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Neovacs S.A.: Stellar Biotechnologies and Neovacs S.A. Expand KLH Supply Relationship - Seite 2
IIb trial of IFNα-Kinoid in approximately 160 patients in Europe, Latin
America and Asia. This Phase IIb study is expected to begin mid-2015. A
U.S. Phase IIa trial of IFNα-Kinoid for the treatment of lupus in the U.S.
is expected to commence by early 2016.
"We have enjoyed a long-standing and successful relationship with Stellar
Biotechnologies as our key KLH supplier," said Miguel Sieler, Chief
Executive Officer of Neovacs. "This new agreement with Stellar comes at a
pivotal point for Neovacs, as we are preparing to launch multicenter
clinical trials with IFNα-Kinoid and are strengthening our U.S. operations
through the recent formation of a wholly-owned subsidiary, Neovacs, Inc.
The new supply agreement will ensure that Neovacs has access to a scalable,
stable supply of GMP grade KLH as our Kinoid products advance through
clinical development and we prepare for the expected commercial launch."
"Expanding our supply commitment to Neovacs to include late-stage clinical
trials and expected initial commercialization is an excellent demonstration
of the growing commercial prospects for our core KLH business," said Frank
Oakes, President and CEO of Stellar Biotechnologies. "We also see this is
as positive validation for the use of Stellar KLH(TM) in the development of
new immunotherapy treatments."
Under the terms of the agreement, Neovacs will purchase Stellar KLH(TM) for
use in its proprietary KLH-based Kinoid immunotherapies in the European
Union, Latin America, Asia, the U.S. and Canada. Neovacs will use Stellar
KLH(TM) for its planned Phase II and Phase III clinical trials and for
expected commercial manufacturing of its products for up to one year
following market approval. Neovacs will manage and fund all product
development and regulatory submissions for its immunotherapy products and
act as the sponsor company for the future clinical trials. Stellar will
supply GMP grade KLH to Neovacs according to agreed specifications,
quantities, and pricing, as well as maintain a master file with the U.S.
FDA for the KLH product. Stellar will also provide professional, technical,
and regulatory support to Neovacs. The agreement has an initial five-year
term, which may be renewed by Neovacs in one-year increments.
About Neovacs
Neovacs (Alternext Paris: ALNEV) is a leading biotechnology company focused
on an active immunotherapy technology platform (Kinoids) with applications
in autoimmune and/or inflammatory diseases. On the basis of the company's
trials and expected initial commercialization is an excellent demonstration
of the growing commercial prospects for our core KLH business," said Frank
Oakes, President and CEO of Stellar Biotechnologies. "We also see this is
as positive validation for the use of Stellar KLH(TM) in the development of
new immunotherapy treatments."
Under the terms of the agreement, Neovacs will purchase Stellar KLH(TM) for
use in its proprietary KLH-based Kinoid immunotherapies in the European
Union, Latin America, Asia, the U.S. and Canada. Neovacs will use Stellar
KLH(TM) for its planned Phase II and Phase III clinical trials and for
expected commercial manufacturing of its products for up to one year
following market approval. Neovacs will manage and fund all product
development and regulatory submissions for its immunotherapy products and
act as the sponsor company for the future clinical trials. Stellar will
supply GMP grade KLH to Neovacs according to agreed specifications,
quantities, and pricing, as well as maintain a master file with the U.S.
FDA for the KLH product. Stellar will also provide professional, technical,
and regulatory support to Neovacs. The agreement has an initial five-year
term, which may be renewed by Neovacs in one-year increments.
About Neovacs
Neovacs (Alternext Paris: ALNEV) is a leading biotechnology company focused
on an active immunotherapy technology platform (Kinoids) with applications
in autoimmune and/or inflammatory diseases. On the basis of the company's
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