HOPKINTON, Mass., June 12 /PRNewswire-FirstCall/ -- Alseres
Pharmaceuticals, Inc. (Nasdaq: ALSE) released a letter to stockholders from
Peter G. Savas, Chairman and Chief Executive Officer, in conjunction with
the company's annual stockholders meeting. The letter which follows,
summarizes the Company's progress and describes its strategy going forward.
(Logo: http://www.newscom.com/cgi-bin/prnh/20070608/NEF043LOGO )
The text follows:
I would like to review the major accomplishments of the past year and
provide some insight into our strategy going forward. Last year I stated
that we would continue with our plans to transform Alseres into a leading
nerve repair company. Our 2007 results reflect our continued progress
towards realizing commercial value from our new product pipeline.
-- Alseres' Cethrin(R) is the world's leading clinical stage nerve repair
product. Cethrin Phase I/IIa interim results demonstrated promising
neurological recovery in the first 37 enrolled patients. In January
2008, enrollment in the Phase I/IIa trial concluded with a total of 48
patients. Based on interim results, Alseres intends to move forward
with its Cethrin Phase IIb trial in the second half of 2008. After
discussions with regulatory authorities and expert advisors we were
able to reduce the planned size of the IIb trial from 200 patients to a
maximum of 100. This significantly reduced the time and funding
required to complete the Phase IIb trial. We plan to initiate the
Phase IIb trial at up to 80 sites in the United States, Canada, Europe
and other selected countries.
-- Cethrin works by inhibiting the action of Rho, a key enzyme that
prevents axon (nerve) regeneration. Rho potentially plays an important
role in a wide range of indications, including acute spinal cord injury,
stroke, bone regeneration, cardiomyopathy and oncology. Alseres has
ongoing, sponsored-research for approaches to activate pro-regenerative
pathways that stimulate axon regeneration and for approaches to
deactivate anti-regenerative pathways that inhibit axon regeneration.
We believe that our Rho inhibitor technology is a fertile and
potentially valuable platform for continued new product research and
-- Altropane(R), the company's lead molecular imaging product candidate,
is in Phase III clinical trials for the diagnosis of Parkinson's
Disease in patients with tremor. After a series of discussions with
the FDA and our expert advisors, we designed a two-part Phase III
program, termed POET-2. The first part of the program is presently
enrolling patients, as planned, in a 7-center clinical study to
generate an image training set. These images will be used to train the
expert readers in the study, as is customary for clinical trials of
molecular imaging agents. The second part of the program involves two
concurrent, replicate Phase III trials which are planned to be
initiated as soon as final agreement with FDA is reached. In addition,
by the end of the year, we plan to begin Phase II trials of Altropane,
in a new indication to aid in the diagnosis of Dementia with Lewy
-- We entered into an option agreement whereby Alseres can exercise an
option to amend certain terms of its Cethrin license with BioAxone
Therapeutic, Inc. in exchange for a $7 million fee payable on or before
October 27, 2008. If Alseres exercises this option, the pre-commercial
milestone payments in the amended license agreement will be reduced
from $25 million to $7 million and 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.
-- In March, Alseres entered into an agreement that provides for the
Company to borrow $5 million from Robert L. Gipson, an existing lender.
The agreement further provides that the Company may borrow up to an
additional $5 million from any existing lender under the agreement on
the same terms and conditions.
We are pursuing a growing number of confidential partnering discussions with leading companies regarding our molecular imaging, our nerve repair and our regenerative therapy programs and assets. Our recent agreement to improve the terms of the Cethrin license may represent a major step forward for Alseres in realizing the full value of our Cethrin spinal cord program and our Rho inhibitor technology platform and, most importantly, may open up key partnering opportunities.
Our primary objective is to bring our promising lead products to market efficiently. Our ability to accomplish our commercialization objective is enabled by an organization that has developed credible relationships with regulatory authorities, world experts and potential partners. In that regard, I am pleased to acknowledge that MIT Professor Robert Langer, a member of our Board and Chairman of our Science and Technology Committee, has been awarded the 2008 Millennium Technology Prize for intelligent drug delivery. The Prize, which is the world's largest for technology innovation, is given by the Technology Academy Finland. Professor Robert Langer's innovations have had a significant impact on fighting cancer, heart disease, and numerous other diseases. Known as the father of controlled drug delivery and tissue engineering, Professor Langer has been cited as "one of history's most prolific inventors in medicine". Professor Langer's research laboratory at MIT is the largest biomedical engineering laboratory in the world.
In the months ahead, we will make additional announcements regarding
the progress of our product, technology and business development programs.
My fellow directors, officers, advisors and employees join me in thanking
you for your interest and encouragement. We remain committed to creating
sustainable, long term value for all of our stockholders.
Peter G. Savas
Chairman & Chief Executive Officer
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.
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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