| From the (latest) preliminary S-1:
PROSPECTUS SUMMARY
This summary highlights information contained elsewhere in this prospectus. You
should read the entire prospectus carefully, especially the risks of investing
in our common stock, which we discuss under "Risk Factors," and our consolidated
financial statements and related notes.
OVERVIEW
We are a biopharmaceutical company engaged in developing small molecule
drugs to treat central nervous system, cardiovascular and inflammatory
conditions. We currently have four product candidates in development for six
indications. Rotigotine CDS, our lead product candidate, is being developed by
Schwarz Pharma AG. Rotigotine CDS is completing Phase III clinical trials for
the treatment of Parkinson's disease and is in a Phase IIb clinical trial for
Restless Legs Syndrome. King Pharmaceuticals Research and Development, Inc., a
subsidiary of King Pharmaceuticals, Inc., has completed Phase II clinical trials
with binodenoson as a pharmacologic stress agent for cardiac imaging and is
expected to start Phase III clinical trials in the fourth quarter of 2003. King
is also developing MRE-0094 as a treatment for chronic diabetic foot ulcers. The
intravenous dosage form of selodenoson is being developed by Fujisawa
Healthcare, Inc. Intravenous selodenoson is in Phase II clinical trials for
heart rate control in atrial fibrillation and has demonstrated slowing of heart
rate. We retain rights to the intravenous formulation outside the United States
and Canada and the worldwide rights to the oral formulations of selodenoson. We
have completed a Phase I clinical trial for an oral dosage form of selodenoson.
We focus on small molecule drug candidates that act to selectively modify
the activity of certain receptors, such as receptors for adenosine and dopamine.
By targeting receptor subtypes responsible for specific effects, our goal is to
produce therapeutic results while minimizing side effects. To limit stimulation
of receptor subtypes in other tissues, we have developed molecules to target
tissues where receptor subtypes may be sensitive to lower levels of drugs. In
addition, to avoid side effects, we have designed molecules that may not enter
certain organs. Small molecule medications are more easily formulated, have
greater potential for absorption and utilization by the body, are more
efficiently manufactured than large molecule therapies and generally offer
greater dosing flexibility so that patients can comply with prescribed dosing
schedules.
OUR PRODUCT CANDIDATES
We currently have four product candidates in development for six
indications.
- Rotigotine CDS, our most advanced product candidate, is being developed
by Schwarz Pharma. Rotigotine is a proprietary dopamine receptor agonist
formulated in a once-daily transdermal patch. Rotigotine CDS is
completing Phase III clinical trials as both a first-line treatment of
early stage and a combination therapy for late stage Parkinson's disease.
Parkinson's disease is an age-related, neurodegenerative disorder that
affects approximately one million people in the United States.
Approximately $2 billion is spent annually on drug therapy worldwide to
treat this disease. Rotigotine CDS is designed to provide a constant
blood level of the drug over a 24-hour period, thereby minimizing daily
symptoms and side effects. We have licensed to Schwarz Pharma the
worldwide development and commercialization rights to rotigotine CDS for
Parkinson's disease. Rotigotine was administered to approximately 1,000
patients and healthy subjects before it entered Phase III clinical
trials. Schwarz Pharma performed a randomized, double-blind, placebo-
controlled, Phase IIb clinical trial in early stage Parkinson's disease
patients that demonstrated a statistically significant improvement in
patient's symptoms compared to placebo (p-value at two highest doses
<0.0001). Schwarz Pharma also performed a Phase II clinical trial in 310
late stage patients. The primary endpoint of this trial measured the
reduction in patient "off" time. Although this trial demonstrated a
reduction in "off" time compared to baseline, the results were not
statistically significant compared to placebo as a result of an
unexpectedly large placebo effect. Schwarz Pharma plans to enroll
approximately 1,200 patients with early stage and late stage Parkinson's
disease into pivotal Phase III clinical trials using the same primary
endpoints used in the Phase II clinical trials. Two of these trials have
been completed. The initial results from the Phase III clinical trials
are expected to be released in the first quarter of 2004. Schwarz Pharma
has announced that it intends to submit a new drug application, or NDA,
for rotigotine CDS by the end of 2004.
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- Rotigotine CDS is also being developed in lower-dose transdermal patches
which are currently in a Phase IIb clinical trial for the treatment of
Restless Legs Syndrome. Restless Legs Syndrome is a common neurologic
movement disorder in which patients suffer an almost irresistible urge to
move their legs that often results in sleep disturbances. Studies
reported by the American Academy of Family Physicians have indicated that
up to 15% of the population in the United States may have Restless Legs
Syndrome. There are currently no medications approved for the treatment
of Restless Legs Syndrome in the United States. A once-daily transdermal
medication may provide continuous therapeutic blood levels of the drug
and symptomatic relief throughout the night and into the daytime. We have
licensed to Schwarz Pharma the worldwide development and
commercialization rights to rotigotine CDS for Restless Legs Syndrome. A
Phase II safety and efficacy pilot trial performed in Europe was
completed in April 2002 and revealed a statistically significant
improvement in symptoms (p-value = 0.04). Schwarz Pharma is currently
conducting a randomized, placebo-controlled, dose-ranging Phase IIb trial
in Europe under a US investigational new drug application, or IND.
