Milestone Payments slated for reduction from $25 Million to $7 Million,
Royalties from 10-12% to 4%
HOPKINTON, Mass., May 6 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE), today announced an agreement with BioAxone Therapeutic, Inc., of Montreal, Canada, whereby, upon payment by Alseres of an option fee of $7 million on or before October 27, 2008, Alseres may exercise an option to amend the Company's Cethrin License Agreement.
Pursuant to the option agreement, the pre-commercial milestone payments in the amended license agreement will be reduced from $25 million to $7 million payable on or before December 31, 2009. In addition, the sales-based royalties in the amended license agreement will be reduced from 10-12% to 4% for spinal cord injury and 1% for all other indications. Finally, the amended license agreement will eliminate all development milestones related to Cethrin.
"This agreement represents a major step forward for Alseres in realizing the full value of our Cethrin spinal cord program and our Rho inhibitor technology platform," stated Peter Savas, Chairman and Chief Executive Officer. "Our strategy for our spinal cord injury program and our other regenerative therapeutics is to demonstrate efficacy in humans and then seek attractive partnerships for the assets. In addition to reducing the future cash burdens of the license, we believe that the reduction in our future royalty obligations will allow us to more freely explore worldwide collaboration and partnership opportunities not only in spinal cord injury but also possibly in other indications like bone repair, oncology, cardiomyopathy and eye disease."
Interim six-month results of 37 subjects in a Phase I/IIa clinical trial indicated that Cethrin was safe and well tolerated. The overall population of patients treated with Cethrin demonstrated an improvement in their impairment level on the American Spinal Injury Association scale that was approximately 400% greater than the conversion rate for patients in a comparable historical study who did not receive Cethrin. When analyzed as a subset, patients with cervical (neck) injuries who were treated with Cethrin showed improvement using the same impairment scale that was almost 700% greater than the full patient group treated with only the standard of care reported in the comparable study.
About Spinal Cord Injury, or SCI
There are approximately 11,000 new cases of SCI each year in the U.S. The average age of injury is 38. The estimated health care costs that are directly attributable to SCI vary greatly according to severity of the injury. The National Spinal Cord Injury Statistical Center estimates that the annual cost of care for spinal cord injury is up to $20 billion annually. The direct lifetime care costs for a patient with the most-severe injury and complete loss of function below the injury site is $2.9 million. Restoring even limited function to those who otherwise would have complete loss of function could reduce total medical costs/patient by $2.2 million over their lifetime and save the economy $9 billion annually while dramatically improving the quality of life for patients and their families.
About Cethrin(R) -- Phase II Drug for Acute Spinal Cord Injury
Cethrin is a recombinant protein drug intended to facilitate the re-growth of axons during the critical period immediately after a major injury to the spinal cord. Following a spinal cord injury 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. Cethrin has been designated as an Orphan Drug by the FDA.
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 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 and ADHD. 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.
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 Annual Report on Form 10-K for the year ended December 31, 2007 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 is a trademark and Cethrin and Altropane are registered
trademarks of Alseres Pharmaceuticals, Inc.
Sharon Correia - 508-497-2360 ext. 224
Alseres Pharmaceuticals, Inc.
Adam Friedman - 212-981-2529 ext 18
Adam Friedman Associates
|SOURCE Alseres Pharmaceuticals, Inc.|
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