Conference Call To Be Held Tuesday, April 1, 2008 At 10:00 a.m. Eastern
HOPKINTON, Mass., March 31 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE) today reported consolidated financial results for the year ended December 31, 2007 and company highlights.
"2007 was a year of significant clinical, regulatory, pipeline and
business accomplishments that helped advance our mission of building a
leading biopharmaceutical company focused on disorders of the central
nervous system," commented Peter G. Savas, Chairman and Chief Executive
Officer of Alseres. "Our progress reinforces our confidence in the broad
potential of our pipeline and in our leadership in nerve repair and
regenerative therapeutics. Our focus in 2008 will be on commencing the
Phase IIb trial of CETHRIN, partnering our molecular imaging assets and
closing collaborations for our regenerative therapeutics."
2007 and Recent Corporate Highlights
Product Pipeline and Scientific Highlights
Advanced the Regenerative Therapeutics pipeline.
-- In April 2007, the Company reported 6-month interim data from its Phase
I/IIa Clinical Trial in Acute Spinal Cord Injury on the first 37
subjects treated with CETHRIN at doses up to 6 mg. The data 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 approximatelmay 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.
Contact: Sharon Correia -- 508-497-2360 ext 224
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. In
subjects with cervical injuries, the interim efficacy data also suggest
that the conversion rate was dose-dependent.
-- In April and June 2007, Health Canada and the U.S. Food and Drug
Administration (FDA), respectively, authorized enrollment at an
increased dose level (9mg) in the CETHRIN Phase I/IIa clinical trial.
-- In January 2008, we ended enrollment in the CETHRIN Phase I/IIa
clinical trial. In total, 48 patients were enrolled at nine sites in
the United States and Canada. The results of the trial will continue
to be analyzed and communicated as the post-treatment evaluations are
-- At the end of 2007 and in early 2008, the Company met with the FDA,
Health Canada and the European Medicines Agency (EMEA), to review the
Phase I/IIa results and our CETHRIN clinical development plan. Based
on these discussions, Alseres plans to initiate a double-blind,
randomized, placebo-controlled, multi-center Phase IIb trial in up to
200 subjects with acute cervical SCI at up to 80 sites in the United
States, Canada, Europe and other selected countries during the second
half of 2008.
Presented results at major scientific and medical meetings.
During 2007, the Company presented data from its clinical programs at a
number of peer-reviewed scientific and medical meetings including:
-- Canadian Spine, March 2007;
-- American Association of Neurological Surgeons (AANS), April 2007;
-- American Spinal Injury Association (ASIA), June 2007;
-- World Spine, July 2007;
-- Congress of Neurological Surgeons, September 2007; and
-- North American Spine Society, October 2007
Advanced the Molecular Imaging Program.
-- In July 2007, Alseres completed a study with our collaborators that
optimized ALTROPANE's image acquisition protocol. We believe the
optimized protocol will enhance ALTROPANE's use once commercialized.
-- After a series of discussions with the FDA and our expert advisors, our
POET-2 program was designed as a two-part Phase III program using the
optimized ALTROPANE image acquisition protocol. The first part of the
program was initiated in December 2007 in a multi-center clinical study
in subjects to acquire a set of ALTROPANE images to train the expert
readers. The second part involves two concurrent, replicate, multi
center Phase III trials. These two concurrent trials will be initiated
once final agreement on the design of the two trials is reached with
-- Data from a study to evaluate the Test/Re-test reliability of ALTROPANE
in Parkinson disease patients were presented at Movement Disorder
Society's 11th International Congress of Parkinson's Disease and
Movement Disorders in June 2007. The data demonstrated that ALTROPANE
uptake is reduced in Parkinson's Disease patients with moderate PD and
has excellent test/re-test reliability.
-- We advanced partnering discussions for our Molecular Imaging Program
the focus of which was the completion of the Phase III clinical
program, development of the product in Dementia with Lewy Bodies,
development of the product in Europe, ultimately the launch and
commercialization of ALTROPANE and product family life cycle management
with our second generation technologies.
Progressed our preclinical programs in regenerative therapeutics,
neurodegenerative disease and molecular imaging.
-- Data from a rodent study designed to measure the levels of Inosine in
the brain during intravenous infusion of high concentrations of Inosine
were presented at the American Society for Experimental
NeuroTherapeutics (ASENT). This study showed that, when administered
intravenously using a new, high concentration formulation of Inosine,
Inosine levels in the brain increased more than 600% over baseline
levels. Inosine is a nerve regenerative factor that has been shown to
promote axon outgrowth in neurons and has potential to be used to treat
CNS disorders such as spinal cord injury, stroke, and traumatic brain
-- Findings from a study to determine brain bioavailability following oral
administration of three of Alseres' highly-selective dopamine
transporter (DAT) blockers were also presented at the ASENT meeting.
The data presented showed that all three of the Company's DAT blockers
given orally were rapidly absorbed into the blood and the brain and
provided favorable brain-to-blood plasma ratios.
-- Working with our scientific collaborators, we initiated a series of
comparative studies in which other of our regenerative technologies,
including Inosine, Oncomodulin and other compounds, are being tested in
parallel in a series of models of CNS disorders to assess their
potential to enhance nerve repair. If successful, these studies may
enable the most promising candidates and indications to be taken
forward in development.
-- We are also evaluating our Rho inhibitors in animal models to assess
their ability to stimulate cells to regenerate bone. It is estimated
by our market research resources that there are approximately two
million bone grafting procedures in the United States every year. The
market for orthopedic biomaterials used in these procedures was
estimated to be approximately $4 billion in 2006. In addition, the
fastest growing segment of this market is recombinant protein products
which is expected to grow to $2.9 billion by 2012.
