Fidelis Pharmaceuticals Announces Name Change to Reflect Corporate Focus

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Apr 06, 2022, 15:15 ET

Fidelis Animal Health, Inc. is the new name of Fidelis Pharmaceuticals, Inc., under which it will be developing and commercializing products that utilize its proprietary extended-release technology as well as seeking to expand into other animal welfare solutions.

NORTH BRUNSWICK, N.J. , April 6, 2022 /PRNewswire/ -- Fidelis Pharmaceuticals is pleased to announce that the company will now be known as Fidelis Animal Health, a name which aligns more closely with the company's focus on developing products that deliver innovative veterinary solutions.

"At this time, we are in an excellent position to realize the immense potential of our extended-release technology to address key areas of unmet need in veterinary medicine. Making this corporate focus clearer to our customers was the impetus driving the name change," said Michael Wells, Chairman and CEO. "Our ultimate vision is to branch out into additional areas of animal welfare beyond our portfolio of therapeutic solutions, so having 'Animal Health' as part of our name just makes good business sense."

The company's initial product offering, Ethiqa XR®, is an innovative formulation of buprenorphine indicated for the control of post-procedural pain in mice and rats. The product uses Fidelis Animal Health's patented extended-release technology to provide up to 72 hours of clinical analgesia with one injection. Since its launch in 2020, Ethiqa XR is currently being used in laboratories at over 200 institutions across the country, including those at the top 10 pharmaceutical companies, many of the country's elite academic institutions, and several government research branches.

IMPORTANT SAFETY INFORMATION

For Rats and Mice:
Only administer Ethiqa XR by subcutaneous injection. Ethiqa XR is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intra-peritoneal injection. Do not use on mice or rats with pre-existing respiratory deficiencies. Do not keep rats on wood chip-type bedding after administration of Ethiqa XR. Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression.

For Humans:
Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids. Protective clothing is recommended to avoid direct contact with human skin or mucus membranes which could result in absorption of buprenorphine and adverse reactions. Not for use in humans. For more information, consult the Prescribing Information including the Boxed Warning.

WARNING: ABUSE POTENTIAL and LIFE-THREATENING RESPIRATORY DEPRESSION and ACCIDENTAL EXPOSURE

Abuse Potential

Ethiqa XR contains buprenorphine, a high-concentration (1.3 mg/mL) opioid agonist and Schedule III controlled substance with an abuse potential similar to other Schedule III opioids. The high concentration may be a particular target for human abuse. Buprenorphine has opioid properties that in humans may lead to dependence of the morphine type. Abuse of buprenorphine may lead to low or moderate physical dependence or high psychological dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of Ethiqa XR. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (suicidal depression). Because of human safety risks, this drug should be used only with veterinary supervision.

Do not dispense Ethiqa XR.

Life-Threatening Respiratory Depression

The concentration of buprenorphine in Ethiqa XR is 1.3 mg/mL. Respiratory depression, including fatal cases, may occur with abuse of Ethiqa XR. Ethiqa XR has additive CNS depressant effects when used with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Because of the potential for adverse reactions associated with accidental injection, Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids.

About Fidelis Animal Health: Fidelis Animal Health is a commercial stage company offering exceptional expertise in the acquisition, development, and marketing of unique pharmaceutical formulations. The company is committed to leading the industry with quality-driven therapeutics and additional innovations for all animals, small and large.

In addition to Ethiqa XR, Fidelis Animal Health has an extensive pipeline utilizing its innovative drug delivery technology and is currently developing an extended-release buprenorphine formulation for companion animals and an extended-release NSAID for rodents and other small animals.

For more information, please visit www.FidelisAH.com.

SOURCE Fidelis Animal Health, Inc.