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: Pfizer Contacts

Key Takeaway: For Immediate Release: Pfizer Contacts: December 1, 2009 Joan Campion (Media) 212 733-2798 Joan.Campion@Pfizer.com Suzanne Harnett (Investors) 212 733-8009 Suzanne.Harnett@Pfizer.com Protalix Contacts: Brad Miles (Media) BMC Communications Group, LLC Bmiles@bm

Full Press Release Details

For Immediate Release: Pfizer Contacts:
December 1, 2009 Joan Campion (Media)
212 733-2798
Joan.Campion@Pfizer.com
Suzanne Harnett (Investors)
212 733-8009
Suzanne.Harnett@Pfizer.com
Protalix Contacts:
Brad Miles (Media)
BMC Communications Group, LLC
Bmiles@bmccommunications.com
917 570 7340
Marcy Nanus (Investors)
The Trout Group, LLC
646 378 2927
Mnanus@troutgroup.com
Pfizer And Protalix Enter Into Agreement To Develop And Commercialize Gaucher s 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 Gaucher s
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
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 Gaucher s 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 Gaucher s
disease, commented Dr. David Aviezer, president and CEO of Protalix. By joining our advances in
biologics manufacturing and protein development with Pfizer s global strengths in patient services
and reimbursement we expect to help make taliglucerase alfa an important and cost-effective
treatment choice for Gaucher s 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 Gaucher s disease,
said David Simmons, president and general manager of Pfizer s 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
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 Pfizer s 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 Gaucher s disease
Gaucher s disease, an inherited condition, is the most prevalent lysosomal storage disorder, with
an incidence of about 1 in 20,000 live births. People with Gaucher s disease do not have enough of
an enzyme, glucosidase (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
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. 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. Taliglucerase alfa is an enzyme replacement therapy in development under a
Special Protocol Assessment with FDA for Gaucher s 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 world s 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 world s 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
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 Pfizer s
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 Protalix s Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and
its reports on Form 10-Q.
Last updated: Dec 1, 2009