The Austrian biotech firm said the decision was made after the candidate “did not meet the endpoints” in efficacy when it failed to protect against enterotoxigenic Escherichia coli (E coli) mediated diarrheal infections during a randomised and placebo-controlled Phase III study involving 2036 travellers.
Intercell expects to post a significantly higher loss for 2010 than the €40m ($54m) it had forecast since it will no longer receive milestone payments related to the Travellers’ Diarrhoea program. The company said the results of the study will “substantially impair” part of its intangible assets related to the program.
As such, an Intercell spokesperson confirmed to in-PharmaTechnologist the firm’s intention to reduce research and development (R&D) expenses by 40 per cent in 2011, removing funds from the Travellers’ Diarrhoea program while ‘realigning’ its organisational structure.
The cost-cutting measures are set to come into effect by mid 2011 and will continue through 2012 and beyond, said the company which admitted that job losses are inevitable, though would not disclose details of the number of employees who will be affected.
Future patch development
While Intercell admits it is “extremely disappointed” with the unexpected outcomes for the Travellers’ Diarrhoea Vaccine Patch, the firm remains upbeat about plans to develop other products from its portfolio.
Intercell said it will use the research from the recent failed study to support the development of its patch technology for other existing and novel vaccines, as well as focusing on the development of its investigational vaccine enhancement patch (VEP) system for treatment against avian pandemic influenza.
The firm added that it will pool its R&D resources on other projects in its clinical portfolio, paying particular attention to its nosocomial programmes following promising results from a Phase II study of its Staphylococcus aureus (S aureus) vaccine candidate, reported by partner company, Merck & Co, and the soon-to-be clinical entry of its novel Clostridium difficile (C difficile) vaccine.
“Hospital-acquired infections represent a major health need and Intercell is well positioned with its portfolio to help address this medical need,” the spokesperson said.