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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Becket Invest Plc | LSE:TAB | London | Ordinary Share | GB00BMWKKL25 | ORD GBP0.01 |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.20 | 0.00 | 00:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
Blank Checks | 0 | -339k | -0.4134 | -0.03 | 9.84k |
RNS No 7128a THERAPEUTIC ANTIBODIES INC 9 August 1999 THERAPEUTIC ANTIBODIES INC SUBMITS DIGITAb FOR FDA APPROVAL London, 9 August 1999 - Therapeutic Antibodies announces that it has submitted a Product License Application (PLA) and Establishment License Application (ELA) to the US Food and Drug Administration (FDA), seeking approval of its product, DigiTAb, which is designed to treat the effects of digoxin toxicity. The FDA's acceptance of the filing for review will trigger a milestone payment from Altana Inc., Therapeutic Antibodies' US marketing partner for DigiTAb. The submission of the DigiTAb PLA and ELA marks Therapeutic Antibodies' second PLA and ELA submission to the FDA in the last 15 months. The Company anticipates the FDA will grant the same standard 12 month review period for DigiTAb as it granted for the Company's rattlesnake antivenom, CroTAb. The CroTAb PLA and ELA were submitted to the FDA in April 1998 and are in the final stages of review. Therapeutic Antibodies developed DigiTAb for treating digoxin intoxication. Digoxin is the most commonly prescribed form of digitalis, which has been in use worldwide for many years to treat a range of heart conditions. However, digoxin has a narrow therapeutic range and can cause life-threatening toxicity as a result of both acute overdose and chronic poisoning. It is estimated that 7,500 cases of digoxin toxicity occur annually in the US and Europe, with the majority in the US. DigiTAb has also been shown to be effective in the treatment of oleander poisoning. Oleander, a common plant found throughout the US coastal states and Southeast Asia, contains seeds and plant parts which are poisonous when ingested. Andrew J. Heath, MD, Therapeutic Antibodies' CEO, commented, 'the submission of the DigiTAb filing within 15 months of the CroTAb submission is evidence of management's focus in meeting product development milestones. With CroTAb approaching the US marketplace and the merger with Proteus moving ahead, we are well on the way to creating a self-sustaining biopharmaceutical business.' For further information, please contact: Stuart Wallis, Chairman - tel: 0171 553 1483 Therapeutic Antibodies Inc Saul Komisar - tel: 615-327-1027 Therapeutic Antibodies Inc Nick Freer - tel: 0171 379 5151 The Maitland Consultancy BACKGROUND INFORMATION The FDA application contains data from three clinical studies of DigiTAb: an ongoing study of DigiTAb in digoxin overdose patients in the US and Europe, a trial in healthy volunteers comparing DigiTAb to Digibind and a study conducted in Sri Lanka in patients with oleander toxicity. In 1986, Glaxo Wellcome introduced Digibind, a similar product, for the treatment of life-threatening digoxin intoxication. DigiTAb will compete directly with Digibind in the emergency medicine product market. DigiTAb will have a broader application than Digibind if the FDA approves the oleander indication. Therapeutic Antibodies is an international biopharmaceutical company specialising in research, development and production of highly-purified polyclonal antibodies for treatment of diseases and other life-threatening conditions for which satisfactory therapies have generally not previously existed. The Company is headquartered in Nashville, Tennessee, adjacent to the Vanderbilt University Medical Center. The Company's research laboratories are located at the Medical College of St. Bartholomew's Hospital in London. Therapeutic Antibodies' products are manufactured at the Company's production facilities in Australia and the UK for worldwide distribution. The Company's common stock is listed on the London Stock Exchange. On 20 May 1999, the Boards of Proteus International plc and Therapeutic Antibodies Inc announced that they had executed an agreement providing for the merger of Proteus and Therapeutic Antibodies, accompanied by a conditional non pre-emptive placing of 23,325,000 new Proteus ordinary shares at 40p per share to raise approximately #7.0 million net of expenses for the enlarged group, which at the placing price has a value of approximately #63.1 million. Upon the merger becoming effective, Therapeutic Antibodies' shareholders will receive 1.163 Proteus ordinary shares for each share of Therapeutic Antibodies common stock. The merger is subject to the approval of shareholders of both Proteus and Therapeutic Antibodies. Shareholders' meetings of both companies are expected to be held as soon as practical following regulatory approvals. An electronic version of this news release, as well as additional information about Therapeutic Antibodies Inc is available at http://www.tab.co.uk on the Company's home page. This release, and oral statements made from time to time by Company representatives concerning the subject matter hereof, may contain so-called 'forward looking statements'. These statements can be identified by introductory words such as 'expects', 'plans', 'will', 'estimates', 'forecasts', 'projects' or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing the Company's growth strategy, operating and financial goals, plans relating to regulatory submissions and approvals and development programs. Many factors may cause actual results to differ from the Company's forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Those and other risks are described in the Company's filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from the Company. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. END MSCSSMSWUUUUFEA
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