Press Releases

EKR Therapeutics Receives Two Additional Patents for Ready-to-Use Cardene® I.V. Bags, Providing Substantial Intellectual Property Protection Through 2027

Bedminster, N.J., February 16, 2010 – EKR Therapeutics, Inc., a specialty pharmaceutical company focused on commercializing acute-care hospital products, today announced that the US Patent and Trademark Office has issued two new patents covering methods of treatment and methods of preparation for the Company’s Ready-to-Use (RTU) Cardene® I.V. (nicardipine hydrochloride) Premixed Injection.

Previously, EKR was granted patent protection covering pharmaceutical formulations of its RTU Cardene I.V. bags, a specialty product line currently marketed in four different preparations for treating acute hypertension in emergency and critical-care settings.  All three patents – formulation, method of treatment, and method of preparation - are effective through 2027 and, collectively, provide broad patent protection against generic or other similar formulations of EKR’s RTU Cardene I.V.

“The active ingredient in Cardene is the antihypertensive agent nicardipine hydrochloride,” said Howard Weisman, EKR’s CEO & President.  “We have pursued and have now successfully secured exceptionally strong intellectual property protection to this key antihypertensive in the ready to use dosage form.  These two new patents coupled with our previously issued formulation patent create significant barriers to generic entry and will enable EKR to continue to expand its Cardene franchise well into the future.”  

EKR noted that it has already filed the previously issued formulation patent for RTU Cardene I.V. with the U.S. Food and Drug Administration (FDA) for publication in the agency’s Orange Book.  The now approved method of treatment patent is also eligible for listing in the Orange Book and EKR will immediately proceed with the necessary filing.  Listing in the FDA Orange Book provides additional protection under Hatch Waxman relative to EKR’s intellectual property rights and proprietary ownership of RTU Cardene I.V.  The Company has also filed for intellectual property protection for RTU Cardene I.V. in other countries.

About Ready-to-Use Cardene® I.V.
Cardene® I.V. (nicardipine hydrochloride) is a calcium ion influx inhibitor indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable.  Formerly supplied only in ampules, Cardene I.V. is now available in patented Ready-to-Use (RTU) preparations consisting of single (0.1 mg/mL) and double (0.2 mg/mL) concentrations of nicardipine in either dextrose or saline premixed in 200 ml intravenous bags.  

Ready-to-Use Cardene I.V. Premixed Injection provides significant practical advantages for hospitals, 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 Pharmacists² 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.
 
Close monitoring of the blood pressure is required during therapy. Cardene I.V. is contraindicated in patients with known hypersensitivity to the drug and in patients with advanced aortic stenosis. Reduction of diastolic pressure and reduced afterload may worsen rather than improve myocardial oxygen balance. Caution is advised when administering Cardene I.V. to patients with impaired renal or hepatic function, in combination with a beta-blocker in patients with congestive heart failure, or portal hypertension. Observe caution in patients with significant left ventricular dysfunction due to possible negative inotropic effect. Cardene I.V. gives no protection against the dangers of abrupt beta-blocker withdrawal; beta-blocker dosage should be gradually reduced. Levels of cyclosporine should be closely monitored during therapy. The most common side effects of Cardene I.V. are headache (14.6%), hypotension (5.6%), nausea/vomiting (4.9%), and tachycardia (3.5%). Less frequent adverse effects, in each case occurring at 1.4%, include ECG abnormalities, postural hypotension, ventricular extrasystoles, injection-site reaction, dizziness, sweating and polyuria.

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.

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

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

3. 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.

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Contact for EKR Therapeutics
Stuart Z. Levine, Ph.D.
Director, Strategic Communications
877-435-2524
s.levine@ekrtx.com