APREA: The European Medicines Agency recommends Orphan Drug Designation for APR-246 in Acute Myeloid Leukemia

Pressmeddelande   •   Feb 18, 2010 12:00 CET

Stockholm, Sweden – February 18, 2010. Aprea, a cancer research and development company, announces today that the European Medicines Agency has adopted a positive opinion recommending Aprea’s drug candidate APR-246 for designation as orphan medicinal product to the European Commission, for the treatment of acute myeloid leukemia (AML).

“We are very pleased that the European Medicines Agency has recommended APR-246 for orphan drug designation in AML, and we are looking forward to receive the final decision from the European Commission in a few weeks,” says Thomas Uhlin, CEO of Aprea AB. “This underscores the high unmet medical need for new drugs to treat patients with AML where only a minority of patients are currently cured from their disease. The incentives provided by orphan drug designation in Europe may enable Aprea to accelerate the clinical development of APR-246 and the designation is an important milestone in the company's strategy to achieve marketing authorization approval for this exciting drug candidate as fast as possible," says Thomas Uhlin.

APR-246 belongs to a new class of anticancer drugs and is currently being tested in clinical phase I. Patient enrolment runs according to schedule and the study is expected to be completed by the end of this year.

The European Commission may grant orphan drug designation to promising products that address life-threatening medical conditions affecting fewer than 5 persons out of 10,000 in the European Union (EU). Orphan drug designation provides companies with financial and regulatory incentives to pursue less common diseases. It should be noted that the orphan drug designation does not limit a drug to less common diseases. The drug may, in parallel or afterwards, also be developed for other diseases. If APR-246 receives marketing authorization approval, the designation will entitle exclusive marketing rights for at least 10 years following the approval.

For more information, please contact:

Thomas Uhlin, CEO, Aprea AB
Telephone: +46 705335137
Charlotta Liljebris, VP. Development, Aprea AB
Telephone: +46 703391534 


About Aprea AB
Aprea AB is a Swedish biotech company founded in 2003 and based on research performed at the Karolinska Institutet, Stockholm, Sweden. The company focuses its activities on discovery and development of novel anticancer compounds targeting the tumor suppressor protein p53. Aberrations in p53 are common in many various cancer forms and are associated with increased resistance to standard chemotherapy and thus poor prognosis. Aprea AB is currently initiating the commercialization process and seeking partners. Aprea is a Karolinska Development AB (publ) portfolio company. The other main owners are Industrifonden, Östersjöstiftelsen and Praktikerinvest.