Elysium’s mission is to disrupt the $10B+ prescription opioid pain medications market by accomplishing what others thought impossible – to create a new class of abuse deterrent opioids that protect individuals from oral misuse, abuse, and fatal overdose (that is, from the simultaneous ingestion of multiple pills). Elysium’s technologies are designed to (i) enhance the ability of pain patients and physicians to employ effective opioid-based pain management, (ii) reduce the costly impact of prescription drug abuse on families and our economy; and (iii) save lives.

Unintentional drug overdoses continued to be the leading cause of injury-related death in 2015, ahead of motor vehicle traffic crashes – a trend which began in 2007. That being the case, perhaps there are lessons to be learned from the auto industry. Unlike the correlation between increased “environmental exposure” to prescription opioids and opioid-related fatalities, the auto industry has seen a 50% decrease in the annual death rate per vehicle miles traveled despite a 3-fold increase in motor-vehicle travel from 1971 to 2016. Why the disparity? Experts indicate that improvements in auto safety played a key role in the decline in automobile fatalities. Beginning in 1968, seat belts became mandatory in US automobiles. Since then, auto safety regulations have required continued improvements in auto safety equipment, including, air bags, center brake lights, anti-lock brakes, and crumple zones. In contrast, from 1999 to 2008, there were no improvements in the safety of prescription opioids.

A balanced solution that addresses both (i) individual patient's needs for effective pain relief, and (ii) the devastating national opioid epidemic is needed.

Elysium’s vision:

· A cutting edge pharmaceutical company with novel technologies will set a new standard of safety for prescription opioids

· Like the auto industry, pharmaceutical companies will soon be required to meet minimum safety standards for their prescription opioid products, whether branded or generic, by a certain date. Such safety standards will be raised over time as new technologies are developed.

· All “unprotected” opioids will be removed from the market by the FDA to for safety reasons in order to maximize the beneficial impact of abuse-resistant, overdose-protected alternatives.

Our new therapeutic entity strategies offer:

· Highly effective pain-relief

· A high probability of success

· First- and best-in-class labeling that competitors’ technologies are incapable of offering, including:

· Oral overdose protection, the primary route of abuse

· Diversion-resistance to deplete the pool of unused/leftover prescription opioids

· Strong key stakeholder interest

· Potential for rapid commercialization with breakthrough therapy designation by the FDA

Alignment with State and Federal Strategies to Fight the Opioid Epidemics

While the words used to communicate strategies to fight the opioid epidemics vary, the underlying objectives are quite similar. Our technologies represent a strong fit with these strategies:

Cracking Down on Drug Trafficking – Because ingesting multiple pills will not provide a dose-proportional increase in systemic exposure to the active opioid, O2P and expired XpiRx opioids will not be desirable for abuse. Consequently, the street value of our opioids is expected to be nominal, rendering them unattractive for the illegal drug trade.
Preventing Youth Drug Use Before It Starts – Experts contend that our technologies will serve to disrupt the heartbreaking and often lethal progression from the “experimental” oral misuse and abuse of prescription opioids, to illicit fentanyl and heroin use and addiction, by eliminating the dose-proportional “high” that they are rewarded with via co-ingesting increasing numbers of pills.
Encouraging Appropriate Use and Availability of Pain Medication – O2P and XpiRx opioids will provide patients with access to highly effective and safe opioid-based pain therapy with unprecedented protection against misuse, abuse, and fatal overdose. Importantly, individuals will not have the ability to self-select their dose by taking more pills because O2P opioids progressively attenuate opioid exposures as the number of co-ingested pills increases, or share/misuse their leftover opioids. Experts believe that this will encourage more effective communication between patients and their doctors in managing pain.
Saving Lives – Because exposure control is an integral component of our technologies, each O2P and expired XpiRx pill will protect against fatal overdose via ALL routes, without the need for intervention with overdose antidotes (i.e. opioid antagonists such as naloxone or naltrexone). By removing the “incentive” to co-ingest multiple pills, experts believe that O2P and XpiRx opioids will play a key role in closing the “gateway” from the misuse of prescription opioids, to illicit fentanyl and heroin addiction which often result in fatal overdoses.

Elysium Therapeutics

Alignment with State and Federal Strategies to Fight the Opioid Epidemics