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To: Findit who wrote (100687)12/9/2003 2:04:45 PM
From: Findit  Read Replies (1) of 208838
 
TRIB involved in another law suit. Tuesday December 9, 1:41 pm ET

DUBLIN, Ireland, Dec. 9 /PRNewswire-FirstCall/ -- Trinity Biotech plc (Nasdaq: TRIB - News) today announced that it has initiated legal proceedings against Inverness Medical Innovations Inc. (Amex: IMA - News) for breach of contract.
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Inverness acts as exclusive distributor for certain of Trinity's infectious disease products in the US. This exclusivity is due to end 30th September 2004, at which time it had been agreed that both Trinity and Inverness would sell the products under their respective labels. Currently the products are sold under the Inverness (Wampole) label and therefore in many instances the customer would not be aware of the identity of the manufacturer.

The suit alleges that Inverness are attempting to convert customers from the Trinity product to a product manufactured by Zeus Scientific by falsely claiming that the Trinity product is unavailable and being discontinued -- while acting as Trinity's exclusive distributor.

The suit further claims that Inverness has made huge efforts to make the Zeus Scientific kit look identical to the Trinity product (same part number, colour coding of bottles, cut-offs, packaging) and having done so, is presenting the change to the customer as a supposed "upgrade," without telling the customer that there is a change of supplier.

The suit further alleges that Inverness is recommending to the customer that the only validation required is the normal validation that would be done for different manufacturing batches by the same manufacturer. Given that the product is manufactured by a different manufacturer with different antibodies used in the tests, it is alleged that Inverness is urging its customers not to perform rigorous validation tests and in doing so is asking its customers to make patient safety judgments without full knowledge and disclosure.

The lawsuit alleges that under the terms of the contract Trinity is entitled to sell direct in the US any product which Inverness sells in competition with Trinity. With immediate effect Trinity is exercising this right.

Commenting on the suit, Ronan O'Caoimh, C.E.O. stated, "We are distressed by the actions of Inverness which seeks to destroy our business before the September deadline and while we seek to avoid litigation, if at all possible, we must take action in this case to protect our position and will therefore offer the products in the US market immediately. We believe that, when given the choice, the customer will want to stay with the product that they have known and trusted for many years.

Separately, under the terms of the contract with Inverness, the marketing rights to the Trinity branded Microtrak product range expires in four months time and from 1st April 2004 Trinity will sell these products direct in the US. End-user value is $3.2m annually, and given the strength of the brand and the uniqueness of the product, Trinity is confident of the transfer of virtually the entire business.

In order to take advantage of these many opportunities, we are actively expanding our US salesforce and strengthening the management team. I am delighted to announce that Dr Philippe Gadal has joined Trinity as C.E.O. of our US Sales & Marketing organisation. Philippe has headed Stago U.S. since 1995 and in that time has built their share of the US hemostasis market from zero to 25% and in each of the past two years achieved the biggest instrument placement numbers in the US. Given Trinity's strength in hemostasis reagents and instrumentation we believe we can equal or exceed that success. In addition, the expanded salesforce will drive increased sales of our infectious disease range, including Bartels, MarDx and our Uni-Gold HIV Rapid test when, and if, it receives the anticipated approval by the FDA."

Trinity Biotech develops, acquires manufactures and markets over 500 diagnostic products for the point-of-care and clinical laboratory segments of the diagnostic market. The broad line of test kits are used to detect infectious diseases, sexually transmitted diseases, blood coagulation disorders, and autoimmune diseases. Trinity Biotech sells worldwide in over 80 countries through its own salesforce and a network of international distributors and strategic partners. For further information please see the company's website: www.trinitybiotech.com.

Forward-looking statements in this release are made pursuant to the "safe harbor" provision of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties including, but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development commercialisation and technological difficulties, and other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission.

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Source: Trinity Biotech plc
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