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October 28, 2009 EKR Therapeutics Receives Notice of Patent Allowance for Ready-to-Use Cardene ®I.V. Bags, a Specialty Product Line for Treating Acute Hypertension in Emergency and Critical-Care Settings

Bedminster, N.J., Oct 28, 2009  Once issued, the patent will cover pharmaceutical formulations of RTU Cardene I.V. through 2027. Additionally, upon issuance of the patent, EKR will file the patent with the U.S. Food and Drug Administration (FDA) for publication in the agency’s Orange Book which will provide additional protection relative to EKR’s intellectual property rights and proprietary ownership of RTU Cardene I.V.

EKR noted that Ready-to-Use Cardene I.V. provides significant practical advantages for its hospital customers, including the convenience of point-of-use access in patient care areas, storage in automated dispensing cabinets, and extended product stability.

In addition to supporting The Joint Commission1 standards and American Society of Health-System Pharmacists 2 guideline for dispensing medication in the most ready to administer form, RTU Cardene I.V. facilitates rapid intervention in emergency settings, eliminates point-of-care medication admixture errors, and is well suited to meet a hospital’s after-pharmacy-hours medication needs3. “Furthermore, RTU Cardene I.V. combines all the advantages of a highly convenient delivery platform with Cardene’s established legacy of managing acute hypertension for over 15 years,” said Howard Weisman, EKR’s President and CEO.

Prior to the launch of the RTU formulations, Cardene IV was available only in a glass ampul which required manual admixture and needed to be discarded after 24 hours. “Market traction for the new Ready-to-Use Cardene I.V. bags has been extraordinary,” noted Weisman. “It is just about a year since we began to actively market these premixed bags and they already account for well over 60% of all Cardene I.V. units sold.”

About Cardene I.V.

Formulated with the anti-hypertensive agent nicardipine hydrochloride and originally approved by FDA in 1992, Cardene® I.V. is a calcium ion influx inhibitor indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. In July and November 2008, FDA approved, respectively, single (0.1 mg/mL) and double (0.2 mg/mL) concentrations of the RTU Cardene I.V. Premixed Injection in dextrose and sodium chloride solutions. Administered intravenously, Cardene I.V. reduces the influx of calcium ions into cardiac and vascular smooth muscle cells through specific ion channels in the cell membrane. The drug, which is more selective for vascular smooth muscle cells, causes arterioles to dilate thereby lowering blood pressure.

In clinical trials, adverse events of Cardene I.V. were generally not serious, and most were expected consequences of vasodilation. Cardene I.V. is arteriolar specific and is not associated with atrial fibrillation. Cardene I.V. is also not associated with rebound hypertension and has no adverse effect on lipid levels. Most common side effects of Cardene I.V. therapy are headache (14.6%), hypotension (5.6%), nausea/vomiting (4.9%), and tachycardia (3.5%). Cardene I.V. is contraindicated in patients with known hypersensitivity to the drug and in patients with advanced aortic stenosis. Close monitoring of the blood pressure is required during therapy. Full prescribing, safety, and additional information on Cardene I.V. is available at www.cardeneiv.com

About EKR Therapeutics

EKR Therapeutics is a specialty pharmaceutical company focused on acquiring, developing and maximizing the potential utility of critical-care hospital products offering broader therapeutic options and greater control to improve in-patient care, speed recovery, and achieve optimal outcomes. Backed by the strength of its award winning management team, the dedication of its field force of product specialists and its commitment to excellence in customer service and medical education, EKR has been organized to be a class leader in commercializing products to address unmet and under-satisfied medical needs or to otherwise enhance the therapeutic value of acute-care products. For additional information about EKR visit the Company’s website at www.ekrtx.com.



Rich DS. New JCAHO medication management standards for 2004. Am J Health-Syst Pharm. 2004; 61(13):1349-1458.



American Society of Health-System Pharmacists. ASHP guidelines: minimum standard for pharmacies in hospitals. Am J Health-Syst Pharm. 1995; 52:2711–7.



Fanikos J, Erickson A, Munz KE, et al. Observations on the use of ready-to-use and point-of-care activated parenteral products in automated dispensing cabinets in U.S. hospitals. Am J Health-Syst Pharm. 2007; 64(19):2037-2043.

EKR Therapeutics
Stuart Z. Levine, Ph.D., 877-435-2524
Director, Corp. Communications
Investor Relations

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