PARSIPPANY, NJ, Oct 03, 2011 (MARKETWIRE via COMTEX) -- The Medicines Company (MDCO) announced today launch of a new twelve hour formulation for Cleviprex(R) (clevidipine) Injectable Emulsion, which was approved by the U.S. Food and Drug Administration (FDA) in June 2011. Cleviprex is an intravenous dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. The new formulation triples the maximum allowable infusion time per vial, commonly referred to in hospitals as "hang time" to 12 hours compared to the original 4-hour hang time vial approved by the FDA in 2008. The longer hang time requires fewer vial changes. The longer hang time was achieved by adding a bacterial growth retardant.
Brent Furse, Senior Vice President, Chief Customer Officer at The Medicines Company said, "This innovation came as a result of feedback from our Cleviprex customers and practitioners -- particularly intensive care nurses who work in settings where patients often need acute blood pressure control for longer periods of time. By requiring fewer vial changes, the new Cleviprex product may potentially reduce medication waste and provide an efficient, economical solution. We plan to study the potential economic benefits of the new Cleviprex formulation compared to alternative acute blood pressure reducing drugs."
The new Cleviprex 12-hour formulation is available for hospital pharmacy order today. It is supplied in single use vials of 50 mL and 100 mL with a concentration of 0.5 mg/mL. The Medicines Company is working with hospital customers to manage the exchange of the new (less than 12 hour hang-time) and old (less than 4 hour hang-time) formulations of Cleviprex to ensure that hospitals do not have both in stock at the same time. Customers with queries regarding this process are invited to call The Medicines Company at 1-888-977-6326 or 1-973-290-6018.
Important Safety Information About Cleviprex
Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism seen in conditions such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and severe aortic stenosis. Cleviprex is intended for intravenous use. Use aseptic technique and discard any unused product within 12 hours of stopper puncture. Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. If either occurs, decrease the dose of Cleviprex. There is limited experience with short-duration therapy with beta-blockers as a treatment for Cleviprex-induced tachycardia. Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully. Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after a gradual reduction in dose. Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped. Cleviprex contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism. There is no information to guide use of Cleviprex in treating hypertension associated with pheochromocytoma. Most common adverse reactions are (greater than 2%) are headache, nausea, and vomiting.
About The Medicines Company The Medicines Company /quotes/zigman/83890/quotes/nls/mdco MDCO +5.36% provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com .
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include the extent of the commercial success of Angiomax, the Company's ability to develop its global operations and penetrate foreign markets, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, risks associated with the establishment of international operations, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on August 2, 2011, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Contact: Michael Mitchell
The Medicines Company
973-290-6000
[email protected]