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Inotiv, Inc.
Company typePublic company
Nasdaq: NOTV
IndustryPharmaceutical industry
Founded1974; 50 years ago (1974) as Bioanalytical Systems
FounderPeter Kissinger
HeadquartersLafayette, Indiana, United States
Key people
ServicesContract research organization
Revenue
  • Increase US$572 million (2023)
  • Increase -US$81 million (2023)
  • Increase -US$105 million (2023)
Total assets
  • Decrease US$856 million (2023)
Total equity
  • Decrease US$269 million (2023)
Number of employees
1,200+ (2020)
Websitewww.inotiv.com
Footnotes / references
[1]
Animal testing
Main articles
Testing on
Issues
Cases
Companies
Groups/campaigns
Writers/activists
Categories

Inotiv, Inc. is a contract research organization organized in Indiana and headquartered in Lafayette, Indiana. The company operates two core business units: Discovery and Safety Assessment (DSA) and Research Models and Services (RMS). The CRS business unit offers drug development and environmental sciences services, including safety assessment, analytical, metabolism, CMC and regulatory consultancy for small molecule drug candidates, biotherapeutics, and biomedical devices. The RMS business unit provides research models (live animals), lab animal diets and bedding and support services.[1]

The company has been criticized for its animal testing practices, most specifically animal testing on non-human primates as well as on beagles. It has also been criticized for its laboratory animal sources. In 2022, the United States Department of Agriculture found multiple violations of the Animal Welfare Act of 1966 at the company's dog-breeding facility in Cumberland, Virginia, to which the company plead guilty, resulting in $35 million in fines. The company is accredited by AAALAC International.[2]

History

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Envigo logo

In July 2018, Bioanalytical Systems, founded in 1974 by Purdue University chemistry professor Peter Kissinger, and Seventh Wave Laboratories, founded in 2003, merged.[3]

In March 2021, the company changed its name to Inotiv. The Inotiv brand had been launched in November 2019 for the company's contract research organization division.[4]

In November 2021, Inotiv acquired Envigo.[5] Envigo was formed in September 2015 by the merger of Huntingdon Life Sciences, Harlan Laboratories and three subsidiaries - GFA, NDA Analytics and LSR Associates.[6] It became a public company via a merger with a special-purpose acquisition company in August 2017.[7][8][9] In June 2019, it acquired the research products business of Fortrea, which acquired the nonclinical contract research services business of the company.[10][11] In December 2019, it acquired the unit of Horizon Discovery that provides animals with clinically relevant gene deletions, insertions and other modifications for testing.[12]

In January 2022, the company acquired Integrated Laboratory Systems for $56 million.[13]

In February 2022, the company acquired Orient BioResource Center, a preclinical contract research organization and animal model supplier for $51 million.[14]

In August 2023, the company sold its Israeli business to Harlan Holdings for $3.7 million.[15]

Criticism

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Animal welfare issues

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Treatment of beagles at facility in Cumberland, Virginia

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The company owned and operated a research and breeding facility in Cumberland, Virginia that housed over 5,000 beagles, bred and sold for medical research. In 2019, PETA conducted an undercover investigation at the facility.[16] After a routine inspection in July 2021, USDA inspectors cited the company for 26 violations of the Animal Welfare Act of 1966.[17] After an inspection in October 2021, inspectors cited the company for 13 violations, including 11 repeat violations.[18] Inspectors noted in their reports that the dogs had inadequate food and water and veterinary care, more than 500 dogs were experiencing pain and discomfort, being left in 85-degree heat without air conditioning for up to five hours, and infrequent cleaning left kennels and feeders hounded by insects. More than a dozen dogs were found to have paw and eye injuries, as well as some with "severe dental disease". Over a seven-month period, more than 300 puppies died from "unknown causes", and the facility had kept unfinished records regarding their deaths. Nursing beagles were denied adequate food, and puppies were euthanized without anesthesia.[19] "Investigators observed "widespread fighting" between beagles sharing food sources ... [and] beagles fighting between adjacent cages ... In multiple enclosures, puppies were unable to access the spigots to get water on their own, and when the investigator 'held down the spigot to release water,' the puppies 'immediately rushed to the spigot to get water and drank heavily and quickly.'"[20] Investigators also found numerous beagles trapped in cage floors, one whose jaw was stuck in the cage bars, and unhygienic conditions including insects, mold and a buildup of old food.[21][22]

