Li and Dragan Named to Lead ACT

Louisville, KY. CreoSalus, Inc. announced Charles Li has been named President/CEO of its  Advanced ChemTech subsidiary. Advanced ChemTech is a respected supplier of fine chemicals to the pharmaceutical industry. Charles has been with Advanced ChemTech for 10 years most recently in the role of international business manager. In this role, Charles was instrumental in marketing the Tetras, the industry’s most advanced automated peptide synthesizer, and expanding Advanced ChemTech’s international footprint. In the fall of 2011 Charles was made acting President/CEO. Under his leadership the business has grown both revenues and profits as well as improved relationships with key customers.

In addition, CreoSalus has named Dragan Ristic, Director of Chemical Operations. Dragan has been with Advanced ChemTech a total of 6 years. As Director of Chemical Operations, Dragan is responsible for process development and production of amino acid derivatives, resins and reagents. Prior to joining Advanced ChemTech, Dragan worked at deCODE Genetics for 10 years and AstraZeneca/Bosnalijek for 11 years providing a leadership role in the organic synthesis of active pharmaceutical ingredients.

CreoSalus is a privately held Louisville, Kentucky based life-sciences company with businesses specializing in the development and manufacturing of finished drugs (Thorn BioScience), human medical devices (Occam Design), and fine chemicals (Advanced ChemTech). CreoSalus is Latin for ‘creating good health.’

Creosalus Signs Distribution Agreement with FK Biotech

CreoSalus has entered into a distribution agreement for South America with FK Biotech of Brazil.

Under the terms of the agreement, FK Biotech will distribute Advanced ChemTech’s fine chemical products that includes over 2,500 peptides, reagents, resins, and amino acids in the growing South American market. Advance ChemTech is currently completing a new kilogram scale laboratory and pilot plan to produce more difficult and value added products for strategic customers. In addition to Advanced ChemTech’s fine chemical product, FK Biotech will distribute the Tetras™. The Tetras™, is the only asynchronic, multiple peptide synthesizer in the world. Customers include the National Institute of Health, Harvard University, Yale University, the University of Kentucky, Aleron, Amgen, and Sun Biotech (China). The Tetras™ was developed and is manufactured in Kentucky.

Craig Kalmer, Advanced ChemTech CEO, said, “FK Biotech is a great addition to our distribution network. South America is a small but growing peptide market. In addition to South America, we now have distributors in the key markets of Europe and China.”

FK Biotech focuses on research, development, production and distribution of immunodiagnostics kits and currently has over 70 products on the market. In 1999, FK Biotech became the first Brazilian biotechnology firm to receive venture capital for the development of its innovative technologies. Since then, the company has grown at a steady pace and is considered a pioneering example of a successful biotech start-up in Brazil.

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 operating businesses all relating to peptides are Advanced ChemTech (fine chemicals), Occam Design (human medical devices), and Thorn BioScience (finished drugs). Thorn BioScience’s products include Sucro Mate™ D – Equine and Sucro Mate™ D – Porcine that regulate the ovulation in mares and sows.

Creosalus Delivers First Sucromate™ Equine Product

In Time for Upcoming Mare Breeding Season
First of its Kind Drug Developed and Manufactured in Kentucky

CreoSalus, Inc. announced its subsidiary Thorn BioScience shipped its first SucroMate ™ Equine vials for the upcoming mare breeding season. SucroMate™ Equine regulates ovulation in mares of all breeds through a single injection allowing for timed ovulation and breeding for both naturally bred and artificially inseminated mares.

Co-Founder Barry Simon, DVM said, “We are pleased to introduce FDA approved SucroMate™ Equine for the 2011 breeding season. Owners and veterinarians can breed their mares confidently knowing that SucroMate™ Equine is delivering a stable, sterile, and consistent dose. Horsemen will no longer need to rely on compounded products that may not meet safety or efficacy specifications. SucroMate™ Equine is another step in improving the health of the Thoroughbred and other equine based industries.”

SucroMate™ Equine is distributed in the United States through partnership with Bioniche Life Sciences (TSX : BNC). Bioniche’s Animal Health division specializes in animal reproduction including embryo transfer, immunostimulants, and nutrition. SucroMate™ Equine is now available for veterinarians through distributors.

Thorn BioScience received FDA approval of SucroMate™ Equine in November 2010. SucroMate™ Equine is the first FDA approved drug of its kind developed and manufactured in Kentucky.

SucroMate™ Equine is 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. SucroMate™ Equine utilizes DURECT Corporation’s (NASQ: DRRX) Saber™ technology.

About CreoSalus

CreoSalus is a privately held Louisville, Kentucky based life-sciences company with businesses specializing in the development and manufacturing of finished drugs (Thorn BioScience), human medical devices (Occam Design), and fine chemicals (Advanced ChemTech). Thorn BioScience’s products include SucroMate™ Porcine (under development) and FDA approved SucroMate™ Equine that regulate ovulation in sows and mares, respectively. CreoSalus is Latin for ‘creating good health.’

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.

 

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.