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BioMarck Pharmaceuticals Announces the Issuance of Two United States Patents


Tuesday, June 16, 2009

Research Triangle Park, NC -- BioMarck Pharmaceuticals, a research and development company involved in the treatment of respiratory diseases, announced today that the United States Patent and Trademark Office has issued two new patents enhancing its intellectual property portfolio in support of its current lead drug for the treatment of COPD.

One of the two issued U.S. patents (No. 7,524,926), titled "Mucin Hypersecretion Inhibitors and Methods of Use," provides broad protection for BioMarck’s lead drug, BIO-11006 Inhalation Solution, as well as a series of other first-in-class mucus inhibiting peptides. This patent will provide protection for BioMarck’s lead drug at least until 2026. The second U.S. patent (No. 7,544,772), titled "Methods for Regulating Inflammatory Mediators and Peptides useful Therein," provides broad protection for methods of using another series of BioMarck’s anti-inflammatory peptides. These two new patents also provide broad protection for peptides and methods of treatment for a variety of pulmonary diseases involving mucus hypersecretion and airway inflammation. An extensive series of corresponding international patent applications has been or is being filed.

"These two recently granted United States patents represent a significant milestone for BioMarck and they further strengthen BioMarck’s continually expanding intellectual property portfolio," said Dr. Indu Parikh, President and Chief Scientific Officer of BioMarck Pharmaceuticals.

BioMarck’s lead compound, BIO-11006 Inhalation Solution, is currently being tested in a multicenter, placebo-controlled, double-blind Phase 2 clinical study in COPD patients. The study is designed to enroll 162 patients with COPD, specifically chronic bronchitis. BioMarck initiated the study in the third quarter of 2008 and expects complete enrollment of the planned 162 patients to take 12 to 15 months. BioMarck is currently exploring potential partnerships with pharmaceutical companies with a significant presence in the respiratory field.

About BIO-11006 Inhalation Solution

BIO-11006 inhibits the function of the MARCKS protein (myristoylated alanine-rich C kinase substrate), which has been shown to be a vital component for secretion of mucus and inflammatory mediators. These two inhibitory aspects of BIO-11006 Inhalation Solution have been demonstrated in several different animal models of airway disease.

About COPD

It is expected that more than 50 million individuals worldwide will suffer from chronic obstructive pulmonary disease (COPD) by 2010. In the United States alone, COPD affects at least 12 million patients and causes 120,000 deaths per year, making it the 4th leading cause of death. COPD is generally defined by a limitation of airflow in the lungs. This limited airflow may result from repetitive lung injury and inappropriate injury repair in the lungs. The airways of the lungs are normally covered by mucus that protects the airways from dehydration, pathogens, chemicals, inflammation, reactive oxygen species and particulate irritants. However, in response to repetitive irritant exposure from cigarette smoke, for example, excessive secretion of mucus and inflammation occurs. Excessive secretion of mucus and inflammation are a common and distinguishing feature of COPD/chronic bronchitis, and studies conducted in the last several decades demonstrate the contribution of excessive mucus to the restriction of airflow in the lungs. However, there are no drugs that specifically inhibit excessive mucus secretion in the lungs; development of BIO-11006 Inhalation Solution may fill this therapeutic gap.

The content of this release is solely the responsibility of BioMarck. This press release might contain forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "might," "could," "will," "would," "expect," "plan," "believe," "estimate," "predict," "plan," "intend," "goal," or the negative of such terms or other similar expressions. Forward-looking statements reflect our current expectations and views about future events as of the time we published these documents. The forward-looking statements involve known and unknown risks, uncertainties and other factors that might cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. Given these risks and uncertainties, you should not place undue reliance on any such forward-looking statements. In addition, the information in this press release is believed to be accurate as of the date hereof, but should not necessarily be relied upon to reflect management's current views at any future date.



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