Key Developments: The Medicines Co (MDCO.O)
35.76USD
17 May 2013
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Latest Key Developments (Source: Significant Developments)
Medicines Co Reaffirms FY 2013 Revenue Guidance-Conference Call
Medicines Co announced that for fiscal 2013, it expects year on year net revenue growth of 20% to 22%. The Company reported revenues of $559 million in fiscal 2012. According to I/B/E/S Estimates, analysts are expecting the Company to report revenues of $680 million for fiscal 2013. Full Article
Medicines Co's Intravenous Cangrelor Demonstrates 22% Reduction in Ischemic Events Compared to Oral Clopidogrel
Medicines Co announced results of CHAMPION PHOENIX, a 11,145 patient Phase 3 randomized, double-blind clinical trial comparing the Company's intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing percutaneous coronary intervention (PCI). Patients treated with cangrelor had a 22% (p=0.005) reduced odds of experiencing the primary endpoint, which was a composite incidence of death, myocardial infarction (MI), ischemia-driven revascularization (IDR) or stent thrombosis (ST) at 48 hours after randomization. Cangrelor also showed a 38% reduction in the odds of the key secondary endpoint, incidence of stent thrombosis at 48 hours. The findings were consistent across all analyzed subgroups of patients, including age, geography, diagnosis at presentation, and the choice of periprocedural anticoagulant. At 30 days, the rate of the composite primary efficacy end point remained significantly lower in the cangrelor group than in the clopidogrel group and the relative reduction in stent thrombosis also persisted. The primary safety end point was non-CABG-related severe bleeding, according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria, at 48 hours. Several other bleeding definitions were also applied. More sensitive measures did show an increase in bleeding with cangrelor, though there was no significant difference in the rate of transfusions. Full Article
Medicines Co Issues FY 2013 Revenue Guidance In Line With Analsyts'' Estimates-Conference Call
Medicines Co announced that for fiscal 2013, it expects year on year net revenue growth of 20% to 22%. The Company reported revenues of $559 million in fiscal 2012. According to I/B/E/S Estimates, analysts are expecting the Company to report revenues of $675 million for fiscal 2013. Full Article
Medicines Co and Alnylam Pharmaceuticals Inc Form Strategic Alliance To Develop and Commercialize RNAi Therapeutics Targeting PCSK9 For Treatment Of Hypercholesterolemia
Medicines Co and Alnylam Pharmaceuticals Inc announced that they have formed an exclusive global alliance for the development and commercialization of Alnylam's ALN-PCS RNAi therapeutic program for the treatment of hypercholesterolemia. Under this alliance, Medicines Co and Alnylam intend to collaborate on the advancement of the ALN-PCS program. Alnylam's ALN-PCS program includes ALN-PCS02, an intravenously administered RNAi therapeutic which has completed a Phase I trial, and ALN-PCSsc, a subcutaneously administered RNAi therapeutic currently in pre-clinical development. Alnylam will continue the program for an estimated one to two years to complete certain pre-clinical and Phase I clinical studies. Medicines Co is responsible for leading and funding development from Phase II forward and commercializing the ALN-PCS program. Under the terms of the agreement, Medicines Co will make an upfront cash payment of $25 million to Alnylam. Alnylam may also receive potential development and commercial milestone payments of up to $180 million. Alnylam will be eligible to receive scaled double-digit royalties on global products sales of ALN-PCS products. Alnylam has completed a Phase I trial of ALN-PCS02 in healthy volunteer subjects with elevated baseline LDL-C. Full Article
Medicines Co Announces Positive Results In Phase 3 Trial Of Cangrelor In Treatment Of Patients Undergoing PCI
Medicines Co announced results for its pivotal Phase 3 clinical trial of cangrelor, which is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing percutaneous coronary intervention (PCI). Following the recommendation of the trial's Data Safety Monitoring Board (DSMB) in July 2012 to continue the protocol as planned, the CHAMPION PHOENIX trial completed enrollment in October 2012. After data lock, the data analysis revealed that the protocol defined primary composite efficacy endpoint of death, myocardial infarction, ischemia driven revascularization and stent thrombosis at 48 hours was met. Cangrelor demonstrated statistically improvement as compared to clopidogrel. Safety outcomes were similar to those observed in prior trials. The trial results are planned to be presented at a upcoming scientific meeting. Full Article
Medicines Co Completes Acquisition Of Incline Therapeutics Inc
Medicines Co announced that it has completed its acquisition of Incline Therapeutics Inc a company focused on the development of IONSYS (fentanyl iontophoretic transdermal system), a compact, disposable, needleless Patient-Controlled Analgesia (PCA) system in development for the short-term management of acute postoperative pain in the hospital setting. Incline has become a wholly owned subsidiary of The Medicines Company. Full Article
Medicines Co Announces Positive Trial Results for Oritavancin
Medicines Co announced the results for its SOLO-1 Phase 3 clinical trial of oritavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). All protocol-specified primary and secondary efficacy endpoints of the SOLO-1 trial were met. Oritavancin was shown to be non-inferior to vancomycin in the efficacy analyses for the early clinical evaluation (48-72 hour) endpoints required by the U.S. Food and Drug Administration (FDA) and the later (7-14 days after end of treatment) endpoint required by the European Medicines Agency (EMA). The efficacy was similar in the overall population and in those patients with microbiologically confirmed MRSA infections. Full Article
Medicines Co Agrees To Acquire Incline Therapeutics, Inc.
