Cortecs Plans Macritonin Filing By End-August

Cortecs has completed the statistical analysis of the three-monthclinical endpoint in its ongoing double-blind European Phase II/III trial of Macritonin (oral salmon calcitonin) in osteoporosis, and says it intends to file its first registration application within Europe before the end of August.

The final data provides additional information and confirmation of the initial positive results announced in May. At that time, Cortecs share price fell as the market responded negatively to the data, and there was a feeling among analysts that while the data were strong enough to secure approval, more robust results had been hoped for (Marketletter May 19). The market's reaction afer the latest announcement was much more positive, however, and Cortecs' share price closed the Marketletter's stock reporting period (ended Monday August 11) up 42% to L2.16.

The European trial is set to continue for a further two years, during which time the effects of Macritonin on bone mineral density will be measured at one- and two-year time points. This data will be required for registration in the USA. Cortecs was granted Investigational New Drug status in the USA earlier this year and says it hopes to start clinical trials there in the fourth quarter of 1997.