PURE Bioscience Strengthens Pharmaceutical Development Program

SAN DIEGO, Calif.--(BUSINESS WIRE)--PURE Bioscience (NASDAQ: PURE) today announced the strengthening of its program to develop silver dihydrogen citrate (SDC)-based pharmaceutical products with the addition of a new development partner, FTA Therapeutics, LLC (FTA).

“We believe that FTA's drug delivery systems in combination with free ion agents such as PURE’s silver dihydrogen citrate will be at the forefront of the war against drug resistant microbes in addition to being a superior treatment of common dermatological conditions.”

PURE has entered into an agreement with FTA for the development and licensing of additional silver dihydrogen citrate (SDC)-based products for human use. FTA will immediately begin formulation and clinical projects for FDA-regulated dermatology, wound care and medical biofilm control products containing PURE’s SDC.

FTA's mission is to be the leader in the emerging field of free-ion based antimicrobials by delivering significant clinical benefit and satisfying customer needs through innovative research, formulation and design of an advanced generation of free-ion based topical drug delivery systems and surface applications for the prevention and treatment of infections caused by drug resistant microorganisms in animal and human tissues.

Michael L. Krall, President and CEO of PURE Bioscience stated, “FTA Therapeutics is a well-funded biotechnology company, and the principals include nationally recognized physicians in their respective fields and an accomplished pharmaceutical marketing expert. We are thrilled to be working with professionals of this caliber and are confident that the application of FTA’s significant resources and capabilities will accelerate PURE’s pharmaceutical development program of investigating, developing and commercializing SDC-based products for human use.”

Dr. Francis Papay of FTA commented, “The rapidly increasing incidence of aggressive antibiotic resistant organisms such as Methicillin resistant Staph has become a current major focus in healthcare. The prevention and treatment of such life threatening organisms has been fraught with problems within our healthcare delivery systems. The partnering of FTA and PURE Bioscience creates an ideal mechanism to prevent and combat this critical medical issue worldwide.”

Papay concluded, “We believe that FTA's drug delivery systems in combination with free ion agents such as PURE’s silver dihydrogen citrate will be at the forefront of the war against drug resistant microbes in addition to being a superior treatment of common dermatological conditions.”

To facilitate this contract with FTA, PURE structured an agreement in which Therapeutics, Incorporated (Therapeutics) – with whom PURE had an existing agreement -- transferred its development and license rights for FDA-regulated SDC-based products, with the exception of the in-process investigational new drug skin sanitizer, back to PURE Bioscience. PURE will purchase from Therapeutics all data and other materials generated by Therapeutics in regard to the licenses being returned. PURE intends to subsequently license development rights for these indications to multiple third parties, the first being FTA.

About FTA Therapeutics, LLC

Pennsylvania-based FTA Therapeutics, LLC focuses on development of clinical stage pharmaceutical products. Building on strategic partnerships with highly regarded academic institutions, FTA has established a solid platform for attaining its goal of moving products forward into and through clinical development. FTA is led by Cleveland Clinic physician Francis Papay, M.D., F.A.C.S, Chair of the Cleveland Clinic Dermatology and Plastic Surgery Institute, Section Head of the Cleveland Clinic Craniofacial Surgery/Department of Plastic Surgery and co-founder of Bioneer Surgical Inc.; Anthony J. Balsamo, M.D., F.A.C.S., Makefield Orthopedic, St. Mary Medical Center in Yardley, Pennsylvania, Clinical Professor at the Drexel University College of Medicine, former Orthopedics Department Chair and founder and former Medical Director of Holy Redeemer Sports Medicine Center in Meadowbrook, Pennsylvania; and Anthony J. Balsamo Jr., executive at Philadelphia-based Vynamic, a leading Health & Life Sciences Management Consulting firm. Mr. Balsamo formerly served as an executive with Accenture specializing in pharmaceuticals and medical products and was a financial services analyst with Booz-Allen & Hamilton.

About PURE Bioscience

PURE Bioscience develops and markets technology-based bioscience products that provide solutions to numerous global health challenges, including Staph (MRSA). PURE's proprietary high efficacy/low toxicity bioscience technologies, including its silver dihydrogen citrate-based antimicrobials, represent innovative advances in diverse markets and lead today's global trend toward industry and consumer use of "green" products while providing competitive advantages in efficacy and safety. Patented SDC is an electrolytically generated source of stabilized ionic silver which formulates well with other compounds. As a platform technology, SDC is distinguished from competitors in the marketplace because of its superior efficacy, reduced toxicity and the inability of bacteria to form a resistance to it. PURE is headquartered in El Cajon, California (San Diego metropolitan area). Additional information on PURE is available at www.purebio.com.

This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate," "project,” "expect" or similar expressions. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, acceptance of the Company's current and future products and services in the marketplace, the ability of the Company to develop effective new products and receive regulatory approvals of such products, competitive factors, dependence upon third-party vendors, and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.