Merrion Pharmaceuticals Announces Positive Phase IIB Study For Orazol Tablet Form of Zoledronate IV Infusion At ASCO Annual Meeting

NEW YORK, June 19, 2009 — Merrion Pharmaceuticals plc (IEX: MERR), an international specialty pharmaceutical development company, today announced very positive results from a multi centre Phase II study on Merrion’s Orazol™ drug (MER 101). The study, conducted in hormone refractory prostate cancer patients with proven bone metastases, enrolled patients at 13 sites in the US and Europe. Today’s announcement, also including the publication of comprehensive results, was made at the annual general meeting of the American Society of Clinical Oncology (ASCO).

The published data shows a rapid response to treatment on biomarkers of bone resorption, in each of the study arms. These effects were noted at seven days and were sustained throughout the study period. The preliminary results show that weekly therapy with 20mg Orazol (tablet) appears to be as therapeutically effective as monthly treatment with the intravenous drug Zometa®(4mg), based on movements in observed levels of critical bone biomarkers. This was the primary endpoint of the study. Changes in bone biomarkers (e.g. NTX) have been correlated with improvement in major clinical outcomes such as Skeletal Related Events (such as bone fractures) and death. This study examined the effects of treatment on four separate bone biomarkers: urinary NTX, serum CTX, serum bone specific alkaline phosphatase and serum calcium.

Orazol is a once weekly tablet form of Zoledronate, which is currently only available as an intravenous infusion. Zoledronate is a very potent and thoroughly investigated bisphosphonate compound, which has been used to treat over three million patients worldwide. Orazol, as a weekly tablet formulation, offers many new potential advantages to patients, physicians and healthcare providers.

Commenting on the test results, John Lynch, Chief Executive Officer, Merrion Pharmaceuticals noted, “We are very pleased with these 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.”

Indeed the market opportunity for Orazol is currently substantial and also presents compelling potential for major growth. Sales of Zoledronate (Zometa® and other trademarks, Novartis).in 2008 were $1.65 billion and grew substantially over the prior year. Zoledronate is also used in osteoporosis and Paget’s disease, both of which put patients at risk of bone breakages. These areas are not currently being pursued by Merrion Pharmaceuticals, but could be once the company licenses Orazol to a partner.

Orazol is made possible by Merrion Pharmaceutical’s GIPET® technology, which enables the company to make tablet forms of drugs that otherwise have to be given by injection, like Zoledronate. Several other new products are in development both by Merrion, and in collaboration with partners such as Novo Nordisk for oral insulin and GLP-1. GIPET’s unique approach allows drugs that currently can only be given parenterally to be converted into oral forms, as well as improving the absorption of current oral drugs. GIPET uses specifically designed oral formulations of patented absorption enhancers which activate facilitate transport of the drug and substantially increasing absorption with good reproducibility and a strong safety pro?le. GIPET uses Generally Regarded As Safe (GRAS) rated ingredients, permitting the development of new low-risk oral products, which can be brought rapidly and inexpensively to market to address major unmet clinical and patient needs.

“Merrion Pharmaceuticals is dedicated to the premise that a wide range of injectable treatments, including many biopharmaceuticals, currently cumbersome and expensive and featuring less than satisfactory side effect profiles, may be administered orally as tablets or capsules using our patented GIPET drug delivery technology,” Lynch continued. “We look forward to working closely with licensing partners to bring these treatments to the patient community and in doing so, I am convinced we’ll improve the health and quality of life for a larger, more diverse section of the world population.”

About Merrion Pharmaceuticals: 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 2003 to commercialize various technologies acquired from Elan Corporation, plc. Merrion Pharmaceutical'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 utilizes its technology to develop new oral drugs in two ways; it develops its own proprietary drugs using GIPET and partners with other pharmaceutical companies in developing oral GIPET formulations of their products.

Merrion currently has four internal product development programs based on its GIPET 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 to 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 program 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 program 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 program 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 Pharmaceutical’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.

 

 

 

 

 

Posted: June 2009

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