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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): October 24, 2006
SANGAMO BIOSCIENCES, INC.
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(Exact name of registrant specified in its charter)
Delaware 000-30171 68-0359556
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(State or other jurisdiction of (Commission (I.R.S. Employer
incorporation) File Number) Identification No.)
501 Canal Blvd, Suite A100, Richmond, California 94804
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(Address of principal executive offices) (Zip Code)
Registrant's telephone, including area code: (510) 970-6000
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(Former name and 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))
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ITEM 1.01. ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT.
On October 24, 2006, Sangamo BioSciences, Inc. (the "Company") entered
into a Research, Development and Commercialization Agreement (the "Agreement")
with Juvenile Diabetes Research Foundation International, a Pennsylvania
nonprofit corporation ("JDRF"). Under the Agreement and subject to its terms and
conditions, including the Company's achievement of certain milestones associated
with the Company's Phase 2 clinical trial of SB-509 for the treatment of
diabetic neuropathy, JDRF will pay the Company an aggregate amount up to
$3,000,000. Furthermore, the Company is obligated to cover the costs of the
Phase 2 trial that are not covered by JDRF's grant.
SB-509 is administered as an injectable formulation of plasmid DNA that
encodes a zinc finger protein transcription factor, designed to upregulate the
VEGF-A gene. VEGF-A has been demonstrated to have direct neurotrophic and
neuroprotective properties. The Company has completed a Phase 1a dose-escalation
study and has an ongoing Phase 1b study of SB-509 in subjects with mild to
moderate diabetic neuropathy.
Pursuant to the Agreement, the Company is obligated to use commercially
reasonable efforts to carry out the Phase 2 trial and, thereafter, to develop
and commercialize, a product containing SB-509 for the treatment of diabetes and
complications of diabetes. If the Company fails to satisfy such obligations,
JDRF may have the right, subject to certain limitations, to obtain an exclusive,
sublicensable license, of the intellectual property generated by the Company in
the course of the Phase 2 trial, to make and commercialize products containing
SB-509 for the treatment of diabetes and complications of diabetes (the "JDRF
License"). If JDRF obtains such a license, it is obligated to pay to the Company
a percentage of JDRF's revenues on account of product sales and sublicensing
arrangements. If JDRF fails to satisfy its obligations to develop and
commercialize a product containing SB-509 under the Agreement, then the JDRF
License will terminate and the Company will receive a non-exclusive, fully paid
license, for any intellectual property developed during JDRF's use of the JDRF
License, to research, develop and commercialize products containing SB-509 for
the treatment of diabetes and complications of diabetes.
In addition, after the first commercial launch of SB-509 in a major
market, JDRF has the right to receive, subject to certain limitations, annual
payments from the Company, until such time when the total amount paid to JDRF,
including payments made on account of the Company's licensing arrangements,
equals three times the amount received by the Company from JDRF. If the
Company's aggregate net sales of SB-509 products exceeds specified thresholds in
the first 5 years after its first commercial launch in a major market, the
Company is required to make certain payments to JDRF, provided that the
aggregate amount of such payments shall not exceed two times the amount received
by the Company from JDRF.
The Agreement also provides that if the Company licenses its SB-509
program to a third party, the Company will use its best commercial efforts to
include in the license agreement certain rights to terminate such license if the
third party/licensee fails to develop and commercialize a product containing
SB-509 for the treatment of diabetes and complications of diabetes. If the
Company actually licenses its SB-509 program to a third party, JDRF has the
right to receive, subject to certain limitations, a percentage of the
consideration received by the Company from such license.
The Agreement will terminate when no further payments are due or owed
by either party under the Agreement, unless earlier terminated by either party
upon the uncured material breach of the other party or by JDRF in the event that
the FDA substantially changes the additional clinical endpoints in the Phase 2
protocol.
JDRF was founded in 1970 by the parents of children with juvenile
diabetes. Since its inception, JDRF has provided more than $1 billion to
diabetes research worldwide. More than 80 percent of JDRF's expenditures
directly support research and education about such research. JDRF's mission is
to find a cure for diabetes and its complications through the support of
research.
