Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, has received approval from the US Department of Agriculture (USDA) to market its proprietary product, Settle, for the treatment of equine endometritis caused by Streptococcus zooepidemicus. It is the Company's intent to register this product in other jurisdictions as well.
"We are pleased to introduce this new therapy into the US market in time for the 2005 equine breeding season," said Martin Warmelink, president of Bioniche Animal Health, a Division of Bioniche Life Sciences Inc. "Settle has been clinically proven as a fast-acting, specific endometritis therapy for broodmares. It is the end result of clinical research conducted over a period of five breeding seasons," he added.
Endometritis is a non-life threatening disease that affects 25 per cent to 40 per cent of broodmares worldwide. The disease results in low conception rates or loss of pregnancies if conception occurs. It is a serious concern for breeders, often resulting in economic losses from low foaling rates, therapies, and repeated inseminations. If not successfully treated during the acute phase (conventional treatment involves intrauterine or intravenous antibiotics for three to four consecutive days), the original infection can result in a chronic, degenerative inflammatory condition compromising future fertility and requiring a laborious and costly battery of treatments. Settle offers breeders an additional therapy that can be easily assimilated into reproductive treatment protocols.
Graeme McRae, president & CEO of Bioniche Life Sciences Inc said, "It has been developed from one of our core proprietary technologies that has been shown in both humans and animals to induce a profound response in the immune system. Enhancing the body's natural immune system to fight disease is preferable to introducing antibiotics and other pharmaceuticals. Excessive or inappropriate use of antibiotics can result in the proliferation of antibiotic-resistant bacteria."
In August of this year, Bioniche released the first results of a fully controlled and monitored (GCP) study using a proprietary formulation of mycobacterial cell walls (SETTLE) to treat bacterial-induced endometritis in susceptible mares. The study results were presented at the Modern Vaccine/Adjuvant Formulation Conference in Prague, Czech Republic.
The study demonstrated that immunomodulation with a single dose of Settle resolved the bacterial infection and normalized the uterine inflammatory responses, resulting in successful treatment of the endometritis, the company release said.