EDEN PRAIRIE, Minn. & CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--Nov. 2, 2009--
Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface
modification technologies to the healthcare industry, and NuPathe
Inc., a neuroscience-focused specialty pharmaceutical company,
announced today that the companies have entered into a license agreement
for drug delivery technology. The companies have been collaborating
since 2007 on the development of a biodegradable sustained release
formulation of an approved dopamine agonist. The result is NuPathe’s NP201,
the first long-acting treatment available in broadly acceptable dose
form that maintains the potential to provide sustained relief from
Parkinson’s disease without motor response complications. NP201
leverages NuPathe’s long-acting delivery (LAD™) technology and
SurModics’ proprietary biodegradable polymer matrix implant technology
to achieve optimal drug release over an extended period of time.
Under the licensing agreement, NuPathe will lead and fund development
and commercialization. SurModics will provide technical and
manufacturing expertise and will be eligible to receive licensing fees
and milestone payments related to development of products for the
treatment of Parkinson's disease and other clinical indications.
SurModics will also receive royalties on product sales.
"The use of SurModics’ biodegradable implant technology is an ideal
match in this clinical area, as maintaining desired drug levels are
critical for achieving the optimal clinical outcome,” said Bruce
Barclay, president and CEO of SurModics. “We have enjoyed a strong
collaboration with NuPathe and look forward to continuing in the
development and commercialization of this important product for patients
with Parkinson's disease."
SurModics is nearing completion of a major facility expansion at its
SurModics Pharmaceuticals site in Birmingham, Alabama. The agreement
with NuPathe anticipates the use of this facility for the production of
clinical materials and, ultimately for commercial supply.
"We are thrilled to have SurModics Pharmaceuticals as our development
partner on this product,” said Jane Hollingsworth, CEO of NuPathe. “We
evaluated a number of potential partners for technical experience and
selected the SurModics team based on their depth of capabilities.
SurModics’ technical knowledge coupled with their investments in a new
cGMP manufacturing facility were important factors in our decision to
execute the license agreement. Thus far, our collaboration has been
extremely successful. NP201 has demonstrated efficacy in a validated
Parkinson’s model and has the potential to significantly improve the
lives of Parkinson’s patients."
Parkinson's disease is a brain disorder. It occurs when certain nerve
cells (neurons) in a part of the brain called the substantia nigra die
or become impaired. Normally, these cells produce a vital chemical known
as dopamine. Dopamine allows smooth, coordinated function of the body's
muscles and movement. When approximately 80% of the dopamine-producing
cells are damaged, the symptoms of Parkinson's disease appear.
Approximately 1.4 million people suffer from Parkinson’s disease in the
United States, Europe, and Japan. By 2050, this number is expected to
have doubled with the population of elderly (over age 65) individuals.
Parkinson’s patients are treated with a variety of therapeutics designed
to replace lost dopaminergic function. Primary treatments include
dopamine supplementation through dopamine agonists and/or
carbidopa/levodopa. While these treatments are effective, dose
complications, such as movement disorders, on/off fluctuations, and
dyskinesias, are common. Many experts attribute these complications to
variable drug levels resulting from frequent dosing or poor compliance
with the prescribed dosing.
NP201 consists of a dopamine agonist formulated to provide effective
relief of the signs and symptoms of Parkinson’s disease (e.g., tremor,
rigidity, postural instability) for 1-3 months with a single
administration. By providing stable, continuous drug delivery over an
extended period, NP201 may significantly decrease the dose complications
associated with current treatments. Furthermore, many researchers
believe that continuous, stable stimulation of the dopamine receptors
may slow the progression of the disease.
NuPathe Inc. is a privately-held specialty pharmaceutical company,
located in Conshohocken, PA. The company was founded in 2005 and is
supported by leading healthcare venture capitalists. NuPathe specializes
in the development of therapeutic products for the neurosciences.
NuPathe’s mission is to identify and address the needs of patients that
are insufficiently met by current treatments. In addition to NP201,
NuPathe’s portfolio includes Zelrix™, a novel transdermal patch for the
treatment of acute migraine. NuPathe reported positive Phase III results
in 3Q09 and plans a 2010 NDA filing. If approved by the FDA, Zelrix will
be the first and only transdermal patch for the treatment of acute
migraine. For more information, please visit www.nupathe.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, 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 those 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
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 Financial