Accumetrics, Inc. Forms Partnership With Grifols as Its Distributor in Spain, Portugal...

SAN DIEGO, Sept. 2 /PRNewswire/ -- Accumetrics, Inc. has announced the signing of a new exclusive distribution agreement for its VerifyNow(R) System in Spain, Portugal and Chile with Grifols S.A.. This distribution agreement will continue to expand Accumetrics' reach in both scope and geography, and add to the growing numbers of countries where physicians have access to the VerifyNow System. The VerifyNow System assesses response to life-saving antiplatelet therapies, such as aspirin, Plavix(R), Effient(R) and GP IIb/IIIa inhibitors. Patients respond to antiplatelet medications differently and these tests help physicians ensure their patients are receiving the optimal treatment. "We're extremely excited to see distribution of our VerifyNow System reach Spain, Portugal and Chile. We have chosen Grifols as our exclusive partner based on their demonstrated market development expertise as well as their existing customer base," said Timothy I. Still, President and CEO of Accumetrics. "This partnership continues to emphasize our focus on expanding our global distribution channels, and supports our vision to provide

physicians access to critical information for managing their cardiovascular patients on antiplatelet therapies." "We are pleased to join forces with Accumetrics in the distribution of the VerifyNow System in the Spanish, Portuguese and Chilean markets. This system perfectly complements Grifols' Hemostasis line of products and aligns with our marketing and sales strategy," added Ramon Riera, Vice President of Grifols S.A.
About Accumetrics (www.accumetrics.com) Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment. Accumetrics' VerifyNow System is the first rapid and easy to use platform for measuring an individual's response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient(R)) and clopidogrel (Plavix)), and the GP IIb/IIIa inhibitors (e.g. ReoPro(R) and Integrilin(R)), the VerifyNow System provides a valuable tool to help physicians make informed treatment decisions. The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of sanofi-aventis. Effient is a registered trademark of Lilly-Daiichi Sankyo.
About Grifols (www.grifols.com) Grifols is a Spanish-based holding company specializing in the pharmaceutical-hospital sector and is present in more than 90 countries. Since 2006, the company has been listed on the Spanish Continuous Market and forms part of the Ibex-35. Currently it is the first company in the European sector in plasma derivatives and the fourth in production worldwide. In upcoming years, the company will strengthen its leadership in the industry as a vertically integrated company, thanks to recent investments and those which will be carried out in 2008-2012, representing 400 million euros. In terms of raw materials, Grifols has ensured its plasma supply with 80 plasmapheresis centers in the United States and in terms of fractionation, its plants in Barcelona (Spain) and Los Angeles (United States) will allow the company to respond to the growing market demand. Nevertheless, the company is preparing for sustained growth in the following 8-10 years and has launched an ambitious investment plan. Grifols has created three divisions to offer specialized products and services grouped according to the distinctive needs they serve: Bioscience, Hospital and Diagnostics. Distribution of the VerifyNow System will complement its Diagnostics division as well as provide significant leverage to its Hospital Supply division.

Endoscopic ligation plus terlipressin prevents rebleeding of esophageal varices

NEW YORK (Reuters Health) - Combining the vasoconstrictor terlipressin with endoscopic variceal ligation reduces very early bleeding of esophageal varices significantly more than terlipressin alone, Taiwanese researchers report in the September issue of Gut.
"Acute esophageal variceal hemorrhage is a dreadful complication of portal hypertension," note Dr. Gin-Ho Lo and co-researchers at I-Shou University in Taipei. Even after treatment, "a high frequency of early rebleeding (30%-50%) may still be encountered in the first few days of acute hemostasis."
To see if dual therapy would lessen that risk, the research team studied 93 adult patients with cirrhosis who did not have active variceal bleeding at initial emergency endoscopy, comparing endoscopic variceal ligation plus two days of terlipressin infusion (intravenous infusion 1 mg every 6 hours for 48 hours) with five days of

terlipressin alone. Between February 2005 and January 2007, the study recruited patients from 18 to 75 years old, with 46 randomized to the terlipressin-only group and 47 assigned to the combination-therapy group.
Very early rebleeding (within 48 to 120 hours) was seen in seven patients in the terlipressin-only group, but in none of the patients who also received endoscopic variceal ligation (p = 0.006).
Treatment failure, defined as failure to control acute bleeding episodes or very early rebleeding or death within five days, occurred in 24% of the terlipressin-only group and only 2% of the combined-therapy group (p = 0.002). In addition, the need for transfusion was significantly lower in the terlipressin-plus-ligation group, as was the likelihood of needing intensive care.
Three patients died in the terlipressin group (two from variceal hemorrhage and aspiration pneumonia in one), and one patient in the combined group died of sepsis.
Nonetheless, the researchers noted that complication rates and 6-week survival were similar in both groups.
Although endoscopic therapy plus vasoconstrictors is the standard therapy for acute variceal hemorrhage, Dr. Lo told Reuters Health, there has been concern that the use of endoscopic therapy could increase adverse events.
An accompanying editorial by Drs. Francesco Salerno and Massimo Cazzaniga of the University of Milan, Italy, noted that the risk of death from shock, terminal liver failure, kidney failure, sepsis or multiorgan failure is "markedly increased by early rebleeding."
Both the report and the editorial noted that, considering the reasons for which patients were excluded from the study (such as hepatocellular carcinoma, age over 75 or taking beta-blockers), the results apply only to the specific subpopulation studied.
Gut 2009;58:1182-1183,1275-1280.

Safety of topical thrombins: the ongoing debate

Until recently, only bovine-derived thrombin was available for use as a stand-alone topical hemostat or as a component of other hemostatic devices. Concerns over a number of case reports of immune-mediated coagulopathies associated with the use of bovine-derived thrombin resulted in a United States Food and Drug Administration warning letter being issued in 1996 and the later addition of a boxed warning ("Black Box Warning") to all bovine-derived thrombin products.

Since 2007, both a human-pooled plasma thrombin product and a recombinant thrombin have entered the market.With the addition of these two products to the topical thrombin class, a unique situation has developed in which only a single member (bovine-derived thrombin) within the class carries the Food and Drug Administration's strongest cautionary language about possible adverse events related to an agent's use. Neither the human-pooled plasma thrombin nor the recombinant thrombin products have a boxed warning; although, the human-pooled plasma product does include a precaution/warning about infectious agent transmission - a warning common to products derived from human sources.

This report will address this unique situation and the impact, clinical and non-clinical, that thrombin choice may have. Since alternatives are now available, institutions may need to revisit their formulary choice of thrombin preparation, taking into consideration the potential risks associated with bovine-derived products.