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Company Presentation. corporate vision & strategy. Our mission is to... • be a solution partner for medical society and patients in specific therapeutic areas with using the principles of ethical and scientific working skills.
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corporate vision & strategy Our mission is to... • be a solution partner for medical society and patients in specific therapeutic areas with using the principles of ethical and scientific working skills. • help the individuals for a longer and healthier life with high quality and trust based products and services. • create a bridge between our company, medical society, state bodies and patient organizations, which is based on mutual respect and care. • create a mutual, long-run commitment with our customers. Our vision is to... • become a company which can easily adapt to the ever changing conditions of today’s world. • give the best service to the patients & society with team effort rather than individual movement.
current therapeutic area focus & capabilities Current main areas of interests are neurology and endocrinology (80% neurology, 20% endocrinology)
future (2011) therapeutic area focus & capabilities Future main areas of interest are neurology, onco-hematology and endocrinology(60% neurology, 20% onco-hematology, 20% endocrinology)
corporate financial results (million USD) There has been price cuts since 2002 in the Turkish pharma market sales forecast for 2009-2010
key economic indicators * estimated
key economic indicators • IP situation Turkey accepted the patent law and there is no genericor biosimilar risk for the patented products until patent expiry. • Data protection Data protection is not valid in Turkey yet. Expected time for validity in 2011.
healthcare system • Social Healthcare Association (SGK–State Controlled) isnow the mainbody for the control of healthcare system. • 2/3 of the population is under coverage. • Private Health Insurance covers 3%–4% of the population. • For state controlled healthcare system rules andregulations are announced by the related Ministries andSGK. Private Insurance Companies usually are very stricton the conditions of the agreements and try to limit the personal budget.
regulatory timeline • After the submission of the registration dossier,registration approval will be in 18 to 24 months. • FDA or EMEA files are accepted. • As of January 1st 2006, only CTD format is accepted by Turkish MOH.
pricing Cheapest ex-factory price of the 5 reference countries (Portugal,Spain, France, Italy, Greece) and country of originwill be accepted as Turkish exfactory price.
reimbursement MOH, MOF and SGK decides the product to be reimbursed(fully/partly) or not. There may be a indication limitation.Company applies for the reimbursement after getting theregistration. If there is any competitor (as a generic) which isalready registered, the new product’s reimbursement pricemust be lower than the competitor’s. If there is a registeredtherapeutic competitor, than the company should prove thatthe new product is more efficacious or has less side effectsin order to get a higher, same or lower reimbursement price. Pharmaco-economical data is required.
reimbursement discount By law, for all products which are accepted to the reimbursement list, 11% reimbursement discount is obligatory. Additional discount may be asked in some cases.
