FOR IMMEDIATE RELEASE
`
`Reckitt Benckiser Pharmaceuticals Inc. Enters Into Agreement to
`Develop and Market First Naloxone Nasal Treatment for Opioid Overdose
`
`RICHMOND, Va. (May 19, 2014) – Reckitt Benckiser Pharmaceuticals Inc. (RBP) announced
`today that it has entered into a definitive agreement with AntiOp, Inc. to co-develop a naloxone
`nasal spray to aid in the reversal of opioid overdose with the option to acquire all rights to the
`product upon receipt of regulatory and marketing approval. The product has the potential to be
`the first of its kind to treat overdose from opioid prescription painkillers and heroin – a growing
`epidemic in the United States.1,2
`
`for treating opioid overdose is to administer an
`the standard medical protocol
`Currently,
`injectable form of naloxone.3,4,5 It must be administered intravenously or as a shot into muscle or
`the skin.4,5 There is a lack of
`under
`familiarity or comfort with injectable medication
`administration among non-medical personnel and emergency first responders. This product
`aims to fulfill an unmet need by providing family members and caregivers – who are often on the
`frontlines at the time of overdose – with a nasal alternative utilizing the novel medication
`delivery expertise of AntiOp.
`
`led by Dr. Daniel
`“This strategic agreement partners the innovative science of AntiOp,
`Wermeling, renowned for his work in the nasal delivery of medication, with the pioneering
`leadership of Reckitt Benckiser Pharmaceuticals as an innovator
`in opioid dependence
`treatment
`for more than a decade,” said Shaun Thaxter, CEO, Reckitt Benckiser
`Pharmaceuticals Inc. “Together, we are uniquely suited to bring this product to market and are
`excited about
`the potential
`to help the many patients each year who succumb to opioid
`overdose.6 Naloxone nasal spray is a strong, strategic fit to our portfolio further strengthening
`our capabilities to provide much needed treatment services for the chronic relapsing conditions
`of addiction.”
`
`Drug overdose deaths, driven largely by opioid prescription medication overdose deaths, are
`now the leading cause of
`injury death in the United States – surpassing motor vehicle
`crashes.6,7 Use of opioids has been steadily increasing over the past decade,8,9 while opioid-
`related drug overdose deaths have more than tripled in the past 12 years driven primarily by the
`abuse of opioid prescription painkillers.9 The U.S. Centers for Disease Control and Prevention
`reports that more than 45 people died each day on average from opioid prescription painkiller
`overdoses, claiming more than 16,651 lives in 2010 alone.6
`
`AntiOp’s nasal formulation is a pre-filled, unit-dose, disposable delivery system designed for
`insertion into the nose of an overdose victim to administer naloxone across the nasal mucosal
`membrane for absorption.10 The needle-free device was selected to facilitate broader access to
`this treatment.
`
`About Reckitt Benckiser Pharmaceuticals Inc.
`Reckitt Benckiser Pharmaceuticals Inc. is a specialty pharmaceutical company with a decade of
`heritage in serving the opioid dependence treatment community. Committed to expanding
`education and access to medical therapies, the company innovates, manufactures and markets
`
`GEN-0164-oMay2014
`
`Opiant Exhibit 2198
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 1
`
`

`

`treat opioid
`in conjunction with counseling and psychosocial support,
`medications that,
`dependence. Reckitt Benckiser Pharmaceuticals Inc. 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 addicted patients. The company aims to help
`patients by enabling opioid dependence to be managed within mainstream medical practice
`through medication-assisted treatment. Reckitt Benckiser Pharmaceuticals Inc.
`is a wholly
`owned subsidiary of Reckitt Benckiser Group plc, a global company publicly traded on the UK
`stock exchange.
`
`Media Contacts
`Alana Rockland, Biosector 2 Phone: 1-212-845-5651
`Alice Sofield, Biosector 2
`Phone: 1-703-861-5654
`
`Email: ARockland@Biosector2.com
`Email: ASofield@Biosector2.com
`
`References
`
`1 Substance Abuse and Mental Health Services Administration. (September 2010). Treatment Episode Data Set:
`Characteristics of Substance Abuse Treatment Admissions Reporting Primary Abuse of Prescription Pain Relievers:
`1998 and 2008. Accessed May 6, 2014. Available at
`http://www.oas.samhsa.gov/2k10/230b/230bPainRelvr2k10Web.pdf.
`
`2 Centers for Disease Control and Prevention (CDC). Vital Signs: Overdoses of Prescription Opioid Pain Relievers—
`United States, 1999-2008. MMWR, 2011; 60: 1-6. Accessed May 6, 2014. Available at:
`http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm?s_cid=mm6043a4_w.
`
`3 FDA News Release. FDA approves new hand-held auto-injector to reverse opioid overdose. April 3, 2014.
`Accessed May 6, 2014. Available at:
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391465.htm.
`
`4 Kaleo, Inc. Evzio Prescribing Information. April 2014. Accessed May 6, 2014. Available at:
`http://www.evzio.com/pdfs/Evzio%20PI.PDF.
`
`5 Hospira, Inc. Naloxone Hydrochloride Injection, USP Product Insert. Accessed April 24, 2014. Available at
`http://www.hospira.com/Images/EN-1367_32-5515_1.pdf
`
`6 Jones CM, Mack KA, Paulozzi LJ. Pharmaceutical overdose deaths, United States, 2010. JAMA 2013;309:657-659.
`Accessed May 6, 2014. Available at: http://jama.jamanetwork.com/article.aspx?articleid=1653518
`
`7 Centers for Disease Control and Prevention. Wide-ranging OnLine Data for Epidemiologic Research (WONDER)
`[online]. (2012) Available from URL: http://wonder.cdc.gov/mortsql.html.
`
`8 Substance Abuse and Mental Health Services Administration. (2011). Results from the 2010 National Survey on
`Drug Use and Health: Summary of National Findings, NSDUH Series H-41, HHS Publication No. (SMA) 11-4658.
`Accessed May 6, 2014. Available at
`http://www.samhsa.gov/data/NSDUH/2k10ResultsRev/NSDUHresultsRev2010.htm.
`
`9 Centers for Disease Control and Prevention (CDC). Policy Impact: Prescription Painkiller Overdoses. Accessed May
`6, 2014. Available at: http://www.cdc.gov/HomeandRecreationalSafety/pdf/PolicyImpact-PrescriptionPainkillerOD.pdf.
`
`10 AntiOp, Inc. Press Release. Naloxone Nasal Spray on Development Fast Track as Emergency Treatment for
`Opioid Overdose. September 20, 2013. Accessed May 6, 2014. Available at:
`http://www.businesswire.com/news/home/20130920005500/en/Naloxone-Nasal-Spray-Development-Fast-Track-
`Emergency.
`
`GEN-0164-oMay2014
`
`Opiant Exhibit 2198
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 2
`
`