With four programs in the clinic and a buzz of Big Pharma interest in its drug delivery technologies, Merrion Pharmaceuticals, the latest addition to Ireland's roster of listed drug development firms, is exciting local analyst expectations.

Researcher at Merrion Pharmaceuticals

Courtesy of Merrion Pharmaceuticals

Currently valued at just €65 million ($100 million US) following an IPO in Dublin last December, the specialty pharmaceutical company has a quartet of development programs underway. One of them, MER-103, has completed a Phase II proof-of-concept study in osteoporosis and is now the subject of partnering discussions. "It's a drug that's got a large potential," says analyst Ian Hunter at Goodbody Stockbrokers in Dublin. Merrion also has research agreements with several of Europe's largest pharmaceutical firms, which are evaluating its delivery technology. "This platform they have is attracting attention from the large-cap pharmas," says Hunter.

Although only four years in existence, Merrion is commercializing a suite of oral drug delivery technologies that originated at Elan Corp., which had invested more than a decade in their development. Growcorp, a Dublin-based life sciences investment firm, acquired the platforms - Gastrointestinal Permeation Enhancement Technology (GIPET) and Gastrointestinal Retention System (GIRES) - in early 2004, and formed Merrion to bring them to market. GIPET enhances the bioavailability of drugs that are poorly absorbed across the gastrointestinal tract; GIRES is a controlled-release system for drugs absorbed through the stomach but degraded too rapidly in their native form.

Merrion's two most advanced clinical projects, MER-103 and MER-101, are based on the GIPET technology. They represent, respectively, reformulations of the blockbuster bisphosphonates: alendronate (Fosamax) marketed by Merck, and zoledronic acid (Zometa) from Novartis.

Bisphosphonates have been a successful drug class in osteoporosis and in oncology-related indications, such as prevention of bone metastases, because of their ability to inhibit the activation of osteoclasts, the specialist cells responsible for bone breakdown or resorption. Fosamax for osteoporosis racked up sales of $3 billion in 2007, but that franchise is now winding down, following a patent expiry earlier this year. "It doesn't take a huge slice of that to make it highly attractive from our point of view," says John Lynch, Merrion's CEO.

MER-103 is based on the same molecule as Fosamax but with some additional advantages. Fosamax has a "complicated dosing regimen" and "nasty" side effects, says Lynch. "The advantage we're looking at with MER-103 is that we can really deal comprehensively with those issues." It has 12-fold better bioavailability than Fosamax, he says, so the dose can be reduced dramatically. And unlike Fosamax, it is absorbed across the upper portion of the small intestine rather than the stomach, so it eliminates the risk of esophageal damage caused by reflux of the stomach contents.

Unlike Zometa, which is administered intravenously, MER-101 is an oral version that is currently in a 90-patient Phase II study to optimize its dosing regimen. Also in the pipeline are MER-102, an oral, low-molecular weight heparin undergoing a Phase I study for treating deep vein thrombosis, and MER-104, a peptide-based gonadotropin-releasing hormone antagonist in preclinical development for prostate cancer and benign prostatic hyperplasia.