|
Marketing Authorization Normally Anticipated within 67 Days in the EU
TARRYTOWN, NY, USA | Jul 25, 2008 | Regulatory News: EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion regarding the marketing authorization for Ceplene(R) (histamine dihydrochloride), for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. Ceplene is to be administered in conjunction with low-dose interleukin-2 (IL-2). This positive opinion was issued following a request made by EpiCept to have the initial negative opinion of March 2008 re-examined by the CHMP. Ceplene has been designated as an orphan medicinal product, and as such is entitled to 10 years of marketing exclusivity in the EU.
EpiCept attended an oral explanation hearing at the CHMP's plenary meeting on July 22, 2008. Following this oral explanation, the CHMP recommended that Ceplene be granted a full marketing authorization under the provision of Exceptional Circumstances.
As part of granting of the marketing authorization under Exceptional Circumstances, EpiCept has agreed to perform two post-approval clinical studies. One of the studies seeks to further elucidate the clinical pharmacology of Ceplene by assessing certain biomarkers in AML patients in first remission. The other study will assess the effect of Ceplene/IL-2 on the development of minimal residual disease in the same patient population. EpiCept is entitled to seek further guidance on the design of such studies from the EMEA through the protocol assistance procedure.
"We are thrilled with the positive opinion reached by the CHMP and are pleased by the overwhelming support for Ceplene we received from key opinion leaders in hematology across Europe during this successful re-examination effort," stated Jack Talley, President and CEO of EpiCept. "Ceplene, in conjunction with IL-2, is the first therapy shown to significantly prolong leukemia-free survival and prevent relapse in AML patients in first remission."
The CHMP's recommendation will now be forwarded to the European Commission for issuing a marketing authorization in the form of a Commission Decision, which normally occurs within 67 days. The marketing authorization with unified clinical usage for Ceplene granted under the Centralized Procedure will be valid for the entire European Union as well as in Iceland, Liechtenstein and Norway.
"We are highly optimistic about the commercial prospects for Ceplene and we intend to pursue its commercial introduction as expeditiously as possible," continued Mr. Talley. "We are evaluating all of our strategic options for the marketing of Ceplene, and will continue to work towards realizing the drug's potential to fulfill an important unmet medical need for AML patients in Europe."
About Acute Myeloid Leukemia (AML)
AML is the most common type of leukemia in adults. There are approximately 40,000 AML patients in the EU, with 16,000 new cases occurring each year. Once diagnosed with AML, patients are typically treated with induction chemotherapy and consolidation therapy, with the majority achieving complete remission. However, about 75-80% of patients who achieve first remission will relapse, with the median time in remission before relapse being only 12 months with current treatments. Less than 5% of relapsed patients survive long term.
About Ceplene
Ceplene is EpiCept's compound for the treatment of AML. Ceplene is designed to protect lymphocytes responsible for immune-mediated destruction of residual leukemic cells. Laboratory research has demonstrated that Ceplene reduces formation of oxygen radicals from phagocytes, inhibiting NADPH oxidase and protecting IL-2-activated NK-cells and T-cells.
About EpiCept Corporation
EpiCept is focused on unmet needs in the treatment of cancer and pain. The Company's broad portfolio of pharmaceutical product candidates includes several pain therapies in clinical development and a lead oncology compound for AML. In addition, EpiCept's ASAP technology, a proprietary live cell high-throughput caspase-3 screening technology, can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells. Two oncology drug candidates currently in clinical development that were discovered using this technology have also been shown to act as vascular disruption agents in a variety of solid tumors.
SOURCE: EpiCept Corporation |
