Merrion Announces Positive Clinical Results For Osteoporosis Drug MER 103

Merrion
Pharmaceuticals Ltd, an international specialty pharmaceutical company,
today announced the successful completion of a clinical pharmacology study
of MER 103, a novel oral formulation of alendronate sodium. MER 103 is an
enteric- coated tablet of alendronate and GIPET(TM), Merrion's proprietary
platform technology which increases drug absorption. The study confirmed
several important improvements for patient convenience and compliance
relating to the administration of alendronate, the leading bisphosphonate
for the prevention and treatment of osteoporosis, marketed as Fosamax(R)
(Merck).


The study was conducted in postmenopausal women and compared the
absorption of a 6mg dose of MER 103 administered to patient volunteers
under three different conditions: in the fasted state, together with a high
fat meal, and at bedtime, against a 35mg dose of Fosamax(R) administered in
the fasted state as per label directions.



Subjects who received 6mg MER 103 after an overnight fast absorbed
approximately twelve times more alendronate on a dose adjusted basis than
when they received 35mg of Fosamax(R) under the same conditions. In
practice, these data indicate that a 6mg weekly dose of MER 103 will be
bioequivalent to a 70mg weekly dose of Fosamax(R).



Subjects who received MER 103 at bedtime, approximately 4 hours after
the evening meal, absorbed the same amount of alendronate as they did when
taking the drug after an overnight fast. Subjects were instructed to lie
down for at least 2 hours after taking their medication rather than to
remain upright per the dosing instructions for the marketed oral
bisphosphonates. There were no serious or clinically significant adverse
events in this treatment group. The study also showed that, as with all
bisphosphonate drugs, co-administration with food reduced the absorption of
MER 103, although the percent drug absorbed was still greater than for the
Fosamax(R) dose.



"The results of this clinical trial are very encouraging. The
combination of improved bioavailability and the elimination of the morning
dosing ritual addresses directly two of the major limitations of oral
bisphosphonates. Compliance with the morning dosing ritual is a major issue
in treating osteoporosis. Merrion's improvements in this therapy constitute
a significant advance," said Michael McKenna, CEO of Merrion. "We are very
pleased with the trial results and look forward to discussing these results
and the further clinical development of MER 103 with prospective
collaborators."



About Osteoporosis



Osteoporosis, a skeletal disorder characterized by weakened bones
leading to an increased risk of fracture, is a major cause of disability
and death. It contributes to an estimated 300,000 hip fractures in the US
each year. Thirty three percent of women and 20% of men over the age of 50
will experience a fracture at the hip, spine or wrist in their lifetime.
Ten million people in the US are estimated to have osteoporosis and 34
million more have low bone mass, placing them at greater risk for fracture.
Bisphosphonates are the most commonly prescribed class of drugs for the
prevention and treatment of osteoporosis. The bisphosphonate market is $6
billion and growing rapidly. However, poor adherence to therapy is a key
market dynamic. Sixty percent of patients taking weekly bisphosphonates
discontinue therapy within the first year, primarily due to difficulty in
complying with the morning dosing ritual.
















About GIPET(TM)



Merrion's Gastrointestinal Permeation Enhancement Technology
(GIPET(TM)) is a clinically proven platform technology for the oral
delivery of many poorly permeable compounds, with resultant improvements in
patient compliance, safety and efficacy. In all more than 20 different
drugs, including small organics, peptides, and other macromolecules have
shown substantial improvement in oral bioavailability with GIPET(TM).
Merrion's model allows rapid and low cost screening of several GIPET(TM)
formulations to select the optimal form for further development. The
leading GIPET(TM) enhancer matrices enjoy food additive status (GRAS) and
are normal dietary components with long records of safe use. Clinical
safety data for GIPET(TM) show that all GIPET(TM) treatments were well
tolerated and no treatment-related adverse events were recorded.



About Merrion



Established in 2004, Merrion Pharmaceuticals (merrionpharma/) is
a privately held international specialty pharmaceutical company engaged in
the development of improved oral dosage forms of drugs that have poor
bioavailability, including injectable drugs, certain existing oral drugs
and large molecule drug candidates. Merrion's drug delivery technologies
increase bioavailability by improving absorption in the gastrointestinal,
or GI, tract, thereby enhancing efficacy, reducing side effects and
improving drug tolerability. Merrion's primary focus is on developing
patentable improved oral therapeutics that can replace injectable drugs,
thereby increasing physician and patient acceptance. Merrion holds more
than 25 issued and in- process patents for the delivery of a variety of
drugs and biologics based on our patented GIPET(TM) and GIRES(TM) drug
delivery platforms. Merrion has operations in Wilmington, NC and Dublin,
Ireland.


Merrion Pharmaceuticals Ltd

merrionpharma/