Archive for the ‘Merrion’ Category

Merrion Pharmaceuticals plc, (“Merrion” or the “Company”) (IEX: MERR) an international pharmaceutical product development company, announced today its preliminary financial results for the year ended 31 December 2010. Among the operating highlights is Merrion’s continuous work on four internal products based on its GIPET® technology; specifically its Orazol ™ oncology drug. The company has also been issued two important U.S. patents covering the GIPET technology and Orazol product.

During November and December 2010, Merrion signed a number of feasibility and option agreements which significantly expanded the Company’s partnered pipeline by an additional six compounds. The deals signed were with Novo Nordisk, Rebel Pharmaceuticals and an international ‘top ten’ pharmaceutical company.

In November 2010, Merrion finalized a Phase III development program for Orazol™ under Rule 505b  (2) with the Food and Drug Administration (FDA) in the USA. The study will compare Orazol against placebo as an adjuvant breast cancer treatment (a new indication for zoledronic acid) with a primary    endpoint of disease free survival of patients with breast cancer.

“The decrease in revenue compared to the prior year is a result of the completion of product development work for Novo Nordisk. We were contracted by Novo Nordisk to manufacture clinical trial supplies for their Phase I trials,” said John Lynch, CEO, Merrion Pharmaceuticals. “We completed this activity during 2010 and the products are now in clinical trials. The additional capacity of our new facility has allowed us to enter 3 recent agreements to work on six new compounds including one for Novo Nordisk. This is providing Merrion with new revenue sources in 2011.”

The Company continues to work with Novo Nordisk on its oral insulin and oral GLP1 product. Novo
Nordisk has commenced Phase I clinical trials for oral GLP-1 and oral insulin analogues using Merrion’s GIPET technology. The Company expects these clinical trials to continue through 2011.
In addition, during the year, several feasibility studies were conducted on potential new products, new technology development programs were initiated and Dr. Hing Kin Chan was appointed as Chief Business Officer.

Commenting further on the outlook for 2011, Lynch added, “The hard work carried out in 2010 has set us in good stead for the next year. In the last quarter of 2010, Merrion signed pre-license agreements with two new partners and with Novo Nordisk for a new compound. Work on these programs is underway and we are pleased with progress to date. There are other license opportunities in the Company’s own portfolio and in existing partner programs. We are hopeful that some of these agreements will become full license agreements following the results of the feasibility work.
About Merrion:

Merrion Pharmaceuticals is a publicly listed product development company focused on delivering innovation to the market by:
· designing our own patented products and
· partnering with other pharmaceutical companies to develop patented products.
Established in 2003, Merrion are engaged in the development of oral forms (tablets/capsules) of drugs that have poor absorption and are generally given by injection. Merrion Pharmaceutical’s patented drug delivery technologies (GIPET®) hugely increase bioavailability, by improving absorption in the gastrointestinal tract, of drugs that are otherwise poorly absorbed. As well as increasing absorption, Merrion’s technologies also increase the consistency of absorption.
These new products can provide substantial benefits in enhanced drug efficacy, improved safety, toxicity and side effect profile, health economics, patient experience and quality of life.
Merrion has agreements with several pharmaceutical companies. Merrion has two license agreements with Novo Nordisk A/S to develop and commercialise oral Insulin and oral GLP-1 using Merrion’s GIPET technology. Merrion also has an oral drug delivery research collaborative program with Ferring Pharmaceuticals, a Swiss based international pharmaceutical company. There are other, unannounced collaborations. Merrion Pharmaceuticals is based in Dublin, in a state of the art, purpose built cGMP facility which allows rapid development and reduced risk in taking product ideas from conception to final product formulation.

Merrion also has operations in Wilmington, North Carolina.
Merrion is listed on the Irish Stock Exchange (ESM) under the symbol MERR.

Tags:
Posted in Merrion | Comments Off

Merrion Pharmaceuticals Plc, a publicly listed product development company, today announced the commencement of an oral drug delivery Feasibility and Option agreement with one of the world’s top ten biggest pharmaceutical companies. The agreement will evaluate the ability of Merrion’s patented GIPET® technology to boost the bioavailablity of three of the ‘big pharma’ company’s compounds. The three compounds have a range of molecular weights. Following the feasibility studies, the company will have the option to enter into a licensing agreement for Merrion’s GIPET technology.  Merrion’s GIPET technology is a platform technology with broad applicability which covers a wide range of compounds with varying physiochemical properties and molecular weights.
Commenting on the announcement, John Lynch, CEO, Merrion Pharmaceuticals said, “We are very pleased to be entering into this agreement with one of the world’s leading pharmaceutical companies to assess the ability of our unique GIPET technology to substantially improve the product profile of three of their compounds. This agreement is further validation of the broad applicability of our GIPET technology and the high level of interest in using the power of GIPET in the pharmaceutical industry.”

Merrion’s patented drug delivery technology, GIPET®, is supported by a large database reflecting 10 years research and development by drug delivery experts and 21 clinical studies conducted on a broad range of drug types. In a database comprising more than 40 compounds, GIPET has shown the ability to improve absorption by as much as 200 times, achieving excellent intersubject reproducibility and with a positive safety database. This includes traditional small molecules as well as biopharmaceutical peptides and proteins, making GIPET a platform technology with broad applicability.
Merrion’s technology is endorsed through collaborations with pharmaceutical companies such as Novo Nordisk (oral insulin, oral GLP-1), Ferring Pharmaceuticals and others.

Tags: ,
Posted in Merrion | Comments Off

Merrion Pharmaceuticals Finalizes Phase III Development Program For Orazol™

After recent consultation with the FDA this November, Merrion Pharmaceuticals is preparing for its Phase III study for Orazol™. If successful, the Phase III study will allow a new drug application for Orazol to be made under the FDA’s abbreviated approval procedure section 505(b)(2) using a single Phase III study. The study will compare Orazol against placebo as an adjuvant breast cancer treatment with a primary endpoint of Disease Free Survival of patients with breast cancer.
If approved, this drug would provide a new treatment, which could improve prognosis, in combination with existing treatments, for early stage breast cancer patients. Merrion has been focused on an oral form of this drug (zoledronic acid) for the bone metastases indication. However, this trial would expand Orazol’s potential by allowing Orazol to be used for early treatment of breast cancer in addition to bone metastases for laste stage cancer patients. Zoledronic acid has been shown to improve Disease Free Survival in large-scale Phase III clinical studies, involving thousands of breast cancer patients.

Commenting on the announcement, John Lynch, Chief Executive Officer said, “Merrion is still focused on licensing Orazol and believes this news will facilitate its discussions. Following the conclusion of its licensing discussions, Merrion would anticipate that, in conjunction with a license partner, it would request a special protocol assessment (SPA), from the FDA, of the detailed protocol. Subject to approval from the FDA, the intention is to commence Phase III trials in 2011.”
Merrion has previously received scientific advice from the Committee for Medicinal Products for Human Use (CHMP) agreeing the approval pathway for Orazol in Europe for the existing bone metastases indication. Following a licensing agreement, Merrion would seek agreement from the CHMP to expand the use of Orazol to earlier stage breast cancer treatment.
Orazol, Merrion’s lead product, is a unique tablet formulation of zoledronic acid, made possible by Merrion’s proprietary GIPET® technology, and for which there are issued US Orazol patents to 2027. Orazol provides an ideal product profile to address the market needs, as a well-tolerated table formulation with weekly dosing.

Tags: ,
Posted in Merrion | Comments Off

© 2013 Definition Branding & Marketing