Zeltia to press ahead with rejected cancer drug
pharmafile | February 4, 2004 | News story | |Â Â Â
Zeltia has unveiled a three-year business plan to put itself back on track after lead cancer drug Yondelis was rejected by the EMEA.
A panel of experts at Europe medicines regulator voted against approving the drug by a narrow margin because of a lack of sufficiently convincing data, a decision which has now forced the company to make radical cuts to remain solvent.
The primary goal is to extend Zeltia's cash resources, currently about E100 million, until the end of 2006 and to launch Yodelis in Europe by 2006.
The company expects Yondelis' first indication to be soft tissue sarcoma, endometrial or ovarian cancer and says partner Johnson & Johnson remains fully committed to the joint development plan.
Zeltia chairman Jose Fernandez said: "The objective of the revised plan is to use our existing resources to progress the development of our most advanced drug candidates, with a view to launching a product on the market as soon as possible and taking the company into profit."
In addition to Yondelis and Aplidine, Zeltia drug unit PharmaMar has two other clinical cancer products Kahalalide F and ES-285 in phase II trials for several indications.
The key features of the 2004-2006 plan are:
- Registering Yondelis in Europe in 2006.
- Licensing out anticancer drug Aplidine within the period 2004-2006.
- Cutting cash burn by 33% (commercial, production and drug discovery) in 2004, and maintaining a fairly stable rate in 2005 and 2006.
- Focusing its activities on development of compounds in advanced clinical and pre-clinical trials.
Zeltia does not plan to raise further capital during the planning period, expecting the E100 million plus extra-revenues of E60 million, mostly from expected sales of Yodelis (E20 million) and the licensing out of Aplidine (E25 million) and grants (E12 million) to tide them over.
The company also implemented a number of cost-saving measures in the second half of 2003 which should result in savings of E20 million per year.
The measures included a 37% cutback in R&D expenditure to 14.3 million and PharmaMar shedding 45 staff to its current level of 215 people.
PharmaMar plans to end 2006 with net cash of E12.4 million.
