Shares at biotechnology group Zeltia have been slipping the last couple of days after partner Johnson & Johnson said it probably will not seek approval for the cancer drug Yondelis in the USA this year but the Spanish firm believes that the announcement is no cause for alarm.
A spokesman for the Madrid-headquartered company told PharmaTimes World News that J&J is not likely to present Yondelis (trabectedin) to the US Food and Drug Administration as a second-line treatment for advanced soft tissue sarcoma
this year but a filing for the treatment, discovered by Zeltia subsidiary PharmaMar, in the more lucrative indication of ovarian cancer is expected to made next year.
Over on this side of the Atlantic, Zeltia is still waiting to hear from the European Agency for the Evaluation of Medicinal Products as to whether Yondelis will be approved in the soft tissue sarcoma indication. The company submitted its request at the end of July last year and industry observers have noted that as the six-month period since the filing is almost up, an announcement may be forthcoming.
However the Zeltia spokesman said that the EMEA’s time for making a decision runs up to 15 months, with the average time being 10-11 months, so there is no great hurry. However, the company, which kept the European marketing rights to the drug when the J&J deal was signed in 2001, is preparing the groundwork for when, or if, the green light comes.
This is the second time that Yondelis has been up in front of the EMEA which rejected the compound in July 2003. Zeltia appealed that decision but was turned down again the following November.
Partner soon for aplidine
As for the firm’s second anti-tumour compound, aplidine, the Zeltia spokesman told PharmaTimes World News that discussions are well-advanced in terms of securing a licensing partner. Talks are taking place with both US pharmaceutical and biotechnology firms but he would not be drawn on how many prospective partners there are. Any deal would likely be similar in structure to the Yondelis pact with J&J but the spokesman concluded by saying that Zeltia is flexible in these matters.
An announcement would halt the decline in the firm’s share price, though the importance of the fall has been exaggerated in some circles, given that Zeltia’s stock has risen 20% over the last year.