Positive results with Oralgen(R) Grass Pollen in second season of treatment

Follow-up study with the anti-allergy medication Oralgen® Grass Pollen demonstrates that the efficacy of sublingual immunotherapy (drops applied under the tongue) increases when the treatment period is extended. Clinical efficacy convincingly demonstrated during second season of treatment

Lelystad, The Netherlands | January 15, 2009 | On 15 February 2008, Fornix BioSciences (Euronext Amsterdam: AFORBI) issued a press release announcing the results of a major clinical study into the efficacy and safety of Oralgen® Grass Pollen after one season of treatment. This press release also stated that this study would be continued for a second season of treatment by means of a follow-up study. Upon completion of the first year of the study (i.e. at the end of the 2007 pollen season), patients and investigators were requested to participate in the follow-up study, which ran until the end of the 2008 pollen season. The follow-up study comprised 356 adult patients with a history of moderate to severe grass pollen-related rhinoconjunctivitis (’hay fever’).

Fornix BioSciences N.V. is disclosing the main results of the follow-up study into the efficacy and safety of Oralgen® Grass Pollen during the second season of treatment. The follow-up study involved the evaluation of three different dosage regimens of Oralgen® Grass Pollen, whereby the most substantial improvement of the parameters indicative of allergic symptoms occurred in the highest dosage group. The study revealed a substantial improvement of the efficacy of Oralgen® Grass Pollen during the second season of treatment compared to the first season.

The allergic symptom score (median value) in the highest dosage group decreased significantly by 47% (p<0.01) during the second season of treatment compared with the placebo group, while the medication score (median value) in this group (a measure for the use of symptomatic medication for the immediate and temporary relief of allergic symptoms) also decreased significantly by 74% (p<0.05) in relation to the placebo group. The corresponding values during the first season of treatment were 27% (symptom reduction) and 56% (decrease in medication score).

The results of the follow-up study confirm the hypothesis that the efficacy of sublingual immunotherapy increases when the treatment period is extended.

During the follow-up study, all the dosage regimens included in the study proved to be safe and well tolerated. As expected, the number of side effects during the second season was substantially lower than during the first season. The study did not reveal any serious side effects related to Oralgen®. Responding to the positive result, Fornix CEO Cees Bergman said: ‘This follow-up study has clearly demonstrated the efficacy of Oralgen® Grass Pollen during the second season of treatment. The results encourage us in our efforts and in our decision to make substantial  nvestments to ensure that our products receive registration. Registration of Oralgen® Grass Pollen, as well as of our sublingual drops for the treatment of mite allergy and tree pollen allergy, is vital to achieve our objective of eventually becoming a key player in the still fast-growing  European allergy market’.

It is currently unclear to what extent the results of the follow-up study might contribute to ensuring that Oralgen® Grass Pollen receives registration; as soon as more information is available, this will be communicated. A comprehensive overview of the results of the follow-up study  will be published in a scientific article in due course.

Profile of Fornix BioSciences N.V.

Fornix BioSciences N.V. is a listed company (Euronext Amsterdam, code AFORBI) which engages in the development and sale of diagnostic and therapeutic allergen products and the distribution of medical aids and medical and nursing consumables. Fornix BioSciences N.V. has sites in Lelystad, Beuningen and Hamburg. The company currently has a workforce of around 130 and is active mainly in the Netherlands and  Germany.

Its activities are carried on by two divisions, which in turn are made up of operating companies.

The Allergy Division, which consists of Artu Biologicals Europe and, since 1 June 2007, Artu Biologicals Deutschland, is the most profitable division. Its activities include the development, production and sale of a wide range of patient-friendly immunotherapeutic products, under the Oralgen®, Igevac® and other trade names. These products are used in the causal treatment of allergies triggered by various allergens, such as grass and tree pollen and house-dust mites. The development programme is supported by high-quality R&D activities and pan- European clinical studies of the effectiveness of the various products. The Medical Aids Division, which consists of Laprolan in Beuningen, engages in the sale, marketing and distribution of a wide range of medical aids and medical and nursing consumables.

SOURCE: Fornix BioSciences N.V.

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