Key Developments For The Medicines Co
The Medicines Co (MDCO.O) (Nasdaq)
The Medicines Company Announces Cleviprex Results Reported From Study In Patients With Intracerebral Hemorrhage
The Medicines Company announced the first reported interim data from the Evaluation of patients with acute hypertension and intracerebral hemorrhage with intravenous clevidipine treatment (ACCELERATE) trial were presented at the Neurocritical Care Society (NCS) 2009 Annual Meeting, showing that Cleviprex (clevidipine butyrate) effectively and safely reduces blood pressure in patients with acute, non traumatic intracerebral hemorrhage (ICH). In ACCELERATE: Reduction to target blood pressure was achieved in 100% of patients within 30 minutes; 97% of patients reached target with Cleviprex monotherapy; Median time to target blood pressure was 6.5 minutes; There were no instances of hypotension and no need for supplemental therapy to raise blood pressure in the initial 30 minute period of Cleviprex therapy.
The Medicines Company Lowers FY 2009 Guidance
The Medicines Company has changed its guidance for fiscal 2009. The Company now expects net sales to be in the range of $395-$405 million, compared to prior range of $430-$455 million, GAAP net income in the range of ($13)-($10) million, non-GAAP net income in the range of $8-$13 million GAAP EPS to be in the range of ($0.25)-($0.19) and non-GAAP earnings per share (EPS) to be in the range of $0.14-$0.24. The Company's prior guidance for fiscal 2009 is, GAAP net income to in the range of $13 - $18 million, non-GAAP net income in the range of $47-$59 million, GAAP EPS in the range of $0.24 - $0.34 and non-GAAP EPS in the range of $0.88-$1.10. The guidance includes the Targanta acquisition impact. According to Reuters Estimates, analysts are expecting the Company to report revenues of $407 million for fiscal 2009.
The Medicines Company Announces Positive CHMP Opinion For Angiox (Bivalirudin) For Use In Heart Attack Patients Undergoing Emergency Heart Procedures
The Medicines Company announced that the Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion applicable to all Member States of the European Union/European Economic Area that will extend the use of Angiox (bivalirudin) to include patients with heart attacks (so-called ST segment elevation myocardial infarction (STEMI)) undergoing emergency heart procedures called primary percutaneous coronary intervention (PCI). The trial showed that patients treated with Angiox compared with today's treatment - heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) - were more likely to survive and had less frequent severe bleeds. The HORIZONS-AMI trial compared Angiox to heparin plus a GPI in 3,602 patients (57% of whom were recruited in Europe) presenting with severe form of heart attack, known as STEMI, undergoing a emergency (primary) PCI. Results at 30 days showed that Angiox: - Significantly improved overall mortality including a reduction in the incidence of heart-related deaths by 38% (1.8% vs. 2.9%, p=0.03) - Significantly reduced the incidence of major bleeding by 42%(5.1% vs. 8.8%, p< 0.0001). - Significantly reduced the incidence of net adverse clinical events, a composite of major adverse cardiac events or major bleeding, by 26% (9.3% vs. 12.7%, p = 0.0015). - Demonstrated comparable rates of major adverse cardiac events (5.4% vs. 5.5%, p = 0.8901).
The Medicines Company Files Patent Infringement Lawsuits
The Medicines Company announced that it has filed lawsuits against Teva Parenteral Medicines, Inc., Pliva Hrvatska d.o.o. and APP Pharmaceuticals, LLC, and related entities in the United States District Court for the District of Delaware alleging patent infringement based on Abbreviated New Drug Applications seeking U.S. Food and Drug Administration approval to market and sell generic versions of The Medicines Company's Angiomax product prior to expiration of U.S. Patent No. 7,582,727 (the '727 patent). Each lawsuit alleges infringement of the '727 patent. As previously announced, the '727 patent was issued to The Medicines Company on September 1, 2009.
The Medicines Company Announces Second New Patent Issuance For Angiomax
The Medicines Company announced that the United States Patent and Trademark Office (PTO) issued a new United States patent No. 7,598,343 ('343 patent). The '343 patent relates to a more consistent and improved Angiomax drug product made by processes described in the patent. The new patent has been listed in the United States Food and Drug Administration's publication "Approved Drug Products with Therapeutic Equivalence Evaluations," which is commonly known as the Orange Book, for Angiomax.
