Development Programs
The Medicines Company is conducting several development programs with planned and executed clinical trials.
The Medicines Company believes Angiomax will become the leading replacement for heparin in acute cardiovascular care. Heparin, an indirect thrombin inhibitor and commonly used anticoagulant, was discovered almost 100 years ago. Across studies in angioplasty, Angiomax has been shown to be better than heparin in preventing bleeding and ischemic complications such as heart attack, which are associated with angioplasty procedures.
Definition of terms:
- PCI: percutaneous coronary intervention is a general term used to describe non-surgical revascularization procedures of the coronary arteries.
- HITTS: heparin-induced thrombocytopenia and thrombosis syndrome (an allergic-like reaction to heparin)
- ACS: acute coronary syndromes, such as heart attack
- CABG: coronary artery bypass graft surgery (commonly called bypass or "open-heart" surgery)
- Neonates: prematurely born babies with active thrombosis (clotting)
Angiomax is an anticoagulant currently approved in the United States and other countries for use in patients undergoing coronary angioplasty procedures. The Medicines Company is conducting several clinical trials to study potential additional indications and to establish a clearer clinical basis for Angiomax use.
Background information on Angiomax...
 Cleviprex is the latest-generation IV dihydropyridine calcium channel blocker. The first-cycle U.S. approval of Cleviprex was based on six Phase III trials involving 1,406 patients medical and surgical patients treated with Cleviprex. All Phase III trials met all of their primary endpoints. Cleviprex may produce systemic hypotension and reflex tachycardia. The most common adverse reactions (>2%) seen with Cleviprex are headache, nausea and vomiting.
Please see full prescribing information available at
Cangrelor is a short-acting injectable platelet inhibitor agent that prevents the aggregation of platelets in the clotting process. The Medicines Company believes that cangrelor may fit into its hospital acute care product portfolio because of potential uses in the cardiac catheterization laboratory and the operating room. Cangrelor is an investigational agent not yet approved by the FDA.
Cangrelor acts directly on the P2Y12 platelet receptor, a clinically validated target to treat or prevent arterial thrombosis by acting on a specific, well studied, enzyme pathway known as ADP. There is currently no short-acting, intravenous P2Y12 antagonist approved for acute patient care. In the cardiac catheterization laboratory, the use of platelet inhibitors that block activation is considered important therapy because of several studies of oral platelet inhibitors that have demonstrated better patient outcomes when these agents are administered before coronary angioplasty.
CU2010 is an investigational antifibrinolytic agent designed to limit blood loss during surgery.
Our clinical program for CU2010 is being run out of our Leipzig, Germany office. After acquiring the product from Curacyte Discovery GmbH in August of 2008, we designed a development plan to begin in 2009 which includes Phase I studies.
Toxicology, pharmacokinetic and efficacy studies in animals have been completed. In preclinical studies, CU2010 has demonstrated a pharmacokinetic profile in the surgical setting with a rapid onset and offset of effect, due to its short half life.
Oritavancin is an innovative, investigational hospital-based antibiotic with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria including staphylococcal strains with resistance to methicillin (MRSA) and vancomycin. The safety and efficacy has not been established by the FDA for any use; however, further clinical studies are expected to commence in 2009 to evaluate oritavancin.
We believe that oritavancin can become an important anti-infective for serious infections involving difficult-to-treat bacteria in difficult-to-treat hospitalized patients. Many of those critically ill patients are the same patients treated with our existing products. This synergy makes oritavancin a natural fit with our strategy and focus on critical care medicine.
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