The Medicines Company Announces Acquisition of Rights to Clevidipine
Phase 3 Drug Candidate to be Tested for Use in Hospital Hypertension Patients
PARSIPPANY, N.J.--(BW HealthWire)--March 6, 2002--The Medicines Company (NASDAQ: MDCO - news) announced today that it has entered into an agreement with AstraZeneca PLC for the licensing, development and commercialization of clevidipine, an intravenous, short-acting calcium channel blocker. Clevidipine will be developed in Phase 3 by The Medicines Company for the short-term control of high blood pressure in the hospital setting. AstraZeneca has completed clinical pharmacology, dose-finding and efficacy studies that demonstrate that clevidipine has a short duration of action, a short plasma half life, and a selective effect on blood pressure.
The agreement covers all worldwide territories except Japan. The Medicines Company will perform further clinical development and has the right to commercialize the product in all other territories worldwide including the United States. Financial terms of the agreement were not disclosed.
``Acquisition of the rights to clevidipine is consistent with our execution of a strategy to build a franchise in acute hospital care,'' said Clive Meanwell, M.D., Ph.D., Executive Chairman of The Medicines Company. He went on to state, ``Commercially, the product's pharmacological and clinical attributes make it an ideal candidate for Phase 3 testing in a range of hospital indications including malignant hypertension, and the control of blood pressure during and after cardiac surgery, percutaneous coronary intervention and other acute interventions where precise control of blood pressure is clinically important. An estimated 18.2 million surgical procedures are performed annually on hypertensive patients in the United States. These patients are often treated with multiple medications that have been shown to increase the duration of a patient's stay in the Intensive Care Unit and require a physician's attention. We believe clevidipine has the potential to demonstrate a substantial pharmacoeconomic benefit by reducing complex treatment with multiple medications and patients' time in the ICU.''
Dave Stack, President and CEO of The Medicines Company, added, ``This is a perfect fit with our current U.S. sales configuration. We believe that clevidipine will be of value to many of the same customers who are currently adopting ANGIOMAX® (bivalirudin) into their practice. This leverages many of our existing commercial relationships in the U.S. We look forward to forging a strong relationship with Astra Zeneca and bringing this potentially important new medicine to patients.''
Clive Meanwell will host a conference call at 8:30 AM (Eastern Time) on March 7, 2002. To participate in the call, please dial 800.472.8325. If you are calling from outside the United States please call 1.706.679.0816. There will be a digital replay of the call available until March 9 at midnight Eastern Time. To listen to the replay, please dial 800.642.1687 in the United States or 1.706.645.9291 outside the United States and enter conference ID #3425937. A webcast of the call will also be available on The Medicines Company's website, www.themedicinescompany.com.
The Medicines Company was founded in 1996 to acquire, develop and commercialize selected pharmaceutical products in late stages of development and approved products. In December 2000, the Company received marketing approval from the U.S. Food and Drug Administration for ANGIOMAX for use as an anticoagulant in combination with aspirin in patients with unstable angina undergoing coronary balloon angioplasty. The Company began selling ANGIOMAX in the United States in January 2001. The Company expects ANGIOMAX to be the cornerstone product of a planned acute hospital franchise. The Company is also developing a second product, CTV-05, a proprietary biotherapeutic agent with a potentially broad range of applications in the treatment of gynecological and reproductive infections. Additional information about the company and its products can be found at www.themedicinescompany.com.
This press release contains forward-looking statements that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, ``believes,'' ``anticipates,'' ``plans,'' ``expects,'' ``intends,'' and similar expressions are intended to identify forward- looking statements. Important factors that could cause actual results to differ materially from the expectations described in these forward- looking statements are set forth under the caption ``Certain Factors that May Affect Future Results'' in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2001 and incorporated herein by reference. These risk factors include risks as to the commercial success of ANGIOMAX; how long the Company will be able to operate on its existing capital resources; whether the Company's products (other than ANGIOMAX for its approved indication and including clevidipine without limitation) will advance in the clinical trials process, the timing of such clinical trials, whether the clinical trial results will warrant continued product development, whether and when, if at all, the Company's products will receive approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and for which indications, and, if such products receive approval, whether they will be successfully marketed; whether the Company will be able to develop or acquire additional products; the Company's history of net losses; and the Company's dependence on third parties, including manufacturers, suppliers and collaborators. We do not assume any obligation to update any forward-looking statements.
--------------------------------------------------------------------------------
Contact:
The Medicines Company
Peyton Marshall, 617/225-9099
Jill Sawdon, 617/225-9099 |
