King Pharmaceuticals Reports FDA Approval of Revised Labeling Regarding Purity of Thrombin-JMI
BRISTOL, Tenn.--(BUSINESS WIRE)--Jan 14, 2008 - King Pharmaceuticals, Inc. today reported that the U.S. Food and Drug Administration (FDA) has approved revised labeling for Thrombin-JMI (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 King'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-JMI with this labeling will be available beginning in March 2008.
"This new labeling for Thrombin-JMI reflects King's commitment to continually enhance the processes utilized in the manufacture of this product for the benefit of surgeons, healthcare professionals and patients," said Craig A. Paterson, MD, MBA, Senior Director, Medical Development, King Pharmaceuticals, Inc.
The new labeling states:
"Thrombin-JMI has been chromatographically purified and further processed by ultrafiltration. Analytical studies demonstrate the current manufacturing process' 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 (less than 92 ng/mL, when reconstituted as directed). The clinical significance of these findings is unknown."
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-JMI have not demonstrated an increase in coagulopathy. Therefore, the clinical significance of antibodies to bovine proteins remains unknown.
Thrombin-JMI 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-JMI has been used in an estimated 12 million patient procedures.
Thrombin-JMI, 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-JMI syringe spray kits, these include: THROMBI-Gel (thrombin/gelatin foam hemostat), which provides a convenient topical hemostat option for operating room surgeons; THROMBI-Pad(TM) (3x3 hemostatic pad), the only composite of Thrombin-JMI 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-JMI Epistaxis Kit, an intranasal spray delivery device to aid in stopping epistaxes (nosebleeds).
About King Pharmaceuticals, Inc.
King Pharmaceuticals, 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
management's current views of future events and operations,
including, but not limited to, statements pertaining to the
Company's expectations regarding the availability of
Thrombin-JMI 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 King's ability to
make Thrombin-JMI 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 "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 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-JMI 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-JMI 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-JMI is a registered trademark of King Pharmaceuticals Research and Development, Inc., a wholly owned subsidiary of King Pharmaceuticals, 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
FDA Drug Approvals Archive
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Oct | Dec
