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Osmotics Corporation Licenses Worldwide Exclusive Rights From Brigham Young University For Novel Compounds That Treat Antibiotic-Resistant Infections

10/19/2005 5:11:52 PM

DENVER and PROVO, Utah, Oct. 18 /PRNewswire/ -- Osmotics Corporation, an emerging specialty pharmaceutical company focused on dermatology and infectious diseases, today announced that it has entered into a worldwide exclusive licensing agreement with Brigham Young University to acquire rights to a family of patented compounds, cationic steroid antibiotics, and methods for treating antibiotic-resistant bacterial infections. The licensed technology is based on the research of Paul B. Savage, professor of chemistry at BYU.

CSAs act as potent antibiotics against Gram-negative and Gram-positive bacteria, and can be used alone or with conventional antibiotics. Extensive in vitro testing has shown that CSAs are highly effective at very low concentrations against multi-drug resistant strains of Pseudomonas aeruginosa, Salmonella and other potentially lethal bacteria. The technology is covered by two U.S. Patents (6,350,738 and 6,486,148) and has been the subject of more than 10 peer-reviewed journal articles.

P. aeruginosa is a major cause of hospital-acquired infections and tends to infect people with immunodeficiency or burns and those with catheters or on respirators. In addition, P. aeruginosa is the most common cause of lung infection in cystic fibrosis patients. P. aeruginosa can survive under conditions that few other organisms can tolerate and is increasingly resistant to most antibiotics, including tobramycin. Recent clinical testing has shown efficacy of these CSAs against tobramycin-resistant strains of P. aeruginosa obtained from cystic fibrosis patients. Clinical testing is now underway to evaluate the CSAs for the use in the treatment of Gram-negative bacterial infections in burn victims. Approximately 60 percent of the deaths that occur among burn victims are due to uncontrolled bacterial infections.

Most antibiotics target specific bacterial enzymes to inhibit bacterial growth. Enzymes are proteins that control the chemical reactions necessary to sustain life. Over time, bacteria can mutate their enzymatic pathways and become resistant to enzyme-targeting antibiotics. Savage and his colleagues at BYU have modeled CSAs after the body's defense system, which includes antimicrobial peptides, antibiotics that destroy bacteria by targeting and destroying their membranes instead of enzymatic pathways. However, unlike the body's antibiotics, which are relatively large molecules, CSAs are small molecules that are easy to manufacture and purify.

"Although the triumph of antibiotics over disease-causing bacteria is one of modern medicine's greatest success stories, widespread use of antibiotics has led to the development of new strains that are resistant to many antibiotics," said Savage. "The development of antibiotic resistance makes it more difficult to purge infections from the body and heightens the risk of acquiring infections in a hospital. Consequently, discovery of new antibiotics, especially those unlikely to cause bacterial resistance, is an essential step in controlling the spread of drug-resistant bacteria."

Carl Genberg, president of Osmotics Pharma, a division of Osmotics Corporation, stated, "We see this class of antibiotics to be a very significant market opportunity for Osmotics because infections caused by drug resistant bacteria can affect anyone. Antibiotic resistance is a particularly serious problem for patients with comprised immune systems such as people with HIV/AIDS and patients in critical care units. It is estimated that the cost to the health care system of resistant pathogens that require more expensive drug therapy or increased hospital stays is approximately $5 billion."

Steven Porter, chief executive officer of Osmotics Corporation, stated, "We licensed this novel antibiotic technology because we believe it will address many of the drug resistant bacteria that cause infections, such as pneumonia, Staphylococcus aureus and other staph infections, and Salmonella. Ultimately, this unique technology may demonstrate antiviral characteristics in addition to the antibiotic efficacy for which we are currently testing."

Porter concluded, "There is an increased need for a new antibiotic that can address key issues in the global healthcare environment: increased drug resistant bacteria, the increased cost of antibiotic therapy which in many instances has limited efficacy, and the limited number of new novel antibiotics in the drug development pipeline. Our goal is to bring to market an easy-to-manufacture alternative to current antibiotic therapy which can be effective across a broad range of therapeutic categories."

According to the Centers of Disease Control and Prevention: * Nearly two million patients in the United States get an infection in the hospital each year. Healthcare infections contribute to the deaths of up to 88,000 of these patients. * More than 70 percent of the bacteria that cause hospital-acquired infections are resistant to at least one of the drugs commonly used to control infection. * Persons infected with drug-resistant organisms are more likely to have longer hospital stays and require treatment with second or third choice drugs that may be less effective, more toxic and more expensive. About Osmotics

Osmotics is a specialty pharmaceutical company focused on the discovery, development and commercialization of a portfolio of innovative products focused in the areas of dermatology and infectious diseases as well as anti-aging cosmeceutical skin care products. Osmotics works with leading university medical centers and renowned scientists to commercialize advances in medical research. Founded in 1992 by Steven and Francine Porter, Osmotics nationally markets more than 32 cosmeceutical products in its skin care line through Saks Fifth Avenue, Nordstrom, Sephora and leading dermatologists.

Osmotics Corporation

CONTACT: Evan Smith, CFA, +1-212-896-1251, or Erica Pettit,+1-212-896-1248, both of KCSA Worldwide, for Osmotics Corporation; or GrantMadsen of Brigham Young University, +1-801-422-9206, or +1-801-362-1628

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