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Victory Pharmaceuticals - Late Stage Development Program in Pain Management

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Development-stage pain products

The Company seeks to divest its development-stage pain products MGX-001 (extended release morphine combined with an atypical stimulant) and MGX-002 (a follow-on opioid combined with an atypical stimulant). These products are expected to significantly reduce commonly-experienced side effects versus existing opiate therapies. 

Victory has completed its first Phase II "proof of concept" trial for MGX-001 and has evaluated formulation partnerships. Both programs represent high potential, late-stage development programs that utilize the 505(b)(2) regulatory pathway. This regulatory strategy significantly reduces the risks, costs and time to market associated with the NDA approval process. The MGX-001 and MGX-002 programs provide improved pain management solutions by utilizing novel formulations of FDA approved products to treat chronic and/or acute pain while minimizing side effects commonly associated with other widely-used pain therapeutics. Victory estimates the estimated revenue opportunity of the MGX-001 program to exceed $100 million based on an assumed 10% capture of the extended-release, oral morphine market. Victory has completed a phase II dose ranging clinical trial that investigated the use of MGX001 for the treatment of pain in patients also suffering from chronic OIS. Results from the dose ranging study provided appropriate guidance for dose and population selection for the upcoming Phase II proof of concept study. The Phase II(a) trial demonstrated a clinically meaningful reduction in daytime sedation as measured by the Epworth Sleepiness Score (ESS) without altering pain relief efficacy.

In March 2005, Victory purchased an exclusive license to an issued patent whose claims cover both composition and use of novel combinations of opioids with modafinil. The patent expires in 2018. Additional patents with expiries beyond 2018 are available through formulation partners. Victory's license rights to the technology cover the following territories: Australia, Austria, Belgium, Canada, Denmark, France, Germany, Luxembourg, Monaco, Netherlands, Spain, Sweden, Switzerland, UK and USA.

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