ITEM 7.01 REGULATION FD DISCLOSURE
On October 26, 2006, the Company issued press releases announcing the
transaction described in Item 1.01 above. A copy of the press releases is
attached as Exhibit 99.1 hereto and is incorporated herein by reference.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(d) Exhibits. The following document is filed as exhibits to this report:
99.1 Press Release of Sangamo Biosciences, Inc., dated October 26, 2006
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
SANGAMO BIOSCIENCES, INC.
Date: October 26, 2006 By: /s/ Edward O. Lanphier
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Name: Edward O. Lanphier
Title: Chief Executive Officer
Exhibit 99.1
Sangamo BioSciences, Inc.
Point Richmond Tech Center
501 Canal Boulevard
Richmond, CA 94804
510-970-6000 o 510-236-8951(Fax)
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SANGAMO BIOSCIENCES AND JDRF ANNOUNCE PARTNERSHIP FOR ZFP
THERAPEUTIC FOR DIABETIC NEUROPATHY PROGRAM
New York and Richmond, Calif., October 26, 2006 - Sangamo BioSciences, Inc.
(Nasdaq: SGMO) announced today that it has established a partnership with the
Juvenile Diabetes Research Foundation (JDRF) to provide financial support of
Sangamo's Phase 2 human clinical studies of SB-509, a ZFP Therapeutic that is in
development for the treatment of diabetic neuropathy (DN).
JDRF, the major charitable funding organization of research leading to a cure
for type 1 diabetes and its complications, will provide up to $3 million toward
the Phase 2 clinical trial based upon the achievement of certain milestones. The
funding will enable Sangamo to accelerate development of its ZFP Therapeutic for
the treatment of DN and conduct additional clinical tests that may provide
important information related to the mechanistic basis for therapeutic efficacy.
"This partnership provides an opportunity to accelerate the progress of a
potential treatment for a significant unmet medical need in diabetes," said Dr.
Richard A. Insel, M.D., Executive Vice President for Research at JDRF.
"Currently, more than fifty percent of patients with diabetes for ten years or
longer will experience diabetic neuropathy and the treatments currently
available are drugs that only address neuropathy-associated pain. Sangamo's
novel approach to DN has the potential to modify the disease at a more
fundamental level by modulating neuroprotective and neurotropic pathways."
"We are very pleased to have the confidence and support of JDRF as we advance
the clinical development of SB-509," said Edward Lanphier, Sangamo's President
and CEO. "This agreement demonstrates JDRF's commitment to ground-breaking
clinical research and to the development of novel therapeutics that can
potentially have an important impact on the quality of life for people with
diabetes." He added: "We believe that SB-509 represents a new therapeutic
approach for diabetic neuropathy, designed to directly protect and restore nerve
function, in contrast to the current standard of care designed to address only
the pain associated with this condition. Sangamo's ZFP technology provides a
unique approach designed to upregulate vascular endothelial growth factor or
VEGF, a factor that has been shown to have direct neuroprotective and
neurotrophic effects. The goal is to preserve and possibly restore nerve health.
The data collected from these Phase 2 studies will help establish the foundation
and mechanism of our ZFP technology as a novel class of therapeutics."
JDRF funds diabetes research across a range of scientific areas, including beta
cell regeneration, immunology, islet cell replacement, complications, genetics,
and technological innovations and therapeutics. The agreement with Sangamo is a
part of JDRF's innovative Industry Discovery and Development Partnership
program, through which JDRF partners with pharmaceutical, biotech, and medical
device businesses looking to develop drugs, treatments, technologies, and other
therapeutics leading to a cure, reversal, or prevention of type 1 diabetes and
its complications.
ABOUT THE SB-509 CLINICAL PROGRAM
Sangamo has completed a Phase 1a dose-escalation study and has an ongoing Phase
1b study of SB-509 in subjects with mild to moderate diabetic neuropathy. Later
this year, the company intends to initiate a double-blind placebo-controlled,
multi-treatment Phase 2 study in diabetics with mild to moderate sensory/motor
neuropathy. Safety will be monitored throughout the study. Clinical evaluations
will include evaluation of pain intensity, TNS, neurological examination and
electrophysiological testing as well as assessment of changes in nerve integrity
by examining changes in the density of nerve fibers in the skin using punch
biopsies.
