Celsion’s GEN-1 Immunotherapy Receives Orphan Drug Designation from the European Medicines Agency
Approval Adds 10 Years of Market Exclusivity Following Marketing Authorization in
The OVATION 2 Study combines GEN-1 with the standard of care for the treatment of newly diagnosed patients with Stage III and IV ovarian cancer who will undergo standard neoadjuvant chemotherapy followed by interval debulking surgery. The OVATION 2 Study is a randomized Phase I/II study designed to evaluate the safety of 100 mg/m² of GEN-1 in the Phase I portion, followed by a continuation at the safe dose in the Phase II portion in an open-label, 1:1 randomized design.
"EMA's orphan drug designation for GEN-1 recognizes the urgent need for new therapies to treat ovarian cancer, an aggressive, rapidly progressing disease with few effective treatment options," stated
As established by the EMA, Orphan Medicinal Product Designation (the “Designation”) by the
Benefits for the Designation are manifold and include:
- 10 years of market exclusivity (in which other industry sponsors are prevented from entering the market with a similar product for the same therapeutic indication);
- EMA protocol assistance for sponsors on the conduct of the tests and trials necessary to demonstrate their quality, safety and efficacy, or regulatory assistance;
- EMA advice will be free or given in return for reduced fees;
- Access to a centralized procedure allowing immediate marketing authorization in all Member States and facilitating the availability of medicines to all patients in the EU;
- Eligibility for a reduction of regulatory fees associated with pre-authorization inspections, as well as, marketing authorization application fees and certain other fees for qualifying companies.
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Source: Celsion CORP