Medicines Co announced that it has entered into an agreement to acquire Incline Therapeutics, Inc., a company focused on the development of IONSYS (fentanyl iontophoretic transdermal system), a compact, disposable, needleless Patient-Controlled Analgesia (PCA) system in development for the short-term management of acute postoperative pain in the hospital setting. The Medicines Company has agreed to pay Incline $185 million in an upfront payment with additional payments if certain regulatory and commercial milestones are met. The Boards of Directors of both companies have unanimously approved the agreement. Subject to obtaining requisite consents and approvals and the satisfaction or waiver of certain conditions, including, without limitation, the approval of the agreement by Incline's stockholders and the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, the acquisition is expected to close in the first quarter of 2013. BofA Merrill Lynch served as exclusive financial advisor and WilmerHale served as legal advisor for the transaction for The Medicines Company. Incline's exclusive financial advisor for the transaction was Leerink Swann LLC, while Cooley LLP served as its legal advisor. Full Article
Medicines Co And Bristol-Myers Squibb Agree To Global Alliance for Recothrom
Medicines Co and Bristol-Myers Squibb Company announced that the companies have signed a global license and two year collaboration for Recothrom, a recombinant thrombin approved by the U.S. Food and Drug Administration for use as a topical hemostat to control non-arterial bleeding during surgical procedures. The transaction is expected to be accretive to earnings per share (EPS) for The Medicines Company in 2013. Under terms of the agreement, The Medicines Company will pay Bristol-Myers Squibb an upfront collaboration payment of $105 million and an upfront option fee of $10 million. The Medicines Company has also agreed to pay Bristol-Myers Squibb a tiered royalty on annual net revenues of Recothrom during the two-year collaboration term. Bristol-Myers Squibb will retain responsibility for the manufacturing of Recothrom and will be The Medicine Company's exclusive supplier of Recothrom during the term of the agreement. The option enables The Medicines Company to acquire the Recothrom assets for a purchase price based on average net sales during the two-year collaboration term. The transaction is expected to be minimally accretive to EPS for Bristol-Myers Squibb in 2013 and 2014. Full Article
Medicines Co's Emergency Hypertensive Acute Heart Failure Study PRONTO Demonstrates Clevidipine Superior To Standard of Care
Medicines Co announced the presentation of PRONTO, a study of emergency patients with acute heart failure associated with high blood pressure enrolled within hours of their hospital arrival, making it the earliest examination of acute heart failure treatment ever performed in a clinical trial. The primary objective and the main secondary objective of the PRONTO clinical trial were met. Patients randomized to early treatment with Cleviprex (clevidipine) Injectable Emulsion demonstrated more rapid and greater blood pressure reductions (p-value < 0.001). Patients reported that shortness of breath, their most distressing symptom, resolved more rapidly than with the current standard of care (SOC) (overall p-value 0.037). Safety measures were similar for both randomized treatments. PRONTO Study Methods, Results and Limitations A randomized open-label, multi-center trial, PRONTO (A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure -- A Pilot Study), enrolled 104 emergency department hypertensive acute heart failure patients who exhibited pulmonary congestion. After setting a 30-minute target systolic blood pressure (SBP) range, patients were randomly treated with clevidipine or SOC (predominantly nitroglycerin and nicardipine), each administered per approved labeling. Full Article
Medicines Co's Cangrelor clearly tops Plavix in pivotal trial
* Cangrelor reduced serious heart risk by 22 pct vs Plavix * Reduces clots in heart stents by 38 percent * Serious bleeding very low for both drugs By Bill Berkrot SAN FRANCISCO, March 10, - The Medicines Co's experimental intravenous blood clot preventer Cangrelor, which is intended for use during angioplasty procedures, solidly outperformed commonly used Plavix in a pivotal late stage study, likely resurrecting the drug's prospects. The aptly named Champion-Phoe
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