Merrion Pharmaceuticals is Issued a Key U.S. Patent for Orazol(TM), Their Lead Product to Treat Bone Metastases Associated With Prostate, Breast and Other Cancers


DUBLIN, Ireland, May 7, 2010 (GLOBE NEWSWIRE) -- Merrion Pharmaceuticals plc (IEX:MERR), a pharmaceutical development company, today announces that it has been granted a further U.S. Patent, increasing the protection for their lead product, Orazol™.

United States Patent No. 7,704,977, "Solid Oral Dosage Form Containing an Enhancer" covers Orazol™ tablets, an oral form of zoledronic acid, a bisphosphonate. Orazol is in development to treat bone metastases associated with prostate, breast and other cancers; the current gold standard of treatment is intravenous bisphosphonates. Orazol has been designed to improve this treatment through the numerous benefits of oral administration combined with comparable efficacy.

Orazol uses Merrion's proprietary GIPET technology which allows the oral dosing of drugs previously only available in intravenous form. Efficacy, safety and side effect profiles of drugs can be improved substantially using this delivery technology. Thus, products developed with this technology have potential for significantly improving the Quality of Life for patients as well as providing greater access to the medication with substantial economic improvements for hard pressed healthcare systems. The expiry date on this patent is 2027.

A separate patent, covering GIPET® technology combined with bisphosphonates, of which zoledronic acid is a member, was issued in the U.S. in March 2010 and a patent covering the GIPET technology, including its use with bisphosphonates, has been granted in Europe.

Mr. John Lynch, Merrion's Chief Executive Office, commented, "This is the second key U.S. patent issued for Merrion's GIPET technology this year and is a significant development for our patent estate. This further establishes us as one of the leading companies in this space.

"The clinical validation for GIPET technology is also growing. For example Orazol™ demonstrated excellent results in a Phase 2b study published at last year's meeting of the American Society of Clinical Oncology (ASCO). This U.S. patent is another step towards achieving our overall vision."

About Merrion:

Merrion Pharmaceuticals (www.merrionpharma.com) is 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 is listed on the Dublin Stock Exchange under the symbol MERR.

  • Orazol™ (MER-101) is an oral bisphosphonate for oncology indications currently in Phase 2 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.

About GIPET®: Gastrointestinal Permeation Enhancement Technology

Merrion's unique approach using GIPET technology allows drugs that currently can only be given parenterally (injectable) to be converted into oral (tablet/capsule) forms, as well as improving the absorption of current oral drugs. GIPET uses specifically designed oral formulations of patented absorption enhancers which activate micelle formation, facilitating transport of drug and substantially increasing absorption with good reproducibility and a strong safety profile.

In a database comprising more than 30 compounds having poor permeability, GIPET has shown the ability to improve absorption by as much as 200 times, achieving excellent intersubject reproducibility with a positive safety database.  Moreover, this database covers a wide range of compounds with varying physiochemical properties and molecular weights. These include traditional small molecules as well as biopharmaceutical peptides and proteins, making GIPET a platform technology with very broad applicability.


            

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