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King Pharmaceuticals Acquires License from Gelita Medical to Hemostatic Products.


BRISTOL, Tenn. & AMSTERDAM, Netherlands -- King Pharmaceuticals, Inc. (NYSE NYSE

See: New York Stock Exchange
:KG) and Gelita Medical BV announced today that the companies have entered into an exclusive license agreement relating to Gelita's absorbable gelatin hemostatic hemostatic /he·mo·stat·ic/ (he?mo-stat´ik)
1. causing hemostasis, or an agent that so acts.

2. due to or characterized by stasis of the blood.


he·mo·stat·ic
adj.
 products.

Pursuant to the agreement, King received an exclusive license to market, distribute and sell Gelita's absorbable gelatin sponge absorbable gelatin sponge,
n brand name: Gelfoam;
drug class: hemostatic;
action: absorbs blood and provides area for clot formation;
uses: hemostasis during and following surgery.
 in the U.S. Gelita will manufacture and supply the hemostatic product to King under the agreement. King's THROMBIN-JMI[R] (thrombin thrombin: see blood clotting. , topical, bovine, USP USP - unique sales point ), a topical active hemostatic agent, is often used by surgeons together with a variety of passive hemostatic agents, including absorbable gelatin sponges.

Brian A. Markison, President and Chief Executive Officer of King, stated, "The addition of Gelita's absorbable gelatin hemostatic agents to our product line will further strengthen our expanding portfolio of hospital products. Importantly, this transaction further enhances the wide array of hemostatic options that our hospital sales team of over 110 professionals can offer physicians for the purpose of controlling bleeding during surgery."

Dr. Harrie van Baars, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Gelita Medical, stated, "With King we have attracted an excellent and well focused marketing partner for our products in the U.S. market."

King plans to begin marketing Gelita's absorbable gelatin sponge in the U.S. after the product receives approval from the U.S. Food and Drug Administration for use during surgery. The license also provides King an exclusive option to acquire U.S. commercialization rights to any new hemostatic products developed by Gelita. The companies did not provide financial details relating to the transaction.

About THROMBIN-JMI[R]

THROMBIN-JMI([R]) is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules venules (vēnˑ·yōōlz),
n.pl small blood vessels that merge with the veins and return blood from other tissues to the heart.
 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-JMI([R]) 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 coagulation (kōăg'ylā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or  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 Gelita's Hemostatic Gelatin Sponges

Gelita absorbable hemostatic products are fast working, absorbable hemostats hemostats Surgery A hand-held surgical instrument with flattened opposing surfaces used to occlude blood vessels for hemostasis  derived from pharmaceutical grade gelatin for a wide range of applications. Absorbing 50 times its own weight, they stop bleeding fast, generally within 2 minutes. The U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has classified the products as GRAS GRAS - A public domain graph-oriented database system for software engineering applications from RWTH Aachen.  (Generally Recognized As Safe Generally Recognized as Safe (GRAS) is a United States of America Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food ) and they have been used in over 100 million procedures worldwide.

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.

About Gelita Medical

Gelita Medical is internationally known for its hemostatic agents, which assist in many surgical procedures worldwide. The gelatin based products are supplied by Gelita AG, the world's largest producer of pharmaceutical gelatin with more than 125 years experience.

Forward-looking Statements

This release contains forward-looking statements which reflect managements' current views of future events and operations, including, but not limited to, statements pertaining to King's plans to begin marketing the absorbable gelatin sponge following approval from the FDA for use during surgery. 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 the companies' abilities to obtain regulatory approval for surgical indications for the products; dependence on the unpredictability of the duration and results of the FDA's review of Pre-Market Approval Applications (PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.

PMA Progressive muscular atrophy
), Investigational New Drug Applications (IND), New Drug Applications (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ), and Abbreviated New Drug Applications (ANDA ANDA
abbr.
abbreviated new drug application
) and/or the review of other regulatory agencies worldwide that relate to the products; dependence on the availability and cost of raw materials; dependence on the companies' compliance with FDA and other government regulations that relate to their respective businesses; 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, 2005 and Form 10-Q for the quarter ended September 30, 2006, which are on file with the U.S. Securities and Exchange Commission (SEC). The companies do not undertake to publicly update or revise any of their forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Feb 13, 2007
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