Major interest in and potential for cyclosporine

An article published recently in the renowned medical journal The New England Journal of Medicine presented promising results which indicate that cyclosporine can be used to reduce damage in connection with heart attacks. This article has generated considerable interest, so potential investors in NeuroVive’s current rights issue have questioned the company about its potential in this area. NeuroVive would therefore like to comment on this and clarify royalty matters in relation to the company’s first product, NeuroSTAT®.

Background

The New England Journal of Medicine has published an article entitled “Effect of Cyclosporine on Reperfusion Injury in Acute Myocardial Infarction” (NEJM 359:5 p. 473-481). This article presents the results of a clinical study showing that damage from heart attacks can be reduced by administering cyclosporine to patients at risk. The journal also comments on this article (NEJM 359:5 p. 518-520).

Subscribers to the journal can view the article and comment on it at http://content.nejm.org

NeuroVive’s views on treating heart attacks with cyclosporine

This article is interesting first and foremost from a general care perspective, but is also specifically of interest to NeuroVive for two reasons. Firstly, the active substance, cyclosporine, which is used in the company’s first product, NeuroSTAT®, and was also used in the study above, influences mitochondrial energy production. This makes it possible to protect cells in the heart in the event of a heart attack, but also underlines the ability of the product (NeuroSTAT®) to protect brain cells in connection with cell death in the brain.

Secondly, this is one way in which NeuroVive can help treat patients with heart attacks, which should broaden the product’s applications. The company’s management intends to draw up a strategy for using NeuroSTAT® in heart attacks and assess the possibilities of developing a separate business unit for this purpose in autumn 2008. Of course, it helps that NeuroVive has a patented product with good pharmaceutical characteristics which could be used to treat patients with heart attacks. New and interesting areas and uses for the company’s products will always be considered, but the company remains focused on treating acute neurological damage. It is worth noting that these results further underline cyclosporine’s ability to protect mitochondriae as a cyclophilin-D inhibitor, which may be considered as reducing the risks in NeuroVive’s impending clinical studies in brain-damaged patients.

MD Eskil Elmér comments:

“As stated in the prospectus, NeuroSTAT® can already be used for existing indications after our phase I study. Of course, our product may also come to be used in new applications in the future. If cyclosporine starts to be used in heart attack patients, NeuroSTAT® could be an interesting candidate, bearing in mind that it is cremophore-free. There is potential here, but we haven’t yet discussed this in more detail at management level. I would like to point out that the focus is on enabling the treatment of patients with acute neurological damage, traumatic brain damage initially, although it would be great, of course, if our product could also be used for new indications or purposes in the future, as this would benefit our sales.”

Clarifying royalty relationship

NeuroVive has also been asked about royalties on the company’s first product, NeuroSTAT®, and would like to clarify matters here. NeuroVive has exclusive rights to the patent rights to a cyclosporine-A-based lipid emulsion from CicloMulsion AG. This exclusive global licence means that CicloMulsion AG receives royalties of 10% of NeuroVive’s net income attributable to neurological and non-immunosuppressive drugs (including drugs for treating heart attacks). The royalties for the immunosuppressive field alone amount to 30%.

NeuroSTAT®

NeuroSTAT® is an intravenous nerve-cell-protecting product which is free from cremophore (castor oil) and alcohol. Cremophore has been reported as causing hypersensitivity reactions (anaphylaxis) in some patients being treated. Using a cremophore-free product reduces the risks involved in treating various indications compared with cremophore-based products.

For more information contact:

Eskil Elmér
MD and CSO, Neurovive Pharmaceutical AB (publ)

Telefon: 46 (0)46-288 01 10
eskil(punkt)elmer(snabel-a)neurovive(punkt)se

NeuroVive is involved in research and development into cyclosporine-based drugs, also known as cyclophilin-D inhibitors. The company’s first product, NeuroSTAT®, is now ready for clinical trials in humans. NeuroVive is also involved in advanced research and development into new potential drugs that could protect nerve cells. The company holds broad patent rights to a family of drugs known as cyclosporines. NeuroVive intends to license products to major pharmaceutical companies for registration and marketing.