British Biotech PLC results for the three months ended 31st July 1995.OXFORD, England--(BUSINESS WIRE)--Sept. 14, 1995-- Results for the three months ended 31st July 1995 Highlights - Positive lexipafant Phase II results announced today. - Clinical trials of BB-2516, the oral anti-cancer drug, are progressing well in the USA and Europe. - Batimastat clinical trials are under way in the USA and UK. - Other clinical programs on track. - Loss of pounds 7.0 (US$11.2 million) million well within budget. - Balance sheet remains strong, with pounds 35.5 million (US$56.8 million) in cash at the end of the quarter. Commenting on the quarter, Dr Keith McCullagh, Chief Executive said, "With the positive outcome of our second Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of lexipafant in pancreatitis pancreatitis Inflammation of the pancreas, associated with alcohol, trauma, or pancreatic-duct obstruction. Activated enzymes escaping into pancreatic tissues cause irritation and inflammation. , British Biotech British Biotech was a British based biotech company. British Biotechnology Limited was founded in 1986 by former G D Searle managers Keith McCullagh and Brian Richards, [1] has started the current financial year well. Meanwhile, BB-2516, British Biotech's innovative new oral anti-cancer drug, is progressing well in clinical trials in a variety of different cancers on both sides of the Atlantic. We look forward to being able to report initial results in at least one type of cancer at the end of November." British Biotech plc Results for the three months ended 31st July 1995 British Biotech made considerable progress in the first quarter of the 1995/1996 financial year with three significant drug programs. During the quarter, clinical trials of the company's potentially most important drug, BB-2516, expanded rapidly. Batimastat received regulatory approval to restart To resume computer operation after a planned or unplanned termination. See boot, warm boot and checkpoint/restart. clinical trials in June and a US study commenced in the quarter. Lexipafant completed an important Phase II trial in pancreatitis and, as announced in a separate release, this trial has shown lexipafant to have positive effects on clinical outcome. Financial review The loss, before and after tax, for the first quarter of the 1995/96 financial year was pounds 7.0 million (US$11.2 million), (1994/95: loss of pounds 5.6 million or US$9 million), well within budget. The increase is attributable to the planned expansion of the development programs and facilities. Turnover of pounds 344,000 (US$550,400) in 1995/96 arises from EUREKA Eureka (y  rē`kə), port city (1990 pop. 27,025), seat of Humboldt co., NW Calif., on Humboldt Bay; inc. 1856. grant fundings and a biological research agreement with R&D Systems
Europe. Turnover of pounds 767,000 (US$1.2 million) for the first
quarter of 1994/95 included income from Glaxo Wellcome under the
collaborative agreement to develop lexipafant for asthma.Operating expenditure increased from pounds 7.1 million (US$11.4 million) in 1994/95 to pounds 7.8 million (US$12.5 million) in 1995/96. This increase was attributable to the expansion of the company's clinical development programs, particularly in the USA, and additional depreciation and running costs running costs npl [of business] → gastos mpl corrientes [of car] → gastos mpl de mantenimiento running costs npl [of business following completion of new chemical scale-up facilities at the end of 1994/95. Net interest receivable reduced from pounds 735,000 (US$1.2 million) to 481,000 (US$770,000), reflecting the reduced cash balances held during the quarter. The cash utilised by operations reduced from pounds 6.6 million (US$10.6 million) in 1994/95 to pounds 6.5 million (US$10.4 million) in 1995/96. The reduced outflow is due to the receipt, in the quarter, of pounds 2.0 million (US$3.2 million) of net interest following the maturity of long-term deposits placed following the Rights Issue in 1994 and lower levels of capital expenditure. These were offset by the increased loss for the quarter. Cash resources, comprising cash equivalents and short-term investments, were pounds 35.5 million (US$56.8 million) at the end of the quarter, slightly ahead of expectations. Products in clinical development Cancer BB-2516 BB-2516, the company's new oral anti-cancer matrix metalloproteinase inhibitor (MMPI MMPI abbr. Minnesota Multiphasic Personality Inventory MMPI Child psychiatry A personality assessment tool widely used in making psychologic evaluations, which is normally given at age 16 and older. Personality testing ), is potentially British Biotech's most important product and the development of an oral and effective MMPI is now the company's principal goal. During the quarter, Phase II clinical studies started in Europe in ovarian ovarian /ovar·i·an/ (o-var´e-an) pertaining to an ovary or ovaries. ovarian pertaining to an ovary. ovarian agenesis and gastric cancer gastric cancer Stomach cancer, see there and in the US in lung and colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. ; by the end of the quarter, more than 70 patients had been enrolled into eight trials in six different types of tumour tumour or neoplasm Mass of abnormal tissue that arises from normal cells, has no useful function, and tends to grow. Cell abnormalities may include increased size or number or loss of characteristics that differentiate their tissue of origin. . The company is encouraged by progress in these trials and expects to be in a position to issue preliminary data on at least one of the trials at the end of November. Batimastat British Biotech achieved regulatory approval on schedule, in June 1995, to restart trials with batimastat, the injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. MMPI. The first trial, in patients with malignant pleural effusion Pleural Effusion Definition Pleural effusion occurs when too much fluid collects in the pleural space (the space between the two layers of the pleura). It is commonly known as "water on the lungs. , began in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. in late July. 90 patients are due to be recruited into this dose- ranging study, the first study of batimastat in pleural effusion in the USA. A second trial, in the UK, started after the end of the quarter. BB-10010 BB-10010, stem cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. protector protector /pro·tec·tor/ (-tek´ter) a substance in a catalyst that prolongs the rate of activity in the latter. , has been designed to reduce some of the side effects Side effects Effects of a proposed project on other parts of the firm. of cancer chemotherapy. In July, two new trials began in the UK, the first a 30-patient multicentre trial in breast cancer patients and the second in Manchester in 12 non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. patients. These studies complement two other Phase II studies already under way in the UK and USA investigating BB-10010 in the context of aggressive regimens of chemotherapy. Other disease areas Lexipafant intravenous Lexipafant, the company's PAF PAF platelet activating factor. PAF abbr. platelet-aggregating factor PAF platelet activating factor. antagonist antagonist /an·tag·o·nist/ (an-tag´o-nist) 1. a substance that tends to nullify the action of another, as a drug that binds to a cell receptor without eliciting a biological response, blocking binding of substances that could , is being investigated as an intravenous (iv) infusion in a range of inflammatory conditions, the most advanced programme being in acute pancreatitis acute pancreatitis Inflammation of the pancreas of abrupt onset, often with gallstones and alcohol ingestion Epidemiology 109,000 hospitalizations, 2251 deaths–US; 10-fold ↑ from 1960s to 1980s–reason unclear; . A 51-patient placebo-controlled double blind Phase II study was completed during the quarter. This trial was designed to assess whether lexipafant could improve the clinical outcome of patients with, or at risk of developing, severe acute pancreatitis. The results of the trial, announced in detail simultaneously with this release, showed a statistically significant difference in organ failure scores between patients receiving lexipafant and placebo. Data from the trial suggest that patients with acute pancreatitis entering hospital with complications of organ failure are likely to recover more quickly if treated with lexipafant. In addition, patients entering hospital with mild disease are less likely to develop complications, including organ failure, if treated with lexipafant. This second Phase II trial is believed by British Biotech to be particularly significant, because it was similar in design to the 300-patient Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial already under way in the UK. Provided the results of this pivotal Phase III trial confirm the Phase II trial results, British Biotech expects to apply for European regulatory approval to market lexipafant iv for the treatment of acute pancreatitis. Lexipafant oral Lexipafant has also been formulated as a tablet to be taken by mouth. Under the terms of a collaborative agreement with the company, Glaxo Wellcome began in May a Phase II trial of lexipafant oral, taken twice a day, in 450 chronic asthma patients. The trial is a double blind study in 12 countries comparing patients treated with lexipafant, inhaled in·hale v. in·haled, in·hal·ing, in·hales v.tr. 1. To draw (air or smoke, for example) into the lungs by breathing; inspire. 2. steroids steroids, class of lipids having a particular molecular ring structure called the cyclopentanoperhydro-phenanthrene ring system. Steroids differ from one another in the structure of various side chains and additional rings. or placebo. Recruitment is progressing well. British Biotech Inc As described above, the US clinical research programme continued to expand in the quarter with studies starting with BB-2516 and batimastat. A US study of lexipafant in acute pancreatitis is due to begin before the end of 1995 following the encouraging UK results described above. Board of directors Mr. Henny de Ruiter has been appointed to British Biotech plc's board of directors with immediate effect. Mr De Ruiter is a member of the Supervisory Board Supervisory board The board of directors that represents stakeholders in the governance of the corporation. of Royal Dutch Petroleum Company and a director of Shell Petroleum N.V. and The Shell Petroleum Company Limited having had a distinguished career with the Royal Dutch/Shell organisation. Mr De Ruiter is also a member of the Supervisory board of a number of prominent Dutch companies This is a list of companies from the Netherlands. See for lists of companies from other countries. Independent companies
