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To: Chairman of the Board of Directors, President and CEO of Chugai Dr. O.Nagayama

 Dear Dr. Nagayama,

 Allow me to express my deepest respect to you personally and to your Company. F.Hoffmann-La Roche is very well-known in Russia. I have many very fruitful interactions  with representatives from the  Russian office, particularly regarding interferon therapy for  viral hepatitis.

The purpose of my contact concerns another issue: lymphangioma of the head and neck in children. Chugai Pharmaceutical produces the preparation picibanil (Trade Mark OK432) that is now under license to F.Hoffmann-La Roche. Many countries, including the US, Canada, Israel and those of the European Community, have certified Picibanil. Unfortunately it was not used in the USSR. As a result it is not approved in any former Soviet countries including Russia and Ukraine. All children in the former Soviet Union (and adults as well) who are diagnosed with this pathology are treated surgically. There is documented evidence that surgery has many negative side effects for patients with lymphangioma. Among the side effects most often mentioned by investigators are damage to the facial nerve and severe blood loss.

Sclerotherapy of lymphangioma with picibanil is an established therapy for those suffering from this pathology.  Professor Kurosh Paya of the University of Vienna has successfully treated my daughter. She has undergone four injections with very positive results. The results of treatment by picibanil are very encouraging.

Unfortunately  no medical practitioners here are familiar with this method.  Local pediatric surgeons have no exposure to picibanil. My goal is to register picibanil in Russia. For me this is a philanthropic undertaking, not a commercial one. The law here requires that a legal entity initiate the registration process after having obtained your consent. I have found a company that is willing to undertake the registration process. The company is a distributor of pharmaceuticals in Russia. To begin the registration process they need an official approval from F. Hoffmann-La Roche.

Once picibanil is registered in Russia I will find appropriately experienced practitioners who can be trained in the proper use of this treatment. Initially I anticipate that we can have 2-3 medical centers qualified to treat children with lymphangioma by injections of picibanil.  The absence of official registration is now the only restriction. Dr. Nagayama, can you please advise me whether it is possible to have authorization from your Company to initiate the picibanil registration process in the Russian Federation and what steps we need to take to receive this authorization.

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