0001144204-13-034416.txt : 20130612 0001144204-13-034416.hdr.sgml : 20130612 20130612074009 ACCESSION NUMBER: 0001144204-13-034416 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20130612 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20130612 DATE AS OF CHANGE: 20130612 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Protalix BioTherapeutics, Inc. CENTRAL INDEX KEY: 0001006281 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 650643773 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33357 FILM NUMBER: 13907890 BUSINESS ADDRESS: STREET 1: 2 SNUNIT ST STREET 2: SCIENCE PARK, POB 455 CITY: CARMIEL STATE: L3 ZIP: 20100 BUSINESS PHONE: 972-4-988-9488 MAIL ADDRESS: STREET 1: 2 SNUNIT ST STREET 2: SCIENCE PARK, POB 455 CITY: CARMIEL STATE: L3 ZIP: 20100 FORMER COMPANY: FORMER CONFORMED NAME: ORTHODONTIX INC DATE OF NAME CHANGE: 19980422 FORMER COMPANY: FORMER CONFORMED NAME: EMBASSY ACQUISITION CORP DATE OF NAME CHANGE: 19960124 8-K 1 v347593_8k.htm 8-K

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): June 12, 2013

Protalix BioTherapeutics, Inc.

(Exact name of registrant as specified in its charter)

Florida

001-33357

65-0643773

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)


2 Snunit Street		20100
Science Park, POB 455
Carmiel, Israel
(Address of principal executive offices)		(Zip Code)

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):

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨	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 June 12, 2013, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing that the Company will be hosting an analyst event on Thursday, June 20, 2013 at 8:00 AM EDT in New York City. The meeting will feature presentations on ELELYSO®, PRX-102 for the treatment of Fabry disease and Oral GCD for the treatment of Gaucher disease, as well as presentations on previously undisclosed product candidates.

The event audio and slide presentation will be webcast live and archived on the Company’s website for a 30-day period. The webcast will be available at www.protalix.com on the Events Calendar page. The slides will be available under the presentation tab on the Company’s website after the presentation.

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

(d) Exhibits

99.1 Press release, dated June 12, 2013.

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: June 12, 2013	By:	/s/ David Aviezer
	Name:	David Aviezer, Ph.D.
	Title:	President and
		Chief Executive Officer

EX-99.1 2 v347593_ex99-1.htm EX-99.1

Exhibit 99.1

Protalix BioTherapeutics to Host Analyst Event in New York City

CARMIEL, Israel, June 12, 2013 /GlobeNewswire /Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX, TASE:PLX), will be hosting an analyst event on Thursday, June 20, 2013 at 8:00 AM EDT in New York City. The meeting will feature presentations on ELELYSO®, PRX-102 for the treatment of Fabry disease and Oral GCD for the treatment of Gaucher disease, as well as presentations on previously undisclosed product candidates.

Guest speakers include:

- Dr. Gregory Pastores, Associate Professor of Neurology and Pediatrics and Director of the Neurogenetics Laboratory, The New York University School of Medicine

- Vera Wu, Global Asset Lead, Taliglucerase Alfa, Pfizer Inc.

- Dr. Ari Zimran, Associate Professor, Director of the Gaucher Clinic, Shaare Zedek Medical Center, Jerusalem, Israel

- Dr. Yaron Ilan, Head, Internal Medicine A, Dept. of Medicine and Liver Unit, Professor, Hadassah Medical Center, Jerusalem, Israel

Company representative speakers include:

- Dr. Einat Almon, Senior Vice President, Product Development, Protalix BioTherapeutics

- Dr. Yoseph Shaaltiel, Executive Vice President, Research and Development, Protalix BioTherapeutics

- Dr. David Aviezer, President and Chief Executive Officer, Protalix BioTherapeutics

The analyst event is by invitation only. For information on attending the event, please contact Marcy Nanus at mnanus@troutgroup.com.

About Protalix BioTherapeutics, Inc.

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. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012, by Israel’s Ministry of Health in September 2012, by the Brazilian National Health Surveillance Agency (ANVISA) in March 2013, by the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) in April 2013, and by the regulatory authorities of other countries. Marketing applications for taliglucerase alfa have been filed in additional territories as well. Protalix has partnered with Pfizer Inc. for the worldwide development and commercialization of taliglucerase alfa, excluding Israel, where Protalix retains full rights. 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 produced and encapsulated within 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.

Investor Contact

Marcy Nanus
The Trout Group, LLC
646-378-2927
mnanus@troutgroup.com

Media Contact

Kari Watson
MacDougall Biomedical Communications
781-235-3060
kwatson@macbiocom.com

Source: Protalix BioTherapeutics, Inc.