Includes Development and Commercialization of a Sustained Drug
Delivery Formulation of Lucentis® and Potentially Other Genentech
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Oct. 6, 2009--
SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and
surface modification technologies to the healthcare industry, announced
today that it has signed a License and Development Agreement with Roche
(SIX: RO, ROG; OTCQX: RHHBY) and Genentech, Inc., a wholly-owned member
of the Roche Group. Under this agreement, Roche and Genentech have
obtained an exclusive license to use SurModics’ proprietary
biodegradable microparticles drug delivery system to develop and
commercialize a sustained drug delivery formulation of Lucentis®
(ranibizumab injection). The agreement further provides Roche and
Genentech with opportunities to develop additional compounds for the
treatment of ophthalmic diseases.
Under the terms of the agreement, SurModics will receive an up-front
licensing fee of $3.5 million. In addition, SurModics could be eligible
to receive up to approximately $200 million in fees and milestone
payments in the event of the successful development and
commercialization of multiple products. Roche and Genentech will pay
SurModics for its development services and have the right to obtain
manufacturing services from SurModics. Also, SurModics will receive
undisclosed royalties on product sales.
“This agreement represents yet another major advancement toward
realizing our strategic vision of developing technologies that address
important clinical needs in the large and growing ophthalmology market,”
said Bruce Barclay, president and CEO of SurModics. “We believe that
partnering with Genentech, among the world’s largest and most prominent
biotechnology companies and an established market leader in
ophthalmology, serves to validate our critically enabling technologies.
The agreement, which includes Lucentis and potentially other products,
addresses a wide range of ophthalmic diseases and leverages our
expertise and technology platforms in ophthalmology, employs our
proprietary biodegradable microparticles drug delivery system from
SurModics Pharmaceuticals, and will utilize our new world-class cGMP
manufacturing facility in Birmingham, Alabama.”
Barclay added, “This agreement has the opportunity to provide both near-
and long-term value to SurModics’ shareholders. The combination of the
up-front payment, R&D and manufacturing fees and contingent milestone
payments underscore the unique advantages and power of our business
model. The prospect of developing a sustained delivery formulation for a
known, approved and highly successful drug in Lucentis, is a tremendous
opportunity for SurModics.”
SurModics will host a webcast at 10:00 a.m. ET (9:00 a.m. CT) today to
discuss the license and development agreement. To access the webcast, go
to the investor relations portion of the Company’s website at www.surmodics.com,
and click on the corresponding webcast icon. If you do not have access
to the Internet and want to listen to the audio or participate in the
conference call by phone, dial 877-941-2332 (conference ID# 4167942). A
replay of this conference call will be available by dialing 800-406-7325
and entering the previously stated conference call ID. The audio replay
will be available beginning at noon CT on Tuesday, October 6, until noon
CT on Tuesday, October 13.
Lucentis® is a vascular endothelial growth factor (VEGF) inhibitor
approved by the U.S. Food and Drug Administration (FDA) for the
treatment of neovascular (wet) age-related macular degeneration (AMD).
Lucentis is the only FDA-approved therapy for wet AMD, which in clinical
trials showed an improvement in vision of three lines or more on the
study eye chart in up to 41 percent of patients at two years.
Lucentis is designed to bind to and inhibit VEGF-A, a protein that is
believed to play a critical role in the formation of new blood vessels
(angiogenesis) and the hyperpermeability (leakiness) of the vessels.
Lucentis was discovered at Genentech and is being developed by Genentech
and the Novartis Ophthalmics Business Unit for diseases or disorders of
the eye. Genentech retains commercial rights in the United States and
Novartis has exclusive commercial rights for the rest of the world.
Lucentis is a prescription medication given by injection into the eye.
Lucentis has been associated with detached retina and serious eye
infection and should not be used in patients who have an infection in or
around the eye. Increases in eye pressure have been seen within one hour
of an injection. Although uncommon, conditions associated with eye- and
non-eye-related blood clots (arterial thromboembolic events) may occur.
Serious side effects included inflammation inside the eye and, rarely,
effects related to the injection procedure such as cataract. The most
common non-eye-related side effects were nose and throat infection,
headache, and respiratory and urinary tract infections. The most common
eye-related side effects were the feeling that something is in a
patient's eye, and increased tears. If a patient's eye becomes red,
sensitive to light, painful, or has a change in vision, they should seek
immediate care from their eye doctor.
Please see the Lucentis Full Prescribing Information on http://www.gene.com.
About SurModics, Inc.
SurModics’ vision is to extend and improve the lives of patients through
technology innovation. The Company partners with the world’s foremost
medical device, pharmaceutical and life science companies to develop and
commercialize innovative products that result in improved diagnosis and
treatment for patients. Core offerings include: drug delivery
technologies (coatings, microparticles, nanoparticles, 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. SurModics is headquartered in Eden Prairie, Minnesota and
its SurModics 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
This press release contains forward-looking statements. Statements that
are not historical or current facts, including statements about beliefs
and expectations, such as our expectations about our pipeline, the
potential of biodegradable microparticles in combination with Lucentis
or other compounds as a treatment for retinal diseases, 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 Company's
agreement with Genentech requires the development of new products and
applications of technology, and the successful build-out of our Alabama
facility in compliance with current Good Manufacturing Practice and
other regulations; (2) our reliance on third parties (including our
customers and licensees) and their failure to successfully develop,
obtain regulatory approval for, market and sell products incorporating
our technologies may adversely affect our business operations and our
ability to realize the full potential of our pipeline; (3) costs or
difficulties relating to the integration of the businesses of SurModics
Pharmaceuticals, and the drug delivery assets and collaborative programs
acquired from PR Pharmaceuticals, Inc., with SurModics’ business may be
greater than expected and may adversely affect the Company’s results of
operations and financial condition; (4) developments in the regulatory
environment, as well as market and economic conditions, may adversely
affect our business operations and profitability; and (5) 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, 2008, 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
Source: SurModics, Inc.
Phil Ankeny, Senior Vice President and Chief