics for AJ201 development.
• Upfront payment of $3 million from Avenue, with potential additional milestone payments up to $250 million.
• AJ201 has Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency.

Negative

• None.

TAIPEI, March 10, 2023 /PRNewswire/ -- AnnJi Pharmaceutical Co. (AnnJi) has entered into an exclusive license agreement with Avenue Therapeutics Inc. (Avenue, NASDAQ: ATXI) for the development and commercialization of AJ201 in the U.S., Canada, European Union, Great Britain, and Israel for spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's Disease. Under the terms of the license agreement, AnnJi will receive upfront payments of $3 million and is entitled to receive future development, regulatory and commercialization milestone payments amounting up to 250 million USD, as well as up to 2-digit percentage royalty of the net sales. In addition, AnnJi will retain the manufacturing right to provide clinical and commercial supply of AJ201 to Avenue under agreed sale price and will be compensated for any Avenue's sublicense activity. Avenue will also issue 831,618 shares of its common stock to AnnJi in connection with the initial closing of the license transaction as an equity upfront and additional share upon achievement of a clinical milestone, aggregating in total to not more than 19.99% of Avenue's current total number of outstanding shares of common stock. This agreement is one of the largest license deals for a small molecule drug in early Phase 1b/2a clinical development in the past twenty-four months. Greenberg Traurig served as AnnJi's legal advisor in this transaction.

AJ201 is a novel small molecule new drug and a first-in-class treatment, which has the potential to treat Kennedy's Disease through multiple mechanisms including degradation of the abnormal androgen receptor (AR) protein, which is believed to be the cause of the disease, as well as suppression of proinflammatory cytokines and protection of cells from oxidative stress. Phase 1 clinical trial in healthy subjects has demonstrated the safety of AJ201 in humans. AJ201 is currently being investigated in a multicenter, randomized, double-blind clinical trial in six clinical sites across the U.S. The study aims to evaluate the safety and clinical response of AJ201 in Kennedy's Disease patients.

AJ201 has been granted Orphan Drug Designation ("ODD") by the U.S. FDA for the indications of SBMA, Huntington's Disease and Spinocerebellar Ataxia. AJ201 also received ODD from European Medicines Agency for the indications of SBMA.

About AnnJi

Founded in 2014, AnnJi Pharmaceutical Co., Ltd. (AnnJi) is an R&D based, clinical-stage new drug company dedicated to the development of first-in-class small molecules for indications with highly unmet needs in the therapeutic areas of neurology, dermatology, and inflammatory disorders, including rare diseases such as idiopathic pulmonary fibrosis and Spinal and Kennedy's disease. Other development projects including a selective HDAC6 inhibitor for the treatment of chemotherapy-induced peripheral neuropathy, which is expected to enter the first clinical trials in Q4 2023 and a topical AR degradation enhancer for the treatment of alopecia, which is expected to enter the clinical trials in Q3 2024.

For more information, visit  https://www.ajpharm.com.

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SOURCE AnnJI

FAQ

What is the significance of the licensing agreement between AnnJi and Avenue Therapeutics (ATXI)?

The licensing agreement allows Avenue Therapeutics to develop AJ201 for SBMA, with substantial financial terms beneficial for AnnJi.

What are the financial terms of the licensing deal for AJ201?

AnnJi will receive $3 million upfront, up to $250 million in milestone payments, plus royalties on net sales from AJ201.

What is AJ201 and what disease does it target?

AJ201 is a novel small molecule drug targeting spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's Disease.

What clinical trials is AJ201 undergoing?

AJ201 is currently evaluated in a Phase 1 clinical trial for safety and a multicenter trial for clinical response in Kennedy's Disease patients.