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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 4, 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 (Commission (I.R.S. Employer
of 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 December 4, 2006, Sangamo BioSciences, Inc. ("Sangamo") entered into
an Asset Purchase Agreement (the "Agreement") with Edwards Lifesciences LLC, a
Delaware limited liability company ("Edwards"), pursuant to which Sangamo will
acquire all of the assets in Edwards' angiogenesis program including regulatory
filings, clinical data, and GMP product (the "Transaction"). Under the
Agreement, as partial consideration for the sale of such assets, Sangamo will
issue to Edwards one million shares of its Common Stock, par value $0.01 per
share (the "Shares").
As additional consideration for the sale, Sangamo agrees to pay Edwards
royalties generated by the sales of certain human therapeutic products,
including products to treat ischemic cardiovascular and vascular disease and
diabetic neuropathy, based upon zinc finger protein (ZFP) activation of the
vascular endothelial growth factor (VEGF) gene, the first of which product is
not expected to be available for sale before 2012. The amount of royalties
payable to Edwards is equal to (i) five percent (5%) of the net sales of each
such product sold by Sangamo and (ii) the greater of (a) five percent (5%) of
the net sales of each such product sold by a sublicensee of Sangamo or (b)
twenty-five percent (25%) of the royalty payment received by Sangamo from its
sublicensee on account of such product sold by such sublicensee; provided that
total royalties paid by Sangamo under the Agreement shall not exceed $20 million
in any calendar year or $100 million in the aggregate.
In connection with the Transaction, Sangamo and Edwards have entered
into a termination agreement and a release agreement. Pursuant to these
agreements, upon the closing of the Transaction, the License Agreement, dated as
of January 11, 2000, between Sangamo and Baxter Healthcare Corporation, Edwards'
predecessor in interest ("Baxter"), including all amendments thereto, will be
terminated, and the obligations of Sangamo and Edwards under the Research
Funding Agreement, dated as of January 11, 2000, between Sangamo and Baxter,
including all amendments thereto, will be terminated and released. The closing
of the Transaction is expected to occur by December 31, 2006.
ITEM 3.02. UNREGISTERED SALES OF EQUITY SECURITIES
The disclosures set forth in Item 1.01 above in this Form 8-K are
incorporated herein by reference. The issuance of the Shares is exempt from the
registration requirements pursuant to Section 4(2) of the Securities Act of
1933, as amended, and Rule 506 of Regulation D promulgated pursuant thereto.
Edwards has represented that it is an "accredited investor" as defined in Rule
510(a) of Regulation D, and the issuance of the Shares was made without general
solicitation or advertising.
ITEM 7.01 REGULATION FD DISCLOSURE
On December 4, 2006, the Company issued a press release announcing the
transaction described in Item 1.01 above. A copy of the press release 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 exhibit to this report:
99.1 Press Release of Sangamo BioSciences, Inc., dated December 4, 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: December 4, 2006 By: /s/ Edward O. Lanphier
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Name: Edward O. Lanphier
Title: Chief Executive Officer
Exhibit 99.1
EDWARDS' ANGIOGENESIS PROGRAM TO BE ACQUIRED BY SANGAMO
Agreement Transfers Edwards' ZFP Therapeutics Program to Sangamo and Enables
Coordinated Implementation of Future Clinical Trials
IRVINE, Calif. and RICHMOND, Calif., Dec. 4 /PRNewswire-FirstCall/ --
Edwards Lifesciences Corporation (NYSE: EW) and Sangamo BioSciences, Inc.
(Nasdaq: SGMO) jointly announced today that the two companies have entered into
a definitive asset purchase agreement under which Sangamo will acquire Edwards'
angiogenesis program. The Edwards program was originally initiated in 2000 in
collaboration with and under license from Sangamo using their proprietary zinc
finger protein (ZFP) platform. Under the agreement announced today, Edwards will
transfer the assets of its program to Sangamo in exchange for 1 million shares
of Sangamo common stock. Edwards will also receive royalties on certain products
commercialized in the future based upon ZFP activation of the vascular
endothelial growth factor (VEGF) gene. The transaction is expected to be
completed by December 31, 2006.
"This transaction with Sangamo provides for focused, combined development of
our respective ZFP therapeutics programs and resolves the ongoing issue between
the two parties regarding the scope of our respective rights," said Michael
Mussallem, Edwards' chairman and CEO. "We're proud that our program has
developed products with the potential to help patients dealing with ischemic
vascular and cardiovascular disease. Additionally, the transfer of these assets
allows these important programs to continue under Sangamo's stewardship and
frees up additional Edwards' resources to drive R&D priorities more central to
our strategy."
