Speaking of squeezing, BBIOY's recent discussions with regulatory agencies in Europe will probably have a negative impact on European Biotechs:
Brit Biotech Delays Zacutex's Europe Mkt Application
LONDON (Dow Jones)--British Biotech PLC (BBIOY) said Thursday
that it won't apply for a license to market its acute pancreatitis treatment
Zacutex in Europe until Phase III results are available.
The decision follows a consultation with the European Medicines Evaluation
Agency, whose rapporteurs felt a second pivotal placebo-controlled trial
was necessary to provide definitive proof of clinical efficacy.
British Biotech said a second Phase III trial involving 1,500 patients is well
under way. The company said the EMEA assessment report, which was
based on an earlier 290-patient Phase III trial, didn't identify any issues that
would be likely to prevent a recommendation for approval.
Assuming the results of the second Phase III trial confirm the drugs' clinical
benefits, British Biotech expects to submit new data to the EMEA during
the first quarter of 1999.
British Biotech also expects to file a marketing application for Zacutex with
the U.S. Food and Drug Administration during the first half of next year.
The company believes the drug will qualify for a priority review on the basis
of the need for an acute pancreatitis treatment.
'Deferral of the decision on the European Zacutex application will obviously
be a disappointment to shareholders,' British Biotech Chief Executive Keith
McCullagh said. 'However, as a result of helpful discussions with the
EMEA, we agree that it makes good sense to wait for the outcome of the
ongoing Phase III trial.'
British Biotech also expects to file a marketing application for Zacutex with
the U.S. Food and Drug Administration during the first half of next year.
(An item that ran at about 0818 GMT gave the incorrect name of the U.S.
drug approval agency.)
British Biotech PLC is a pharmaceutical research and development
company that develops cancer treatments and therapies to treat
inflammatory, vascular and viral diseases, particularly AIDS. It was floated
in July 1992. The company's most promising drug in development is
Marimastat, an injectable drug intended to reduce cancer tumors or slow
their growth. Headquarters: Watlington Road, Oxford, OX4 5LY.
Significant developments: February 1998, British Biotech said it won't
submit Zacutex, the registered trademark for acute pancreatitis treatment
lexipafant, for European approval until the first quarter of 1999. The
company will apply to market the drug in the U.S. in the first half of 1999.
October 1997, British Biotech said it had scrapped a collaboration with
Glaxo Wellcome over development of BB-2983, an anti-inflammatory
drug, because of adverse side effects. November 1996, British Biotech said
Marimastat passed Phase-II testing. The drug entered Phase-III testing -
the final trial stage for Europe and north America - in June 1996.
All figures are in sterling
6 mos 6 mos 12 mos 12 mos
ended ended ended ended
10/31/97 10/31/96 4/30/97 4/30/96
Pretax Loss (19.9 mln) (16.1 mln) (28.5 mln) (25.1 mln)
Sales 266,000 782,000 10.9 mln 8.46 mln
EPS (3.0 p) (2.6 p) (4.5 p) (4.9 p)
Figures in parentheses are losses
Currency history (dollar vs sterling)
London 10/31/97 10/31/96 4/30/97 4/30/96
close 1.6771 1.6280 1.6240 1.5040 |
