Healthcare Industry News:  PDL BioPharma 

Biopharmaceuticals FDA

 News Release - August 1, 2008

EKR Therapeutics Receives Approval for Ready-to-Use Intravenous Bags of Cardene(R) I.V.

EKR is Introducing New Products Immediately

BEDMINSTER, N.J.--(HSMN NewsFeed)--EKR Therapeutics, Inc., a specialty pharmaceutical company focused on providing novel products for the acute-care hospital setting, today announced that it received approval from the U.S. Food and Drug Administration for Cardene® I.V. (nicardipine hydrochloride) premixed injection, a patented, ready-to-use (RTU), single use intravenous bag for the administration of this calcium channel blocker. The 200 ml RTU bags contain 20 mg of the anti-hypertensive agent nicardipine hydrochloride (0.1 mg/ml) in either dextrose or sodium chloride.

EKR further noted that it will start taking orders immediately for the new RTU bags of Cardene I.V.

The RTU formulations significantly expand the Cardene franchise which has primarily consisted of sales of ampoules of Cardene I.V. “Market acceptance and growth in utilization of Cardene have been strong in the past several years,” noted Howard Weisman, EKR’s Chairman & CEO. Based on data on file at EKR, over 900,000 patients have been treated with Cardene I.V. since 2003.

“We expect the convenience and readiness of the intravenous bags to significantly complement and build upon the market success of the ampoules,” said Weisman. “With the addition of the ready-to-use bags, the breadth of our Cardene product offerings has expanded greatly and we foresee opportunities for wider utilization of this anti-hypertensive across a range of acute-care settings.”

Weisman concluded by noting, “This is a particularly exciting event for EKR, because many of us were part of the original team at ESP Pharma that identified, acquired, and relaunched Cardene I.V. on what has since proved to be a road of successful growth.” Weisman cofounded ESP Pharma in 2002 and that company was acquired by PDL BioPharma (NASDAQ:PDLI ), along with Cardene I.V., in 2005. The EKR team re-acquired the product line in early 2008.

About EKR Therapeutics

EKR Therapeutics is a privately held specialty pharmaceutical company that has brought together a highly seasoned team of industry professionals. The Company focuses on the acquisition, development and commercialization of proprietary products to enhance patient quality-of-life in the acute setting, including cardiovascular, pain management and oncology supportive care medications. From its inception in late 2005, 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. EKR’s goal is to be the pre-eminent provider of specialty acute-care products, backed by a commitment to excellence in customer service and medical education programs. The Company’s growing portfolio of specialty acute-care products includes Cardene® IV (nicardipine hydrochloride), Cardene SR®, Retavase® (reteplase recombinant), DepoDur® (morphine sulfate extended-release liposomal injection) and Gelclair® (bioadherent oral gel). For additional information about EKR visit the Company’s website at www.ekrtx.com.


Source: EKR Therapeutics

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