Spain’s Zeltia and its PharmaMar unit are in celebratory mood this morning having just received European approval for its cancer agent Yondelis for soft tissue sarcoma.
The European Commission has acted on the European Medicines Agency’s Committee for Medicinal Products for Human Use’s positive opinion given two months ago and approved commercialisation in the 27 countries of the European Union of Yondelis (trabectedin) as a second-line treatment for advanced soft tissue sarcoma. The drug “is the first of marine origin and resulting from Spanish research”, Zeltia noted.
Luis Mora, deputy general manager of PharmaMar, said that the treatment will be available as soon as negotiations with the relevant health authorities in each country regarding price and other administrative issues have begun. The first two countries to get access to the drug will be the UK and Germany, where the aforementioned negotiations are not necessary. After that, claimed Alfonso Casal, PharmaMar’s marketing and sales director, the company expects to cover 75% of the potential market of Yondelis in the 12 months following the EC authorisation.
In terms of selling the drug, PharmaMar has set up what it calls “a specialised sales structure” which means that a number of deals have been struck with “prestigious European organisations” to market the product.
In Western Europe,, PharmaMar will have a sales network established in
collaboration with Innovex (a Quintiles Group subsidiary). Also
promotion and commercial distribution agreements have been signed with Swedish Orphan International for the Nordic Countries and Eastern Europe and with Genesis Pharma for Greece and Cyprus.
Jose María Fernandez Sousa said that it is “a challenge for us to be the head office of a multinational sales network”, but “we are convinced that our spirit and determination…will allow us to accomplish this activity successfully. The decision ends a long wait for Zeltia and the firm’s US partner Johnson & Johnson said earlier this year that it is not likely to present Yondelis to the US Food and Drug Administration for soft tissue sarcoma this year but a filing for the treatment in the more lucrative indication of ovarian cancer is expected to be made next year.