London, Mar12: British-based biotechnology group Cortecs Plc said it was likely to appoint a single distributor in the key US market for oral osteoporosis drug Macritonin.In an interview with Reuters, chairman Glen Travers said a single distributor would be more appropriate in the US than in Europe, where differences in national markets will dictate agreements with a number of suppliers.
Macritonin, an oral version of two-decade old osteoporosis drug Calcitonin, which up to now has been given largely through injection, is Cortecs' most advanced project and is currently being considered by regulators in seven European states.
"We are optimistic that by the end of this year we could have our first regulatory approval, and then we can start marketing in the first territory," Travers said.
Analysts said marketing deals for Macritonin will be a keydriver for the group's share price this year. Travers said Cortecs was talking to a number of national and international players and hoped to make announcements "in the coming months".Macritonin will compete with a Novartis nasal spray version of Calcitonin, Miacalcic, which performed strongly for the Swiss group last year, especially in the US.
"Sales have been strong and we find that very interesting because elderly people have to administer it by squirting it up their noses. That is not easy," Travers said.Analysts believe the market potentital for user-friendly forms of the drug is large, given that only around three per cent of the post-menopausal market is currently treated for osteoporosis.
Distributors have already been appointed in countries accounting for around 40 per cent of the world Macritonin market, notably in Japan and in Spain, which accounts for around half of all Macritonin used in Europe.
Later this year, Travers said Cortecs planned to initiate trials of its insulin capsule Macrulin in insulin-dependent diabetics, much the hardest group of patients to treat.The company plans to complete Phase II studies of Macrulin alone before seeking partners to help develop and market the drug.Cortecs also announced positive results on Tuesday of a Phase II trial of its mucosal vaccine Pseudostat in a severe form of chronic bronchitis.
"We now have three leading therapeutic programmes, with one Phase III going onto lodgement (Macritonin), two Phase IIs on Pseudostat and a very important Phase II on Macrulin, so we are very pleased with the pharmaceutical side of the business," Travers said.
Analysts, however, where less happy about the performance of Cortecs's diagnostics business, with sales of its Helisal rapid test kit for ulcer-related Helicobacter Pylori flat in the six months to December.
Travers said the kit was still dogged in Europe by the question of whether the cost of using it was reimbursable by health services and insurers.With 33 million pounds in the bank at the end of December, Travers told Reuters the group was in a strong financial position. Despite higher-than-expected cash burn of 9.1 million pounds in the first half of the year, Travers said Cortecs still expected to be close to its full-year target of 15 million pounds of spending.
"We are broadly in that area for spending and are likely to sustain that level of spending," he said.
However, he would not be drawn on whether the company would be forced to return to shareholders for more cash, noting that biotech companies often needed extra funds in the early stages of launching successful new products.
Copyright © 1998 Indian Express Newspapers (Bombay) Ltd.
