Aminocaproic Acid

VistaPharm, Glemark Pharmaceuticals, Teva and Apotex all issued voluntary recalls posted on the FDA website. The FDA posted a flurry of voluntary drug recalls by drug manufacturers on its website. Below are the companies and products being recalled. VistaPharm issued its Class III recall Oct. 17 for more than 2,300 bottles of aminocaproic acid oral solution that is used to treat serious bleeding conditions, especially when the bleeding occurs after dental surgery or other kinds of surgery. The company cited failed specifications for the action, specifically, a high content of ethylene glycol. Where the product was manufactured was not provided. The bottles were distributed nationwide in the U.S. Class III recalls involve products that violate federal regulations but are unlikely to cause adverse health consequences. Aptotex issued four separate Class II recalls Nov. 1 for more than 149,000 bottles distributed nationwide in the U.S. of prescription-only paroxetine hydrochloride tablets that are used to treat a variety of conditions, including depression, obsessive-compulsive disorder and panic disorder. The company cited failed impurities and/or degradation, out-of-specification results. The products were manufactured at the company’s Toronto production site. A Class II recall is issued with a product has a lower chance of causing major injuries or death, but it is still possible for serious enough adverse events to have irreversible consequences. Glenmark Pharmaceuticals issued two separate Class II recalls for products due to a mislabeling issue involving Indomethacin and Naproxen. The recalls for both were issued Nov. 7. The company recalled 37,200 bottles of Indomethacin, which is a non-steroidal anti-inflammatory used to treat pain and arthritis symptoms. It recalled five lots (no bottle count provided) of Naproxen that is used to reduce fever or relieve mild pain due to headaches and muscle aches and other minor maladies. Both products may have been mislabeled as the other, the company said. The drugs were manufactured at both the Glenmark facility in Goa, India, and the company’s New Jersey facility. Teva issued a Class III recall for one lot of 30 unit-dose packets per carton of testosterone gel due to out-of-specification issues related to viscosity. The product, which was produced at the Teva facility in North Wales, Pennsylvania, is used to treat hypogonadism in men. The recall was issued Nov. 10 for the lot that was distributed nationwide in the U.S.

SEATTLE, Feb. 10, 2011 /PRNewswire via COMTEX/ -- Omeros Corporation (Nasdaq: OMER) today announced that research on the antifibrinolytic agents it is developing has been published in the February 11, 2011 issue of the Journal of Biological Chemistry and selected by the editors as one of the top one percent of papers reviewed by the Journal in terms of significance and overall importance. This work from the laboratory of S. Paul Bajaj, Ph.D., demonstrates that unique antifibrinolytic agents can be derived from tissue factor pathway inhibitor-2 (TFPI-2). Omeros recently announced that it holds an exclusive license to these agents. The authors of this paper exploited structural differences between the fibrinolytic enzyme plasmin and enzymes of the coagulation cascade to design a plasmin-selective inhibitor to replace Trasylol(R), which was withdrawn from the market in 2008. Because plasmin degrades fibrin clots, a drug that inhibits plasmin may have potential utility for reducing blood loss due to trauma or surgery. Prior to withdrawal from the market for safety concerns, Trasylol(R) had been shown in a number of studies to be more effective at reducing blood loss than the other two most commonly used antifibrinolytic agents on the market today, tranexamic acid and epsilon aminocaproic acid. While Trasylol(R) is a potent inhibitor of plasmin, it is non-selective. In addition to plasmin, it significantly inhibits kallikrein and Factor XIa, two enzymes important in promoting clotting, and their inhibition can increase bleeding. Trasylol(R) was found to be associated with a number of safety issues, including increased mortality. Further, it is a bovine protein associated with anaphylactic reactions. While the specific cause of increased death remains unknown, an often-cited explanation is the lack of specificity of Trasylol(R). A single domain of TFPI-2, referred to as KD1, inhibits plasmin but, like Trasylol(R), also inhibits kallikrein and Factor XIa. Dr. Bajaj and her colleagues demonstrate that a minimal change to the sequence of the KD1 protein increases its activity against plasmin approximately 6-fold while dramatically reducing its inhibition of kallikrein and Factor XIa by more than 100-fold. Because the variant KD1 proteins developed by the authors and exclusively licensed to Omeros are more selective than Trasylol(R), they could provide more effective bleeding control with fewer side effects. Additionally, as a human protein derivative, these agents are expected to reduce the potential for immunological side effects. The paper shows the variant KD1 reduced blood loss in a rodent model of surgical bleeding by 85 percent relative to saline treatment, demonstrating an antifibrinolytic effect at least equal to Trasylol(R). Similar antifibrinolytic activity of a related variant KD1 also controlled by Omeros was confirmed by other researchers using human plasma evaluated by thromboelastography. Thromboelastograms are used clinically to assess the level of fibrinolysis in patients during surgical procedures at risk for extensive blood loss. Importantly, the authors also found that the variant KD1 does not slow blood clotting as measured by the partial thromboplastin time (aPTT), a standard indicator of blood's ability to coagulate. Conversely, Trasylol(R) increased aPTT by 60 percent, which could significantly prolong bleeding in trauma and surgical patients. Omeros believes the efficacy and improved selectivity of the variant KD1 provides a novel approach to the control of bleeding from surgery and trauma. Omeros has initiated scale-up activities of its lead antifibrinolytic compound in preparation for clinical trials. About Omeros' Antifibrinolytic Program Omeros is developing a series of novel antifibrinolytic agents for the control of blood loss during surgery or resulting from trauma. Omeros' agents are designed to selectively inhibit plasmin, the enzyme responsible for fibrinolysis and dissolving blood clots, while avoiding significant inhibition of kallikrein and Factor XIa, important enzymes in the coagulation cascade. These agents could provide a superior replacement for the antifibrinolytic agents Trasylol(R) (aprotinin), tranexamic acid and epsilon aminocaproic acid. About Omeros Corporation Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system. The Company's most clinically advanced product candidates are derived from its proprietary PharmacoSurgery(TM) platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures. Omeros has five ongoing clinical development programs, including four from its PharmacoSurgery(TM) platform, the most advanced of which is in a Phase 3 clinical program, and one from its Addiction program. Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of protein and small-molecule preclinical programs targeting inflammation, bleeding and central nervous system disorders. Forward-looking Statements This press release contains forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, which are subject to the "safe harbor" created by those sections. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release and include the ability of Omeros' antifibrinolytic agents to provide more effective bleeding control with fewer side effects than other agents. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 4, 2010. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future. SOURCE Omeros Corporation