Healthcare Industry News: bivalirudin
News Release - August 5, 2008
Curacyte Sells Its Subsidiary Curacyte Discovery GmbH to The Medicines CompanyMUNICH, Germany--(HSMN NewsFeed)--Curacyte AG today announced that it has sold its wholly owned subsidiary, Curacyte Discovery GmbH based in Leipzig (Germany) to The Medicines Company (NASDAQ: MDCO ). Curacyte Discovery is engaged in the development of synthetic serine protease inhibitors in the area of hemostasis and anti-coagulation. Its rationally-designed lead development candidate, CU-2010, is being developed for preventing surgical blood loss. It is scheduled to enter Phase I clinical development by the end of 2008.
Curacyte AG and its wholly owned subsidiary Apex Bioscience (Chapel Hill, NC, USA) will continue to develop its lead product hemoximer (Pyridoxalated Hemoglobin Polyoxyethylene, PHP) in a Phase III pivotal trial in patients suffering from catecholamine-resistant distributive shock.
Curacyte received a payment of € 14.5 million upon signing of the agreement. In addition, Curacyte will be eligible to receive a payment of € 10.5 million when The Medicines Company progresses CU-2010 into Phase II clinical development as well as future commercial milestone and royalty payments.
“We are very proud of The Medicines Company acquiring Curacyte Discovery and thereby acknowledging what we have built and developed over the past years. At The Medicines Company, Curacyte Discovery will be embedded in and complement a fully integrated value chain with direct access to the critical care markets.” said Dr. Helmut Giersiefen, CEO of Curacyte AG. He further stated that “the transaction will help the parent company, Curacyte AG, to focus on fully developing its key product, hemoximer, in a pivotal Phase III study in distributive shock.”
Curacyte is currently initiating the Phase III study which will be conducted in patients suffering from distributive shock and not responding to standard therapy in form of catecholamines. Worldwide, more than 2 million patients suffer from distributive shock per annum. Recent clinical data suggests that more than 50% of these patients do not respond to catecholamines, e.g., norepinephrine, the only therapy to treat shock. Non-responders have only a 20% chance to survive this serious condition with no alternative treatment option. The Phase III study is expected to last for two years and is planned to be conducted in the Europe and the United States.
Curacyte Discovery GmbH, is a wholly-owned subsidiary of Curacyte AG. Curacyte AG is an advanced biopharmaceutical company dedicated to the development of new therapeutics for acute and critical care conditions.
Curacyte’s lead product is hemoximer (Pyridoxalated Hemoglobin Polyoxyethylene, PHP). Hemoximer has been developed as a scavenger of nitric oxide, the causative agent responsible for vasodilation and hypotension in shock. The ability to scavenge and metabolize NO is one of the important physiological functions of natural hemoglobin. Hemoximer has been demonstrated to reverse the vasodilation and resolve the hypotension associated with distributive shock. Hemoximer has completed Phase II clinical development in its primary indication, distributive shock, and is now entering a Phase III study in catecholamine-resistant distributive shock. Apart from distributive shock, hemoximer is also being studied as an adjunct to high-dose interleukin 2 (IL-2) cancer therapy for patients with metastatic melanoma and renal cell carcinoma. Shock is a frequent dose-limiting side effect of high-dose IL-2 therapy. Hemoximer is the proposed International Non-Proprietary Name (INN) for PHP. The Company’s website is www.curacyte.eu.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO ) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, as well as Cleviprex™ (clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Company also has one product, cangrelor, in late-stage development. The Company's website is www.themedicinescompany.com.
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