Kiadis Pharma obtains SME status from EMEA
Groningen, 21 July 2007 – Oncology focused pharmaceutical product development company Kiadis Pharma announced today that the European Agency for the Evaluation of Medicinal Products (EMEA) has granted the company the SME (Small and Medium Sized Enterprises) status. This status for medical companies provides access to provisions for administrative and financial assistance. Kiadis Pharma will use this status to support the development of novel treatments for significant unmet medical needs in the field of bone marrow transplants and the treatment of aggressive cancers.
The SME program is an EMEA initiative to address the needs of small and medium sized companies who are developing medicinal products in Europe. Companies with SME status can receive assistance, information and training from dedicated EMEA employees. These companies are also eligible for reduced or deferred fees associated with regulatory submissions, scientific advice and inspections.
The SME status will immediately benefit Kiadis Pharma by facilitating the regulatory filing processes for the companies most advanced products in clinical development. Kiadis Pharma’s lead products include ATIR™ under development for a treatment that may enable end stage blood cancer patients to receive bone marrow transplants, including donor immune cells from mismatched donors. ATIR selectively eliminates cells from donors graft that can cause acute Graft-versus-Host-Disease. Rhitol™ under development for treatment of severe, steroid resistant chronic Graft-versus-Host-Disease and Reviroc™ for elimination of blood cancer cells from autologous grafts.
More news
- Kiadis Pharma signs license agreement with Hospira to commercialize ATIR™ in Europe and Asia - Partnership would advance innovative stem cell transplant product 4-1-2011
- Kiadis Pharma receives IND approval from FDA to start pivotal clinical trial with ATIR™ 8-7-2010
- Kiadis Pharma Provides ATIR™ Update: Two Year Follow-Up Data Show No Cases of Transplant Related Mortality - FDA grants ATIR™ Orphan Drug Status as a Medicinal Cell Based Therapy to Reduce Transplant Related Mortality 28-4-2010
- Kiadis Pharma announces enrollment of first patients in a multinational registration study for ATIR™ 29-11-2009
- Promising clinical data from Kiadis Pharma’s lead product ATIR™ will be presented at the 51st American Society of Hematology’s (ASH) Annual Meeting 5-11-2009
- Kiadis Pharma reports ATIR™ clinical data, further supporting its potential in mismatched bone marrow transplantations - ATIR™ data presented at the annual EBMT Presidential Symposium 8-4-2009
- Kiadis Pharma presents at the EBMT in Göteborg 31-3-2009
- Kiadis Pharma’s lead investigator presents results ATIR™ clinical trial at the BMT tandem meeting 6-2-2009
- Kiadis Pharma appoints Dr. Maarten Egeler, MD PhD as Chief Medical Officer 6-1-2009
- Kiadis Pharma announces appointment of Mark Skaletsky to its Supervisory Board 11-12-2008


