Sagene Pharmaceuticals Announces Issuance of US Patent for Erectile Dysfunction
Oldsmar, FL, June 15, 2010 – Sagene Pharmaceuticals, Inc., a biopharmaceutical company focused on developing combinations of FDA- approved drugs to treat diseases associated with aging, today announced that the United States Patent and Trademark Office has issued US Patent 7,737,147 covering methods and compositions of enhancing PDE-5 inhibitors, such as Viagra®, Cialis® or Levitra® using MAO-B inhibitors for the treatment of erectile dysfunction. This proprietary combination technology is applicable to developing a more effective and lower dose treatment for erectile dysfunction. Sagene has exclusive rights to the patented technology and has combination candidates in preclinical development. Erectile Dysfunction (ED) affects over 150 mil ion men worldwide with cases expected to double in 10 years. Most men experience ED at some point in their lives, but 85% of cases are undiagnosed. PDE-5 inhibitors (Viagra®, Levitra®, Cialis®) are the main treatment for ED and generated almost $4.3 bil ion of sales in 2010. However, up to 40% of men with ED do not respond adequately to PDE- 5 inhibitor monotherapy and patients become less responsive over time. Penile erection involves a physiological interaction between the CNS and the peripheral target tissue. PDE-5 inhibitors only target ED through its actions on erectile tissue, but do not impact the CNS centers that regulate this function. Sagene’s new combination treatment for erectile dysfunction has a unique dual action. The combination of selegiline and a PDE-5 inhibitor would impact both the CNS and peripheral tissue sites. Sagene’s preclinical studies demonstrate that selegiline enhances the effects of PDE-5 inhibitors in erectile tissue at low doses. Accordingly, the combination of selegiline and a PDE-5 inhibitor is expected to address many of the current shortcomings of monotherapy. The recently issued patent is part of an intel ectual property portfolio developed by Tom Thomas, MD, PhD, Founder and CEO of Sagene, and includes previously issued patents covering novel actions of MAO-B inhibitors like selegiline. Sagene’s approved and pending patents cover methods and compositions for treating several indications including erectile dysfunction (ED), pulmonary arterial hypertension (PAH), pain/inflammation and cardiovascular diseases.
“We have developed our dual action erectile dysfunction combination to overcome the limitations of currently available therapies and are very pleased with the progress being made towards commercialization. The approval of this patent is an important step in the process, and in the development of our intel ectual property portfolio.” said Dr. Thomas. “Our ED product has the potential to become the new standard of care in patients and we expect to make several steps toward a commercial y marketed product over the next year.” About Sagene Pharmaceuticals, Inc. Sagene Pharmaceuticals is a biopharmaceutical company developing novel applications for combinations of FDA-approved drugs to treat diseases associated with aging. Sagene has shown that selective MAO-B inhibitors, specifical y selegiline (l-deprenyl), can reduce side effects and enhance efficacy in combination with current treatments for erectile dysfunction (ED), pulmonary arterial hypertension (PAH), pain/inflammation and cardiovascular diseases by targeting multiple disease pathways not typical y addressed by currently approved drugs. These novel actions of selegiline have been patented by Sagene. The combination approach for treating diseases with FDA-approved drugs to improve their therapeutic effect, reduces development risk, time and costs by utilizing the 505(b)(2) NDA approval process. Sagene has conducted preclinical studies showing proof of concept and the benefits of selegiline in laboratory animals and human platelets. The company is headquartered in Oldsmar, FL. For more information about Sagene Pharmaceuticals, please visit the Company’s website at www.sagenepharma.com. For Further Information Contact:
Prem Thomas CFO and Cofounder Sagene Pharmaceuticals +1 919 452 7317 [email protected]
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