Cardiome and AOP Orphan Pharma Enter ESMOCARD Commercialization Agreement

Cardiome Pharma Corp.

today announced that the company has entered a commercialization agreement with AOP Orphan Pharma ("AOP") to sell AOP's cardiovascular products, ESMOCARD® and ESMOCARD LYO® (esmolol hydrochloride) in Italy, France, Spain and Belgium. Financial details of the agreement were not disclosed. ESMOCARD is indicated for supraventricular tachycardia (except for pre-excitation syndromes) and for the rapid control of the ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other circumstances where short-term control of the ventricular rate with a short-acting agent is desirable. ESMOCARD is also indicated for tachycardia and hypertension occurring in the perioperative phase and non-compensatory sinus tachycardia where, in the physician's judgement the rapid heart rate requires specific intervention. ESMOCARD is not intended for use in chronic settings. ESMOCARD is available in two presentations including a 10mg/ml 10ml solution for injection (branded as ESMOCARD) and a 2500mg powder for concentrate for solution for infusion (branded as ESMOCARD LYO). Data from the Marshfield Epidemiologic Study Area (Wisconsin, U.S.A) suggested that the incidence of paroxysmal supraventricular tachycardia is 35 per 100,000 person years and the estimated prevalence is 2.25 per 1000.1 In the European Union, the prevalence of atrial fibrillation in adults >55 years of age was estimated to be 8.8 million in 2010 and was projected to rise to 17.9 million by 2060.2 "We are pleased to extend our relationship with AOP by adding their ESMOCARD franchise to our offering of cardiovascular products in Italy, France, Spain and Belgium," said William Hunter, M.D., President and CEO of Cardiome. "Commercializing ESMOCARD is highly synergistic with BRINAVESS and AGGRASTAT in terms of our target customer that potentially creates a highly efficient detail for our sales force. Furthermore, we believe that by increasing the product's share of voice, we can remind physicians of the value of this important drug while offering them convenient dosing options, especially with ESMOCARD LYO. " "We are excited to develop our partnership with Cardiome to expand the reach of ESMOCARD across Western Europe," said Rudolf Widmann, AOP's CEO and Chairman. "ESMOCARD has been a great success for us in Austria and other Eastern European countries and we believe Cardiome has the expertise and capability to duplicate this success. Furthermore, early clinical research in the use of beta-blockers, such as esmolol, for the management of septic patients remaining tachycardic after 24 hour resuscitation bundle suggests an overall beneficial effect by decreasing heart rate and other positive hemodynamic responses. Additional clinical studies are needed, but if the early beneficial findings are replicated, this could lead to substantial new and exciting growth opportunities for this drug." Sepsis is defined as the presence of infection together with systemic manifestations of infection.3 Severe sepsis is defined as sepsis plus sepsis-induced organ dysfunction or tissue hypoperfusion.3 The incidence of severe sepsis in the EU has been estimated at 90.4 cases per 100,000 population (est. incidence of ~450,000 based on a population of 503M5) and has a mortality rate of around 35%.4 The incidence of sepsis is likely to be rising.4 The cost of treating sepsis is substantial with estimates ranging from US $25,000 to $50,000 per episode.6 References: Orejarena LA et al. Paroxysmal supraventricular tachycardia in the general population. J Am Coll Cardiol 1998;31:150-7. Krijthe BP et al. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J. 2013;34:2746–2751. Dellinger RP et al. Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2012. Crit Care Med. 2013;(41):580-637. http://bestpractice.bmj.com/best-practice/monograph/245/basics/epidemiology.html, accessed May 6, 2015. http://europa.eu/about-eu/facts-figures/living/index_en.htm, accessed May 6, 2015. Martin G. Sepsis, severe sepsis and septic shock: changes in incidence, pathogens and outcomes. Expert Rev Anti Infect Ther. 2012;10:701-706.