BioMarck Pharmaceuticals Announces The Allowance Of Two US Patents On Lead COPD Therapeutic

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 a Notice of Allowance for two of its patent applications.



The first allowed patent, titled "Mucin Hypersecretion Inhibitors and Methods of Use," will provide broad protection for BioMarck's lead drug, BIO-11006 Inhalation Solution, as well as a series of other first-in-class mucus inhibiting peptides. The second allowed patent, titled "Methods for Regulating Inflammatory Mediators and Peptides useful Therein," will provide broad protection for another series of BioMarck's anti-inflammatory peptides. The two new patents will also provide broad protection of methods of treatment for a variety of pulmonary diseases involving mucus hypersecretion and airway inflammation. Corresponding international patent applications are pending. Dr. Indu Parikh, President and Chief Scientific Officer of BioMarck Pharmaceuticals, said "BioMarck believes that allowance of these two patents significantly strengthens its overall intellectual property portfolio."



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 Q3 of 2008 and expects complete enrollment of the planned 162 patients to take 12 to 15 months. After completion of the Phase 2 study, 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 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 lung. 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.



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