FDA move gives biotech shares a rocket ELI GREENBLAT July 14, 2010 - 11:05AM .Biotech company ChemGenex Pharmaceuticals shares soared after the company said it had agreed with the powerful US Food and Drug Administration for a potential regulatory path to advance its treatment of patients with Chronic Myeloid Leukemia.
It said that based on the discussion with the FDA, ChemGenex intended to combine data from its two pivotal studies, Study 202 and Study 203, and submit a new drug application for its leukemia drug Omapro for those patients with CML who have failed prior treatment with two or more currently approved tyrosine kinase inhibitors.
The proposed indication of this new drug application will be for the treatment of CML patients regardless of their mutation status.
ChemGenex shares reacted positively to the agreed process with the FDA, surging 6 cents, or 21 per cent, at 34.5 cents.
In March, the FDA delayed giving its blessing to the treatment, sending the local junior biotech's shares crashing 62 per cent.
At the time ChemGenex chief executive Greg Collier said the market might have misunderstood the FDA process that ChemGenex was going through to gain eventual commercialisation of Omapro, and that despite an FDA subcommittee voting seven to one to review diagnostic aspects of the drug, the regulator made no negative commentary about its safety or efficacy.
The regulatory stumble was triggered when the FDA asked its Oncologic Drugs Advisory Committee if a diagnostic test to determine whether a CML patient had a particular mutation should be required and reviewed before Omapro was approved.
ChemGenex believes its Omapro drug will be able to treat patients with the mutation, known as T315I, which can develop in some patients and is not treatable by the traditional leukaemia drug Gleevec.
This morning Dr Collier said the FDA's agreement that a combined data set could serve as the basis of a new drug application and provided the company with a pathway to an expanded indication for Omapro to treat CML patients who are resistant to at least two TKIs.
``We welcome the opportunity granted by the agency to submit combined data from our two completed pivotal studies and to potentially provide a new therapeutic choice for this significant group of patients who currently have very limited treatment options,'' he said.
ChemGenex expects to file the new drug application by the end of 2010.
