UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
Report
of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16
Under the Securities Exchange Act of 1934
For
the Month of July 2015
001-13248
(Commission File Number)
SCIVAC
THERAPEUTICS INC.
(Exact
name of Registrant as specified in its charter)
Gad
Feinstein Rd.
POB
580
Rehovot,
Israel 7610303
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under cover
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): ____
On
July 30, 2015, SciVac Therapeutics Inc. (the “Company”) issued a press release announcing that, following discussions
with the Israeli Ministry of Health, it is recalling from the market all Sci-B-Vac™ sold by the Company from January 1,
2012 to the present. The Company is carrying out the recall solely as a precautionary measure, as, following inspection by SciVac,
it was determined that certain unshipped packages of the Sci-B-Vac™ hepatitis B vaccine contained a small number of damaged
vials. There have been no reports of harm to any patients, nor have there been any reports with respect to Sci-B-Vac’s™
efficacy or safety. A copy of the press release is furnished as Exhibit 99.1 to this Report on Form 6-K and is incorporated herein
by reference.
Exhibit
Index
Exhibit
No. |
|
Description |
|
|
|
99.1 |
|
Press
Release, dated July 30, 2015 |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
|
SciVac
Therapeutics Inc. |
|
|
|
Date:
July 30, 2015 |
By: |
/s/
Dr. Curtis Lockshin
|
|
|
Dr.
Curtis Lockshin |
|
|
Chief
Executive Officer |
SciVac
Therapeutics Announces Precautionary Recall of Sci-B-Vac
SciVac
Therapeutics Inc. (“SciVac” or the “Company”) announced today that, following discussions with the Israeli
Ministry of Health (the “IMOH”), it is recalling from the market all Sci-B-Vac™ sold by the Company from January
1, 2012 to the present.
The
Company is carrying out the recall solely as a precautionary measure, as, following inspection by SciVac, it was determined that
certain unshipped packages of the Sci-B-Vac™ hepatitis B vaccine contained a small number of damaged vials. SciVac then
reported its findings to the IMOH. There have been no reports of harm to any patients, nor have there been any reports with respect
to Sci-B-Vac’s™ efficacy or safety. Currently, the Company believes that an issue in the labeling process caused the
damage, and the IMOH informed the Company that it may continue manufacturing Sci-B-Vac™ uninterrupted, so long as the Company
uses an alternative labeling process until the issue can be appropriately remedied. The Company is diligently investigating the
failure that resulted in the damaged vials.
The
recall primarily affects the Israeli and Hong Kong markets.
About
SciVac Therapeutics Inc.
SciVac
Therapeutics Inc., headquartered in Rehovot Israel, is in the business of developing, producing and marketing biological products
for human healthcare. The Company’s flagship product, Sci-B-Vac™, is a recombinant 3rd generation hepatitis B vaccine.
The Company also has in-licensed an early-stage enzyme-based product designated S-Graft, which is a recombinant human deoxyribonuclease
I, a repurposed biological therapeutic intended for the prevention and treatment of graft-versus-host disease (GVHD). The Company
also offers contract development and manufacturing services to the life sciences and biotechnology markets.
For
Further Information, Please Contact:
SciVac
Therapeutics Inc.
Gad
Feinstein Rd., P.O. Box 580, Rehovot, 7610303, Israel
Curtis
Lockshin, Chief Executive Officer
Tel:
+972-8-948-0625
Email:
lockshin@scivactherapeutics.com
Website:
www.scivactherapeutics.com
Neither
the TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX), the Frankfurt Stock Exchange
nor the OTCQX accepts responsibility for the adequacy or accuracy of this news release.
Cautionary
Statement on Forward-looking Information
Certain
statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform
Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical
fact, including without limitation statements containing the words “believe”, “may”, “plan”,
“will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”
and similar expressions. All statements other than statements of historical fact included in this release, including, without
limitation, statements regarding the expected effect of the product recall on the Company’s business are forward-looking
statements that involve various risks and uncertainties.
Such
forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results,
events or developments to be materially different from any future results, events or developments expressed or implied by such
forward-looking statements. Many such known risks, uncertainties and other factors are taken into account as part of our assumptions
underlying these forward-looking statements and include, among others, the following: market reaction to the recall, the
effect of the recall on the use of Sci-B-Vac™ vaccine, the effect on the Company’s operations of rectifying the issues
that lead to the recall, litigation or regulatory action relating to the recall, the effect of the recall on the Company’s
actual financial results, general economic conditions and other factors detailed from time to time in the Company’s periodic
disclosure. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking
statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements
and information made herein are based on the Company’s current expectations and it undertakes no obligation to revise or
update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.