-- We are developing second-generation technetium-based imaging agents to
aid in the diagnosis of PD, Dementia with Lewy Bodies (DLB), and
Attention Deficit Hyperactivity Disorder (ADHD). We have previously
demonstrated in non-human primate studies that our technetium-based
agents are effective in binding the to DAT in sufficient quantity and
with high-selectivity to provide a readable image in the normal brain.
During 2007, we devised a new radiolabeling procedure for our
technetium agents that results in a high purity, high yield product as
a prelude to obtaining definitive images in non-human primates.
Continued Intellectual Property (IP) leadership notably in regenerative
Alseres' IP portfolio includes issued, allowed or granted patents from the
U.S. and other key countries worldwide. During 2007, the company
submitted 14 new patent applications covering our regenerative
therapeutics, molecular imaging, and neurodegenerative disease assets. We
were granted three new patents covering CETHRIN, four additional patents
covering other regenerative therapies and one patent covering our DAT
Business & Operational Highlights
Licensed Phase I/IIa Regenerative Therapeutics Program in acute SCI.
In December 2006, Alseres licensed, from BioAxone Therapeutic, Inc. of
Montreal, Canada, development and commercialization rights of CETHRIN, as
well as other specified compounds.
Renamed Company to reflect strategic vision.
In June 2007, Boston Life Sciences was renamed Alseres Pharmaceuticals.
The new name, which derives from the Latin meaning to take root and grow,
better reflects the transformation of the Company from a life sciences
company into a biopharmaceutical company with late stage product
candidates in clinical development for CNS disorders.
Raised $27 million in new cash in 2007, an additional $5 million in
2008 and eliminated $10 million of debt.
-- In early 2007, we borrowed $2 million in debt that, along with the $8
million of debt outstanding at December 31, 2006, converted into our
common stock in June 2007.
-- In 2007 and in March 2008, we borrowed an aggregate of $30 million
under convertible notes that mature on December 31, 2010. These notes
are convertible into our common stock at a conversion price of $2.50
per share or the right to receive future payments related to our
molecular imaging products (including ALTROPANE and FLUORATEC) in
amounts equal to 2% of our pre-commercial revenue related to such
products plus 0.5% of future net sales of such products for each
$1,000,000 of outstanding principal and interest that a purchaser under
this agreement elects to convert into future payments.
Continued to expand management team with key additions.
In 2007, Alseres added Dr. Frank Bobe to the position of Executive Vice
President and Chief Business Officer and Susan Flint to the position of
Senior Vice President Drug Development.
Continued development of the Board of Directors.
In 2007, Alseres elected Gary Frasier and Henry Brem to its Board of
Directors. The Company also formed a Science and Technology Committee
comprised of independent directors of the Board. The committee consists
of Robert Langer, Sc.D., of MIT who serves as chair of the committee,
Henry Brem, M.D., of Johns Hopkins University School of Medicine and Gary
Frashier, of Management Associates.
Named key thought leaders in the area of spinal cord injury research to
advise on the CETHRIN development program.
In May 2007, Alseres formed a scientific and clinical advisory panel. The
panel is composed of some of the world's leading experts in the field of
SCI and nerve repair: John F. Ditunno, Jr. M.D., of Jefferson Medical
College; James Fawcett, M.D., of Cambridge University Centre for Brain
Repair; Michael G. Fehlings M.D., Ph.D., of the University of Toronto and
Principal Investigator in the CETHRIN Phase I/IIa trial; Daniel P.
Lammertse, M.D., of Craig Hospital; John Steeves, Ph.D., of the University
of British Columbia (UBC) and Vancouver Coastal Health (VCH); and Mark
Tuszynski, M.D., Ph.D., of the University of California at San Diego. They
joined the Company's current scientific advisors: Larry Benowitz, Ph.D.,
Children's Hospital Boston; Zhigang He, Ph.D., Children's Hospital Boston;
and Joseph Bianchine, M.D., former advisor to Schwarz Pharma.
Financial Highlights for 2007
-- Cash, cash equivalents and marketable securities at December 31, 2007
totaled $4.2 million as compared to $1.5 million at December 31, 2006.
Convertible notes payable at December 31, 2007 totaled $23.3 million as
compared to $8 million in notes payable at December 31, 2006.
-- Net loss attributable to common stockholders for 2007 was $19.5
million, or $1.04 per share, as compared to a net loss attributable to
common stockholders of $26.4 million, or $1.59 per share, for 2006.
-- Research and development (R&D) expenses totaled $10.5 million during
2007 as compared to $18.5 million during 2006. The decrease in R&D
expenses was primarily attributable to the CETHRIN license fee of $10
million in 2006.
-- General and administrative (G&A) expenses were $8.4 million in 2007 as
compared to $7.9 million in 2006. The increase in G&A expenses was
primarily related to higher commercialization and communication costs
and higher headcount offset by lower costs related to our collaboration
and fundraising efforts.
Conference Call Access Information
The Company will host a conference call to discuss results on, April 1,
2008, at 10:00 a.m. Eastern Daylight Time. The call can be accessed by
dialing dial 877-718-5104 (or 719-325-4843 for international
participants). The participant pass code for this conference call is
7767549. Please dial in 5 to 10 minutes prior to the scheduled start
time. A replay of the call will be posted on the Investor Relations
section of the website, http://www.alseres.com, within 48 hours following
the conference call and will be available through Tuesday, April 15, 2008.
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 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
|SOURCE Alseres Pharmaceuticals, Inc.|
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