Spain's Zeltia says appeal on cancer drug rejected
By Julia Hayley
MADRID, Nov 20 (Reuters) - Spanish biotech company Zeltia (Madrid:ZEL.MC - News) said on Thursday European regulators rejected its appeal of a decision denying marketing approval for Yondelis, an anti-cancer drug it is developing with Johnson & Johnson (NYSE:JNJ - News).
The news sent its share price tumbling more than 10 percent and analysts said Zeltia was now unlikely to have any drugs on the market before 2006.
Yondelis, made from sea squirts, was denied clearance for use on soft tissue sarcomas in July.
The regulator, however, has since granted it "orphan drug" status for ovarian cancer, which will give it 10 years of exclusivity if it is approved for that use.
Zeltia's Pharma Mar unit is developing the drug in partnership with Johnson & Johnson and may still win approval for the U.S. market for soft tissue sarcomas, or for use in treating ovarian or breast cancer, analysts said.
Trading in Zeltia shares was delayed when the market opened because of a rush of sell orders. When it did start, the stock tumbled almost 12 percent. At 1030 GMT, it was 10.5 percent lower at 5.52 euros.
U.S. POSSIBILITIES
The European Agency for the Evaluation of Medicinal Products (EMEA) told Zeltia on July 24 it was refusing clearance for Yondelis for soft tissue sarcomas -- rare and usually fatal forms of cancer that attack muscles, fat or blood.
The company subsequently said it would appeal and that it had widespread support from oncologists.
But the regulator stuck by its decision, which maintained the drug's benefits were not sufficiently well proven to offset the risk involved. It also questioned the testing methods.
"It's the end of the line for Yondelis and soft tissue sarcomas in Europe," said an analyst at a foreign broker in Madrid.
The next step is for the regulator to send its final opinion to the European Commission, an EMEA spokesman said. Zeltia could still challenge the decision at a higher level, but the Commission has never reversed an EMEA ruling.
"It's now up to J&J to take the whole process of approval forward by winning Food and Drug Administration (News - Websites) approval for larger indications such as ovarian and breast cancer in the U.S.," the analyst said.
"The problem is, this has pushed out the potential to 2006 to get the drug into the market, so we are taking a big step backwards," added the analyst, who has a "sell" recommendation and a target share price of 4.5 euros.
He said the logical next step for Zeltia would be to seek marketing agreements with multinationals, not necessarily J&J, for the second and third drugs in its pipeline.... |
