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TRx Pharma Introduces FOLMOR for the Treatment of Cardiovascular Disease

February 6, 2007

TRx Pharma announced today the availability of FOLMOR™ (folic acid 2.5mg, B6 25mg, B12 2mg and primorine 875mg), its novel, proprietary prescription product for the treatment of cardiovascular disease. Cardiovascular disease (CVD) is the leading cause of death among Americans. According to the American Heart Association, too much homocysteine is related to a higher risk of CVD. Oxidative stress, a harmful chemical process, is also implicated in the pathology of the disease. FOLMOR helps reduce elevated homocysteine levels and it thwarts the harmful effects of oxidative stress.

“We are pleased to announce the introduction of FOLMOR for the treatment of cardiovascular disease, the leading cause of death in the U.S.,” said Dr. Philip Tabbiner, chief executive officer of TRx Pharma. “FOLMOR effectively lowers elevated homocysteine levels, one of the many controllable risk factors associated with the development of cardiovascular disease, while hindering the harmful effects of oxidative stress which can lead to the development of cardiovascular disease.”

FOLMOR contains folic acid, B6 and B12 which have been shown to lower homocysteine blood levels. Several studies have demonstrated that higher blood levels of B vitamins are related, at least partly, to lower concentrations of homocysteine. Studies have demonstrated that a 25% reduction in homocysteine levels is associated with an 11% lower risk of coronary heart disease and a 19% lower risk of stroke.

There are several, controllable risk factors associated with the development of cardiovascular disease. High cholesterol and elevated levels of homocysteine, an amino acid found in the blood, are two of these risk factors. Other risk factors include high blood pressure, obesity, family history, smoking and diabetes. In 2006, the estimated healthcare costs associated with cardiovascular diseases and stroke in the United States equaled $403.1 billion. This figure includes physician visits, hospitalizations, nursing home services, medications to treat cardiovascular disease, home healthcare costs and lost productivity.

About FOLMOR

FOLMOR, a new treatment from TRx Pharma, breaks down homocysteine in the body. Patients benefit from the dual effect of folic acid, combined with primorine, a novel carbonyl-trapping combination, thus reducing the risk of developing cardiovascular disease. TRx Pharma’s proprietary, novel carbonyl-trapping, primorine, enables its products to react with, or “trap,” toxic carbonyl groups such as aldehydes and ketones that the body produces under conditions of oxidative stress to form less-harmful derivatives that are then eliminated through the kidneys.

FOLMOR is not for everyone. FOLMOR should not be given to patients taking levodopa, as the B6 vitamin antagonizes the action of levodopa. FOLMOR can be given to patients taking both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may decrease the effectiveness of phenytoin, but no such decrease has been reported with the use of FOLMOR. The most common side effects seen with vitamin B6 include paresthesia, drowsiness, nausea and headaches. The most common side effects associated with vitamin B12 include mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body.

About TRx Pharma

TRx Pharma is a specialty pharmaceutical company made up of two subsidiaries — Deston Therapeutics and Zylera Pharmaceuticals. The current focus is on therapies for cardio-respiratory diseases through its Deston Therapeutics subsidiary, and for metabolic diseases through its Zylera Pharmaceuticals subsidiary. Its near-term pipeline includes products for diabetes, elevated cholesterol, osteoporosis, and osteoarthritis, utilizing proprietary and patented chemical entities designed to restore key metabolic processes. Chief among these is Cytac™, a carbonyl-trapping technology. TRx Pharma (www.trxpharma.com) and its subsidiaries are located in Research Triangle Park, NC.




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