A guideline outlining how companies should prepare to conduct first-in-man studies of novel medicinal products in Europe, should be completed in July, 2007, according to Patrick Le Courtois, head of the Unit for Pre-Authorisation of Medicines for Human Use at the European Medicines Agency (EMEA).
Amsterdam Molecular Therapeutics (AMT) Holding NV, which develops gene-based therapies for orphan diseases, expects to raise around €45 million in an initial public offering on the Eurolist-by-Euronext section of the Euronext Amsterdam Stock Exchange.
Santaris Pharma A/S of Denmark announced at the June 2007 annual meeting of the American Society of Clinical Oncology in Chicago that its RNA antagonist for chronic lymphocytic leukaemia (CLL) showed promising results in an initial Phase I/II clinical trial.
The number of international patent applications filed by biotechnology companies under the Patent Cooperation Treaty (PCT) dropped by two-thirds from 2002 to 2006, while applications to national and regional agencies were little changed over the same period, according to the UK solicitors, Marks & Clerk.
Light regulation, low cost and flexible admission criteria make the London Stock Exchange’s Alternative Investment Market (AIM) an attractive venue for small companies that want to issue shares for the first time, according to the chief executive officers of four life science companies that have issued IPOs on AIM since 2004.
The European biotechnology industry increased its revenues by 13% in 2006, while narrowing its losses. At the same time, spending on research and development increased, especially on the part of the 32 companies that made initial public offerings during the year.
One advantage of a stock exchange listing is that it raises a company’s profile and makes it easier for it to raise further capital. This adage seems to be borne out by the annual biotechnology review of the accounting firm, Ernst & Young.
Companies that want to know how quickly their applications for first-in-man trials will be evaluated in the UK will soon be able to go to the regulatory authority’s website for information on the review process, according to Elaine Godfrey of the Medicines and Healthcare products Regulatory Agency (MHRA).
Gordon Duff, a professor at the University of Sheffield School of Medicine and chairman of Britain's Commission on Human Medicines, said the Tegenero incident illustrates how little scientists understand about the safety of novel therapies. He said it is important that regulators in future share more information from preclinial studies of novel therapies.
Evotec Ag is a German biotech company that has financed much of its proprietary research by engaging in drug discovery and development for other biotech companies in a strategy that looks like it will pay off.