Osmotics Corporation Licenses Worldwide Exclusive Rights From BYU for Novel Compounds That Treat Antibiotic-Resistant Infections

DENVER and PROVO, Utah -- 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.

Source: Osmotics Corporation