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Merrion sets out business strategy amid Orazol outlicensing plans

This article was originally published in Scrip

Executive Summary

Merrion Pharmaceuticals, the Irish oral drug specialist, is looking to license its lead oral drug Orazol (zoledronic acid), developed internally, to an outside partner. This is part of a business strategy that has stood the company in good stead since its inception in 2003, its chief financial officer Jonathan O'Connell told Scrip.

The company is committed to developing products to the end of Phase II, and then licensing them out to a marketing partner. Orazol has recently completed Phase IIb trials, and the company will most likely out-license it in the US or Europe.

Merrion has applied its GIPET technology, which is designed to improve the oral bioavailability of marketed products, to a wide range of programmes. The firm currently has around 20 programmes in development.

GIPET, used to formulate Orazol, can increase the absorption of APIs in the intestine by up to 46 times compared with conventional delivery methods, , Mr O'Connell said.

The product is a formulation of Novartis's Zometa, an intravenous medicine that has been approved in more than 90 countries for various indications including bone metastasis in cancer patients and osteoporosis.

Unlike Zometa, Orazol is a once-weekly tablet compared with the once-monthly, hospital-administered intravenous infusion. Orazol may be more efficacious, as Zometa's side-effects are mostly associated with the peak drug concentration delivered in the infusion, Mr O'Connell asserted.

The majority of Merrion's internal work is focused on GIPET, but it is also developing its GIRES technology. The mode of delivery consists of an orally administered drug capsule that contains an inflatable pouch which in turn contains a controlled-release dosage of a desired drug. Once the capsule dissolves in the stomach, a gas-generating system using carbon dioxide inflates the pouch which then disperses the drug into the gut.

Merrion was founded in 2003 to acquire Elan's drug delivery business, which Elan divested to focus on biopharmaceuticals.

Ireland's government agency Enterprise Ireland, one of the company's principal investors, invested significantly into Merrion. This also allowed Merrion to collaborate with researchers at from Irish universities, such as University College Cork and Trinity College Dublin.

Merrion created a management team after the acquisition closed, but no employees came directly from Elan. However, Merrion still has links with the larger Irish company, which receives royalties on income from Merrion's patent portfolio and is a small shareholder in the company.

Merrion went public in December 2007 and has since signed two lucrative deals with Novo Nordisk for the production of oral insulin formulations of a GLP-1 receptor agonist using GIPET (scripnews.com, January 16th, 2009).

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