As a result of these reports and undercover investigations by local news WRIC-TV and PETA, three bills were introduced in Virginia to tighten regulation and subject employees to criminal liability in January 2022; one of such bills passed in April 2022.[23][24][25]

After an inspection on March 8, 2022 found five repeat violations, including unsafe conditions, animal injuries, and mold and feces in the food supply, Virginia Senators Mark Warner and Tim Kaine sent a letter to the USDA requesting that the facility's license be temporarily revoked.[26]

The United States Department of Justice filed a complaint against the company in federal district court on May 19, 2022, seeking an injunction to stop the company from breeding, selling, or otherwise dealing in beagles at the facility.[27] U.S. District Court Judge Norman K. Moon granted the injunction.[28][20] The government also seized nearly 150 beagles from the site that were in desperate need of medical treatment denied by the company.[29][30]

In a settlement reached in July 2022, the company agreed to no longer engage in activities at the Cumberland site that require an Animal Welfare Act license and to relinquish the nearly 4,000 beagles at the facility to the Humane Society of the United States.[22] The company was also ordered to pay a portion of the adoption costs.[31] The remainder of the costs were covered by dog rescue charities.[32] This represented the largest animal welfare seizure in the history of the Humane Society.[33] The Humane Society transported the dogs to a network of shelters across the United States and by September 1, 2022, all of the dogs had been adopted.[34][35] One of the beagles was adopted by Meghan, Duchess of Sussex and Prince Harry, Duke of Sussex.[36] Another rescued puppy was adopted by New Jersey Governor Phil Murphy and is now the First Dog of New Jersey.[37]

In June 2024, the company plead guilty to conspiring to violate the Animal Welfare Act of 1966 and conspiring to violate the Clean Water Act, agreeing to pay $22 million in fines, including the largest-ever fine imposed by the Department of Justice in an animal welfare case, as well as agreeing to pay an additional $13.5 million toward animal welfare and environmental projects, law enforcement expenses, and improvements to facilities.[38][39]

Alleged illegal importation of monkeys

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In August 2023, the U.S. Securities and Exchange Commission investigated the company for possible violations of the Foreign Corrupt Practices Act for knowing using monkeys that were illegally captured in national parks and protected wild habitats.[40]

