Felycin^®-CA1 is the only drug to receive FDA conditional approval for management of ventricular hypertrophy with subclinical hypertrophic cardiomyopathy (HCM) in cats

PBI-Gordon Companies, Inc. the parent company of TriviumVet, which holds sole conditional new animal drug approval from the FDA for Felycin^®-CA1 (sirolimus delayed-release tablets) under its affiliated brand company Pegasus, through its outside counsel issued a cease-and-desist demand letter to Petspan for falsely promoting a compounded version of rapamycin (synonymous with sirolimus) for the treatment and management of clinical hypertrophic cardiomyopathy (HCM) in cats. Petspan’s evaluation and prescribing practices do not comply with established veterinary practice principles and places the health and wellbeing of cats in jeopardy.

Felycin-CA1 is the first and only drug to receive FDA conditional approval for management of ventricular hypertrophy with subclinical HCM in cats. It is also the only conditionally approved drug for which treatment claims are permitted based on studies that were conducted by or on behalf of the holder of the cNADA, TriviumVet. This conditional approval was announced in an FDA press release dated March 14, 2025. Pegasus Laboratories, Inc. (“Pegasus”), another wholly owned subsidiary of PBI-Gordon, launched Felycin-CA1 under the PRN Pharmacal brand at the American College of Veterinary Internal Medicine Forum held June 17-20, 2025, where veterinarians and other participants in attendance were made aware of the availability of Felycin-CA1 through standard distribution channels.

PBI-Gordon asserts Petspan is engaging in a pervasive pattern of intentionally false and misleading communications aimed at both veterinarians and pet owners, including claiming product legitimacy from two clinical trials (RAPACAT and HALT-HCM trials) sponsored and conducted by TriviumVet, not Petspan. TriviumVet is currently conducting the HALT-HCM study which is necessary to produce the data required to advance Felycin-CA1 from a conditionally approved drug to a fully approved drug. Petspan’s false and misleading public assertions imply that the safety and efficacy of TriviumVet’s Felycin-CA1 are applicable to the Petspan compounded product.

“Petspan is illegally marketing an unapproved, unlicensed and potentially unsafe would-be copy of our product, and that has to be stopped,” said PBI-Gordon Companies, Inc. President & CEO Steve Clifford, “We will take action to stop those who threaten patient safety and urgently call on regulators and law enforcement to do the same.”

PBI-Gordon intends to pursue all necessary actions and legal remedies to ensure its product and intellectual property are protected against the false and misleading advertisement and sale of all unapproved versions of sirolimus for HCM, online or otherwise.

Feline HCM is extremely common, affecting 1 in 7 of all pet cats. In animals 9 years of age and older, the prevalence rises to approximately 1 in 3 and is a leading cause of mortality in adult cats. The disease is characterized by abnormal thickening and impaired function of the ventricular wall of the heart. While some cats remain asymptomatic, around half go on to develop congestive heart failure or other severe complications. Subclinical HCM refers to cases that have ventricular wall thickening but have not yet developed clinical signs.

“Petspan’s unlawful sale of its compounded drug – called Rapamycin – and its false and misleading promotion, poses a real danger to thousands of cats with this condition, and is a callous affront to their owners and veterinarians,” said Dr. Heather Davis DVM, PhD, DACVS-LA, Director of Clinical Affairs and Veterinary Services, Pegasus Laboratories, Inc.

PBI-Gordon is also aware that Petspan advertises the diagnosis of HCM and prescription of its compounded “rapamycin” through telemedicine visits with purported veterinarians. Current gold standard as established by veterinary boards, is to diagnose HCM in-person which involves a veterinarian physically performing a thorough evaluation to rule out other medical conditions that may present as HCM; clinical pathology sampling at a minimum is required in addition to physical examination to make such an assessment. Virtual telemedicine visits are insufficient to establish the relationship, diagnosis, and treatment protocol implementation for HCM in cats. A virtual treatment protocol that misdiagnoses HCM risks negative adverse events to the pet and harm to the future utility of Felycin-CA1 for HCM.

More specifically, the letter demands that Petspan immediately cease and desist the following activities:

• Advertising compounded rapamycin (sirolimus) for the treatment of HCM in cats

• Relying on studies conducted by or on behalf of TriviumVet as the basis for the Petspan treatment protocol

• Posting misleading promotional and advertising materials on Petspan’s website and social media, including references to studies conducted by or on behalf of TriviumVet

• Confusing the public by using a synonym for the drug (sirolimus) for which FDA approved the cNADA (i.e., “rapamycin”)

About PBI-Gordon Companies

PBI-Gordon Companies has been in business in the Kansas City metro area since 1947 and is 100 percent employee-owned. It is the parent company to four subsidiaries which develop, manufacture, and market leading products for Turf and Ornamental Industries (PBI-Gordon Corporation), Companion Animal Pharmaceuticals (Pegasus Laboratories & TriviumVet), and Companion Animal Nutritional Supplements and Grooming Supplies (PetAg).

About Pegasus Laboratories

Founded in 1986, Pegasus Laboratories is a pharmaceutical development and manufacturing organization focused on novel products to treat chronic conditions in cats, dogs, and horses. Pegasus provides full-service Contract Development and Manufacturing Organization (CDMO) focusing on the development and manufacturing with full turn-key technical services in a DEA-approved CGMP facility. Pegasus also provides a full portfolio of pharmaceuticals, nutritional therapeutics and supplements, parasite control and surgical and wound care under the PRN® and Sē·Qual™ brands.

About TriviumVet

TriviumVet is an Ireland-based research and development company. Working with some of the leading veterinarians and therapeutic specialists around the world to address the gaps in disease management by developing innovative new therapeutic solutions for some of the most serious and underserved conditions. Focused on finding effective treatments for unmet needs in cardiology, renal health, pain management, gastroenterology, wellness testing, and age-related diseases.

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