RICHMOND, Va., Oct. 21, 2014 /PRNewswire/ -- Reckitt Benckiser Pharmaceuticals Inc. (RBP) today announced its UK-based parent company, Reckitt Benckiser Group plc (RB), expects the proposed demerger of the RBP business to complete in 2014. Reckitt Benckiser originally announced plans to demerge the RBP business in late July 2014, and the operational and financial separations, appointment of the new Board and other activities associated with the demerger have been advanced substantially since that announcement. As a stand-alone global specialty pharmaceutical company, RBP will leverage its legacy of leadership, passion and expertise in neuroscience to pioneer innovative and accessible therapies for addiction and related mental health disorders. The demerger is anticipated to occur prior to December 31, 2014 following approval of RB shareholders with RBP operating independently under the separate holding company Indivior PLC, which will be listed on the London Stock Exchange.
“People with addiction are often stereotyped and discounted many are greatly under diagnosed, undertreated and under supported. Since our inception, we have actively partnered with healthcare professionals, the public health community, policy makers and payors to humanize people suffering from addiction and medicalize the condition,” said Shaun Thaxter, Chief Executive Officer, Reckitt Benckiser Pharmaceuticals Inc. “We had always envisioned a day where our business would reach a point of maturity so we could expand our focus across the chronic diseases of addiction. While great strides have been made within the opioid dependence marketplace, we are well positioned to build on our intimate understanding of the patient journey to combat the broader addiction epidemic and bring to market novel treatment solutions worldwide. From our employees to our leadership team, each and every one of us is inspired and invigorated by the promise this next chapter brings forth for expanding availability of treatment and improving patient lives.”
Reckitt Benckiser Pharmaceuticals’ focus on addressing unmet needs is evidenced in its first-to-market approved therapies and growing pipeline with recent mergers and acquisitions. Reckitt Benckiser Pharmaceuticals’ portfolio of opioid dependence treatments spans more than 40 countries and comprises SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII), SUBOXONE® (buprenorphine and naloxone) Sublingual Tablet (CIII) and SUBUTEX® (buprenorphine HCl) Sublingual Tablets. The company has a robust therapeutic pipeline to address addiction and related mental health disorders, including a monthly depot injection and the first swallowable tablet form of buprenorphine for the potential treatment of opioid dependence. Additionally, RBP recently partnered with AntiOp Inc. to develop a naloxone nasal spray for potential treatment of opioid overdose (Phase 3) and entered into a collaboration with XenoPort Inc. to study arbaclofin placarbil as a potential treatment for alcohol use disorders (Phase 1/2).
“Our patient-centric leadership model has enabled us to cement our strong foundation in opioid dependence and rapidly expand our pipeline into the broader addiction space, giving us great potential to improve the lives of individuals touched by these chronic diseases and other mental health disorders,” said Christian Heidbreder, Ph.D., Global Director, Research & Development, Reckitt Benckiser Pharmaceuticals Inc. “We are investing continuously in new initiatives that advance science and evolve treatment paradigms to address the greatest unmet needs amidst these growing disease epidemics. As Indivior, we will do so through continued collaboration with government bodies and strategic partners who share our goal to improve patient lives, partner for change and drive forward innovation.”
The name Indivior and tagline “Focus on you” were selected as they aptly embody RBP’s vision, mission and values dedicated to transforming addiction from a global human crisis to an actively treated chronic disease. Indivior is the fusion of the words individual and endeavor.
About Reckitt Benckiser Pharmaceuticals Inc.
Reckitt Benckiser Pharmaceuticals Inc. is a specialty pharmaceutical company with decades of heritage in serving the opioid dependence treatment community. Committed to expanding education and access to medical therapies, the company innovates, manufactures and markets medications that, in conjunction with counseling and psychosocial support, treat opioid dependence. Reckitt Benckiser Pharmaceuticals continues to invest resources in raising awareness of opioid dependence within the community, while also sponsoring training programs for physicians to become certified to treat opioid dependent patients. Reckitt Benckiser Pharmaceuticals is, and will be until the demerger, a wholly owned subsidiary of Reckitt Benckiser Group plc, a global company publicly traded on the UK stock exchange.
Indication
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.
Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.
Important Safety Information
Do not take SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported.
SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit.
SUBOXONE Sublingual Film contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE Sublingual Film suddenly without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.
SUBOXONE Sublingual Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Sublingual Film.
You should not drink alcohol while taking SUBOXONE Sublingual Film, as this can lead to loss of consciousness or even death.
Death has been reported in those who are not opioid dependent.
Your doctor may monitor liver function before and during treatment.
SUBOXONE Sublingual Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, SUBOXONE Sublingual Film may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.
Keep SUBOXONE Sublingual Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Sublingual Film by a child can cause severe breathing problems and death.
Do not take SUBOXONE Sublingual Film before the effects of other opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.
Injecting SUBOXONE may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
Before taking SUBOXONE Sublingual Film, tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant or become pregnant while taking SUBOXONE Sublingual Film, alert your doctor immediately and you should report it using the contact information provided below.*
Neonatal withdrawal has been reported following the use of buprenorphine by the mother during pregnancy.
Before taking SUBOXONE Sublingual Film, talk to your doctor if you are breastfeeding or plan to breastfeed your baby. SUBOXONE can pass into your breast milk. You and your doctor should consider the development and health benefits of breastfeeding along with your clinical need for SUBOXONE Sublingual Film and should also consider any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE Sublingual Film affects you. Buprenorphine in SUBOXONE Sublingual Film can cause drowsiness and slow reaction times during dose-adjustment periods.
Common side effects of SUBOXONE Sublingual Film include nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.
This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film. Please see full Prescribing Information for a complete list.
*To report negative side effects associated with taking SUBOXONE Sublingual Film, please call 1-877-782-6966. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information about SUBOXONE Sublingual Film or SUBOXONE® (buprenorphine and naloxone) Sublingual Tablet (CIII), please see full Prescribing Information and Medication Guide at www.SuboxoneREMS.com.
This announcement is for information purposes only and does not constitute or form part of an offer to issue or sell, or the solicitation of an offer to acquire, purchase, exchange or subscribe for, any securities of RB or RBP in any jurisdiction, including the United States. This announcement does not constitute a recommendation regarding the proposed demerger referred to in this announcement or otherwise regarding the securities of RB or RBP, and should not be construed as legal, business, tax or investment advice. The securities of RB have not been, and will not be, registered, and any securities of RBP to be distributed in connection with the proposed demerger have not been, and will not in connection with the proposed demerger be, registered, under the US Securities Act of 1933, as amended (the “Securities Act”), or the securities laws of any state or other jurisdiction of the United States, and such securities may not be offered or sold in the United States absent registration or except in transactions exempt from, or not subject to, the registration requirements of the Securities Act, and except in compliance with applicable state securities laws.
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SOURCE Reckitt Benckiser Pharmaceuticals
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