UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER PURSUANT TO RULE 13a-16 AND 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the Month of March 2013
File No. 000-54598
Stellar Biotechnologies Inc.
(Name of Registrant)
332 E. Scott Street, Port Hueneme, CA 93041
(Address of principal executive offices)
Indicate by check mark whether the Registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
FORM 20-F __X__
FORM 40-F ______
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ___
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ___
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Form 6-K to be signed on its behalf by the undersigned, thereunto duly authorized.
Stellar Biotechnologies Inc.
(Registrant)
Dated: March 19, 2013 | By: /s/ "Darrell Brookstein" Darrell Brookstein Director |
Exhibits:
99.1
News Release dated March 19, 2013
Stellar Biotechnologies Submits Biological Master File to U.S. FDA for Subunit KLH
PORT HUENEME, CA, (March 19, 2013) -- Stellar Biotechnologies, Inc. ("Stellar" or “the Company”) (OTCQB: SBOTF) (TSX-V: KLH), the world leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), today announced the Company has submitted a Type IV Biologics Master File (BB-MF) to the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) for its subunit KLH.
A Biologics Master File is a confidential, detailed dossier submitted to the FDA which contains the proprietary information on the manufacture and safety of a drug component.
Stellar continually updates and maintains master files at the FDA for its KLH products. These files allow Stellar to provide controlled access to a single source of information on file with the FDA, for customers to reference as part of their product applications.
This new BB-MF is intended to support Stellar’s KLH customers who file applications under the CBER division, thus expanding applicability of the Company’s KLH for broader uses.
Stellar’s goal is to help accelerate the regulatory approval process for products that use the Company’s KLH. Only Stellar KLH is derived from proprietary, cultured keyhole limpet colonies. This allows Stellar to deliver an unprecedented level of control over its KLH quality and performance; benefits valued by vaccine manufacturers and drug developers using KLH.
“Stellar is always looking for effective ways to support our customers’ applications through the regulatory process,” commented Catherine Brisson, Chief Pharmaceutical Officer at Stellar Biotechnologies. “We are very pleased to have this master file submitted to CBER. By ensuring that the information required by FDA is accessible, we can facilitate regulatory approvals for KLH-based products.”
For more information:
Visit www.StellarBiotech.com and the KLH knowledge base www.KLHSite.com.
About Stellar Biotechnologies, Inc.
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX-V: KLH) is the world leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH). KLH is an important immune-stimulating protein used in wide-ranging therapeutic and diagnostic markets. Potent, yet proven safe in humans, KLH operates as both a vital component for conjugate vaccines (targeting cancer, autoimmune, and infectious diseases) as well as an antigen for measuring immune status. Stellar Biotechnologies was founded to address the growing demand for renewable, commercial-scale supplies of high-quality, GMP-grade KLH. Stellar has developed leading practices, facilities and proprietary capabilities to address this need. To receive regular updates, enter email at bottom of http://stellarbiotechnologies.com/investors/news_releases/
Contacts:
Stellar Biotechnologies, Inc.
Darrell Brookstein, Executive VP, Corporate Development & Finance
dbrookstein@stellarbiotech.com
Frank Oakes, Chairman
foakes@stellarbiotech.com
Main +1 (805) 488-2800
Investor Relations:
MZ Group
Mark A. McPartland
Senior Vice President
Phone: 1 212-301-7130
Email: markmcp@mzgroup.us
Web: www.mzgroup.us
Forward Looking Statements
There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Readers should not place undue reliance on such statements. Except in accordance with applicable securities laws, the Company expressly disclaims any obligation to update any forward-looking statements or forward-looking statements that are incorporated by reference herein. This news release does not constitute an offer to sell, or a solicitation of an offer to buy any of the Company's securities set out herein in the United States, or to, or for the benefit or account of, a U.S. Person or person in the United States. Neither TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of these releases.