The signing last month of the 21st Century Cures Act into law by President Barack Obama signals a major revamp in the treatment of opioid addiction because of the promise of $1 billion in research funding, as well as a system to hasten approval of drugs and medicine devices by the Food and Drug Administration.
In all, the Act pledges $6.3 billion in fresh funding over the next two years to fast track regulatory review with the aim of bringing drugs and medicines to the market faster. The new funds are expected to create major changes in the pharmaceuticals and medical device industries.
The signing of the Act quickly drew positive response from the Coalition to Stop Opioid Overdose, the eminent lobby group in the fight against opioid abuse.
The group said in a statement, “This legislation can help create real change for the millions of Americans impacted by the opioid crisis. In addition to the passage of this bill, we are calling for the upcoming continuing resolution to include a provision to immediately start the flow of these funds into communities across America.”
Opioid crisis in the U.S.
Brady Granier, president, CEO and director of BioCorRx Inc. (BICX, Financial), said that the opioid epidemic affects millions of Americans. Independent data released by the Centers for Disease Control and Prevention showed that over 33,000 Americans lost their lives from opioid overdose in 2015. In that same year, the number of persons who have died due to heroin overdoses surpassed those who were killed due to gun homicides, the first in U.S. history.
“It’s a sad reality. Many lives are being lost because of this opioid epidemic that is showing no signs of slowing. There are many factors contributing to this crisis and there is no single solution,” Granier said. “More resources need to be focused on prevention and treatment. There are some very encouraging new tools being used on the treatment side that should be getting more recognition than they are currently. I think that will change soon as the treatment industry is rapidly evolving into more evidence based treatment.”
Addiction treatment has an annual market size of $41 billion in the U.S. with more than 23 million Americans addicted to alcohol and drugs. Of these only 12% receive addiction treatment. The Substance Abuse and Mental Health Services Administration and the National Institute on Drug Abuse estimate it costs the U.S. more than $600 billion every year due to health care, law implementation/enforcement, sponsored treatment and counteractive action endeavors.
Indeed, the treatment for opioid addiction is not cheap. In fact, the price of opioid overdose antidote and treatment are rising at an alarming rate.
Price of Narcan and anti-opioid drugs on the rise
First responders usually administer naloxone, more commonly known by its brand name Narcan, as an opioid overdose antidote naloxone. But as the number of cases of opioid overdoses increase, the price of the drug multiplies.
Brandon Heard, chief of the Farmington fire department in New Mexico, commented on CNBC, “I’ve seen the price of Narcan as well as epinephrine just skyrocket.” He added, “It makes it difficult for us as a municipality to purchase the same medications and provide the same treatment and abilities that we have in years past.”
Although naloxone now comes in a generic form, big pharmaceutical companies still jack up the prices. Hospira, a generic naloxone manufactured by Pfizer Inc. (PFE, Financial), now costs $15 per milliliter from less than $1 in 2005. The newer delivery method of the drug ranges between $125 and $3,750 for two doses.
Another opioid addiction treatment drug available in the market is the injectable naltrexone, currently exclusively manufactured by Alkermes PLC (ALKS, Financial), a $9 billion pharmaceutical company which sells the drug under its brand name Vivitrol. The cost of one Vivitrol injection is $1,300.
New and cheaper opioid and alcohol addiction treatment
But less expensive opioid and alcohol addiction treatment options may be coming soon. BioCorRx, an addiction treatment solutions company, is developing a newer form of injectable naltrexone that is expected to cost less than the leading Vivitrol brand and perhaps even less painful when administered. BioCorRx’s injectable naltrexone product in development, BICX101, is expected to last over 30 days. Naltrexone can reduce cravings for alcohol and opioids, but can also block the effects of opioids and the euphoric effects of consuming alcohol.
Vivitrol was expected to generate $180 million to $200 million in revenue for 2016, and $220 million for 2017. It seems their dominance may be poised for disruption should BioCorRx prevail with BICX101. BioCorRx has stated that they expect to be able to file a 505(b)(2) application with the FDA for approval of BICX101. This sort of application is generally regarded as a fast track to approval. BioCorRx hopes to be able to submit an NDA by 2018 and begin generating sales in 2019.
Last year, BioCorRx announced an initial investment of $2.5 million with an additional option of $2.5 million from private equity firm Alpine Creek Capital. This is the single largest investment made in the company thus far, which Granier views as a strong indicator of the investment merits of the business given the intense due diligence performed by a firm such as Alpine Creek Capital.
Given BioCorRx’s high growth two-pronged growth strategy with centers and the new naltrexone injection in development, JGR Capital Partners recently initiated coverage on BioCorRx with an 18-month price target of 9 cents.
DISCLOSURE: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I am receiving compensation from BioCorRx for the article.
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