e8vkza
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K/A
(Amendment No. 1)
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 15, 2009
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
|
|
|
|
|
Florida
|
|
000-33357
|
|
65-0643773 |
(State or other jurisdiction
of incorporation)
|
|
(Commission File Number)
|
|
(IRS Employer
Identification No.) |
|
|
|
2 Snunit Street |
|
|
Science Park, POB 455 |
|
|
Carmiel, Israel
|
|
20100 |
(Address of principal executive offices)
|
|
(Zip Code) |
Registrants 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))
Explanatory Note
This amendment to the Current Report on Form 8-K originally filed by Protalix
BioTherapeutics, Inc. (the Company) on October 15, 2009 amends such filing to correct a typographical error in the attached press release.
Item 8.01. Other Events
On October 15, 2009, the Company issued a corrected press release
announcing positive top-line results from the Companys pivotal Phase III clinical trial of UPLYSO
(taliglucerase alfa) in treatment naive patients diagnosed with Gaucher disease. A copy of the
press release is attached hereto as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
99.1 Press release dated October 15, 2009.
2
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: October 15, 2009 |
By: |
/s/ David Aviezer
|
|
|
|
Name: |
David Aviezer, Ph.D. |
|
|
|
Title: |
President and
Chief Executive Officer |
|
|
3
exv99w1
Exhibit 99.1
Protalix BioTherapeutics Announces Positive Top-line Results from its Phase III Clinical Trial of
UPLYSO for the Treatment of Gaucher Disease
CARMIEL, Israel, October 15, 2009 (Business Wire) Protalix BioTherapeutics, Inc. (NYSE-Amex:
PLX), announced today positive top-line results from the Companys pivotal Phase III clinical trial
of UPLYSO (taliglucerase alfa, previously referred to as prGCD) in treatment naive patients
diagnosed with Gaucher disease.
The trial met its primary endpoint, mean reduction in spleen volume after nine months compared with
baselines, in both 60 U/kg dose and in the lower 30 U/kg dose treatment groups (P<0.0001). The
primary endpoint was stipulated in the Special Protocol Assessment (SPA) agreed on by the Company
and the U.S Food and Drug Administration (the FDA) prior to the commencement of the trial.
Additionally, the primary endpoint was observed already after six months of treatment in both
treatment groups.
Statistically significant improvements compared with baselines were also observed in the secondary
endpoints, including increase in hemoglobin level, decrease in liver size and increase in platelet
count at the 60 U/kg dose.
Statistically significant improvements compared with baselines were observed in hemoglobin level
and liver size and significant nominal elevation in platelet count in the lower dose of 30 U/kg.
The safety analysis for both doses showed that UPLYSO was well tolerated and no serious adverse
events were reported. Only 6% of patients in the trial developed antibodies to UPLYSO during the
study. None of the patients in the trial developed neutralizing antibodies to UPLYSO. Only 6% of
the patients in the trial experienced hypersensitivity.
Most adverse events were mild in intensity and not drug related and were transient in nature.
The Company plans to present more comprehensive results in the near future, and at upcoming medical
meetings.
Clinical studies with UPLYSO to date demonstrate very encouraging efficacy results with a high
safety profile and a low rate of antibody formation, said Professor Ari Zimran, M.D. Director of
the Gaucher Clinic at Shaare Zedek Medical Center in Jerusalem and Coordinating Investigator of the
Companys pivotal Phase III trial of UPLYSO. The results of this pivotal trial suggest that UPLYSO
has the potential to become an attractive treatment alternative for Gaucher disease patients.
We are extremely pleased with the top line Phase III safety and efficacy results for UPLYSO for
the treatment for Gaucher disease, said Dr. David Aviezer, President and Chief Executive Officer.
We expect to complete the ongoing rolling New Drug Application (NDA) submission for marketing
clearance with FDA before the end of this year. In addition, these results further validate our
ProCellEx platform for the expression of safe and efficacious human therapeutic proteins in plant
cell cultures, and sets the ground for many other lucrative opportunities
Additional Study Details
The Phase III clinical trial for UPLYSO was a nine month, randomized, double-blind, parallel group,
dose-ranging safety and efficacy study in patients with Gaucher disease. Patients were randomized
to receive either 60 units/kg or 30 units/kg of UPLYSO administered intravenously once every two
weeks. A total of 31 patients were enrolled at 11centers in Europe, North America, South America,
Israel and South Africa.
The FDA granted UPLYSO orphan product designation and fast track development status and was
developed under a Special Protocol Assessment (SPA). The Company is currently making UPLYSO
available to Gaucher disease patients in the U.S. and other countries under an Expanded Access
Program approved by the FDA.
About Protalix BioTherapeutics
Protalix is a biopharmaceutical company. Its goal is to become a fully integrated
biopharmaceutical company focused on the development and commercialization of proprietary
recombinant therapeutic proteins to be expressed through its proprietary plant cell based
expression system. Protalixs ProCellEx(TM) 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 successfully completed a pivotal Phase III clinical trial for its lead product
candidate, UPLYSO, to be used in enzyme replacement therapy for Gaucher disease, a rare and serious
lysosomal storage disorder in humans with severe and debilitating symptoms. Protalix and the U.S.
Food and Drug Administration agreed on the final design of the pivotal Phase III clinical trial
through the FDAs SPA process. Protalix is also advancing additional recombinant biopharmaceutical
drug development programs.
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 clinical trials;
the review process of the FDA, foreign regulatory bodies and other governmental regulatory bodies,
including the FDAs review of any filings we make in connection with the treatment protocol; delays
in the FDAs or other health regulatory authorities approval of any applications we file or
refusals to approve such filings; refusals by such regulatory authorities to approve the marketing
and sale of a drug product even after acceptance of an application we file for any such drug
product; the identification of lead compounds; the risk that we may fail to satisfy certain
conditions relating to grants we have received from the Office of the Chief Scientist of Israels
Ministry of Industry and Trade which may lead to our being required to refund grants previously
received together with interest and penalties; the risk that the Office of the Chief Scientist may
not deliver to us all of the funds awarded to us; 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 by
clinical trials of drug products, the FDA may not accept or approve an NDA filed by a
pharmaceutical or biotechnology company for such drug product. Failure to obtain FDA approval of
any of our drug candidates in a timely manner, if at all, will severely undermine our business and
results of operation by reducing our potential marketable products and our ability to generate
corresponding product revenues. Under our approved treatment protocol, UPLYSO might be provided
only to a limited number of patients and only for a limited time. The FDAs approval of the
treatment protocol or the fast track designation will not have any effect on the FDAs approval of
any NDA we file with respect to UPLYSO, if any, and the review by the FDA of any data from our
Phase III clinical development programs in connection with the approval of the treatment protocol
will not have any effect on the FDAs subsequent review of our complete Phase III clinical trial
data in the future. The statements in this release are valid only as of the date hereof and we
disclaim any obligation to update this information.
Contact:
Marcy Nanus
The Trout Group, LLC
Telephone: 646-378-2927
Email: mnanus@troutgroup.com
Media Contact:
Brad Miles
BMC Communications Group, LLC
Telephone: 212-477-9007 x17
Email: brad@bmccommunications.com