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Helix BioMedix Announces U.S. Patent Issuance for Novel Class of Antimicrobial

Wednesday, August 06, 2008

Bothell, WA -- Helix BioMedix, Inc., a developer of bioactive peptides, today announced that it has been issued U.S. Patent number 7,407,940 by the United States Patent and Trademark Office, which includes the company's lead pre-clinical lipohexapeptide candidates.

The patent covers a family of hexapeptide antimicrobial agents, including HB1345, for use as broad spectrum topical anti-infectives. HB1345 will be developed initially for dermatological indications such acne, rosacea and atopic dermatitis. Subsequent clinical applications are anticipated to include prevention of hospital acquired infections, such as those caused by MRSA and other multi-resistant pathogens.

"The issuance of this patent is another step in the development and protection of our leading intellectual property portfolio and represents one of the most important patents in the company's history," commented R. Stephen Beatty, President and Chief Executive Officer of Helix BioMedix. "HB1345 is currently the primary focus of our clinical efforts, and we are actively taking steps to move into clinical development by the end of 2008. We believe that the clinical success of HB1345 will serve as a pivotal step in the company's development and a key driver of the company's future growth."

The market potential for a therapeutic capable of addressing these diseases is significant. According to the American Academy of Dermatology, acne is the most common skin disorder in the United States, affecting 40 to 50 million Americans. The topical prescription acne market is estimated by Data Monitor to exceed $1.2 billion annually.

The US National Rosacea Society estimates that 14 million Americans are affected by rosacea and that for over 70 percent of sufferers the condition negatively impacts their lives.

Additionally, according to the National Institute of Health, 20 percent of infants and young children experience symptoms of atopic dermatitis and an estimated 15 million people in the U.S have symptoms of the disease. U.S. health insurance companies are reported to spend more than $1 billion per year on atopic dermatitis.

According to the CDC, approximately 32 percent (89.4 million persons) and 0.8 percent (2.3 million persons) of the U.S. population is colonized with S. aureus and MRSA respectively. The proportion of healthcare-associated staphylococcal infections that are due to MRSA has been increasing dramatically: 2 percent of S. aureus infections in U.S. intensive-care units were MRSA in 1974, 22 percent in 1995, and 64 percent in 2004. There are an estimated 292,000 hospitalizations with a diagnosis of S. aureus infection annually in U.S. hospitals. Of these approximately 126,000 hospitalizations are related to MRSA. Invasive MRSA infections occur in approximately 94,000 persons each year and are associated with approximately 19,000 deaths. Of these infections, about 86 percent are healthcare-associated and 14 percent are community-associated.

About Helix BioMedix, Inc.

Helix BioMedix, Inc. is a biopharmaceutical company with an extensive library of diverse bioactive peptides and patents covering six distinct classes and hundreds of thousands of peptide sequences. Our mission is to enrich clinical practice and the patient/consumer experience by developing topically-applied products which offer the health, beauty and safety benefits of our advanced bioactive small molecule technology. Our vision is to be recognized as the world leader in the identification, qualification and commercialization of natural and synthetic peptides.

Our core competencies include peptide design, synthesis and characterization together with assay development, screening, tissue culture and microbiology, leveraged through relationships with contract research organizations and peptide manufacturers. We have the capability to take our product development programs from theoretical concept to a validated and qualified skin care active ingredient fully validated as to efficacy and safety. Applications for Helix BioMedix peptides include anti-aging cosmeceutical skin care and acne treatment as well as other topical anti-infective pharmaceuticals and wound healing applications. In addition, we are developing finished, peptide-based products to market with our partners.

More information about the company and its proprietary peptides may be found on the company's website at

Forward-Looking Statements

This press release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding activities, events or developments that the company expects, believes or anticipates may occur in the future, including statements related to its potential growth, product development and commercialization and revenue. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including the company's ability to successfully raise additional capital, enter into revenue generating license agreements, continue its research and development efforts, including pre-clinical and clinical studies, continue developing marketable peptide-based products and general economic conditions. Additional assumptions, risks and uncertainties are described in detail in the company's reports and other filings with the Securities and Exchange Commission. Such filings are available on the company's website or at Readers are cautioned that such forward-looking statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances.

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