Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: Andrew H who wrote (14262)	2/5/1998 6:51:00 AM
From: Henry Niman	Respond to of 32384

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

To: Andrew H who wrote (14262)	2/5/1998 6:54:00 AM
From: Henry Niman	Respond to of 32384

The decision has clearly impacted BBIOY's price: British Biotech Shrs Dive As Analysts Cut Valuations By Erik Portanger LONDON (Dow Jones)--Shares in British Biotech PLC (BBIOY) dived Thursday, as analysts dramatically cut their valuations on the stock amid doubts over one of the company's key development drugs. Around 1015 GMT, shares in the U.K. biotech company are down 39.5 pence, or 30%, to 93.5 pence, having earlier traded as low as 89 pence. Market watchers said there is little hope the stock will recover in the short-to-medium term, with some even predicting a fall to 50 pence. The sell-off came after British Biotech said European regulators had requested more extensive clinical data on its Zacutex drug for acute pancreatitis. The company has begun a second Phase III trial involving 1,500 patients to meet the requirements of the European Medicines Evaluation Agency, but this won't be completed until the first quarter of 1999. 'Obviously the data from the first trial wasn't convincing enough,' said Peter Laing, an analyst at Societe Generale. 'It's a very long wait now before there's any more news. I think sentiment is going to stay negative now for quite a while.' As the U.K.'s largest biotech company, with a market capitalization of more than GBP600 million at current prices, British Biotech has a lot to live up to. It doesn't make any money and probably won't for several years, so its shares are highly sensitive to news about the drugs it is developing. Societe Generale's Laing said the delayed launch of Zacutex shouldn't affect projected earnings too significantly, as long as it eventually receives approval. However, he said the news raises questions about British Biotech's management and the likely success of its other key drugs. 'To have gone ahead with a (regulatory) filing that is inadequate is pretty unprofessional,' he said. The analyst believes some investors might have to reassess their bullish expectations for British Biotech's anti-cancer drug, Marimastat, which is currently in late stage trials. 'I think Marimastat will find a use in cancer treatment but it will disappoint,' Laing said. 'To meet all the expectations that everyone has, it would have to cure cancer and do the dishes while you wait.' Ian Smith, an analyst at Lehman Brothers, said it is now less likely that Zacutex will be approved, especially in the larger U.S. market. He also believes negative sentiment and a lack of news will see the stock remain lackluster for most of this year. 'There isn't going to be any news for 12 months and that's a long time to be hanging in limbo,' he said. It also isn't the first time that British Biotech has disappointed. Last October, the company halted development of its oral anti-inflammatory drug BB-2983 because of unexpected side-effects. It had been developing the drug in collaboration with Glaxo Wellcome PLC, but this relationship collapsed due to the failure. British Biotech insists the problems with Zacutex are of a different kind. Katie Arber, a company spokeswoman, said in an interview with Dow Jones Newswires that regulators aren't satisfied with the company's trial data showing Zacutex helps reduce organ failure in people with pancreatitis. She said they want proof the drug stops people dying from the disease. 'They want statistically significant information on death rates,' she said. British Biotech PLC is a pharmaceutical research and development company which is developing cancer treatments and therapies to treat inflammatory, vascular and viral diseases. It listed 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: In 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. In 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. In 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 indicate a loss 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

To: Andrew H who wrote (14262)	2/5/1998 6:59:00 AM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

On a positive note, it looks like merger mania in pharmas is beginning to spill over into Biotechs: Pharmacopeia to acquire Molecular PRINCETON, N.J., Feb 4 (Reuters) - Pharmacopeia Inc and Molecular Simulations Inc said Wednesday that they have signed a definitive deal in which Pharmacopeia will acquire MSI for about 7.0 million newly-issued Pharmacopeia common shares. In a statement, Pharmacopeia and MSI said it will also convert the outstanding MSI options into Pharmacopeia options, potentially resulting in the net issuance of another 1.5 million new Pharmacopeia shares. Based on the $16.50 per share closing price of Pharmacopeia common stock on February 3, 1998, the transaction is valued at approximately $140 million. MORE Rtr 17:45 02-04-98