Healthcare Industry News: thrombin
News Release - June 21, 2007
King Pharmaceuticals Announces FDA Approval of Epistaxis Kit for THROMBIN-JMI(R)BRISTOL, Tenn.--(HSMN NewsFeed)--King Pharmaceuticals, Inc. (NYSE:KG ) announced today the U.S. Food and Drug Administration (FDA) approval of the Company's thrombin-JMIŽ Epistaxis Kit, a new intranasal spray delivery device for thrombin-JMIŽ (thrombin, topical, bovine, USP) for use to aid in stopping epistaxes (nosebleeds).
J. David Owens, Senior Vice President of King's Hospital & Surgical Products Division, commented, "We are excited about the addition of the thrombin-JMIŽ Epistaxis Kit to our portfolio of thrombin-JMIŽ based products. The kit offers healthcare professionals in the emergency department (ED) and trauma center a convenient new option to achieve fast, active hemostasis during epistaxes." Mr. Owens emphasized, "This milestone demonstrates King's ongoing commitment to thrombin-JMIŽ and further broadens its range of delivery options. We plan to begin marketing the thrombin-JMIŽ Epistaxis Kit in the U.S. by the fourth quarter of this year."
About three in five Americans experience nosebleeds during their lifetime. Certain high-risk groups, such as the elderly, require rapid intervention to stem bleeding, in order to prevent further complications and potentially life-threatening events. Active hemostats, such as thrombin-JMIŽ, the only bovine-derived thrombin currently available as a single agent, are biologically active agents that work directly at the end of the coagulation cascade (the process by which the multiple coagulation factors in the blood interact to form a clot). These products are effective at aiding in hemostasis of oozing blood and minor bleeding from accessible capillaries and small venules.
With the approval of the thrombin-JMIŽ Epistaxis Kit, King will now offer two products for ED and trauma center use. Launched earlier this year, THROMBI-Pad(TM) (3x3 hemostatic pad), the only composite of lyophilized (freeze-dried) thrombin-JMIŽ and gauze pad, offers healthcare professionals in the ED and trauma center a new option to achieve active hemostasis at bleeding sites where they would typically use trauma dressings.
"In the ED and trauma center, healthcare professionals often do not have access to active hemostats to control nosebleeds, relying instead on plugging of the nostrils with gauze and other packing agents. However, these methods are often uncomfortable for patients and may impose certain health risks," said Abhi Mehrotra, MD, Assistant Medical Director, Department of Emergency Medicine University of North Carolina, Chapel Hill, NC. "The approval of the thrombin-JMIŽ Epistaxis Kit will provide an alternative to current methods for treating nosebleeds in a convenient, easy-to-use device, and may enhance my ability to rapidly control active bleeding."
thrombin-JMIŽ is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible. Because of its clotting mechanisms, it should not be allowed to enter large blood vessels. In various types of surgery, solutions of thrombin-JMIŽ may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis.
In a small percentage of patients, the use of topical bovine thrombin preparations has been associated with abnormalities in hemostasis which rarely have been fatal and appear to be related to the formation of inhibitory antibodies. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding, or abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.
About King Pharmaceuticals
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management.
This release contains forward-looking statements which reflect management's current views of future events and operations, including, but not limited to, statements pertaining to the Company's plans to begin marketing the thrombin-JMIŽ Epistaxis Kit by the fourth quarter of this year. These forward-looking statements involve certain significant risks and uncertainties, and actual results may differ materially from the forward-looking statements. Some important factors which may cause actual results to differ materially from the forward-looking statements include dependence on King's ability to begin timely marketing the product as expected; dependence on the availability and cost of raw materials; dependence on the Company's compliance with FDA and other government regulations that relate to its business; dependence on changes in general economic and business conditions; changes in current pricing levels; changes in federal and state laws and regulations; changes in competition; unexpected changes in technologies and technological advances; and manufacturing capacity constraints. Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of King's Form 10-K for the year ended December 31, 2006 and Form 10-Q for the quarter ended March 31, 2007, which are on file with the U.S. Securities and Exchange Commission. The Company does not undertake to publicly update or revise any of its forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.
Source: King Pharmaceuticals
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