Zeltia (ZEL) . Edison Healthcare Insight | 30 June 2015 // Analyst Christian Glennie .
INVESTMENT SUMMARY :
Zeltia is focused on the potentially high-growth marine oncology activities of its PharmaMar business and plans to conduct a reverse-merger whereby PharmaMar would absorb Zeltia, in advance of seeking a US IPO. PharmaMar has built a pipeline of first-in-class cancer drugs for development with strategic partners.
Zeltia’s FY14 results highlighted ongoing revenue (+6% to €149.7m) and profit (EBITDA €25.7m, +8%) growth, with Yondelis remaining the key contributor. Further potential catalysts in 2015 include fresh Yondelis approvals for soft tissue sarcoma in the US (PDUFA in October) and Japan (Q315); Aplidin Phase III data in multiple myeloma (Q415); and a Phase III study initiation for PM01183 (2nd generation Yondelis) in small cell lung cancer (SCLC).
INDUSTRY OUTLOOK :
Repositioning the group behind the PharmaMar name and conducting a US IPO could be transformational. The oncology portfolio has been validated through multiple global partnerships, eg J&J in the US and Taiho in Japan (over Yondelis) and Chugai in certain EU countries (for Aplidin).
DESPUES DE 18 AÑOS CON SOLO TOPOTECAN CON FULL APPROVAL EN EEUU COMO TREATMENT 2a LÍNE SCLC-ES ... LA USFDA ACABA DE APROBAR AL TARLATAMAB CON FULL APPROVAL ... POR LO QUE ES YA EL NEW TREATMENT STÁNDARD EN EEUU . TIENE APROBACIÓNES ACELERADAS EN CANADA , UK, COREA ... Y EN DÍAS PODRÍA ALCANZAR LA APROBACIÓN TAMBIÉN EN CHINA QUE EN JULIO 2025, LA NMPA ACEPTÓ LA SOLICITUD DE REGISTRO (NDA) PARA TARLA OTORGÁNDOLE ADEMAS LA REVISIÓN PRIORITARIA . LA EMA TAMBIÉN LO ESTÁ YA EVALUANDO .
