Every day, 115 people drop dead due to opioid overdoses — about half from prescription drugs and the rest from illicit drug use. So what if Narcan — a nasal-spray antidote to opioid overdose — becomes as widely available as flu shots?
That's the hope of Radnor-based Adapt Pharma, which recently got a shout-out from President Trump and backing from the surgeon general.
"We're trying to make sure first responders, hospitals, universities all have access to our Narcan nasal spray," Seamus Mulligan, founder and CEO, said in an interview from Dublin, his native country and site of the company's world headquarters. Mulligan splits his time between Ireland, his native country, and Radnor, where Adapt Pharma has its U.S. headquarters.
Other drug companies also make naloxone, the drug used in Narcan nasal spray. Those companies include Kaleo and Amphastar Pharmaceuticals. Naloxone can be administered by non-medically trained people using two versions approved by the Food and Drug Administration: Narcan Nasal Spray and Evzio, an auto-injector. Narcan Nasal Spray is the leading product in units distributed, Adapt executives said, in part because it's easier for nonmedical folks to use than injectables.
Like many drugs, cost has been a sore point.
"We dealt with a number of patient groups and the governmental agencies, and we know price is an issue," Mulligan noted.
Currently, Narcan is available without a prescription at any participating pharmacy — at a retail cost of $125 for two doses. In response to the epidemic, Adapt prices Narcan 40 percent lower for nonprofits, first responders, schools, and any government agency, which pays $75 for two doses, or $37.50 a dose. Narcan Nasal Spray's list price hasn't changed since then.
Mulligan is a longtime Philadelphia drug company executive. He founded Azur Pharma, which was acquired by Jazz Pharmaceuticals of California in 2011. Then, in 2013, he took the money he earned from that acquisition to start Adapt Pharma in Radnor.
"One of our first projects was a nasal formulation of naloxone," Mulligan said. "We took over a development program [of nasal spray] from Opiant, and we completed the development and had it out in 14 weeks. We got fast-tracked and got priority review with the FDA" in November 2015. The product Narcan launched in 2016. Narcan is a brand name for Adapt's nasal spray of naloxone.
"Part of the additional value we brought was we're quick to recognize the need," he said. "We also applied for the trademark — that was the key value-add. In addition, we're spreading the message of awareness, access, and affordability. The brand name gave us a start on awareness, and at a price point that's affordable. There's also 95 percent insurance coverage, and the average co-pay for 74 percent of people is less than $10. We work to ensure affordability."
Adapt Pharma is private and doesn't release revenues or profit projections, but last year the company shipped one million cartons (each carton contains two doses) and in the first quarter of 2018 shipped 375,000 cartons, or 750,000 doses, Maguire said. Narcan holds just more than 80 percent share of the retail market, and the total market ranges between $100 million and $150 million.
Adapt licensed the nasal-spray version from Opiant in exchange for royalty fees. And that FDA-approved spray delivery system is key.
"Not many people want to inject other people," Roger Crystal, CEO of Opiant, told the Associated Press. "Once you have a nasal spray, you open up a huge patient population and bystander population who are now willing and able to use it. … Police officers in certain counties [hold] up Narcan like a trophy. They're proud. They're empowered. They can do something about an overdose rather than arriving to a cold body."
What's the potential market? According to the Centers for Disease Control and Prevention, 60 million people in the United States were prescribed opioids in 2017. Of those, 20 million people were prescribed high-dose opioids, or greater than 50 MME (morphine milligram equivalent). The CDC recommends patients prescribed 50 MME should receive a co-prescription of naloxone to prevent overdose.
Will Adapt one day go public? "Our focus at this moment is trying to maximize awareness and distribution of Narcan Nasal Spray across the U.S. and Canada," Mulligan said.
Currently, the company doesn't need capital. Mulligan and other management contributed $115 million of their own money to start the company.
"We believe fervently in this, and the benefit is that it gives us control," he said. "We don't have to look to a VC or private equity fund."
How did Adapt Pharma end up in Philadelphia? Adapt's chief operating office, Eunan Maguire, and other Adapt executives worked here with prior drug companies; Maguire worked with Azur and lived in Center City from 2007 to 2012.
"We really like the area," Maguire said. "Philly is just very pro-business. Jazz is testament to what a start-up company can become." Since Adapt is based in Radnor, home to drug giants such as Wyeth and Pfizer, "there's a great network of talent here. As mid- and large-sized companies move here, we're tapping into that talent."
In total, Adapt employs roughly 50 people, 30 in the U.S. and the remainder in Dublin, where finance, R&D, and management executives are based. Adapt has other drugs in the pipeline, including very early-stage drugs to treat addiction rather than overdose, Maguire said.
Adapt faces stiff competition on many fronts, including competitors developing new products. Adapt sued Teva Pharmaceuticals USA in federal court in New Jersey in 2016, saying Teva's application to sell a generic version of Adapt's Narcan nasal-spray treatment for opioid overdoses infringes on the drug's patent. The suit is ongoing.
And it helps when the U.S. president speaks up for your product. U.S. Surgeon General Jerome Adams added his voice in early April: "Each day we lose … one person every 12.5 minutes," he said. Although Adams didn't name the brand Narcan, he did urge Americans to carry naloxone. "It is time to make sure more people have access to this lifesaving medication, because 77 percent of opioid overdose deaths occur outside of a medical setting, and more than half occur at home."
Adapt is now looking to diversify. "We have a pipeline of overdose treatments and early-stage treatment programs we're starting to bring through," Maguire said. "But in the U.S., they have to ensure affordable access through agencies such as Medicaid, Medicare, and commercial insurance. Secondly, availability: Naloxone is a prescription drug, but you can also walk into a pharmacy and buy it without a prescription from a doctor. We're trying to get that message out through retailers such as Walgreens, Rite Aid, and CVS, which carry Narcan in stores."
Insurers such as Independence Blue Cross said this year that its clients will have access to Narcan without charge. CVS last week said it would sell Narcan for $95 for those without insurance.
Narcan and other forms of naloxone are not a cure-all. It often must be administered multiple times and sometimes fails to revive the person who overdoses. But public health advocates have embraced it as a key weapon.
"We think this is the right medication to have if there are opioids in the home, people who are potential witnesses or first responders to overdoses," Maguire said. "In the state of Pennsylvania, the state and city police carry Narcan," and other states are beginning to follow suit.