PR99754

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

TAIPEI, March 14, 2023 /PRNewswire=KYODO JBN/ --

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.

SOURCE: AnnJI pharmaceutical