Unaudited Consolidated Profit and Loss Account
for the three months ended 31st July 1995
Quarter ended Quarter ended
31st July 1995 31st July 1994
pounds 000 pounds 000
Turnover 344 767 Operating expenditure (7,778) (7,137) Operating loss (7,434) (6,370) Interest receivable 621 878 Interest payable (140) (143) Loss before and after tax (6,953) (5,635) Loss per share (Note 1) (14.4p) (11.9p)
Statement of Recognised Gains and Losses
for the three months ended 31st July 1995
Quarter ended Quarter ended
31st July 1995 31st July 1994
pounds 000 pounds 000
Loss for the quarter (6,953) (5,635) Translation of overseas subsidiary financial statements (5) - Total losses recognised for the quarter (6,958) (5,635)
Unaudited Consolidated Cash Flow Statement
for the three months ended 31st July 1995
Quarter ended Quarter ended
31st July 1995 31st July 1994
pounds 000 pounds 000
Net cash outflow from operations (7,856) (5,818) Return on investments Net interest 1,977 386 Investing activities Purchase of fixed assets (582) (1,175) Net sale/(purchase) of short-term investments 8,000 (38,000) Net cash flow before financing 1,539 (44,607) Financing Issue of shares 6 45,875 Repayment of loan (68) (68) Net cash flow from financing (62) 45,807 Increase in cash and cash equivalents 1,477 1,200 Cash utilised by operations Increase in cash and cash equivalents 1,477 1,200 Net (sale)/purchase of short-term investments (8,000) 38,000 Cash flow from financing 62 (45,807) Cash utilised by operations (6,461) (6,607)
Unaudited Consolidated Balance Sheet
at 31st July 1995
31st July 1995 30th April 1995
pounds 000 pounds 000
Tangible fixed assets 23,050 23,131
Current assets
Stocks 94 72
Debtors 2,048 3,510
Short-term investments 23,000 31,000
Cash and cash equivalents 12,494 11,017
37,636 45,599
Creditors due within
one year (4,911) (5,916)
Net current assets 32,725 39,683
Total assets less
current liabilities 55,775 62,814
Creditors due after
one year (3,640) (3,727)
Net assets 52,135 59,087
Capital and reserves
Share capital 2,418 2,418
Share premium 138,001 137,995
Warrants 3,337 3,337
Profit and loss account (91,621) (84,663)
Shareholders' funds 52,135 59,087Notes
1. Losses per share are based on the loss attributable to shareholders before and after taxation of pounds 7.0 million (1994:loss of pounds 5.6 million) and on 48.4 million (1994: pounds 47.4 million) shares, being the weighted average number of shares in issue for the three month period. In calculating the weighted average number of shares, the number of shares in issue prior to the Rights Issue have been adjusted to reflect the bonus element of the Rights Issue. 2. The directors do not propose a dividend for the period. 3. The financial information on the group set out above does not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985. The financial information for the year ended 30th April 1995 is an extract from the group's statutory accounts which have been delivered to the Registrar of Companies The introduction to this article provides insufficient context for those unfamiliar with the subject matter. Please help [ improve the introduction] to meet Wikipedia's layout standards. You can discuss the issue on the talk page. ; the report of the auditors on these accounts was unqualified and did not contain a statement under Section 237(2) or (3) of the Act. 4. Where they appear, US dollar figures were translated on the basis of $1.6 equals 1 pounds. CONTACT: British Biotech plc On 9/14/95: 011-44-171 253 2252 James Noble This article is about the U.S. senator. For the actor, see James Noble (actor). ''Note: James Noble is also the name of an early settler of Ohio. James Noble (December 16, 1785–February 26, 1831) was the first U.S. Senator from the U.S. , Finance Director or Thereafter: 011-44-1865 748747 Katie Arber, Head of Corporate Communications Corporate communications is the process of facilitating information and knowledge exchanges with internal and key external groups and individuals that have a direct relationship with an enterprise. or British Biotech Inc. 410-266-7909 Peter P. McCann, President or G.A. Kraut kraut n. 1. Sauerkraut. 2. often Kraut Offensive Slang Used as a disparaging term for a German. [German; see sauerkraut.] Noun 1. Company 212-696-5600 Gerard Coffey, Vice President |
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