UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): January 4, 2011 (January 4, 2011)
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Florida | 001-33357 | 65-0643773 | ||
| (State or other jurisdiction | (Commission File Number) | (IRS Employer | ||
| of incorporation) | Identification No.) |
| 2 Snunit Street | 20100 | |
| Science Park, POB 455 | (Zip Code) | |
| Carmiel, Israel | ||
| (Address of principal executive offices) |
Registrant’s telephone number, including area code +972-4-988-9488
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01. Regulation FD Disclosure
On January 4, 2011, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release
announcing that it has been invited to deliver an oral presentation on PRX-105, the Company’s plant
cell expressed pegylated recombinant human acetylcholinesterase in development for use in several
therapeutic and prophylactic indications, as well as in a biodefense program and an
organophosphate-based pesticide treatment program, at the Biomedical Advanced Research and
Development Authority (BARDA) Industry Day. BARDA resides within the Office of the Assistant
Secretary for Preparedness and Response in the U.S. Department of Health and Human Services (HHS).
The BARDA Industry Day is being held in conjunction with the HHS 5th Annual Public Health Emergency
Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop being held on January 10 through
12, 2011, in Washington, D.C.
The information in Item 7.01 of this report (including Exhibit 99.1) is being furnished pursuant to
Item 7.01 of Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of
that section, nor shall it be deemed to be incorporated by reference in any filing under the
Securities Act of 1933 or the Exchange Act.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
99.1 Press release dated January 4, 2011.
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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 hereunto duly authorized.
| PROTALIX BIOTHERAPEUTICS, INC. |
||||
| Date: January 4, 2011 | By: | /s/ David Aviezer | ||
| Name: | David Aviezer, Ph.D. | |||
| Title: | President and Chief Executive Officer | |||
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Exhibit 99.1
Protalix BioTherapeutics Announces Presentation of PRX-105 Data at the BARDA Industry Day
CARMIEL, Israel, January 4, 2011 (PR NEWSWIRE) — Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX,
TASE:PLX), announced today that it has been invited to deliver an oral presentation on PRX-105, the
Company’s plant cell expressed pegylated recombinant human acetylcholinesterase in development for
use in several therapeutic and prophylactic indications, as well as in a biodefense program and an
organophosphate-based pesticide treatment program, at the Biomedical Advanced Research and
Development Authority (BARDA) Industry Day. BARDA resides within the Office of the Assistant
Secretary for Preparedness and Response in the U.S. Department of Health and Human Services (HHS).
The BARDA Industry Day is being held in conjunction with the HHS 5th Annual Public Health Emergency
Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop being held on January 10 through
12, 2011, in Washington, D.C.
The Company’s presentation, entitled “PRX-105: A Novel Biological Countermeasure for Nerve Agents,”
includes preclinical and Phase I data and will be presented on January 12, 2011. In pre-clinical
studies, PRX-105 successfully protected animals exposed to organophosphate nerve gas agent analogs
in both the prophylactic and post-exposure settings. The Phase I clinical trial of PRX-105
established the pharmacokinetics of the protein and demonstrated that single dose, intravenous
administration of PRX-105 is safe and well tolerated.
About the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)
PHEMCE is a coordinated interagency effort that is responsible for defining and prioritizing
requirements for public health emergency medical countermeasures; focusing research, development,
and procurement activities on the identified requirements; and establishing deployment and use
strategies for medical countermeasures in the strategic national stockpile. The Stakeholders
Workshop includes plenary talks from the U.S. federal government, the American Medical Association,
and state and local speakers, as well as seven breakout sessions on various topics related to the
PHEMCE mission. The BARDA Industry Day will include a poster session, exhibitor hall and over 40
oral presentations highlighting cutting edge medical countermeasure research.
About PRX-105
We are developing PRX-105, our proprietary plant cell-based acetylcholinesterase (AChE) and its
molecular variants, for use in several therapeutic and prophylactic indications, as well as in a
biodefense program and an organophosphate-based pesticide treatment program. We have received from
the Yissum Research and Development Company and the Boyce Thompson Institute, Inc. an exclusive,
worldwide right and license to certain technology, including patents and certain patent
applications relating to AChE for the therapeutic and prophylactic indications as well as an
exclusive license not limited to such indications with respect to certain of those patents and
patent applications.
About Protalix
Protalix is a biopharmaceutical company focused on the development and commercialization of
recombinant therapeutic proteins expressed through its proprietary plant cell based expression
system. Protalix’s ProCellEx™ presents a proprietary method for the expression of recombinant
proteins that Protalix believes will allow for the cost-effective, industrial-scale production of
recombinant therapeutic
proteins in an environment free of mammalian components and viruses. Protalix is also advancing
additional recombinant biopharmaceutical drug development programs, including its PRX-105
development program. Taliglucerase alfa is an enzyme replacement therapy in development under a
Special Protocol Assessment with the FDA for Gaucher disease. Protalix’s new drug application
(NDA) for taliglucerase alfa has been accepted by the U.S. Food and Drug Administration (FDA) and
granted a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2011.
Safe Harbor Statement
To the extent that statements in this press release are not strictly historical, all such
statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private
Securities Litigation Reform Act of 1995. These forward-looking statements are subject to known
and unknown risks and uncertainties that may cause actual future experience and results to differ
materially from the statements made. These statements are based on our current beliefs and
expectations as to such future outcomes. Drug discovery and development involve a high degree of
risk. Factors that might cause material differences include, among others, risks relating to: the
successful preclinical development of our product candidates; the completion of our clinical
trials; the review process of the FDA, the EMEA, other foreign regulatory bodies and other
governmental regulatory bodies; delays in the FDA’s, the EMEA’s or other health regulatory
authorities’ approval of any applications we file or refusals to approve such filings;
uncertainties related to the ability to attract and retain partners for our technologies and
products under development; and other factors described in our filings with the Securities and
Exchange Commission. Companies in the pharmaceutical and biotechnology industries have suffered
significant setbacks in advanced or late-stage clinical trials, even after obtaining promising
earlier trial results or in preliminary findings for such clinical trials. Further, even if
favorable testing data is generated from clinical trials of drug products, the FDA, EMEA or any
other foreign regulatory authority may not accept or approve an NDA filed by a pharmaceutical or
biotechnology company for such drug product. Failure to obtain approval from the FDA, EMEA or any
other foreign regulatory authority of any of our drug candidates in a timely manner, if at all,
will severely undermine our business and results of operations by reducing our potential marketable
products and our ability to generate corresponding product revenues. The statements in this
release are valid only as of the date hereof and we disclaim any obligation to update this
information.
Investor Contact
Marcy Nanus
The Trout Group, LLC
Telephone: 646-378-2927
Email: mnanus@troutgroup.com
The Trout Group, LLC
Telephone: 646-378-2927
Email: mnanus@troutgroup.com