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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): December 1, 2009 (November 30, 2009)
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Florida
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000-33357
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65-0643773 |
(State or other jurisdiction
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(Commission File Number)
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(I.R.S. Employer |
of incorporation)
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Identification No.) |
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Snunit Street
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20100 |
Science Park
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(Zip Code) |
POB 455 Carmiel, Israel |
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(Address of principal executive offices) |
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Registrants telephone number, including area code: +972-4-988-9488
Not Applicable
(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:
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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)) |
Item 1.01. Entry into a Material Definitive Agreement
On December 1, 2009, Protalix BioTherapeutics, Inc. (the Company) and Pfizer Inc. (Pfizer)
announced that the Companys wholly owned subsidiary, Protalix Ltd. (Protalix), had entered into
an Exclusive License and Supply Agreement, dated November 30, 2009, with Pfizer (the License
Agreement), to develop and commercialize taliglucerase alfa, a plant-cell expressed form of
glucocerebrosidase (GCD) in development for the potential treatment of Type 1 Gauchers disease.
Under the terms of the License Agreement, Pfizer will receive exclusive worldwide licensing rights
for the commercialization of taliglucerase alfa, while Protalix will retain the exclusive
commercialization rights in Israel. Pfizer will make an upfront payment of $60 million to
Protalix. Protalix is eligible to receive additional regulatory milestone payments of up to $55
million. In addition, Pfizer and Protalix will share future revenues and expenses for the
development and commercialization of taliglucerase alfa on a 60 percent/40 percent basis,
respectively.
The License Agreement includes mutual non-competition covenants for a specified period and subject
to specified exceptions, as well as customary termination provisions.
The Company has agreed to unconditionally guarantee the obligations and liabilities of Protalix
under the License Agreement.
Item 8.01. Other Events
On December 1, 2009, the Company and Pfizer Inc. issued a press release announcing the entry into
the License Agreement. A copy of the press release is attached as Exhibit 99.1 to this Current
Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits
(d) |
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Exhibits |
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99.1 |
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Press Release dated December 1, 2009 |
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: December 1, 2009 |
By: |
/s/ David Aviezer
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David Aviezer, Ph.D. |
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President and Chief Executive Officer |
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Exhibit Index
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Number |
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Description |
99.1
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Press Release dated December 1, 2009 |
exv99w1
Exhibit 99.1
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For Immediate Release:
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Pfizer Contacts: |
December 1, 2009
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Joan Campion (Media) |
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212 733-2798 |
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Joan.Campion@Pfizer.com |
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Suzanne Harnett (Investors) |
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212 733-8009 |
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Suzanne.Harnett@Pfizer.com |
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Protalix Contacts: |
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Brad Miles (Media) |
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BMC Communications Group, LLC |
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Bmiles@bmccommunications.com |
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917 570 7340 |
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Marcy Nanus (Investors) |
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The Trout Group, LLC |
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646 378 2927 |
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Mnanus@troutgroup.com |
Pfizer And Protalix Enter Into Agreement To Develop And Commercialize Gauchers Disease Treatment
New Drug Application (NDA) expected to be filed with FDA for novel enzyme replacement therapy with
Fast Track Orphan Drug designation
New York, NY, 2009 Pfizer (NYSE: PFE) and Protalix (NYSE-Amex: PLX) today announced that they
have entered into an agreement to develop and commercialize taliglucerase alfa, a plant-cell
expressed form of glucocerebrosidase (GCD) in development for the potential treatment of Gauchers
disease. Under the terms of the agreement, Pfizer will receive exclusive worldwide licensing
rights for the commercialization of taliglucerase alfa, while Protalix will retain the exclusive
commercialization rights in Israel. Taliglucerase alfa is the first enzyme replacement therapy
derived from a proprietary plant cell-based expression platform using genetically engineered carrot
cells.
With the successful completion of Phase III clinical studies, Protalix is preparing to complete a
rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The FDA has
granted Orphan Drug designation and Fast Track status, facilitating the development and expediting
the review of drugs to treat rare conditions or diseases, as well as an Emergency Use
Authorization. The FDA has also requested, and subsequently approved, an Expanded Access Program
(EAP) treatment protocol. Taliglucerase alfa is
currently being provided to Gauchers patients in the U.S. under the EAP protocol, as well as to
patients in the European Union under a compassionate use protocol.
