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Indivior's Opioid Use Disorder Drug Inching Closer To FDA Approval...

IndiviorPLC 112717

The American Depositary Receipts of Indivior plc (INVVY.OB), a global specialty pharmaceutical company focused on developing opioid dependence treatments, are up nearly 38% year-to-date.

After getting thumbs up from an FDA panel for RBP-6000, its investigational treatment for opioid use disorder, Indivior now awaits the regulatory agency's final decision, which is expected on November 30, 2017.

The American College of Obstetricians and Gynecologists defines opioid use disorder as a pattern of opioid use characterized by tolerance, craving, inability to control use, and continued use despite adverse consequences.

RBP-6000 is a subcutaneous (SC) long-acting monthly depot injection that delivers a sustained-release formulation of buprenorphine. It aims to reduce opioid drug misuse by decreasing cravings and addressing withdrawal symptoms.

According to the most recent National Survey on Drug Use and Health report, 11.8 million Americans engaged in misuse of opioids last year, and about 2 million American adults (age 12+ years old) met the criteria for opioid use disorder. The same report suggested that 935,000 adults have used heroin in the past year, and 625,000 adults had a heroin use disorder.

If approved, Stifel analyst Max Herrmann expects RBP-6000 to generate peak sales of $700 million by 2021 while Jefferies analysts have pegged the drug's sales at $1.3 billion by 2025.

Currently, the Company derives all its revenues from sales of SUBOXONE Film, currently marketed in the United States, Australia and Malaysia; SUBOXONE Tablet, currently marketed in 40 countries, and SUBUTEX Tablet, marketed in 21 countries, all of which are treatments to reduce withdrawal symptoms and help ease cravings.

The results of a study comparing the effectiveness of Suboxone, given daily as a sublingual film, and Vivitrol, a monthly intramuscular injection, on patients dependent on non-prescribed opioids, were released recently. The study involved 570 participants, and they were followed for up to 24 weeks of outpatient treatment. The results were published in The Lancet recently.

According to the study results, both the drugs were equally effective once medication treatment is initiated. But it is more difficult to initiate patients to Vivitrol than Suboxone. The patients need to get through detox in order to start Vivitrol.

Suboxone, which costs around $144 for a supply of 30 film, generated revenue of $828 million in the first nine months of 2017. In contrast, Vivitrol, which costs around $1,300 per shot, logged net sales of $193.8 million in the same period.

Recent events:

-- On August 31, 2017, the US District Court for the District of Delaware ruled that Dr. Reddy's Laboratories' proposed generic version of Suboxon sublingual film does not infringe the patents '150, '514 and '497, as asserted by Indivior.
-- On September 15, 2017, Indivior filed patent lawsuits against Dr. Reddy's, Actavis, Par, Alvogen, Teva, and Mylan for infringement of patent '454 relating to their respective proposed generic versions of Suboxon sublingual film. The '454 patent was issued to Indivior on June 27, 2017.
-- On September 28, 2017, the Company submitted its New Drug Application to the FDA for RBP-7000 Risperidone Monthly Depot for the treatment of Schizophrenia.

Indivior is listed on the London Stock Exchange Main Market, under ticker symbol INDV, and its American Depositary Receipts are publicly traded in the US on the OTC Market, under symbol INVVY.

INVVY closed Friday's trading at $25.30, unchanged from the previous day's close.

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