pSivida Corp. PSDV, a specialty pharmaceutical company that
is a leader in the development of sustained release ophthalmic drug
treatments, today announced that its licensee Alimera Sciences, Inc. reported
a number of updates with respect to ILUVIEN® for chronic diabetic macular
edema (DME).
Alimera announced that it intends to resubmit its New Drug Application for
ILUVIEN for DME to the U.S. Food and Drug Administration (FDA) by the end of
March 2013. Using data from Alimera's two previously completed pivotal Phase
III clinical trials (FAME™ Study), the resubmission will focus on the safety
aspects of ILUVIEN and the population of patients with chronic DME considered
insufficiently responsive to available therapies, the same group for which
marketing approval for ILUVIEN has been granted in various EU countries,
according to Alimera. Approval in the U.S. would entitle pSivida to a $25
million milestone payment from Alimera and 20% of net profits, as defined,
from U.S. sales of ILUVIEN by Alimera.
Alimera also announced that shipments of ILUVIEN to the German market are
expected to begin in the second quarter of 2013 upon acceptance from the
Medicine and Health products Regulatory Agency of the intended commercial
batch size, a delay from Alimera's previous expectation that this would occur
in the first quarter of 2013. Alimera further reported that it also expects to
begin shipments to the U.K. in the second quarter of 2013 for treatment of
privately insured patients.
Alimera reported the submission of a patient access scheme (PAS) for ILUVIEN
for DME has been agreed to by the UK's Department of Health and is now under
consideration by NICE for inclusion in its rapid review facility. NICE had
previously issued final guidance that ILUVIEN is not a cost-effective
treatment for chronic DME considered insufficiently responsive to available
therapies. Alimera reported that under the review facility, NICE is expected
to assess the impact of the PAS on ILUVIEN's cost effectiveness and determine
whether an update to the final guidance is warranted.
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