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02/09/2022

Independent, 13 January 2003

T he Times (London) July 12, 1999, Monday The bitter pill for biotech

Shareholders poised for British Biotech action.

…“ M Sauer (Head of the EMEA) … says the Stock Exchange's ruling on British Biotech's handling of Zacutex was "reasonable". The Committee for Proprietary Medicinal Products told the firm that Zacutex was unapprovable in June 1997, but British Biotech waited until the following February before telling the stock market about the setback. …British Biotech's implosion was spectacularly public. However, M Sauer sees evidence of similar weaknesses in other young development companies… His explanation is that the managers of many young drug development firms are new to pharmaceutical regulation. He says: "These people who just come from the academic scientific world do not understand the rigour of the system…” “M Sauer believes biotech companies need to invest more in understanding the regulatory process to eliminate unnecessary failings such as poorly designed trials. "Biotech companies generate a lot of money in terms of intellectual property. They make a lot of money and they get very rich. They don't understand that you have to invest a lot of money in the regulatory process if you're going to get anywhere."

Class Law, the combative legal firm, is stepping up the pressure on British Biotech, saying it will begin legal proceedings against the company by the end of this month. The solicitors say they have the backing of a number of institutional investors to launch an action alleging the pioneering biotech company issued misleading information to the stock market in the Nineties. It has given investors until the end of this week to join a claim for damages, which could run into tens of millions of pounds ....

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Recommendations

Listed companies must consider their obligations to the market and investors when communicating on safety and efficacy issues

Internal co-ordination for simultaneous release

Internal communications about significant issues should be restricted to those who need to know ● insider dealing risk ● internal communications may later be made public

The Organisation for Professionals in Regulatory Affairs

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