Following an agreement with Pfizer, Axsome Therapeutics now has exclusive rights to develop and commercialize AXS-14 (esreboxetine) — a drug candidate for treatment of fibromyalgia — in the United States.
Axsome also has obtained an exclusive U.S. license for Pfizer’s AXS-12 (reboxetine), in development for the treatment of narcolepsy.
“We are very pleased to announce this agreement with Pfizer to help advance the development of AXS-12 for the treatment of narcolepsy and of AXS-14 for the treatment of fibromyalgia, two serious CNS [central nervous system] disorders which currently have limited treatment options,” Herriot Tabuteau, MD, CEO of Axsome, said in a press release.
According to the agreement, Axsome will be given an exclusive U.S. license to Pfizer’s data for AXS-12 and AXS-14, which encompasses a wide range of nonclinical studies, and both short-term and long-term clinical trials that involve more than 5,000 patients.
The data also includes results from a Phase 2 and Phase 3 clinical trial of AXS-14 for the treatment of fibromyalgia. A highly selective norepinephrine reuptake inhibitor, AXS-14 has been shown to block the sensation of pain in preclinical models.
Results from the Phase 3 clinical trial (NCT00612170), conducted in 1,122 patients with fibromyalgia, showed significant improvements compared with placebo in the weekly mean pain score, Fibromyalgia Impact Questionnaire (FIQ) total score, Patient’s Global Impression of Change (PGIC) scale, and fatigue.
Further, results from the Phase 2 trial (NCT00357825) showed significant improvements compared with placebo in the weekly mean pain score, the FIQ total score, the PGIC scale, and fatigue.
“The valuable clinical and nonclinical data under this exclusive license will enable us to potentially significantly accelerate our AXS-12 clinical program while reducing development risk and costs. Furthermore, through this agreement, we are able to expand our CNS pipeline with AXS-14, which has demonstrated efficacy in completed Phase 3 and Phase 2 trials in fibromyalgia,” Tabuteau said.
As per the agreement, Axsome will have the exclusive right and responsibility for developing AXS-14 in the U.S. for the treatment of fibromyalgia and for other indications.
In exchange, Pfizer will be given shares of the Axsome common stock that are valued at approximately $8 million. Additionally, Pfizer will receive an upfront payment of $3 million, and up to $323 million in regulatory and sales milestones, as well as royalties on potential sales.
Pfizer also will have the right to negotiate first on any future dealings that involve AXS-12 and AXS-14.
In addition to completing the trials for AXS-14, Axsome recently finished a Phase 2 study of AXS-12 (NCT03881852) for the treatment of narcolepsy, which showed promising results. Axsome is now preparing to progress AXS-12 into Phase 3 trials, which it expects to launch in 2020, as previously disclosed.
“With the recently announced Phase 2 success of AXS-12 resulting in its planned advancement to Phase 3 this year, and with the addition of AXS-14, our pipeline will now contain four differentiated Phase 3-stage product candidates with the potential to positively affect many of the millions of people living with distressing CNS disorders,” Tabuteau said.