The European Commission Grants Orphan Drug Designation To Alseres Pharmaceuticals' Spinal Cord Injury Treatment, Cethrin(R)

Main Category: Neurology / Neuroscience
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 19 Sep 2008 - 4:00 PDT

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Alseres Pharmaceuticals, Inc., (Nasdaq: ALSE) announced that Cethrin has been granted designation as an orphan medicinal product for the treatment of traumatic spinal cord injury (SCI) by the European Commission. The European Commission's decision was adopted on September 5, 2008 following the favorable opinion issued by the European Medicine Agency (EMEA) Committee of Orphan Medicinal Products (COMP) at their meeting on June 10 and 11, 2008. The designation was granted to Triskel EU Services, Alseres' representative in the European Union (EU).

"The European orphan drug designation represents another important step for Alseres in the development of Cethrin," said James R. Weston, Senior Vice President of Regulatory Affairs and Quality. "We value the positive recognition from the EMEA's Committee on Orphan Medicinal Products of the potential for Cethrin to provided significant benefit to patients who experience a serious spinal cord injury."

Cethrin received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) in 2005 for the treatment of acute spinal cord injury. Currently in Phase II clinical testing in the U.S. and Canada, Cethrin is being investigated for its potential to restore motor and sensory function after acute spinal cord injury.

"Cethrin is one of only two drugs to ever receive Orphan Medicinal Product designation in the EU for the treatment of severe acute spinal cord injury. Having Orphan Designation in both the EU and U.S. creates competitive advantages that further enhance Cethrin's value particularly because of the market exclusivity that comes with the designation," commented Dr. Mark Pykett, Alseres' President and Chief Operating Officer.

Following drug approval, Orphan Designation provides a drug with market exclusivity for a 10 year period in the EU and for 7 years in the U.S. for a particular indication. European Orphan Medicinal Product designations are based on various criteria that include: the life-threatening or debilitating nature of the condition, the lack of availability of other effective therapies, and the rarity of the condition. The European Union currently has 27 member countries, including France, Germany, Italy, Spain and the United Kingdom with a population of nearly half a billion people.

About Cethrin

Cethrin is a recombinant protein drug that is being investigated for its potential to restore motor and sensory function after spinal cord injury. Following an SCI, about two-thirds of patients undergo decompression/stabilization surgery. During surgery, Cethrin is delivered by a single application to the injured region of the spinal cord. A total of 48 patients with acute SCI were enrolled in a Phase I/IIa open label study at nine sites across Canada and the United States. An escalating dose of Cethrin (0.3, 1, 3, 6 or 9 mg) was administered to the injured spinal cord during spinal decompression surgery. Neurological outcomes were measured using the ASIA Impairment Scale, or AIS. Evaluations were completed at 0, 1.5, 3, 6 and 12 months after treatment. The data for the first 37 patients who completed the 12-month evaluation indicate that at 6 and 12 months after treatment, 38% (5/13) of cervical injury patients showed marked recovery of motor and sensory function after treatment as measured by a 2-grade or better improvement in the American Spinal Injury Association, or ASIA, Impairment Scale. A double-blind, randomized, placebo-controlled, multi-center, Phase IIb trial in patients with acute traumatic cervical SCI in the United States and Canada is expected to begin in 2009.

About Alseres Pharmaceuticals, Inc.

Alseres Pharmaceuticals, Inc. (ALSE) is engaged in the development of therapeutic and diagnostic products primarily for disorders in the central nervous system (CNS). The Company maintains a world-class intellectual property position in the field of regenerative therapeutics. The Company's energy and focus is reflected in several important initiatives. Cethrin, a recombinant-protein-based drug designed to promote nerve repair after acute spinal cord injury, demonstrated positive interim results in a Phase I/IIa clinical trial. The Company's research and pre-clinical programs include, Inosine for the treatment of spinal cord injury and stroke, Oncomodulin for the treatment of ocular injury and disease and research programs directed at a number of regenerative therapies including bone repair. The Company has a robust molecular imaging development program targeting diagnosis of Parkinson's disease and potentially dementia. The Company's lead molecular imaging product candidate is Altropane which is in Phase III clinical trials for the diagnosis of Parkinsonian Syndromes including Parkinson's Disease. The Company has research collaborations with Harvard Medical School and Children's Hospital Boston.

Forward Looking Statements

The foregoing release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward- looking statements include statements regarding Alseres' future expectations, beliefs, intentions, goals, strategies, plans or prospects regarding the future, including the development and commercialization of Altropane and Cethrin, the prospects of the Company's CNS and regenerative therapeutics programs, the Company's strategies to develop and commercialize axon regeneration technologies and the breadth of the Company's technologies and intellectual property portfolio. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including those risks, uncertainties and factors referred to in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Alseres from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Alseres is providing the information in this press release as of this date and assumes no obligations to update the information in this press release.

Alseres, Cethrin and Altropane are registered trademarks of Alseres Pharmaceuticals, Inc

Alseres Pharmaceuticals, Inc
http://www.alseres.com