DGAP-News: Neovacs S.A. / Key word(s): Miscellaneous
Neovacs S.A.: Stellar Biotechnologies and Neovacs S.A. Expand KLH
01.04.2015 / 08:00
Stellar Biotechnologies and Neovacs S.A. Expand KLH Supply Relationship
Companies Sign KLH Supply Agreement for Neovacs' Kinoid Clinical Trials and
PORT HUENEME, CA and PARIS, FRANCE, (April 1st, 2015) -- Stellar
Biotechnologies, Inc. ("Stellar" or the "Company") (OTCQB: SBOTF) (TSX-V:
KLH) and Neovacs S.A., ("Neovacs") (Alternext Paris: ALNEV) today announced
that the Companies have entered into an expanded supply agreement to meet
Neovacs' requirements for Keyhole Limpet Hemocyanin (KLH), a primary
component of Neovacs' proprietary Kinoid immunotherapy technology.
The new agreement extends and expands the supply contracts previously in
place between the Companies, in order to ensure the continued supply of
Stellar KLH(TM) to Neovacs during its Kinoid clinical trials and to support
the expected commercial roll-out of Neovacs' lead product candidate
IFN?-Kinoid, an immunotherapy being developed for the treatment of systemic
lupus erythematosus ("lupus").
Stellar is a leader in the sustainable manufacture of KLH, an
immune-stimulating protein widely used as a carrier molecule in
immunotherapies under development for a variety of disease indications.
Immunotherapy uses a patient's own immune system to target and treat
diseases. KLH can only be produced from a scarce marine source. Stellar
believes it is the only company with the proprietary technology to manage
sustainable, scalable production of GMP quality KLH to meet future
pharmaceutical industry demands.
Neovacs is a leader in the development of active immunotherapies for the
treatment of chronic autoimmune diseases. Neovacs' patented Kinoid
technology combines a select cytokine of interest attached to KLH as the
immune-stimulating carrier protein. The resulting immunotherapy uses the
patient's immune system to generate antibodies against the targeted
Neovacs' lead product candidate, IFN(-Kinoid, has successfully completed a
Phase I/IIa clinical trial for lupus. The Company's Scientific Advisory
Board (SAB) members have announced their full support for the planned Phase
IIb trial of IFN?-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 IFN?-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 IFN?-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.
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
proprietary technology for inducing a polyclonal immune response (covered
by five patent families that potentially run until 2032) Neovacs is
focusing its clinical development efforts on IFN?-Kinoid, an immunotherapy
being developed for the indication of lupus. Neovacs is also conducting
preclinical development works on other therapeutic vaccines in the fields
of auto-immune diseases, oncology and allergies. The goal of the Kinoid
approach is to enable patients to have access to safe treatments with
efficacy that is sustained in these life-long diseases.
For more information on Neovacs, visit www.neovacs.fr
About Stellar Biotechnologies, Inc.
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX-V: KLH) is a leader in
sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), an important
immune-stimulating protein used in wide-ranging therapeutic and diagnostic
markets. KLH is both an active pharmaceutical ingredient (API) in many new
immunotherapies (targeting cancer, immune disorders, Alzheimer's, and
inflammatory diseases) as well as a finished product for measuring immune
status. Stellar Biotechnologies is unique in its proprietary methods,
facilities, and KLH technology. It is committed to meeting the growing
demand for commercial-scale supplies of GMP grade KLH, ensuring
environmentally sound KLH production, and developing KLH-based active
Visit www.stellarbiotech.com and the Stellar KLH knowledge base
Stellar Biotechnologies Company Contact:
Mark A. McPartland
Vice President of Corporate Development and Communications
+1 (805) 488-2800 ext. 103
Neovacs Company Contacts:
NEOVACS - Investor Relations
+33 (0)1 53 10 93 00
Investor Relations / Financial Communications - NewCap
Valentine Brouchot / Pierre Laurent
+33 (0)1 44 71 94 94
Investor Relations / Financial Communications Germany - MC Services
Press / U.S. Inquiries - The Ruth Group
Forward Looking Statements
This press release may contain forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements may be identified by the use of words such as
"anticipate," "believe," "plan," "estimate," "expect," "intend," "may,"
"will," "would," "could," "should," "might," "potential," or "continue" and
variations or similar expressions. Readers should not unduly rely on these
forward-looking statements, which are not a guarantee of future
performance. There can be no assurance that forward-looking statements will
prove to be accurate, as all such forward-looking statements involve known
and unknown risks, uncertainties and other factors which may cause actual
results or future events to differ materially from the forward-looking
statements. Such risks include, but may not be limited to: general economic
and business conditions; technology changes; competition; changes in
strategy or development plans; governmental regulations and the ability or
failure to comply with governmental regulations; the timing of anticipated
results; and other factors referenced in the Company's filings with
securities regulators. For a discussion of further risks and uncertainties
related to the Company's business, please refer to the Company's public
company reports filed with the TSX Venture Exchange and the U.S. Securities
and Exchange Commission. All forward-looking statements are made as of the
date hereof and are subject to change. Except as required by law, the
Company assumes no obligation to update such statements. This press release
does not constitute an offer or solicitation of an offer for sale of any
securities in any jurisdiction, including the United States. Neither the
TSX Venture Exchange nor its Regulation Services Provider (as that term is
defined in the policies of the TSX Venture Exchange) accepts responsibility
for the adequacy or accuracy of the information contained in this press
01.04.2015 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
Company: Neovacs S.A.
3-5, Impasse Reille
Phone: +33 (0)1 53 10 93 00
Fax: +33 (0)1 53 10 93 03
Listed: Regulated Unofficial Market in Stuttgart; Open Market in
End of News DGAP News-Service