"We are excited about the opportunity to add an additional clinical stage
ZFP therapeutic program to our portfolio," said Edward Lanphier, founder,
president and CEO of Sangamo BioSciences. "We initiated this program in 2000 and
are pleased with the significant investment and progress that Edwards has made
in the past six years. In addition to acquiring two clinical stage programs in
peripheral vascular disease (PAD) and a late stage pre-clinical program in
ischemic heart disease (IHD), this agreement will have a significant impact on
Sangamo's future corporate partnering opportunities involving VEGF-ZFP
therapeutic programs."
In January of 2000 Edwards, then a division of Baxter International, entered
into an exclusive license and research funding agreement with Sangamo to develop
and commercialize VEGF-ZFP therapeutics for the treatment and prevention of
ischemic cardiovascular and peripheral vascular diseases. Edwards completed
pre-clinical efficacy and toxicology studies and initiated a Phase 1 clinical
trial in June of 2004 for EW-A-401, a drug based on the VEGF-ZFP transcription
factor and designed to treat critical limb ischemia (CLI) as well as
intermittent claudication, both painful and limiting conditions of vascular
disease. Edwards has stated that early results from the CLI trial have been
encouraging and has submitted for approval with the U.S. Food and Drug
Administration to begin a randomized, placebo controlled, repeat dosing Phase 2
clinical trial in patients with CLI.
Independently, Sangamo has initiated clinical trials in diabetic neuropathy
with a VEGF-ZFP therapeutic known as SB-509. SB-509 and EW-A-401 are nearly
identical in design and function. Sangamo recently announced that it has
initiated a multi-center, double-blind, placebo controlled, repeat-dosing Phase
2 clinical trial in patients with diabetic neuropathy.
Sangamo and Edwards will host a conference call at 9:00 a.m. EST, Monday,
December 4, 2006. The conference call dial-in numbers are 866-543-6411 for
domestic callers and 617-213-8900 for international callers. The passcode for
the call is 10338848. Participants may access the live webcast via a link on the
Sangamo BioSciences website
http://phx.corporate-ir.net/phoenix.zhtml?c=120938&p=irol-IRHome in the Investor
Relations section under "Company Overview." For those unable to listen in at the
designated time, a conference call replay will be available for one week
following the conference call, from approximately 11:00 a.m. on December 4, 2006
to December 11, 2006. The conference call replay numbers for domestic and
international callers are 888-286-8010 and 617-801-6888 respectively. The
conference ID number for the replay is 16084942. The webcast will be available
on the Sangamo website for two weeks after the call.
About Sangamo BioSciences
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 Therapeutic(TM) development program is currently in a Phase 2
clinical trial for evaluation of safety in patients with diabetic neuropathy.
Phase 1 clinical trials are ongoing to evaluate a ZFP Therapeutic for 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 TF(TM)) that can control gene expression and, consequently, cell
function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN(TM))
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.
About Edwards Lifesciences
Edwards Lifesciences, a leader in advanced cardiovascular disease
treatments, is the number-one heart valve company in the world and the global
leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards
focuses on specific cardiovascular disease states including heart valve disease,
peripheral vascular disease and critical care technologies. The company's global
brands, which are sold in approximately 100 countries, include
Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, LifeStent, PERIMOUNT
Magna and Swan-Ganz. Additional company information can be found at
http://www.edwards.com.
Statements in this announcement other than historical data and information
constitute forward-looking statements that involve risks and uncertainties. A
number of factors could cause actual results, performance, achievements or
industry results to be very different from the results, performance or
achievements expressed or implied by such forward-looking statements. Some of
these factors include, but are not limited to, the risk factors set forth in
each company's filings with the Securities and Exchange Commission including its
Annual Report on Form 10-K for the year ended December 31, 2005, and such other
filings that Edwards and Sangamo make with the SEC from time to time. Due to
such uncertainties and risks, readers are cautioned not to place undue reliance
on such forward-looking statements, which speak only as of the date hereof.
SOURCE Edwards Lifesciences Corporation; Sangamo BioSciences, Inc.
-0- 12/04/2006
/CONTACT: Media, Jared B. Adams, +1-949-250-5070, or Investor, David K.
Erickson, +1-949-250-6826, both of Edwards Lifesciences; or Media, Justin
Jackson of Burns McClellan, Inc., +1-212-213-0006, for Sangamo BioSciences; or
Investor, Elizabeth Wolffe, Ph.D. of Sangamo BioSciences, +1-510-970-6000, ext.
271/
/Web site: http://www.sangamo.com /
/Web site: http://www.edwards.com /
(EW SGMO)