Monthly Archives: November 2010

Creosalus Announces FDA Approval of Sucromate™ Equine

Synchronizes Ovulation in Mares
First of its Kind Drug Developed and Manufactured in Kentucky

November 29, 2010. CreoSalus, Inc. announced its subsidiary Thorn BioScience received Food and Drug Administration (FDA) approval of SucroMate™ Equine. SucroMate™ Equine regulates ovulation in mares through a single injection increasing the likelihood of conception during breeding for both natural bred and artificially inseminated horses. It is the first FDA approved drug of its kind developed and manufactured in Kentucky. It is one of only eight new FDA approved animal health drugs in 2010.

Co-Founder Barry Simon DVM said, “Over a decade of research and development has been devoted to develop a platform technology that delivers peptides on a sustained release basis. SucroMate™ Equine is the first application of the technology. SucroMate™ Equine delivers a stable, sterile, and consistent dosage of deslorelin for mare ovulation. FDA approval of SucroMate™ Equine provides veterinarians and horse owners’ confidence in breeding their mares. Horsemen will no longer need to rely on compounded products that may not meet specifications or work properly.”

SucroMate™ Equine will be manufactured in CreoSalus’ Class 5 aseptic clean room under the FDA’s current Good Manufacturing Process (cGMP). This Class 5 clean room is the only one in Kentucky for commercial manufacturing of pharmaceuticals. Jim Geisler, COO and CFO, said, “The approval of SucroMate™ Equine is an important step in establishing Kentucky as a leader in health care and high tech industries. The product was developed by Kentuckians in the Commonwealth through collaboration with the Kentucky Economic Development Fund Authority, the University of Kentucky, business partners like Stoll, Keenon, and Ogden, and local investors most of whom are horsemen. Working together we have tremendous capability to advance technology based businesses in Kentucky.”

CreoSalus also announced a national distribution agreement for SucroMate™ Equine with Bioniche Life Sciences (TSX : BNC). Bioniche’s Animal Health division specializes in animal reproduction including embryo transfer, immunostimulants, and nutrition. Jim Phillips, President of Bioniche Animal Health, said, “SucroMate™ Equine is a natural fit with our portfolio of reproductive drugs for large animals, including horses. With up to 300,000 mares bred annually we believe the market prospects for this new product are strong.” SucroMate™ Equine will be available for veterinarians through distributors at the start of the 2011 breeding season in February.

CreoSalus is a privately held Louisville, Kentucky-based life sciences company specializing in the development and manufacturing of finished drugs, fine chemicals, and human medical devices. Mr. Phelps, CEO, stated, “SucroMate™ Equine is the first FDA approved drug in the SucroMate™ family. Successful commercialization highlights a low-risk pathway to development of the second drug in the family, SucroMate™ Porcine. SucroMate™ Porcine addresses the larger market of sow reproduction for which no product currently exists.”

David Phelps, CEO of CreoSalus, holds over 40 medical device patents and has lead successful start-ups including Boston Scientific Corp. and MedVenture. Commenting on CreoSalus’ strategy Mr. Phelps said, “Our three businesses are well positioned to benefit from the growing preference for peptide based medical solutions. For example, our medical device business has begun cultivating a series of ideas from local area physicians. I am extremely optimistic about CreoSalus’ future.”
About CreoSalus

CreoSalus is a privately held Louisville, Kentucky based life-sciences company specializing in the development and manufacturing of finished drugs, human medical devices, and fine chemicals. The Company’s three peptide-based businesses are Advanced ChemTech (fine chemicals), Occam Design (human medical devices), and Thorn BioScience (finished drugs). Thorn BioScience’s products include SucroMate™ Porcine (under development) and FDA approved SucroMate™ Equine and that regulate the ovulation in sows and mares, respectively.
About Bioniche Life Sciences

Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs 214 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company’s primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. Bioniche has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2010. For more information, please visit www.Bioniche.com.

For additional information, please contact Jim Geisler at 502 515 1100 ext 102 or jgeisler@creosalus.com. An overview of the company is also available at www.creosalus.com.