INDIVIOR RESPONDS TO COURT RULING IN ANDA LITIGATION AND ANNOUNCES INTENTION TO APPEAL03.23.2018 | PDF Version
This announcement contains inside information.
Slough, UK, 23 March 2018 – Indivior PLC (LON: INDV) (“Indivior” or the “Company”) today announced that the US District Court for the District of Delaware has found that Alvogen does not infringe the asserted claims of U.S. Patent Nos. 8,017,150 (the “‘150 Patent”), 8,603,514 (the “‘514 Patent”) or 8,900,497 (the “‘497 Patent”). Alvogen did not challenge the validity of any of those asserted claims.
The Company intends to continue vigorously defending its intellectual property and believes that it has grounds to appeal the ruling by the District Court of Delaware. Unless and until the Court’s ruling is reversed on appeal, and in the absence of other judicial relief, the Company will not be able to rely on the ’514, ’150, and ’497 Patents to prevent Alvogen from manufacturing and marketing a generic film alternative in the US. Further, the Company may have increased difficulty successfully defending its intellectual property against future ANDA filers.
As of 22 March 2018, FDA has not indicated that it has granted tentative or final marketing authorization to Alvogen’s generic Suboxone® Film (buprenorphine and naloxone) alternative. If FDA grants approval to Alvogen, it would be able to market a generic alternative to Suboxone® Film in the US. Any market launch would be on an “at risk” basis, as the Company would have a claim for damages against Alvogen if the Company prevails on appeal. In addition, Indivior has asserted two new OrangeBook listed patents (the ’454 and ’221 patents) against Alvogen and certain other ANDA filers claiming infringement.
Although it is not possible to quantify precisely the financial impact that the launch of generic alternatives to Suboxone® Film would have on the Company’s revenues generated from Suboxone® Film in the US, or how quickly such an impact would take effect, the Company believes that it could potentially result in a rapid and material loss of market share for Suboxone® Film in the US, an effect that could occur within months of a successful launch of a generic film alternative into the US market.
The Company recognizes the significant challenges that an “at risk” generic film launch would present to its Suboxone® Film business in the US based on industry analogs in the near-term. As such, along with its strengthened balance sheet and growing net cash position, the Company has prepared robust contingency plans based on various potential generic film launch scenarios.
The financial guidance for FY 2018, provided by Indivior on February 15, 2018, in its FY 2017 results, assumed no generic film launch in 2018. The Company will continue to monitor market conditions and will update its financial guidance if appropriate.
Commenting today, Shaun Thaxter, CEO, said: “We believe we have strong intellectual property for Suboxone® Film. We will appeal this ruling and continue to vigorously defend our intellectual property, including asserting the two new Orange-Book listed patents that have been granted for Suboxone® Film. We remain confident in Indivior’s long-term outlook and vision. With the successful launch of SUBLOCADE® (buprenorphine extended-release injection for subcutaneous use) earlier this month, we have the first and only once-monthly buprenorphine depot injection delivery system. With this potentially transformational treatment, we expect to extend our market leading position in the addiction disease space, and we remain confident in achieving at least $1 billion in peak SUBLOCADE® net revenue.”
For Further Information
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|+1 804 423 8916
|Media Enquiries||Jonathan Sibun||Tulchan
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Corporate Website www.indivior.com
This announcement does not constitute an offer to sell, or the solicitation of an offer to subscribe for or otherwise acquire or dispose of shares in the Company to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation.
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.
This announcement contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. By their nature, forward-looking statements involve risk and uncertainty as they relate to events or circumstances that may or may not occur in the future. Actual results may differ materially from those expressed or implied in such statements because they relate to future events. Forward-looking statements include, among other things, statements regarding the Indivior Group’s financial guidance for 2018 and its medium- and long-term growth outlook, its operational goals, its product development pipeline and statements regarding ongoing litigation.
