Fitting its corporate aim, The Medicines Company is taking over development of clevidipine from AstraZeneca plc.
The Boston-based company entered into the agreement with AstraZeneca for the licensing, development and commercialization of clevidipine, an intravenous, short-acting calcium channel blocker.
The Medicines Company will carry out Phase III testing for the short-term control of high blood pressure in the hospital setting. The company said the product’s pharmacological and clinical attributes make it a viable candidate for testing in malignant hypertension, 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.
“We plan to get one study under way this year,” The Medicines Company Chief Financial Officer Peyton Marshall said. “A million dollars would be triggered by a development event, and the other $5 million would be triggered by regulatory events,” payable to AstraZeneca, which also would receive royalties on sales.
Specific financial terms were not disclosed, though The Medicines Company gains worldwide commercialization rights, except in Japan. It is responsible for further clinical development.
London-based AstraZeneca already completed clinical pharmacology, dose-finding and efficacy studies that demonstrated that clevidipine has a short duration of action, a short plasma half-life, and a selective effect on blood pressure. But it does not necessarily make strategic sense for AstraZeneca to continue development of the product, Marshall said.
“By large pharma standards, this is potentially a modest-sized product,” Marshall said. “Having developed it this far, they’d like to see something come back to them commercially. We’re already selling an acute-care product in hospitals, and we think the natural place to take this product will overlap very strongly with where our existing acute-care sales force is already.”
The company expects Angiomax, which received FDA approval in December 2000 for use as an anticoagulant in combination with aspirin in patients with unstable angina undergoing coronary balloon angioplasty, to be the cornerstone product of a planned acute hospital franchise.
The Medicines Company was founded in 1996 to acquire, develop and commercialize late-stage and approved pharmaceutical products.
The company’s stock (NASDAQ:MDCO) rose 52 cents Thursday to close at $12.35.