Bioenvision, Inc. announced an update on the status of its Marketing Authorization Application to the European Medicines Evaluation Agency (EMeA) to include a new indication for Evoltra (clofarabine) for the treatment of acute myeloid leukaemia (AML) in elderly patients who have one or more of the following: adverse cytogenetics, secondary AML, ? 70 years old or significant co-morbidities and are therefore not considered suitable for intensive chemotherapy.
Evoltra is currently approved in Europe for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.
In May 2007, Bioenvision received a Request for Supplemental Information from the EMeA's Committee for Medicinal Products for Human Use. In order to allow Bioenvision to fully respond to this request, the EMeA has agreed to accept the Company's responses by November 16, 2007. This extension of time to respond will enable Bioenvision to prepare more comprehensive responses to the Request for Supplementary Information, including interim data from the ongoing, multi centre AML 16 study. The Company anticipates that in December, 2007 the EMeA will provide an Assessment Report, and in January 2008 the EMeA will provide either an Opinion on whether or not to grant the request of marketing authorization of the drug for this new indication, or a second request for Supplementary Information.
It should be noted that the foregoing may be subject to change and the Assessment Report and/or Opinion may require Bioenvision to provide further data and/or to attend an oral explanation. The Opinion of the EMeA is also required to be adopted by the European Commission as a pre-condition to the grant of marketing authorization of Evoltra for this new indication. In addition, in relation to the Company's variation application to include a new indication (elderly AML), the EMeA has requested that data from the ongoing AML 16 trial be provided. The AML 16 trial, sponsored by the National Cancer Research Institute (UK), randomizes clofarabine against the standard of care (low-dose cytarabine) for the treatment of elderly patients with adult AML who are not considered suitable for intensive chemotherapy. The company believes it will be able to make data from this trial available to the EMeA by November 2007, to satisfy this request. There can be no assurances, however, that this data will be made available to the Company for its application. The AML 16 trial will not be fully enrolled at the time of submission of the company's response to the EMeA and there can be no assurances that interim data will be satisfactory, or that the data itself will be supportive of the Company's application. Further, if the EMeA does not accept this data, the Company may have to run an additional randomized study.
Evoltra is currently approved in Europe for "the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients less than or equal to 21 years old at initial diagnosis."
Clofarabine is in clinical development for the treatment of other haematological cancers and solid tumours. Bioenvision has conducted a phase I clinical study of Evoltra for the treatment of psoriasis and is planning further worldwide development of Evoltra in autoimmune diseases.
Evoltra (clofarabine) is a next generation purine nucleoside analog. Bioenvision holds an exclusive worldwide license (excluding U.S. and Canada) for the cancer applications of clofarabine and an exclusive worldwide license for all non-cancer indications. Bioenvision granted an exclusive sublicense to Genzyme Corporation to develop and commercialize clofarabine for certain cancer indications in the US and Canada, which Genzyme markets under the name of Clolar. Bioenvision originally obtained clofarabine development and commercialization rights under patents held by Southern Research Institute.
Clofarabine has been granted orphan drug designation for the treatment of both ALL and AML in the U.S. and Europe. In Europe, the designation provides marketing exclusivity for 10 years following Marketing Authorization.