Targacept, Inc. (Nasdaq: TRGT), a clinical-stage biopharmaceutical
company developing a new class of drugs known as NNR Therapeutics™,
today announced that its collaboration and license agreement with
AstraZeneca for the global development and commercialization of TC-5214
for major depressive disorder (MDD) has become effective as a result of
early termination of the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act. Effectiveness of the agreement triggered an
upfront payment of $200 million from AstraZeneca to Targacept.
AstraZeneca and Targacept are preparing for the planned mid 2010
initiation of Phase 3 clinical development of TC-5214 as an adjunct to
antidepressant therapy in adults with MDD who do not respond adequately
to first-line antidepressant treatment, with the goal of filing a new
drug application with the U.S. Food and Drug Administration in 2012. The
companies also plan to conduct a Phase 2 study exploring TC-5214 as a
monotherapy for MDD.
Details of the Collaboration and License Agreement
As previously announced, Targacept is eligible under the agreement to
receive an additional $540 million if specified development, regulatory
and first commercial sale milestones are achieved, up to an additional
$500 million if specified sales related milestones are achieved and
significant stepped double-digit royalties on net sales worldwide. Under
the terms of an existing license agreement, Targacept is required to pay
a percentage of the upfront payment and each of the milestone payments
that may be received from AstraZeneca, as well as royalties, to the
University of South Florida Research Foundation. Targacept has retained
an option for a co-promotion of TC-5214 to a limited target physician
audience in the United States.