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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
August 7, 2008
Date of report (Date of earliest event reported)
SurModics, Inc.
(Exact Name of Registrant as Specified in its Charter)
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Minnesota
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0-23837
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41-1356149 |
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(State of Incorporation)
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(Commission File Number)
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(I.R.S. Employer |
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Identification No.) |
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9924 West 74th Street
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Eden Prairie, Minnesota
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55344 |
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(Address of Principal Executive Offices)
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(Zip Code) |
(952) 829-2700
(Registrants Telephone Number, Including Area Code)
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):
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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 8.01. Other Events.
On August 8, 2008, SurModics, Inc. (the Company) announced in a press release that it had
been informed by Merck & Co., Inc. that, in light of results reported in a recently published study
comparing laser treatment and intravitreal injections of triamcinolone acetonide (TA) in patients
with diabetic macular edema (DME), Merck is reevaluating the design of its Phase IIb clinical trial
for I-vation TA. Pending this review, Merck is temporarily suspending enrollment of new patients
in the Phase IIb clinical trial. The License and Research Collaboration Agreement between the
companies continues. Other development programs with Merck are unaffected. A copy of the press
release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
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Exhibit |
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Description |
99.1
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Press Release dated August 8, 2008. |
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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SURMODICS, INC.
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Date: August 8, 2008 |
/s/ Philip D. Ankeny
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Philip D. Ankeny |
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Sr. Vice President and Chief Financial Officer |
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exv99w1
Exhibit 99.1
FOR IMMEDIATE RELEASE
Enrollment in Phase IIb Clinical Trial for
I-vation TA (MK-0140) Suspended
Pending Review of Study Design by Merck & Co., Inc.
Clinical
Data Support Tolerability Profile;
Other Development Programs with Merck are Unaffected
EDEN PRAIRIE, Minnesota August 8, 2008 SurModics, Inc. (Nasdaq: SRDX), a leading provider of
surface modification and drug delivery technologies to the healthcare industry, announced today
that Merck & Co., Inc. has informed the company that, in light of results reported in a recently
published study comparing laser treatment and intravitreal injections of triamcinolone acetonide
(TA) in patients with diabetic macular edema (DME), Merck is reevaluating the design of its Phase
IIb clinical trial for I-vation TA. Pending this review, Merck is suspending
enrollment of new patients in the Phase IIb clinical trial. The License and Research Collaboration
Agreement with Merck continues, and other ongoing development programs with Merck are unaffected.
Mercks Phase IIb clinical trial is intended to evaluate the safety and efficacy of SurModics
I-vation TA in patients with DME. The suspension of the clinical trial follows the
publication of a study sponsored by the National Eye Institute suggesting a benefit for laser
treatment over intravitreal injections of TA. This recently published report does not discuss
I-vation TA, nor did the study evaluate the safety or efficacy of sustained drug delivery
systems.
The decision to suspend enrollment in this clinical trial is based solely on the results reported
in a recently published study comparing laser treatment and intravitreal injections of TA, said
Bruce Barclay, president and CEO of SurModics. We believe the data from the Phase I and
Phase IIb clinical trials generated to date provide support for the
tolerability profile of I-vation TA, and more generally, that of the I-vation sustained delivery platform.
Additionally, SurModics remains committed to its ongoing development programs with multiple other
customers pursuing the development of products incorporating SurModics sustained delivery
technologies, including the I-vation platform, for the treatment of diseases of the eye.
About SurModics, Inc.
SurModics, Inc. is a leading provider of surface modification and drug delivery technologies to the
healthcare industry. SurModics partners with the worlds foremost medical device, pharmaceutical
and life science companies to develop and commercialize innovative products that result in improved
patient outcomes. Core offerings include: drug delivery technologies (coatings, microparticles, and
implants); surface modification coating technologies that impart lubricity, prohealing, and
biocompatibility capabilities; and components for in vitro diagnostic test kits and specialized
surfaces for cell culture and microarrays. Collaborative efforts include a sustained drug delivery
system in human trials for treatment of retinal disease and the drug delivery polymer matrix on the
first-to-market drug-eluting coronary stent. SurModics is headquartered in Eden Prairie, Minnesota
and its Brookwood Pharmaceuticals subsidiary is located in Birmingham, Alabama. For more
information about the company, visit www.surmodics.com. The content of SurModics website is not
part of this release or part of any filings the company makes with the SEC.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or
current facts, including statements about beliefs and expectations, are forward-looking statements.
Forward-looking statements involve inherent risks and uncertainties, and important factors could
cause actual results to differ materially from those anticipated, including the following: (1)
realizing the full potential benefits of the companys agreement with Merck & Co., Inc. requires
the development of new products and applications of technology, and the successful management of
clinical trials and related foreign and domestic regulatory processes; (2) costs or difficulties
relating to the integration of the businesses of Brookwood Pharmaceuticals and BioFX Laboratories
with SurModics business may be greater than expected and may adversely affect the companys
results of operations and financial condition; (3) developments in the regulatory environment, as
well as market and economic conditions, and our reliance on third parties, may adversely affect our
business operations and profitability, and the companys ability to achieve our fiscal 2008
corporate goals and to realize the potential of our pipeline; and (4) other factors identified under Risk Factors in Part I, Item 1A of our
Annual Report on Form 10-K for the fiscal year ended September 30, 2007, and updated in our
subsequent reports filed with the SEC. These reports are available in the Investors section of our
website at www.surmodics.com and at the SEC website at www.sec.gov. Forward-looking statements
speak only as of the date they are made, and we undertake no obligation to update them in light of
new information or future events.
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Contact
Phil Ankeny, Sr. VP and Chief Financial Officer
(952) 829-2700