Spain’s Zeltia says its PharmaMar unit has concluded patient enrolment, ahead of schedule, for Phase III trials of a treatment for relapsed ovarian cancer that is being developed along with partner Johnson & Johnson.
The study compares the use of the cancer agent liposomal doxorubicin, sold by Schering-Plough in Europe as Caelyx and by J&J unit Ortho Biotech in the USA as Doxil, in combination with PharmaMar’s own lead compound Yondelis (trabectedin) versus doxorubicin alone in ovarian cancer patients who have relapsed after receiving standard first-line platinum-based chemotherapy.
Zeltia said the target number of patients for the study, which began two years ago, was 650 patients in 130 hospitals across 21 countries. In total 672 patients were enrolled in less than the two years initially planned, it added, noting that a marketing application is on track for filing in Europe and the USA during 2008.
Zeltia is still waiting to hear from the European Agency for the Evaluation of Medicinal Products as to whether Yondelis will be approved as a second-line treatment for advanced soft tissue sarcoma. The company recently presented new data at the American Society of Clinical Oncology meeting in Chicago which confirmed the benefits seen in other Phase II studies of Yondelis on the treatment of STS and said that a new study has revealed a significant delay in the onset of tumours for STS patients who have been previously treated with conventional therapies. It also shows a significant increase in life expectancy, Zeltia concluded.
Faes signs deal with Roche and GSK for osteoporosis drug
Meantime, Faes Farma has signed an agreement with Roche and GlaxoSmithKline to market the firms’ postmenopausal osteoporosis agent Bonviva in Spain.
The two European drug giants have been marketing Bonviva (ibandronate) in Spain since January and now Faes will also sell the treatment as Bondenza, once the necessary approval from the country’s health authorities is received. The Bilbao-based company added that the postmenopausal osteoporosis market in Spain is worth around 200 million euros.