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Movetis Announces Start of a Phase IIa Trial for M0002 in Ascites


6/6/2007 10:05:01 AM

TURNHOUT, Belgium, June 6 /PRNewswire/ --

- Other Key Product Programs Continue to Make Anticipated Progress

Movetis NV, a Belgian biopharmaceutical company that specializes in developing compounds for gastrointestinal disorders, announced today the start of a Phase-IIa multiple-dose trial with of one its lead products, M0002, an orally-active selective vasopressin antagonist that inhibits water re-absorption from the kidneys.

The Phase-IIa trial is designed to investigate the efficacy, safety, tolerability and pharmacokinetic profile of M0002 in cirrhotic subjects who experience ascites, an accumulation of fluid in the peritoneal cavity. Conventional diuretic drugs, which are currently used to treat ascites, have the drawback that they promote the excretion of both salt and water, whereas M0002, because it is an electrolyte-sparing aquaretic causes much lower levels of salt excretion. This important differential could potentially offer clinical advantages in the treatment of cirrhosis and other disorders caused by water-retention. In tests conducted to date, single-doses of M0002 (1-5 mg) in patients with liver cirrhosis have resulted in increased output of diluted urine.

Movetis, which was founded in December 2006, has a portfolio of four clinical and four pre-clinical compounds licensed from Janssen Pharmaceutica NV (Belgium) and Ortho-McNeil Pharmaceutical, Inc. (U.S.), both Johnson & Johnson (JNJ) companies. The company has recently moved into new offices in Turnhout (full address: Veedijk 58, Turnhout, B-2300, Belgium). These new offices will allow Movetis to build the organization it needs to achieve its ambitious goals. At present the company is a focused discovery-and-development organization, with a growing team of 22 experienced employees.

The company's two other lead products RESOLOR and M0003, are continuing to progress in line with expectations. Movetis has recently finalized the manufacturing of the characterization batches for RESOLOR, its Phase-III compound for the treatment of chronic constipation. The company has also had meetings concerning its regulatory strategy with RESOLOR with a number of Health Authorities in Europe.

M0003, part of the next generation of "gastrokinetics," has concluded its preclinical toxicology program and is being prepared for a Phase-II trial, which is targeted to start around the end of 2007.

Going forward, Movetis will continue to focus on becoming a profitable and leading GI Specialty company, and to bring innovative therapeutics to the market for the treatment of gastrointestinal disorders - those that currently have inadequate or limited alternatives.

About Movetis NV

Movetis NV is a biopharmaceutical company focusing on the development of innovative gastro-intestinal (GI) products. The privately held company develops and plans to market GI products based on intellectual property in-licensed from Janssen Pharmaceutica NV, Belgium and Ortho-McNeil Pharmaceutical Inc., U.S. The company is headquartered in Turnhout, Belgium.

Movetis' clinical pipeline includes one product, RESOLOR, which has completed phase III for the treatment of chronic constipation, one product, M0002, which has just entered a phase II trial for the treatment of ascites, M0003 (end phase I) and M0004 (in phase I) for the treatment of diabetic gastropathy and paediatric reflux respectively.

The founding team of Movetis consists of Staf Van Reet (Chairman), former Head of Research and Managing Director of Janssen Pharmaceutica and Past Chairman of FlandersBio and board member of a number of scientific institutions and biotech companies, Dirk Reyn (CEO), who was previously Vice-President of New Business Development-Europe for Janssen-Cilag and prior to that Head of Strategic Marketing for GI products at Janssen Pharmaceutica, Remi Van den Broeck (CDO), Founder and ex-CEO of Medisearch Int., an International Contract Research Organisation with affiliate offices in Belgium, Spain and the USA, and previously a Managing Director in the SGS Life Science Services group, and Jan Schuurkes (CSO), formerly the Vice-President of Gastro-Intestinal Research and a Distinguished Research Fellow at the Janssen Research Foundation.

In December 2006, Movetis raised EUR 49 million in a series A financing from major and distinguished EU and US investors including LSP, Sofinnova Partners, Sofinnova Ventures, KBC, GIMV, BIP, Quest for Growth and JNJ.

For further information, please contact: At Movetis Dirk Reyn, CEO +32-(0)14-404-350 Staf Van Reet, Chairman +32-477619762

Movetis NV

CONTACT: For further information, please contact: At Movetis, Dirk Reyn,CEO +32-(0)14-404-350, Staf Van Reet, Chairman +32-477619762


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