SLOUGH, England and RICHMOND, Va., Sept. 12, 2018 /PRNewswire/ -- Indivior PLC (LON: INDV) today announced that due to adverse weather expected from Hurricane Florence, the recently declared state of emergency in Virginia and its likely impact on East Coast travel, the Company is unable to participate in Morgan Stanley's 16th Annual Global Healthcare Conference.
Shaun Thaxter, CEO, was scheduled to address conference attendees on Thursday, September 13th at 11:10 a.m. Indivior has published a SUBLOCADE™ (buprenorphine extended-release) Injection Update on its website at www.indivior.com under "Webcasts / Audiocasts / Presentations."
Shaun Thaxter, CEO of Indivior, Comment:
"Experience and satisfaction with SUBLOCADE continues to be positive based on anecdotal reports from both patients and physicians. While early challenges remain, the metrics we have today published demonstrate that we are continuing to make steady progress in reducing the time taken for the prescription journey, improved payor coverage, as well as demonstrating increased trial and adoption by healthcare professionals. We believe HCP adoption will increase progressively as we sustain the progress we are making to alleviate frustration with the medical benefits approval process and improve the timing of the prescription journey for the patient. We continue to expect full year 2018 net revenues to be in the range of $25 million to $50 million, with sales heavily weighted to the fourth quarter, and we remain confident in achieving our annual peak net revenue goal of $1 billion-plus."
Indivior also announced that Teva has agreed that market entry of its recently FDA approved buprenorphine and naloxone (16mg/4mg) sublingual film will be tied to the outcome of the U.S. Court of Appeals for the Federal Circuit (CAFC) decision on the preliminary injunction that was granted by the U.S. District Court for the District of New Jersey against Dr. Reddy's Laboratories (DRL). This agreement will prevent Teva from selling, offering to sell, or import its generic buprenorphine/naloxone sublingual film product until the earlier of a CAFC decision lifting the preliminary injunction against DRL, and the outcome of filed litigation against DRL related to U.S. patent Nos. 9,931,305, 9,855,221, and 9,687,454.
The CAFC has granted DRL an expedited appeal on the preliminary injunction. Arguments are scheduled to be heard on October 4th, with a decision expected in early November.
Indivior Investor Day
Indivior is confirming that it will hold an Investor Day on Wednesday, December 5th, 2018 in New York City. Presentations will be given by Chief Executive Officer Shaun Thaxter and members of the Indivior management team. The event will begin at approximately 9:00 a.m. Eastern Time. A live video / audio webcast of the event, as well as the presentation slides, will be available to the public on the day of the event on the Company's website at www.indivior.com. Additional event details to follow.
The Indivior team will be available to speak with investors one-on-one on September 13th and 14th. Please contact Jason Thompson, Investor Relations, at 804-379-1033 to arrange a time.
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment models that have revolutionized modern addiction treatment. The name is the fusion of the words individual and endeavour, and the tagline "Focus on you" makes the Company's commitment clear. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a strong pipeline of product candidates designed to both expand on its heritage in this category and address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder and schizophrenia. Headquartered in the United States in Richmond, VA, Indivior employs more than 900 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more.
SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.
SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.
WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY
HIGHLIGHTED SAFETY INFORMATION
Prescription use of this product is limited under the Drug Addiction Treatment Act.
SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of the ATRIGEL® delivery system
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.
Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE.
Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged use of opioids during pregnancy.
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
Risk of Opioid Withdrawal With Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately.
Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment.
Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine before injecting SUBLOCADE.
Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.
Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.
For more information about SUBLOCADE, the full Prescribing Information including BOXED WARNING, and Medication Guide visit www.sublocade.com.
SOURCE Indivior PLC