Envigo enters into an agreement with the United States Department of
WEST LAFAYETTE, Indiana, July 18, 2022 (GLOBE NEWSWIRE) — Inotiv, Inc. (NASDAQ: NOTV) (the “Company”, “We”, “Our” or “Inotiv”), a leading contract research organization specializing in non-clinical and analytical drug discovery and development services and research models and related products and services, today announced that Envigo has entered into an agreement with the United States Department of Justice (DOJ) and United States Department of Agriculture (USDA) resolving an extensive civil and administrative investigation into Envigo’s facility in Cumberland, Virginia (the “Cumberland Facility”).
The settlement, which was mutually reached by all parties involved and approved by the court on July 15, does not require Envigo to pay any fines or penalties to government agencies. Further, it is expressly stated that the settlement does not constitute an admission of liability or wrongdoing by Envigo with respect to its prior operation of the Cumberland facility. The resolution incorporates the transfer plan that was mutually agreed to by the DOJ and Envigo on July 1, 2022 (the “Transfer Plan”) and terminates all civil and administrative claims related to the Cumberland Facility . Additionally, the settlement requires the DOJ and USDA to decide to dismiss civil and administrative complaints with prejudice seven days after all dogs have left the Cumberland facility in accordance with the transfer plan.
This resolution follows Inotiv’s June 13 press release, in which Inotiv President and CEO Robert Leasure, Jr. said, “Since the acquisition of Envigo in November 2021, the Cumberland facility has been identified as in need of upgrades and investment,” and that “The investment required to upgrade these facilities and the time to complete these upgrades has recently increased.” In the same press release, Inotiv announced its decision to stop investing in the Cumberland facility and to close it, considering that sales from the site represent less than 1% of Inotiv’s total sales and have not not contribute to the profits of the company’s research models. and Services since its acquisition.
This settlement confirms the plan for the orderly closure of the Cumberland facility as previously announced in court filings. Inotiv expects it will take approximately 60 days to shut down the Cumberland facility. After the closure, Envigo will not engage in any activity requiring a USDA license on the site.
Mr. Leasure concluded, “As a leading contract research organization and provider of research models, Inotiv has an important responsibility and honor to contribute to the future of medicine. Our work and that of our customers is essential to save human lives. Without critical drug discovery and development efforts, millions of people around the world would go on with their lives without any hope of treatments and cures for life-threatening diseases. Our top priority continues to ensure animal welfare and regulatory compliant practices at all of our facilities. »
Inotiv, Inc. is a premier contract research organization dedicated to providing nonclinical and analytical drug discovery and development services, research models, and related products and services. The Company’s products and services aim to bring new drugs and medical devices through the discovery and preclinical development phases, while increasing efficiency, improving data and reducing the cost of bringing new products to market. medications. Inotiv is committed to supporting discovery and development goals as well as helping researchers realize the full potential of their critical R&D projects, while working together to build a healthier and safer world. Further information about Inotiv can be found here: https://www.inotivco.com/.
This release may contain forward-looking statements that are subject to risks and uncertainties, including, but not limited to, risks and uncertainties relating to changes in the market and demand for our products and services, the development, marketing and sale of products and services, changes in technology, industry and regulatory standards, timing of acquisitions and successful closing, integration and the business and financial impact thereof, government regulations, inspections and investigations, the impact of site closures and consolidations, expansion and related efforts, and various other market and operating risks, including those detailed in the Company’s filings with the Securities and Exchange Commission of the United States.