Merrion Pharmaceuticals Plc Announces Preliminary Results On Phase II Orazol(tm) Study


DUBLIN, Ireland, May 15, 2009 (GLOBE NEWSWIRE) -- Dr. John Fox, of Merrion
Pharmaceuticals ("Merrion" or the "Company"), will address the 7th
International Cancer Conference in Dublin today, and will speak about the very
positive preliminary results from a multi centre Phase II study on Merrion's
Orazol(tm) drug (formerly known as MER 101). The study, conducted in hormone
refractory prostate cancer patients with proven bone metastases, enrolled
patients at sites in the U.S. and Europe. 

The preliminary results show that weekly therapy with 20mg Orazol(tm) (tablet)
appears to be as therapeutically effective as monthly treatment with the
intravenous drug Zometa(r)(4mg) based on movements in observed levels of
critical bone biomarkers. Changes in bone biomarkers, e.g. NTX, have been
correlated with improvement in clinical outcomes such as skeletal related
events (SRE) and death. This study examined the effects of treatment on four
separate bone biomarkers, NTX, serum CTX, serum bone specific alkaline
phosphatase and serum calcium. John Lynch, Merrion CEO said, "We are very
pleased with these preliminary results. It is clear that Orazol has the
potential to make an impact on patient care in the years ahead -- and we will
now work on identifying a licensing partner to complete Phase III development
and market the product." 

Orazol(tm) is a once weekly tablet form of zoledronic acid, which is currently
only available as an intravenous infusion (Zometa(r) and other trademarks,
Novartis). Zoledronic acid is a very potent and thoroughly investigated
bisphosphonate compound, which has been used to treat over 3 million patients
worldwide. Orazol(tm), as a weekly tablet formulation, offers many new
potential advantages to patients, physicians and healthcare providers. 

The preliminary data show a rapid response to treatment on biomarkers of bone
resorption in each of the study arms. These effects were noted at 7 days and
were sustained throughout the study period. 

The Company anticipates that the data will be fully analyzed and comprehensive
results will be published on 31st May 2009 at the annual general meeting of the
American Society of Clinical Oncology (ASCO) in Florida. 

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