King Pharmaceuticals, Inc. Says FDA OKs Revised Label for Blood Clot Product
BRISTOL, Tenn. -- King Pharmaceuticals today reported that the U.S. Food and Drug Administration (FDA) has approved revised labeling for THROMBIN-JMIÂ® (thrombin, topical, bovine, USP) as a result of continuous enhancements the Company has made with respect to its manufacturing processes for the product. The revised labeling recognizes the capability of Kingâ€™s enhanced processes to reduce Factor V light chain content to undetectable levels using currently available methodologies. Supporting data is being published as a paper in an upcoming issue of Clinical and Applied Thrombosis/Hemostasis. High purity THROMBIN-JMIÂ® with this labeling will be available beginning in March 2008.
â€œThis new labeling for THROMBIN-JMIÂ® reflects Kingâ€™s commitment to continually enhance the processes utilized in the manufacture of this product for the benefit of surgeons, healthcare professionals and patients,â€ said Craig A. Paterson, MD, MBA, Senior Director, Medical Development, King Pharmaceuticals, Inc.
The new labeling states:
â€œTHROMBIN-JMIÂ® has been chromatographically purified and further processed by ultrafiltration. Analytical studies demonstrate the current manufacturing processâ€™ capability to remove significant amounts of extraneous proteins, and result in a reduction of Factor Va light chain content levels below the limit of detection of semi-quantitative Western Blot assay (<92 ng/mL, when reconstituted as directed). The clinical significance of these findings is unknown.â€
Some studies have proposed that if bovine Factor V is present in bovine thrombin, it may elicit the formation of antibodies that could cross-react with human Factor V and possibly lead to clinically significant bleeding (coagulopathy). Specific studies evaluating a causative relationship between bovine Factor V levels, human antibody formation to bovine proteins including thrombin and Factor V, and serious coagulopathies have never been performed. However, well-controlled clinical trials with THROMBIN-JMIÂ® have not demonstrated an increase in coagulopathy. Therefore, the clinical significance of antibodies to bovine proteins remains unknown.
THROMBIN-JMIÂ® is an active topical hemostat that achieves fast, active control of surgical bleeding (hemostasis). It is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small veins is accessible, or in conjunction with an absorbable gelatin sponge, USP. Since its approval more than 12 years ago, THROMBIN-JMIÂ® has been used in an estimated 12 million patient procedures.
THROMBIN-JMIÂ®, available in a broad range of delivery options, helps surgeons and healthcare professionals achieve hemostasis in a variety of procedures and bleeding sites. In addition to THROMBIN-JMIÂ® syringe spray kits, these include: THROMBI-GelÂ® (thrombin/gelatin foam hemostat), which provides a convenient topical hemostat option for operating room surgeons; THROMBI-Padâ„¢ (3x3 hemostatic pad), the only composite of THROMBIN-JMIÂ® and gauze pad, offering healthcare professionals in the emergency department a convenient option to achieve active hemostasis at bleeding sites where they would typically use trauma dressing; and the THROMBIN-JMIÂ® Epistaxis Kit, an intranasal spray delivery device to aid in stopping epistaxes (nosebleeds).
About King PharmaceuticalsÂ®, Inc.
King PharmaceuticalsÂ®, Inc., 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.
About Forward-Looking Statements
This release contains forward-looking statements which reflect managementâ€™s current views of future events and operations, including, but not limited to, statements pertaining to the Companyâ€™s expectations regarding the availability of THROMBIN-JMIÂ® with the newly approved labeling in March 2008. 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 results to differ include: dependence on Kingâ€™s ability to make THROMBIN-JMIÂ® with the newly approved labeling available in March 2008. Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the â€œRisk Factorsâ€ section and other sections of Kingâ€™s Form 10-K for the year ended December 31, 2006, and Form 10-Q for the third quarter ended September 30, 2007, which are on file with the U.S. Securities and Exchange Commission. King 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.
Important Safety Information
Because of its action in the clotting mechanism, THROMBIN-JMIÂ® must not be injected or otherwise allowed to enter large blood vessels. Extensive intravascular clotting and even death may result. Please see the full Prescribing Information for THROMBIN-JMIÂ® for a complete listing of the indications, contraindications, precautions and warnings, including boxed warning regarding possible abnormalities in hemostasis, which is available at www.kingpharm.com.
THROMBIN-JMIÂ® is a registered trademark of King Pharmaceuticals Research and Development, Inc., a wholly owned subsidiary of King PharmaceuticalsÂ®, Inc.
Contact: King Pharmaceuticals, Inc. James E. Green, 423-989-8125 Executive Vice President, Corporate Affairs or David E. Robinson, 423-989-7045 Senior Director, Corporate Affairs