throbber

`INDIVIOR’S INTR!N!S!L
`
`
` NALOXONE
`
`
`
`
` Steve Hebert
`
`
`
` Global Therapy Leader
`
`Opiant Exhibit 2173
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 1
`
`

`

`Opiant Exhibit 2173
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 2
`
`

`

`
`
` Our Passion Drives Our Success
`
`
`
` Stock listing:
`
`LON: INDV.L
`
`
`
`
`
` Headquarters: Richmond, Virginia, United States
`
`
`
`
`
`
`
`
`
` Employees: 700+
`
`
`
`
`
` Regions:
`
` ͩΡΰξ; !Ι͂ΰ΁̴̦ͺ EϙΰΡέ͂͹ ͨ΁̾̾Γ͂ E̦δξ & !͌ΰ΁̴̦ ;΂EͨE!͟Ϳͺ
`
`
` Australasia; and Greater China
`
`
`
`
`
` Portfolio:
`
`
`
` SUBOXONE® (buprenorphine/naloxone) Sublingual Film (CIII)
`
` SUBOXONE® (buprenorphine/naloxone) Sublingual Tablets (CIII)
` SUBUTEX® (buprenorphine HCl) Sublingual Tablets (CIII)
`
`
`
`
`
`
` Suboxone
` Patients >5 Million
`
`
` Treated:
`
`
`
`
`
`
` SUBOXONE® Film
` Orange-colored, rectangular film
`
`
`
` with white printed logo
`
`
` SUBOXONE® Tablets
`
`
`
` Orange-colored, hexagonal tablet
` available in a 30-count bottle
`
`
`
` SUBUTEX® Tablets
`
`
` White tablets
`
`
`
`Opiant Exhibit 2173
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 3
`
`

`

`
`
` A Growing Epidemic
`
`
`260 M opioid prescriptions for 50 M Americans
`
`
`
`
`
`25 K overdose deaths in US in 2013
`
`
`
`
`
`69 K fatal overdoses worldwide
`
`
`
`
`
`
` Naloxone is effective in reversing opioid overdose, but…
`
` Not readily available
`
` outside of hospitals and EMS settings
`
`
`
` Source: National Institute of Health, Centers for Disease Control and Prevention and World Health Organization
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Opiant Exhibit 2173
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 4
`
`

`

` What if there was an alternative available that could be accessed by non-
`
`
` healthcare professionals, anywhere at anytime?
`
`
`
` Key Product Attributes
` • Device / Drug Combo
`
`
`
`
`
`
` • Needle free
`
`
`
` • Ready to use
`
`
`
` Accessible to
`
` everyone
`
`
`
` • Compact / Portable
`
`
`
`
`
`NDA Submitted May 2015
`
`
`
`Opiant Exhibit 2173
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 5
`
`

`

` INDIVIOR MISSION: All patients around the world will have access to high quality
`
`
`
` treatment services for the chronic relapsing conditions of addiction
`
`
`
`
`
`
`
` INDIVIOR
` Goal:
`
`Work with communities to
`
` cut annual opioid overdose
` deaths by 50%
`
`
`PRODUCT
`
` Vision:
`
`Everyone understands the
`risks of overdose and
`
` embraces their community
`
` responsibility and personal
`
` role in potentially saving a life
`
`
` from opioid overdose
`
`
`
`Opiant Exhibit 2173
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 6
`
`

`

`
`
` The path to eliminating opioid overdose deaths
`
`
`
`
` ER/Harm Reduction
`
`
`
` Co-Rx
`
`
`
` Community/OTC
`
`
`
`
` OD
`
`
`
` Risk Management
`
`
`
` Prevention
`
` Poor
`
` Awareness
`
`
`
`
` Stigma
`
`
`
` Knowledge gaps
`
`
`
` NALOXONE ACCESS LEGISLATION
`
` Lack of leadership/
`
`
` champion
`
`Opiant Exhibit 2173
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 7
`
`

`

`
`
` Where are the overdoses in the US?
`
`
`
`
`Opiant Exhibit 2173
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 8
`
`

`

` County Segmentation
`
`
`US has ~3 K counties but 251 Counties account for 2/3 of all overdoses1
`
`
`
`
`
` Suburban / Middle Class
`
`
`
`
`
`
`
` Rural / Poor
`
`
`
`
`
`
`
` • Examples: Bell County, KY, Rio Arriba, NM and
`
`
` Cabell, WV
` • Overdose largely driven by prescription Rx
` • High Medicaid population
`
`
`
`
`
`
`
`
`
` • Examples: Worcester, MA, Montgomery, PA and
` New Haven, CT
`
`
` • Overdose largely driven by opioids but heroin on
`
` the rise
`
`
`
` • Examples: Seattle, Albuquerque and Las Vegas
`
` • Mix of Heroin and Opioid Rx
`
`
`• Often younger victims
`
`
`
`
`
`
`
`
` Urban / Middle Class
`
`
`
`
`
` 1: CDC Opioid Overdose Data by County
`
`
`
`
` • Examples: Baltimore, Cleveland and Detroit
`
`• Heroin responsible for a large proportion of
`
` overdoses
`
` • Overdose in public bathrooms, abandoned
`
` houses, etc.
`
`
`
`
`
`
` Urban / Poor
`
`
`
`Opiant Exhibit 2173
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 9
`
`

`

`
`
` Indivior will work with communities to reduce opioid overdose
`
`
` death rates by
`
`
`Working with the top 250 counties for opioid overdose (rate + absolute number)
`
`
`
`
`
`
` Train and mobilize ~500 community champions
`
`
`
`Community champions train at least 500 local advocates
`
`
`
`
`
`
`
`250K trained advocates across 250 communities
`
`
`
`
`
`
`
`
`
`
`
`
` 1: Training 100 – 250 people per 100 K population in high overdose communities in Massachusetts resulted in a significant reduction in opioid
` overdose deaths. Walley et al. BMJ 2013; 346: f174
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Opiant Exhibit 2173
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 10
`
`

`

` Together, we CAN reduce opioid overdose death
`
`
` rates by 50%
`
`Opiant Exhibit 2173
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 11
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket