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SnowWorld N.V. Capital/Financing Update 2005

Dec 23, 2005

3886_iss_2005-12-23_798e5913-fac4-4f7f-a1cc-d54f5e51a6df.pdf

Capital/Financing Update

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P R E S S R E L E A S E

Lelystad, 23 December 2005

FORNIX CHANGES CORPORATE STRUCTURE AND PRESENTS RESEARCH RESULTS

  • Profitable new Medical Aids Division to be formed by combining Artu Medical and Laprolan/Comformed. Addition of Laprolan/Comformed will contribute EUR 6 million turnover and EUR 2 million EBIT.

  • Theranostics Division to be disposed of, clearing over EUR 1 million of negative EBIT from the books in 2006.

  • Remaining R&D activities to be transferred to Allergy Division.

  • Final report confirms previously published provisional results of STARDROP Oralgen[®] for grass pollen. Clinical efficacy to be confirmed with additional studies.

  • F991 study: promising phase IIA study of patients with house dust mite and peanut allergies confirms potential therapeutic effect. Partner sought for further development.

  • Activities relating to clinical research on the Oralgen[®] products to be significantly expanded and placed on a more professional footing in the years ahead, to support the application for registration of these products.

LELYSTAD – Biopharmaceutical company Fornix BioSciences (Euronext: AFORBI) is embarking on a major change in its corporate structure from the start of 2006, having signed the contract to purchase Laprolan B.V. and Comformed B.V. on 22 December 2005. Subject to the usual caveats, the shares will be transferred in early January 2006. Laprolan/Comformed and Artu Medical (currently part of Fornix’s Allergy Division), both of which specialise in the marketing and sale of medical aids and consumables, will be combined from January 2006 to create a new and profitable Medical Aids Division. Laprolan/Comformed, which generated turnover of approximately EUR 6 million and EBIT (earnings before interest and tax) of around EUR 2 million in 2005, will start making a positive contribution to results immediately in 2006.

In the light of its structurally poor performance, the Theranostics Division, consisting of Seapro and Fornix Medical Systems, will be terminated, clearing over EUR 1 million of negative EBIT from the books in 2006. The activities of the R&D Division, which relate primarily to the Allergy Division, will be transferred to the latter division. These changes to the corporate structure, which will have the effect of reducing the number of divisions to three, will create a more efficient and transparent organisation.

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The provisional results reported by Fornix in August of this year of the STARDROP study among patients aged 6–18 of the safety and efficacy of the Oralgen[®] Grass Pollen product, which was completed in 2005, have been confirmed by the final report on the study. The safety profile was found to be excellent but, possibly due to factors beyond Fornix's control, no significant reduction in allergic symptoms was observed. An extensive clinical development programme is being launched to support the application for registration of Oralgen[®] Grass Pollen and other Oralgen[® ] products, for which EUR 10 million has been budgeted over the next five years.

The results of the Phase IIA study for the F991 biotech research project, which was completed in 2005, have confirmed the potentially therapeutic efficacy of the F991 peptide. The expectations are that this positive result will help Fornix BioSciences in its search for a suitable partner for this project.

New Medical Aids Division

Following the announcement on 26 September 2005 of the acquisition of Laprolan/Comformed, Beuningen (Netherlands), a profitable distributor of medical and nursing consumables, washable incontinence materials and pressure-relieving mattresses, the purchase contract was signed on 22 December. Subject to the usual caveats, the shares will be transferred at the beginning of January 2006. Following a change of plan, Laprolan will not now be positioned within the Theranostics Division, but will be combined with Artu Medical, which is operating successfully in marketing and sales predominantly of Scarban silicon dressings and Safehip hip protectors, to form a new Medical Aids Division. Artu Medical, which is at present part of the Allergy Division, will fit particularly well with Laprolan to create a vigorous new division with strong growth potential. Laprolan, which employs 17 people, generated turnover of around EUR 6 million in 2005 and is predicting an EBIT (earnings before interest and tax) of some EUR 2 million. The company will start making a positive contribution to Fornix BioSciences’ result immediately in 2006.

