Dutch biotechnology firm Crucell has posted a significant reduction in its net loss and received fast-track status from US regulators for its rabies monoclonal antibody cocktail.

Net loss narrowed 79% to 4.5 million euros, while revenues shot up 115% to 62.6 million euros, driven by sales of its five-shots-in-one Quinvaxem vaccine (for diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus influenzae type b), the flu jab Inflexal and travel vaccines. The company noted that it has benefited from the spate of acquisitions it made last year, notably Switzerland's Berna Biotech and Sweden’s SBL Vaccin AB, but also revealed that it has sold all the 2.9 million shares it owned in the Swiss firm Pevion Biotech (36% of the latter’s capital) to other stockholders. The deal will result in net proceeds of approximately 6 million euros.

Crucell was particularly pleased with the news that the US Food and Drug Administration has granted fast-track designation to its rabies monoclonal antibody cocktail. It is based on a Phase I study which indicates that the cocktail is well tolerated, provides the expected neutralising activity and can be safely co-administered in combination with a standard rabies vaccine.

Rabies cocktail could be worth $300 million
Jaap Goudsmit, Crucell's chief scientific officer, said that “this designation along with its allowance of frequent interaction with the FDA and possible priority review mechanisms clearly signal the importance of expanding rabies treatment availability”. The cocktail is a combination of two human monoclonal antibodies, produced using the firm’s MAbstract and PER.C6 technologies, and peak sales are expected to exceed $300 million.

A second Phase I study started in India in April 2007, with results to be presented at the end of this month, and Crucell added that it has already contracted partner DSM Biologics with a view to manufacturing antibody batches for Phase III trials. The firm reiterated its guidance that full-year revenues will be between 200-225 million euros.