NEW HAVEN, Conn. ( TheStreet) --The FDA's cancer drug advisory panel voted unanimously against approval of Vion's leukemia drug Onrigin. By a 13-0 vote, the panel recommended that a new randomized controlled trial be conducted before the drug is approved. The same panel rejected Genzyme's leukemia drug during a morning session for similar reasons. Vion shares closed Tuesday down 23% at $2.60.
Sequenom shares jumped 21% Monday to $6.39 on market chatter that an independent study by researchers at Brown University was going to released soon which would show Sequenom's genetic prenatal test for Down syndrome to be highly sensitive. But a researcher at Brown University called the rumor false, according to a story published Tuesday morning in the San Diego Union-Tribune. "I don't know where this rumor comes from, but I guarantee it didn't come from us, Glenn Palomaki, senior research associate at Brown's department of pathology and laboratory medicine, told the San Diego Union-Tribune. "We've done no study, and we're not releasing any interim data in the near future. Sequenom shares were down 10% to $5.73 in recent trading.
Dr. Richard Pazdur, chief of the FDA's cancer drug division, kicked off the advisory committee meeting with critical comments about the Clolar application. He reiterated the FDA's position that between 21% and 41% of the elderly patients enrolled in the study were, in fact, healthy enough to receive chemotherapy for their AML. Treatment with Clolar was associated with a 45.5% remission rate in the study, but Pazdur pointed out that many of these patients also responded to treatment with chemotherapy or other therapies after receiving Clolar. He also criticized Genzyme for seeking approval based on a phase III study that lacked a control arm. The FDA, in a previous meeting, told the company that such a trial would make interpretation of any Clolar data difficult, said Pazdur. A cancer expert invited to speak by the FDA then presented historical data showing that older patients with AML can treated with chemotherapy with positive results. The speaker also refuted Genzyme's notion that a controlled study of elderly patients with AML wasn't feasible. Genzyme experts countered with a presentation of the Clolar data showing that the remission rate in the pivotal study remained strong even when patients who may have benefited from standard chemotherapy were removed from the analysis. The company disagreed with FDA about the suitability of chemotherapy for elderly, high-risk AML patients, stating that historical data show the benefit-to-risk ratio is poor. Genzyme also stated that it tried to design a controlled study of Clolar in elderly AML patients but that the company and the FDA could not reach agreement on the design of the study. This forced the company to conduct the single-arm study.
The FDA presentation to the advisory committee just started. Check back later for updates, including the panel's debate and vote on whether or not to recommend Clolar's approval, expected to take place between 11 am and noon. This afternoon, the same panel of cancer experts will review another drug to treat AML, this one from Vion Pharmaceuticals ( VION.OB).
Barclays Capital analyst Rich Silver is also telling his clients not to chase Endo's stock ahead of the FDA approval decision date, although he's more bullish on the stock long term with an overweight rating and a $29 price target. "Trading at a compelling 7.3x our FY10 EPS estimate, Endo shares offer a very attractive risk/reward profile for longer term oriented investors, in our view," wrote Silver in a recent research note.