Disposal of Theranostics Division

The activities in the field of diagnosis of infectious diseases and urological complaints addressed by the Theranostics Division, which was formed in 2003, will be disposed of. The market launch of its innovative diagnostic products has been less successful than expected. Because the division will not move into profit within the time set by Fornix, further investment is not justified. Fornix stands by its projection of a negative EBIT for the Theranostics Division of just over EUR 1 million in 2005, substantially lower than the 2004 figure of EUR 1.6 million negative. This loss will be cleared from the books in 2006 since these acitivities will be terminated end of 2005. It is possible that Fornix will be able to sell its technology and trademark rights. The termination of the activities also means that a number of studies which the R & D Division was expecting to undertake for the Theranostics Division will not go ahead.

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R&D activities to be transferred to Allergy Division

In the light of this development and Fornix's earlier decision to reduce the focus on preclinical research projects, the emphasis of the company's research activities is shifting towards clinical studies to support the application for registration of the sublingual Oralgen[®] Grass Pollen anti-allergy products and other Oralgen[®] products. This research is crucially important to the company, both commercially and in regard to registration. An important clinical study (STARDROP) with the Oralgen[® ] Grass Pollen product has been completed at the end of 2005. It has therefore been decided to transfer the research activities to the Allergy Division and disband the R&D division as an independent entity, thus making the allocation of R&D activities more transparent.

As announced at the end of last year, further investment has been discontinued in two of the three biotechnology projects on which the R&D Division had been working up to about a year ago. Two of the projects, F992 and VGEF, involved such a complex, time-consuming and expensive development process that they were unlikely to make a contribution to shareholder value within an acceptable time frame. F991, the sole remaining biotechnology project, still has good prospects of a market launch and successfully completed a proof of concept trial in 2005. Fornix is seeking to transfer this project to a suitable pharmaceutical partner.

Simplified corporate structure

The organisational changes referred to above will result in a simplified and more transparent corporate structure of three divisions – Allergy, Trading and Medical Aids – which will focus respectively on production and sale of anti-allergy products (Artu), trading in patented pharmaceuticals ( Fisher) and marketing and sales of medical aids (Laprolan and Artu Medical).

Findings of STARDROP study of Oralgen[®] Grass Pollen

For several years, Fornix has been conducting a large-scale state-of-the-art clinical STARDROP study, in conjunction with the Erasmus Medical Centre in Rotterdam, into the safety and efficacy of the Oralgen[®] Grass Pollen product in the treatment of allergic rhinoconjunctivitis (allergic nose and eye complaints) in children in the Netherlands. The clinical part of this double-blind, placebo-controlled study involving around 200 patients in the 6–18 age range, was completed at the end of 2004.

It was announced in the interim report dated 1 August 2005 that statistical analysis by the Erasmus Medical Centre of the results of the study was taking longer than expected. It was also reported that the initial results of a number of sub-trials had suggested that treatment with Oralgen® Grass Pollen is less clinically effective in the trial population than had been assumed in the study protocol.

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Statistical analysis of the results of the STARDROP study has now been completed and shows that the study did not achieve one of its most important objectives, namely to demonstrate a significant reduction in allergic symptoms in the patient group treated with Oralgen[®] Grass Pollen compared with the placebo group.

The findings of the STARDROP study are inconsistent with a number of recent large-scale clinical studies of comparable products which have convincingly demonstrated the clinical efficacy of these products. A significant part of the work of evaluating the STARDROP study results therefore involved identifying factors which may have been responsible for the divergent findings of the STARDROP study. The factors considered included the following:

  • The efficacy of treatment with Oralgen[®] Grass Pollen was measured over two consecutive pollen seasons. Because of differing weather conditions, the pollen burden – and the incidence of allergic symptoms – was exceptionally low in one of the two seasons.

  • The criteria used in the selection of patients for the study were found afterwards to have resulted in a group with relatively mild allergic complaints and the proportion of patients with moderate-to-serious allergic complaints was relatively small. A low symptom score can make it difficult to achieve a clinically relevant improvement.

  • The studies of similar products referred to above were conducted using only adult patients, whereas the STARDROP study used only children and adolescents. It may be that it is easier to demonstrate efficacy among adults than among young people.

The results of the STARDROP study have been submitted to the Pharmaceuticals Assessment Committee in the context of the application for registration of the Oralgen[®] Grass Pollen product. Fornix has launched a clinical development programme to support the application for registration. The studies required to implement this programme will be starting as soon as possible. The complicating factors identified in the course of evaluation of the STARDROP study results will of course be given full weight in designing and conducting these additional clinical studies.

As well as evaluation of the efficacy of treatment with Oralgen[®] Grass Pollen, evaluation of product safety was also an important objective of the STARDROP study. Analysis of the study results showed Oralgen[®] Grass Pollen to have an excellent safety profile. The patients treated with the product exhibited no serious side-effects and tolerated it well.

The results of the STARDROP study will be submitted by the researchers at the Erasmus Medical Centre to a reputable scientific journal for publication in the form of a scientific paper.

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Status of study with Oralgen[®] Mites

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A double-blind, placebo-controlled study of the safety and efficacy of the Oralgen[®] Mites product started in the autumn of 2005. The final results are expected in the course of 2009.

Results of the F991 R&D biotechnology project

Scientific studies have indicated that the F991 peptide has potential in the treatment of a number of related immunological conditions such as asthma, multiple sclerosis, contact dermatitis and Crohn’s Disease. The clinical development of the peptide is currently in Phase IIA, which involves testing the clinical efficacy of the agent in relatively small-scale trials. In an initial proof-of-concept Phase IIA study in a small group of patients who are sensitive to nickel, a reduction in allergic skin complaints was observed in response to topical application of F991.

The Phase IIA study started in 2004 in collaboration with Groningen University Hospital of the efficacy of F991 in patients with a sensitivity to house dust mite and peanut allergens was completed in 2005. Statistical analysis of the study results showed that, in comparison with a placebo, the F991 peptide, applied topically, produced a significant reduction in allergic skin reactions in treated patients. These results, which confirmed the potentially therapeutic effect of the F991 peptide, will be published in detail in a clinical scientific journal.

Fornix intends to pursue the clinical development of F991 by entering into a cooperation agreement with a suitable pharmaceutical partner and expects the findings of the recent Phase IIA study to improve the prospects of concluding such an agreement.

Future R&D strategy

If Fornix is able to find a partner for F991, it will bring Fornix’s last biotech research project to a conclusion, consistent with the strategy adopted by the company some time ago to focus more on projects which are at an advanced stage of development.

The progress of the clinical development programme for the Allergy Division's Oralgen[®] allergen is crucially important to the company. In the longer term, positive evaluation of the applications for registration of the principal anti-allergy products will be an essential to expansion of the marketing and sales activities on behalf of the Oralgen[®] products. In pursuit of this objective, the company has already implemented, in conjunction with an external consultancy, an extensive clinical development plan for its sublingual immunotherapy products for the coming years. In the context of this clinical development plan, the company has entered into an agreement with a leading clinical research organisation. Given the special regulatory position of anti-allergy products in the Netherlands, Fornix will give full weight in the clinical development plan to the Pharmaceuticals Assessment Committee’s requirements regarding the clinical evidence supporting the relevant applications for registration. Investments in this clinical development plan over the coming five years are expected to amount to at least EUR 10 million (in 2006 an amount of EUR 2,0-2,5 million is expected).

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Several interesting scientific advances are in progress which could lead to fundamentally improved forms of immunotherapy in the future, such as the development of recombinant allergens and new adjuvants which can regulate the immune response. Fornix is monitoring these developments closely, so that it can participate in projects which offer attractive clinical and commercial prospects.

The changes to the corporate structure which will have the effect of reducing the number of core divisions to three will create a more efficient and transparent organisation.

2005 results

More information on the course of business and provisional results for 2005 will be given in a press release published before start of trading on 24 January 2006.

Lelystad, 23 December 2005

Fornix BioSciences N.V. Board of Management

Note for editors

For more information:

C.L. Bergman, CEO Fornix BioSciences N.V. Tel. +31 320 267 799 / +31 65 381 1747 www.fornix.nl

Profile of Fornix BioSciences N.V.

Fornix BioSciences N.V., which has its headquarters in Lelystad (Netherlands), engages in the production, marketing and sale of therapeutic anti-allergy products and medical aids and the purchasing, marketing and sale of patented pharmaceuticals. The activities are carried on by three divisions, which in turn are made up of operating companies. The Allergy Division, consisting of ARTU Biologicals, specialises in the production and sale of anti-allergy products. The Trading Division, consisting of Fisher Farma, trades in patented pharmaceuticals. The newly formed Medical Aids Division consists of Laprolan, which specialises in the marketing, sale and distribution of medical and nursing consumables for urological care, stoma care and wound care, washable incontinence materials and pressurerelieving mattresses, and Artu Medical, which specialises in the marketing and sale of medical aids such as silicon dressings and hip protectors. Fornix BioSciences N.V. shares are listed on the Official Market of the Euronext Amsterdam stock exchange (code AFORBI).

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