We are excited about this collaboration, which represents a significant step towards bringing, for
the first time, a plant-based enzyme replacement treatment option to patients affected by Gauchers
disease, commented Dr. David Aviezer, president and CEO of Protalix. By joining our advances in
biologics manufacturing and protein development with Pfizers global strengths in patient services
and reimbursement we expect to help make taliglucerase alfa an important and cost-effective
treatment choice for Gauchers patients throughout the world.
Under the agreement, Pfizer will make an upfront payment of $60 million to Protalix. In addition,
Protalix is eligible to receive additional regulatory milestone payments of up to $55 million.
Pfizer and Protalix will share future revenues and expenses for the development and
commercialization of taliglucerase alfa on a 60 percent/40 percent basis respectively.
By combining our respective strengths to advance this innovative therapy, Pfizer and Protalix
expect to quickly deliver an alternative treatment for people suffering from Gauchers disease,
said David Simmons, president and general manager of Pfizers Established Products Business Unit.
This agreement supports our goal to meet the needs of many patient populations, including those
affected by rare diseases, and brings the best minds together to challenge the most feared diseases
of our time.
Peter L. Saltonstall, President and CEO, National Organization for Rare Disorders (NORD) stated,
NORD is always pleased when treatment options are expanded for people with rare diseases. We
welcome Pfizers commitment to the rare disease arena, and look forward to working with both Pfizer
and Protalix in support of increased options for patients and families affected by rare diseases.
About Gauchers disease
Gauchers disease, an inherited condition, is the most prevalent lysosomal storage disorder, with
an incidence of about 1 in 20,000 live births. People with Gauchers disease do not have enough of
an enzyme, βglucosidase (glucocerebrosidase) that breaks down a certain type of fat molecule. As a
result, lipid engorged cells (called Gaucher cells) amass in different parts of the body, primarily
the spleen, liver and bone marrow. Accumulation of Gaucher cells may cause spleen and liver
enlargement, anemia, excessive bleeding and bruising, bone disease and a number of other signs and
symptoms.
About Protalix
Protalix is a biopharmaceutical company focused on the development and commercialization of
proprietary recombinant therapeutic proteins expressed through its proprietary plant cell based
expression system. Protalixs
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. Taliglucerase alfa is an enzyme replacement therapy in development under a
Special Protocol Assessment with FDA for Gauchers disease.
Pfizer Inc.: Working together for a healthier world
At Pfizer, we apply science and our global resources to improve health and well-being at every
stage of life. We strive to set the standard for quality, safety and value in the discovery,
development and manufacturing of medicines for people and animals. Our diversified global health
care portfolio includes human and animal biologic and small molecule medicines and vaccines, as
well as nutritional products and many of the worlds best-known consumer products. Every day,
Pfizer colleagues work across developed and emerging markets to advance wellness, prevention,
treatments and cures that challenge the most feared diseases of our time. Consistent with our
responsibility as the worlds leading biopharmaceutical company, we also collaborate with health
care providers, governments and local communities to support and expand access to reliable,
affordable health care around the world. For more than 150 years, Pfizer has worked to make a
difference for all who rely on us. To learn more about our commitments, please visit us at
www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of December 1, 2009, and neither
Pfizer nor Protalix assume any obligation to update forward-looking statements contained in this
release as the result of new information or future events or developments.
This release contains forward-looking information about taliglucerase alfa, a product candidate
that is the subject of a global development and commercialization agreement between Pfizer and
Protalix, including its potential benefits and the anticipated filing of a new drug application
with the FDA that involves substantial risks and uncertainties. Such risks and uncertainties
include, among other things, the uncertainties inherent in research and development; decisions by
regulatory authorities regarding whether and when to approve any drug applications that may be
filed for such product candidate as well as their decisions regarding labeling and other matters
that could affect its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties with respect to Pfizer can be found in Pfizers
Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and in its reports on Form
10-Q and Form 8-K. A further description of risks and uncertainties with respect to Protalix can
be found in Protalixs Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and
its reports on Form 10-Q.
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