Market access for expensive rare disease medications in CEE countries is very challenging and as such difficult to arrange from company headquarters abroad without having a relevant local expertise in each individual country. Small and mid-size companies simply cannot afford to build its direct presence in each country of CEE region, hence they need a reliable and experienced partner representing them in each individual country. That’s what ExCEEd Orphan represents an experienced and reliable provider of full commercialisation services in 17 countries of CEE region (Central & Eastern Europe – including Baltics)for small and mid-size companies developing and marketing medicines for rare or ultra-rare diseases as well asgene therapies. The company is committed to delivering unique medicines of its clientele to each and every patient with rare diseases by providing integral business solutions. “We possess in depth knowledge of our local markets and profound understanding of all processes related to market entry and commercialization of innovative medications,” begins Jiri Hermanek, Founding Partner, CEO & GM, ExCEEd Orphan.

As a single partner, ExCEEd Orphan offers services for all needed aspects of launching and marketing rare disease medications from market assessment through KOL engagement, market access negotiations, medical education and marketing up to distribution. The company provides market assessment for each individual country including identification of key diagnostics and treatment centres and relevant KOL’s while maintaining complete engagement with relevant KOL’s to ensure their support. The company facilitates identification and implementation of optimal market access strategy, preparation and submission of pricing and reimbursement dossier as well.

ExCEEd Orphan represents its clients in the pricing and reimbursement negotiations with authorities and payers. It also offers medical education activities, patients identification programs, distribution of medications to the treatment centres as well as cash collection from the countries. In fact, what makes the company stand out from the crowd is their incomparable experience and expertise in rare disease area in each country mixed with the genuine passion for helping the patients suffering from rare diseases. Moreover, ExCEEd Orphan have profound contacts and strategic partnerships with all relevant stakeholders and decision makers involved in bringing your unique and innovative medicine to each and every patient with rare diseases.

As a company, ExCEEd Orphan has proven and strong track record of more than 100 years of cumulative experience with setting up and developing orphan drug businesses across Central & Eastern Europe. The vision that inspired the creation of ExCEEd Orphan was to bring innovative medications to patients suffering from rare diseases in CEE countries as soon as feasible eliminating years of delays caused by neglecting smaller countries of CEE region. The initial years of the company were dedicated to build up a brand and customer base through multiple consulting engagements with partners like Avexis (providing medical support for introduction of Zolgensma in CEE region before EMA approval). Over the time ExCEEd Orphan hired additional experts in the countries to ensure sufficient coverage of all relevant markets.

An interesting insight that highlights the company’s value proposition is when the team assisted AveXis. Since March 2019 ExCEEd Orphan represented AveXis, a small US-based company developing a revolutionary gene therapy for life-threatening SMA disease. AveXis did not have any direct presence in CEE countries and was completely lacking local know-how. ExCEEd Orphan identified key diagnostics and treatment centres in each country and through KOL’s engagement ensured understanding of SMA gene therapy concept and its life-saving potential. Before EMA approval in May 2020 (and subsequent take-over of AveXis by Novartis) ExCEEd Orphan assisted AveXis in arranging  treatment for 15 babies from CEE countries (some of them traveling for treatment to US despite severe covid restrictions).

In March 2021 ExCEEd Orphan established a central distribution hub in Zagreb, Croatia with the aim to offer full commercialisation service including distribution in CEE region. In the near future ExCEEd Orphan will need to strengthen further its team by adding additional experts in the countries to be able to deliver on all commercialisation contracts, the company already managed to sign and be prepared to serve additional clients interested in the services. “In parallel, with increasing number of products we are strengthening our functional capabilities in Medical, Regulatory, PV and Compliance areas. Our strategic partnership with Rafa Laboratories as well as our membership in Your Pharma Partner Alliance(covering CEE plus Nordic and Benelux countries)will enable ExCEEd Orphan to attract additional important clients,” concludes Hermanek.