UNITED STATES
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
Date of Report (Date of Earliest Event Reported): October 26, 2011
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Florida
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001-33357
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65-0643773
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(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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2 Snunit Street
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20100
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Science Park, POB 455
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Carmiel, Israel
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(Address of principal executive offices)
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(Zip Code)
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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):
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o
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 7.01. Regulation FD Disclosure
On October 26, 2011, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing that senior management will present at four upcoming conferences:
Ernst & Young Journey 2011 Conference
Wednesday, November 2, 2011 at 2:45 PM IDT
Topic: The Pfizer-Protalix Gaucher Collaboration – The Partners’ Point of View
Dr. David Aviezer, President & CEO
Hilton Hotel, Tel-Aviv, Israel
PDA-Parenteral Drug Association / FDA-Food and Drug Administration:
Adventitious Agents and Novel Cell Substrates Conference
Thursday, November 3, 2011 at 1:15-3:15 PM ET
Topic: Potential Safety and Quality Issues Related to Plants and Plant-Based Products
Dr. Yoseph Shaaltiel, Executive Vice President, R&D
Hilton Washington DC / Rockville Hotel & Executive Meeting Center, Rockville, MD, USA
Lazard Capital Markets 8th Annual Healthcare Conference
Wednesday, November 16, 2011 at 1:30 PM ET
Topic: Corporate Presentation
Mr. Yossi Maimon, CFO
Pierre Hotel, New York, NY, USA
A webcast of this presentation will be available at www.protalix.com on the event calendar page. A replay will be archived and available after the conference for 30 days.
World Orphan Drug Congress
Thursday, December 1, 2011 at 10:10 AM CEST
Topic: Regulatory Expectations and Clinical Strategy for Treating Fabry Disease
Dr. David Aviezer, President & CEO
Crowne Plaza Hotel, Geneva, Switzerland
A copy of the press release is furnished as Exhibit 99.1.
The information contained in Item 7.01 of this report and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits
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(d)
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Exhibits
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99.1
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Press release dated October 26, 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.
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PROTALIX BIOTHERAPEUTICS, INC.
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Date: October 26, 2011
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By: /s/ Yossi Maimon
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Name: Yossi Maimon
Title: Chief Financial Officer
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Exhibit 99.1
Protalix BioTherapeutics to Present at Four Upcoming Conferences
CARMIEL, Israel, October 26, 2011 /PR Newswire/Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX, TASE:PLX), today announced that senior management will present at four upcoming conferences:
Ernst & Young Journey 2011 Conference
Wednesday, November 2, 2011 at 2:45 PM IDT
Topic: The Pfizer-Protalix Gaucher Collaboration – The Partners’ Point of View
Dr. David Aviezer, President & CEO
Hilton Hotel, Tel-Aviv, Israel
PDA-Parenteral Drug Association / FDA-Food and Drug Administration:
Adventitious Agents and Novel Cell Substrates Conference
Thursday, November 3, 2011 at 1:15-3:15 PM ET
Topic: Potential Safety and Quality Issues Related to Plants and Plant-Based Products
Dr. Yoseph Shaaltiel, Executive Vice President, R&D
Hilton Washington DC / Rockville Hotel & Executive Meeting Center, Rockville, MD, USA
Lazard Capital Markets 8th Annual Healthcare Conference
Wednesday, November 16, 2011 at 1:30 PM ET
Topic: Corporate Presentation
Mr. Yossi Maimon, CFO
Pierre Hotel, New York, NY, USA
A webcast of this presentation will be available at www.protalix.com on the event calendar page. A replay will be archived and available after the conference for 30 days.
World Orphan Drug Congress
Thursday, December 1, 2011 at 10:10 AM CEST
Topic: Regulatory Expectations and Clinical Strategy for Treating Fabry Disease
Dr. David Aviezer, President & CEO
Crowne Plaza Hotel, Geneva, Switzerland
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, ProCellEx™. Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner in an environment free of mammalian components and viruses. Protalix’s lead compound, taliglucerase alfa, an enzyme replacement therapy for the treatment of Gaucher disease, completed Phase III development. To date, marketing applications have been submitted for taliglucerase alfa in the United States, the European Union, Brazil, Israel and Australia. Protalix’s development pipeline also includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; PRX-105, a pegylated recombinant human acetylcholinesterase in development for several therapeutic and prophylactic indications, a biodefense program and an organophosphate-based pesticide treatment program; an orally-delivered glucocerebrosidase enzyme that is naturally encased in carrot cells, also for the treatment of Gaucher disease; pr-antiTNF, a similar plant cell version of etanercept (Enbrel™) for the treatment of certain immune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis; and others. 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 1, 2012.
Forward Looking Statements
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. The terms “anticipate,” “believe,” “estimate,” “expect” and “intend” and other words or phrases of similar import are intended to identify forward-looking statements. 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. 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
646-378-2927
mnanus@troutgroup.com
Media Contact
Jennifer Conrad or Douglas MacDougall
MacDougall Biomedical Communications
781-235-3060
jconrad@macbiocom.com