DUBLIN, Ireland, Feb. 10, 2009 (GLOBE NEWSWIRE) -- Merrion Pharmaceuticals plc (IEX:MERR), an international specialty pharmaceutical development company, today announces the completion of patient enrolment for their Phase IIb study of Orazol(tm). Orazol(tm) is Merrion's lead product indicated for the treatment of bone metastases secondary to several types of cancer. Orazol(tm) is a weekly tablet form of zoledronic acid, which currently has only been available as an IV infusion (Zometa(r), Novartis). Recent clinical trials of zoledronic acid have demonstrated new, anticancer effects in breast cancer, which could expand the indications for the drug.
The trial is being carried out in 30 hormone refractory prostate cancer patients with bone metastases in clinical centres in the United States and several European countries. This study aims to show that the Orazol(tm) weekly tablet has a similar therapeutic effect to the currently marketed IV infusion, as measured by the biomarkers of osteolysis.
John Lynch, CEO of Merrion, commented:
"The completion of enrolment in this Orazol(tm) Phase IIb study is another significant milestone for Merrion. Once the dosing is complete, we will analyse and announce the data. Then we will look to license Orazol to a suitable partner who will complete the product development, file registration and market this product, which we believe has significant potential."
The market for bisphosphonate used in oncology, of which zoledronic acid is the 'gold standard' treatment worldwide, is estimated at $2Bn for 2007. Zoledronic acid sales were $1.4Bn in 2008.
Merrion anticipates that its new patented Orazol(tm) tablet will bring significant advantages to all stakeholders, including patients, health care professionals and healthcare payors. Availability of Orazol(tm) tablets will allow a very effective medication be available to a wide patient population in a more efficient, convenient and cost effective formulation.
About Merrion:
Merrion Pharmaceuticals (www.merrionpharma.com) is a publicly listed specialty pharmaceutical company engaged in the development of oral forms (tablets/capsules) of drugs that have poor absorption and are generally given by injection. Merrion was established in 2004 to commercialise various technologies acquired from Elan Corporation, plc. Merrion's patented drug delivery technologies increase bioavailability, by improving absorption in the gastrointestinal tract, of drugs that are otherwise poorly absorbed. This can provide substantial benefit in patient convenience and safety, and might also provide enhanced drug efficacy. Merrion utilises its technology to develop new oral drugs in two ways; it develops its own proprietary drugs using GIPET(r) and partners with other pharmaceutical companies in developing oral GIPET(r) formulations of their products.
Merrion currently has four internal product development programs based on its GIPET(r) technology.
* Orazol (MER 101) is an oral bisphosphonate for oncology
indications currently in Phase II development. This product aims
to allow cancer patients with bone metastases take a weekly
tablet to get the gold standard treatment in this area, rather
than an IV infusion.
* Almerol (MER 103) which is also an oral bisphosphonate, for the
treatment of osteoporosis, has completed Phase II clinical
trials. Based on the market leading drug, this programme aims to
provide similar absorption in just 8% of the current dose, with a
simplified dosing regimen and an improved side effect profile.
* Acyline (MER 104) is a second oral oncology product for the
treatment of prostate cancer, which is in Phase I clinical
testing. This programme aims to be the first oral product in the
area of GnRH analogues. Products in this class also have several
other male/female health indications.
* MER 102 an oral anticoagulant is in preclinical testing. This
programme aims to be the first oral product in LMWH class of
drugs, and to offer patients the alternative to daily injections.
Merrion has agreements with several pharmaceutical companies.
* On January 16, 2009 Merrion announced the execution of an
agreement with Novo Nordisk, a world leader in Diabetes, to
develop and commercialize oral forms of Novo Nordisk proprietary
GLP-1 receptor agonist using Merrion's proprietary GIPET
technology. This was the second license agreement between Merrion
and Novo Nordisk, which have combined milestones of $116 Million
for the first product developed which reaches the market, as well
as development fees and royalties on sales.
Merrion has operations in Dublin, Ireland and Wilmington, NC, USA.