References

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  1. ^ a b "Inotiv, Inc. Form 10-K Annual Report for the Fiscal Year Ended September 30, 2023". U.S. Securities and Exchange Commission. December 12, 2023.
  2. ^ "Directory of Accredited Organizations Search Result". AAALAC International.
  3. ^ "BASi and Seventh Wave Laboratories Combine Operations to Provide Broader Solutions and Greater Scientific Expertise to Clients" (Press release). Globe Newswire. July 2, 2018.
  4. ^ "Bioanalytical Systems, Inc. Announces Corporate Name Change to Inotiv, Inc" (Press release). Globe Newswire. March 19, 2021.
  5. ^ "Inotiv, Inc. Completes Purchase of Envigo" (Press release). GlobeNewswire. November 5, 2021.
  6. ^ Garde, Damian (June 25, 2015). "Huntingdon Life Sciences and Harlan Laboratories to become Envigo". Fierce Biotech. MidOcean Partners.
  7. ^ "Avista Healthcare Public Acquisition Corp. To Combine With Envigo International Holdings, Inc" (Press release). PR Newswire. August 21, 2017.
  8. ^ Liu, Angus (August 24, 2017). "Envigo merges with Avista, to be listed on Nasdaq". Fierce Biotech. MidOcean Partners.
  9. ^ "Avista-Backed SPAC Combines With Contract Research Company Envigo". The Wall Street Journal. August 21, 2017.
  10. ^ "LabCorp and Envigo Complete Innovative Transactions" (Press release). Labcorp. June 3, 2019.
  11. ^ Adams, Ben (April 25, 2019). "LabCorp spends $485M as its CRO unit snaps up Envigo's nonclinical business". Fierce Biotech. MidOcean Partners.
  12. ^ Brackley, Paul (November 14, 2019). "Horizon Discovery sells animal models business to Envigo as it refocuses on high-growth areas". Cambridge Independent.
  13. ^ "Inotiv, Inc. Announces Expansion of Safety Assessment Offerings with Acquisition of Integrated Laboratory Systems, LLC" (Press release). GlobeNewswire. January 10, 2022.
  14. ^ "West Lafayette's Inotiv acquires primate quarantine facility in Texas". Journal & Courier. February 1, 2022.
  15. ^ "Inotiv Announces the Sale of its Israeli Businesses to Harlan Holdings Ltd" (Press release). GlobeNewswire. August 29, 2023.
  16. ^ Treisman, Rachel (June 4, 2024). "A beleaguered breeder faces a record $35 million fine for mistreating its beagles". NPR.
  17. ^ "Envigo RMS, LLC July 20, 2021 Inspection Report" (PDF). United States Department of Agriculture. July 20, 2021.
  18. ^ "Envigo RMS, LLC October 18, 2021 Inspection Report" (PDF). United States Department of Agriculture. October 18, 2021.
  19. ^ Hedgpath, Dana (December 26, 2021). "USDA cites dog-breeding facility in Virginia for mistreating animals". The Washington Post.
  20. ^ a b "UNITED STATES OF AMERICA, Plaintiff, v. ENVIGO RMS, LLC, Defendant" (PDF). science.org. May 21, 2022. doi:10.1126/science.add1055.
  21. ^ Fobar, Rachel (May 20, 2022). "Hundreds of beagles died at facility before government took action". National Geographic. Archived from the original on May 19, 2022.
  22. ^ a b Orr, Susan (26 July 2022). "Inotiv says closures of animal-breeding facilities could cost it nearly $10M". Indianapolis Business Journal.
  23. ^ "SB 604 Animal cruelty; companion animals, penalty". Virginia Legislative Information System.
  24. ^ "SB 457 Dogs; breeding dogs for certain research prohibited, penalty". Virginia Legislative Information System.
  25. ^ "SB 442 Dogs and cats; breeding for research, reporting to State Veterinarian". Virginia Legislative Information System.
  26. ^ "Senators call for dog breeding facility's license to be revoked". WRIC-TV. April 4, 2022.
  27. ^ "Feds sue operator of dog breeding facility, seize beagles". Associated Press. May 20, 2022.
  28. ^ "Federal judge bars Envigo from breeding, selling dogs". WRIC-TV. May 22, 2022.
  29. ^ "Feds seize 145 beagles "in distress" from Virginia research facility where hundreds of dogs were found dead". CBS News. Associated Press. 20 May 2022.
  30. ^ KLING, JAMES (29 July 2022). "West Lafayette-based company sued over beagle treatment". Purdue Exponent.
  31. ^ Hammond, Kassidy (July 5, 2022). "Judge approves transfer of all 4,000 remaining beagles at breeding facility to shelters for adoption". WRIC-TV.
  32. ^ "Abcarian: 4,000 abused beagles were liberated from captivity. This one found a home in Sherman Oaks". Los Angeles Times. August 24, 2022.
  33. ^ Johnson, Lizzie (October 17, 2022). "Profit, pain and puppies: Inside the rescue of nearly 4,000 beagles". The Washington Post.
  34. ^ Tepper, Danielle S. (December 9, 2022). "Going big for beagles". Humane Society of the United States.
  35. ^ McCarthy, Lauren; Diaz, Johnny (August 4, 2023). "4,000 Rescued Beagles, Bred for Research, Found Homes and Best Friends". The New York Times.
  36. ^ Rubin, April (August 24, 2022). "Harry and Meghan Adopt a Mistreated Beagle Mom". The New York Times. ISSN 0362-4331.
  37. ^ "Puppy rescued from VA breeding facility adopted by New Jersey governor". WUSA. August 23, 2022.
  38. ^ "US breeder Envigo pleads guilty to mistreating beagles and fined $35.5m". The Guardian. Reuters. June 3, 2024. ISSN 0261-3077. Archived from the original on 2024-06-03.
  39. ^ Jiménez, Jesus (June 3, 2024). "Breeder Ordered to Pay $35 Million for Mistreating Beagles". The New York Times.
  40. ^ Vanderford, Richard (August 15, 2023). "Inotiv Faces SEC Probe on Imports of Monkeys From Asia". The Wall Street Journal.
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