ABOUT SB-509
SB-509 is administered as an injectable formulation of plasmid DNA that encodes
a zinc finger protein transcription factor, designed to upregulate the VEGF-A
gene. VEGF-A has been demonstrated to have direct neurotrophic and
neuroprotective properties.
ABOUT DIABETIC NEUROPATHY
Diabetic peripheral neuropathy is one of the most frequent complications of
diabetes. Symptoms include numbness, tingling sensations and pain particularly
in the toes or feet. This gradually evolves to loss of sensation and motor
function as nerve damage progresses. Ulcers and sores may appear on numb areas
of the foot because pressure or injury goes unnoticed. Despite treatment, these
areas of trauma frequently become infected and this infection may spread to the
bone, necessitating amputation of the leg or foot. More than 60 percent of
non-traumatic lower-limb amputations in the United States occur among people
with diabetes. In the period from 2000 to 2001, this translated to approximately
82,000 amputations. According to the Centers for Disease Control, the incidence
of diabetes in the United States is growing rapidly. From 1980 through 2002, the
number of Americans with diabetes more than doubled.
ABOUT JDRF
JDRF was founded in 1970 by the parents of children with juvenile diabetes--a
disease that strikes children suddenly, makes them insulin dependent for life,
and carries the constant threat of devastating complications. Since inception,
JDRF has provided more than $1 billion to diabetes research worldwide. More than
80 percent of JDRF's expenditures directly support research and education about
research. JDRF's mission is constant: to find a cure for diabetes and its
complications through the support of research.
ABOUT SANGAMO BIOSCIENCES, INC.
Sangamo BioSciences, Inc. is focused on the research and development of novel
DNA-binding proteins for therapeutic gene regulation and modification. The most
advanced ZFP TherapeuticTM development programs are currently in Phase 1
clinical trials for evaluation of safety in patients with diabetic neuropathy
and peripheral artery disease. Other therapeutic development programs are
focused on ischemic heart disease, neuropathic pain, cancer and infectious and
monogenic diseases. Sangamo's core competencies enable the engineering of a
class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs).
By engineering ZFPs that recognize a specific DNA sequence Sangamo has created
ZFP transcription factors (ZFP TFTM) that can control gene expression and,
consequently, cell function. Sangamo is also developing sequence-specific ZFP
Nucleases (ZFNTM) for therapeutic gene modification as a treatment for a variety
of monogenic diseases, such as X-linked SCID and hemophilia, and for infectious
diseases, such as HIV. Sangamo has established several Enabling Technology
Agreements with companies to apply its ZFP Technology to enhance the production
of protein pharmaceuticals. For more information about Sangamo, visit the
company's web site at www.sangamo.com.
This press release may contain forward-looking statements based on Sangamo's
current expectations. These forward-looking statements include, without
limitation, references to the clinical trials of SB-509, funding obligations of
JDRF based on milestones achieved by Sangamo, research and development of novel
ZFP TFs and ZFNs and therapeutic applications of Sangamo's ZFP technology
platform. Actual results may differ materially from these forward-looking
statements due to a number of factors, including uncertainties relating to the
initiation, ability to achieve milestones and completion of stages of the SB-509
clinical trial, whether the SB-509 clinical trial will validate and support
tolerability and efficacy of SB-509, technological challenges, Sangamo's ability
to develop commercially viable products and technological developments by our
competitors. See the company's SEC filings, and in particular, the risk factors
described in the company's Annual Report on Form 10-K and its most recent 10-Q.
Sangamo BioSciences, Inc. assumes no obligation to update the forward-looking
information contained in this press release.
Contact
JDRF
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Eileen Brangan Mell
(212) 479-7577
ebrangan@jdrf.org
Sangamo BioSciences, Inc. Burns McClellan, Inc.
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Elizabeth Wolffe, Ph.D. Justin Jackson (media)
510-970-6000, x271 212-213-0006
ewolffe@sangamo.com jjackson@burnsmc.com
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