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SurModics and NuPathe Partner to Develop Novel Long-Acting Parkinson's Treatment

EDEN PRAIRIE, Minn. & CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--Nov. 2, 2009-- SurModics, 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."

About Parkinson's

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.

About NP201

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.

About NuPathe

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 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 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 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.

Source: SurModics, Inc.

SurModics
Phil Ankeny, Senior Vice President and Chief Financial Officer
(952) 829-2700
or
NuPathe
Theresa Murray
(610) 228-2126