Sagene june 15

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
prem@sagenepharma.com

Source: http://sagenepharma.com/Sagene%20June%2015.pdf