Addex Pharmaceuticals CEO Steps Down

Allosteric modulation company Addex Pharmaceuticals Ltd announced recently that Vincent Mutel, PhD, has stepped down from his position as CEO of the Addex group. Mr. André J. Mueller, chairman of the board of Addex, will act as executive chairman and lead an operational subcommittee of directors to manage the transition until a new CEO is appointed.Under Mr. Mutel's leadership, Addex has become a world leader in the field of allosteric modulator drug discovery and formed significant drug development partnerships with leading pharmaceutical companies. During this time, the company successfully completed several financing transactions, while also receiving grants and awards from non-profit and industry organizations.Mr. Mueller said: "On behalf of the Board, I would like to thank Vincent Mutel for his commitment and drive in building this exceptional company. During his nine year tenure, Vincent played a pivotal role in founding Addex and growing it into the world's leading allosteric drug discovery platform. We wish him success in his future endeavors. The company, which retains key intellectual property and a core group of highly talented experts in allosteric drug discovery, is in an excellent position to successfully leverage its emerging platform in a manner that maintains alignment with its strategic goals and the interests of its shareholders."The Board of Directors will be working closely with Mr. Mueller in order to consider Mr. Mutel's replacement. The Board also has invited Mr. Mutel to consider a possible future advisory role at Addex."It's been an exciting venture and a privilege to lead this group of high caliber researchers and staff in adapting allosteric modulation science to drug development," Mr. Mutel said. "I wish my colleagues at Addex continued success."

Addrenex Pharmaceuticals Expands Product Pipeline by Licensing New Drug to Treat Narcolepsy

DURHAM, N.C., - Addrenex Pharmaceuticals today 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(R) for the treatment of attention-deficit hyperactivity disorder (ADHD) and Sympres(R) 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.

Sciele Pharma and Addrenex Pharmaceuticals Announce Positive Phase III Clinical Results of Clonicel Used in Combination with Stimulants to Treat ADHD

ATLANTA & DURHAM, N.C.-Sciele Pharma, a Shionogi Company, and Addrenex Pharmaceuticals, Inc. today announced that a preliminary analysis showed positive results from a second Phase III trial of Clonicel®, demonstrating that the combination of Clonicel with stimulants provided statistically significant improvements in ADHD symptoms compared to stimulant used alone.

Larry Dillaha, M.D., Chief Medical Officer of Sciele Pharma, said, “We are pleased with the positive Phase III results using Clonicel in combination with stimulants. Clonicel is an important product in our development pipeline, and we are excited about the potential benefit that Clonicel may provide to children and adolescents who have ADHD.”

Based on the positive data from two Phase III trials conducted on Clonicel, Addrenex and Sciele Pharma plan to file with the U.S. Food and Drug Administration (FDA) later this year for Clonicel as both a monotherapy and as an add-on therapy to stimulant medication for children and adolescents with ADHD. The North American rights to market Clonicel are licensed to Sciele Pharma, a Shionogi Company, which is an Atlanta-based specialty pharmaceutical company.

“Our data from the first Phase III study data suggest that Clonicel may be an effective therapy for ADHD when used alone, and now we have evidence from a second study that Clonicel also has a complementary effect when used with stimulants,” said Moise Khayrallah, Ph.D., CEO of Addrenex Pharmaceuticals. “In children who are not receiving optimal benefit from stimulants such as methylphenidate or amphetamine, Clonicel may provide greater relief than using a stimulant medication alone.”

The current study of 200 children with ADHD is the second Phase III trial in a year to investigate the safety and efficacy of Clonicel, a long-acting version of clonidine hydrochloride. Both studies demonstrated that Clonicel improved an aggregate of 18 ADHD symptoms recognized by the American Psychiatric Association and used by doctors to diagnose and classify ADHD in children and adolescents.

In both studies, Clonicel showed improvement across all three symptom domains of ADHD: attention, hyperactivity, and impulsivity. Clonicel was well tolerated and had a favorable safety profile, with mild adverse events such as drowsiness. The multi-center, placebo-controlled, double blind, randomized trial was funded by Addrenex Pharmaceuticals

Clonicel is a non-stimulant medication that selectively targets and calms the adrenergic system, a cascade of stress hormones that regulate the body’s response to stress and other physiologic factors. An overactive adrenergic system can trigger emotional outbursts, irritability, mood swings and other debilitating symptoms.

Addrenex Pharmaceuticals Reports Positive Results in Second Phase 3 Study of ADHD Medication

DURHAM, N.C., - Addrenex Pharmaceuticals, Inc. today announced positive results from a second phase 3 trial of Clonicel demonstrating that the combination of Clonicel with stimulant medications provided statistically significant improvements in attention deficit hyperactivity disorder (ADHD) symptoms compared to stimulant use alone.

Clonicel is the company's lead compound in a pipeline of products that have shown clinical success in alleviating conditions arising from an overactive adrenergic system, the body's control center for regulating stress and a host of other physiologic functions. The Durham-based specialty pharmaceutical company is also developing drugs to treat hypertension, menopausal flushing and potentially insomnia, pain, and migraines.

Based on the positive data from two Phase 3 trials conducted on Clonicel, Addrenex plans to seek approval from the U.S. Food and Drug Administration later this year for Clonicel as both a monotherapy and as an add-on therapy to stimulant medication for children and adolescents with ADHD. The North American rights to market Clonicel are licensed to Sciele Pharma, a Shionogi Company, which is an Atlanta-based specialty pharmaceutical company.

"Our data from the first phase 3 study strongly suggest that Clonicel is an effective therapy for ADHD when used alone, and now we have evidence from a second study that Clonicel also has a complementary effect when used with stimulants," said Moise Khayrallah, Ph.D., CEO of Addrenex Pharmaceuticals. "In children who are not receiving optimal benefit from stimulants such as methylphenidate or amphetamine, Clonicel may provide greater relief than using a stimulant medication alone."

The current study of 200 children with ADHD is the second phase 3 trial in a year to investigate the safety and efficacy of Clonicel, a long-acting version of clonidine hydrochloride. Both studies demonstrated that Clonicel improves an aggregate of 18 ADHD symptoms recognized by the American Psychiatric Association and used by doctors to diagnose and classify ADHD in children and adolescents.

In both studies, Clonicel showed improvement across all three symptom domains of ADHD; attention, hyperactivity, and impulsivity. Clonicel was well-tolerated and had a favorable safety profile, with mild adverse events such as drowsiness. The multi-center, placebo-controlled, double-blind, randomized trial was funded by Addrenex Pharmaceuticals.

Clonicel is a non-stimulant medication that selectively targets and calms the adrenergic system, a cascade of stress hormones that regulate the body's response to stress and other physiologic factors. An overactive adrenergic system can trigger emotional outbursts, irritability, mood swings and other debilitating symptoms. Scientists have hypothesized that the adrenergic system is overactive in a subset of children with ADHD. Adrenergic dysregulation also may play a major role in a host of adult conditions such as post-traumatic stress syndrome, menopausal flushing, hypertension, and migraines.