Various factors may cause differences between Indivior’s expectations and actual results, including: factors affecting sales of Indivior Group’s products; the outcome of research and development activities; decisions by regulatory authorities regarding the Indivior Group’s drug applications; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; the outcome of post-approval clinical trials; competitive developments; difficulties or delays in manufacturing; the impact of existing and future legislation and regulatory provisions on product exclusivity; trends toward managed care and healthcare cost containment; legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access; claims and concerns that may arise regarding the safety or efficacy of the Indivior Group’s products and product candidates; risks related to legal proceedings, including the ongoing investigative and antitrust litigation matters; the Indivior Group’s ability to protect its patents and other intellectual property; the outcome of patent infringement litigation relating to Indivior Group’s products, including the ongoing ANDA lawsuits; changes in governmental laws and regulations; issues related to the outsourcing of certain operational and staff functions to third parties; uncertainties related to general economic, political, business, industry, regulatory and market conditions; and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items.
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 healthcare providers qualified under the Drug Addiction Treatment Act.
Important Safety Information
Do not take SUBOXONE® Film if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported.
SUBOXONE® Film can be abused in a manner similar to other opioids, legal or illicit.
SUBOXONE® Film contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your healthcare provider can tell you more about the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE® Film suddenly without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.
SUBOXONE® 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 (i.e., sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE® Film.
You should not drink alcohol while taking SUBOXONE® Film, as this can lead to loss of consciousness or even death.
Death has been reported in those who are not opioid dependent.
Your healthcare provider may monitor liver function before and during treatment.
SUBOXONE® Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, SUBOXONE® 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® Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE® Film by a child can cause severe breathing problems and death.
Do not take SUBOXONE® Film before the effects of other opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.
Injecting the SUBOXONE® Film product may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
Before taking SUBOXONE® Film, tell your healthcare provider if you are pregnant or plan to become pregnant. If you are pregnant, tell your healthcare provider as withdrawal signs and symptoms should be monitored closely and the dose adjusted as necessary. If you are pregnant or become pregnant while taking SUBOXONE® Film, alert your healthcare provider immediately and you should report it using the contact information provided below.
Opioid‐dependent women on buprenorphine maintenance therapy may require additional analgesia during labor.
Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy, whether that use is medically-authorized or illicit. Unlike opioid withdrawal syndrome in adults, NOWS may be life-threatening if not recognized and treated in the neonate. Healthcare professionals should observe newborns for signs of NOWS and manage accordingly. Before taking SUBOXONE® Film, talk to your healthcare provider if you are breastfeeding or plan to breastfeed your baby. The active ingredients of SUBOXONE® Film can pass into your breast milk. You and your healthcare provider should consider the development and health benefits of breastfeeding along with your clinical need for SUBOXONE® 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® Film affects you. Buprenorphine in SUBOXONE® Film can cause drowsiness and slow reaction times during dose-adjustment periods. Common side effects of SUBOXONE® 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® Film. Please see full Prescribing Information and w͟w͟w͟.͟s͟u͟b͟o͟x͟o͟n͟e͟R͟E͟M͟S͟.͟c͟o͟m͟.
*To report pregnancy or side effects associated with taking SUBOXONE® 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® Film, SUBOXONE® (buprenorphine and naloxone) Sublingual Tablets (CIII), or SUBUTEX® (buprenorphine) Sublingual Tablets (CIII), please see the respective full Prescribing Information and Medication Guide at www.suboxoneREMS.com.
INDICATION AND USAGE
SUBLOCADE™ (buprenorphine extended-release injection for subcutaneous use) 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 a dose adjustment period for a minimum of seven days.
SUBLOCADE™ should be used as part of a complete treatment program that includes counseling and psychosocial support
WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE™ RISK EVALUATION AND MITIGATION STRATEGY
• Serious harm or death could result if administered intravenously. SUBLOCADE™ forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously.
• Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE™ is only available through a restricted program called the SUBLOCADE™ REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE™ must be certified in this program and comply with the REMS requirements.
IMPORTANT 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
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. The full prescribing information, including BOXED WARNING, for SUBLOCADE™ can be found here: http://www.indivior.com/wp-content/uploads/2018/01/2018_01_12-CLEAN-USPI-SUBLOCADE.pdf