Addrenex Pharmaceuticals has expanded its pipeline of products aimed at adrenergic regulation with the signing of an agreement to license a new drug for the treatment of narcolepsy, a chronic and debilitating sleep disorder, as well as other neurologic and psychiatric conditions. The agreement to license ADX-N05 gives Addrenex the worldwide rights (excluding East Asia) to develop, manufacture and commercialize the compound from SK Life Science Business Division, the drug-discovery and development division of SK Holdings Co. Ltd., one of the largest multinational companies based in South Korea. “The partnership with SK Holdings embodies our commitment to seeking global alliances that further our goal of developing drugs for adrenergic regulation,” said Steve Butts, Vice President of Commercial Operations for Addrenex Pharmaceuticals. “We are pleased and excited to partner with an innovative, dynamic company such as SK Holdings, and we expect this to be the first of many global development partnerships for Addrenex,” he added. The licensing deal with SK Holdings provides Addrenex with its fourth drug candidate to enter clinical trials in three years. Each of Addrenex’s drugs in development focuses on the treatment of medical conditions arising from an overactive or improperly regulated adrenergic system, a group of hormones and brain chemical messengers known as neurotransmitters. These hormones and neurotransmitters regulate diverse physiologic functions such as stress, pain, sleep and blood pressure. Addrenex’s lead products are Clonicel® for the treatment of attention-deficit hyperactivity disorder (ADHD) and Sympres® for the treatment of hypertension. The company also plans to develop drugs to treat menopausal flushing and potentially pain, insomnia and migraines, all of which are impacted by the adrenergic system. “ADX-N05 represents a significant advance toward expanding our product portfolio into a more diverse set of disorders for which there is a considerable unmet need for treatment,” said Moise Khayrallah, Ph.D., CEO of Addrenex Pharmaceuticals. “As an orphan disease, narcolepsy has few treatment options on the market that are safe, convenient and address all the symptoms of the disorder.” In preclinical studies, ADX-N05 (also known as SKL-N05) has demonstrated several potential benefits over currently marketed drugs for narcolepsy, according to Khayrallah. ADX-N05 has shown the potential to treat excessive daytime sleepiness as well the associated symptom of cataplexy, an abrupt and temporary episode of weakness that can result in collapse. ADX-N05 also exhibited the potential to decrease DREM, the direct transition from wakefulness to an REM sleep state. In extensive clinical and toxicology studies, ADX-N05 was demonstrated to be safe and well tolerated. “We are delighted to enter into a partnership with an experienced company such as Addrenex, and we are confident that Addrenex will successfully develop and commercialize ADX-N05 for the treatment of narcolepsy and other potential indications in the CNS area,” said Byong-Sung Kwak, Ph.D., Senior Executive Vice President of SK Holdings. Addrenex plans to begin phase 2 testing of ADX-N05 as a treatment for narcolepsy later this year. The company may also investigate ADX-N05 as adjunct therapy for depression. According to Khayrallah, the compound has numerous potential applications because it is thought to engage multiple neurotransmitters, including dopamine and noradrenalin, that play a role in a variety of disorders. Under the terms of the contract, Addrenex will pay licensing fees and royalties to SK Holdings Co. Ltd., as well as milestone payments for achieving specific clinical endpoints and sales performance goals.