Schwarz Pharma expects the results of this trial will be available in the
third quarter of 2004.
- Binodenoson is an adenosine A(2A) agonist that is being developed by
King. King has completed Phase II clinical trials and is expected to
begin Phase III clinical trials during the fourth quarter of 2003.
Binodenoson is being developed as an alternative to exercise prior to
cardiac perfusion imaging for the diagnosis of coronary artery disease.
Many patients cannot perform the level of exercise necessary for an
adequate diagnostic test and require a pharmacologic stress agent in lieu
of exercise. We estimate that approximately 2.6 million cardiac perfusion
imaging procedures are performed annually in the United States using a
pharmacologic stress agent. Binodenoson is designed to minimize the side
effects associated with the most commonly used agents, adenosine and
dipyridamole. Binodenoson is formulated to be dosed as an injection for
ease of administration rather than the continuous infusion with an
intravenous pump required with adenosine and dipyridamole. We have
licensed to King the worldwide development and commercialization rights
to binodenoson as a pharmacologic stress agent. Binodenoson has been
administered to 440 patients and healthy volunteers in six clinical
trials. King completed a multi-center, single-blind, two-arm crossover
Phase IIb clinical trial in patients who received pharmacologic stress
tests with both adenosine and binodenoson. Results from the trial
indicated that binodenoson was comparable to adenosine for detecting the
extent of coronary disease. In addition, this clinical trial demonstrated
that binodenoson had fewer and less severe side effects than adenosine
with a statistically significant p-value of <0.01 in each case. King
intends to initiate Phase III clinical trials in the fourth quarter of
2003 in the United States and internationally.
- Selodenoson is currently being developed in intravenous and oral
formulations for the treatment of atrial fibrillation. The intravenous
dosage form of selodenoson, an adenosine A(1) agonist, is being developed
by Fujisawa Healthcare. Intravenous selodenoson is in Phase II clinical
trials for heart rate control in atrial fibrillation and has demonstrated
slowing of heart rate. An oral formulation of selodenoson has completed a
Phase I clinical trial. In addition to the clinical trials discussed
below, clinical trials are ongoing to evaluate the side effects from A(1)
receptor stimulation on other parts of the body. Selodenoson is designed
to control heart rate in atrial fibrillation by slowing conduction
through the atrioventricular node. Atrial fibrillation is the most common
sustained cardiac arrhythmia, or abnormal heart rhythm, and currently
affects approximately two million people in the United States.
Selodenoson is being developed as both an intravenous formulation for
acute rate control and as a modified release oral formulation for chronic
rate control. We have licensed to Fujisawa Healthcare the rights to
develop and commercialize the intravenous formulation of selodenoson in
the United States and Canada. We retain rights to develop and
commercialize the intravenous formulation in all other countries and
worldwide rights for all oral formulations. We and Fujisawa Healthcare
have performed a total of 11 Phase I and Phase II clinical trials in
which a total of 453 patients and healthy volunteers received
selodenoson. One of these Phase II clinical trials examined the effect on
heart rate of infusions of escalating doses of selodenoson in patients
with atrial fibrillation. The data from this trial demonstrated a
statistically significant decrease (p-value < 0.05) in heart rate
compared to baseline in patients who received the drug, but there was no
change from baseline in patients who received
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placebo. This data has been accepted to be presented at the American
Heart Association's Scientific Sessions in November 2003. Two more of
these Phase II clinical trials have been completed and we anticipate the
release of these results in early 2004.
- MRE-0094 is an adenosine A(2A) agonist formulated as a topical treatment
currently in development for the treatment of chronic diabetic foot
ulcers. Approximately 15% of the estimated 16 million diabetics in the
United States develop foot ulcers. It is estimated that of the more than
50,000 annual amputations of a lower extremity in diabetics, 85% result
from foot ulcers. MRE-0094 appears to promote wound healing. King filed
an investigational new drug application, or IND, in May 2002 for
MRE-0094. We have licensed to King the worldwide development and
commercialization rights for MRE-0094.
We believe there may be additional therapeutic indications for our
portfolio of product candidates. None of our product candidates have been
approved by the Food and Drug Administration or European regulators for
commercialization. We have a history of operating losses and, as of June 30,
2003, we had an accumulated deficit of approximately $44.8 million. In addition,
we are dependent upon third parties, especially our collaborators, for the
successful commercialization of our clinical product candidates.
We are at an early stage of development and face significant challenges in
achieving our business objectives, including successful completion of clinical
trials, obtaining regulatory approvals, market acceptance of our products and
competition from companies with greater resources.
OUR BUSINESS STRATEGY
We intend to develop and commercialize therapies for central nervous
system, cardiovascular and inflammatory conditions. To achieve this objective,
we intend to concentrate on the following key strategies:
- continue to invest to support our corporate collaborators in their
development and commercialization of our advanced product candidates;
- expand our product candidate portfolio by acquiring or in-licensing
product candidates and programs that are 18-24 months from human clinical
trials;
- retain development responsibility for and marketing rights to selected
drug candidates through late stage development to maximize product value;
and
- maintain balanced in-house expertise and capabilities in synthetic
chemistry, pharmacology and key elements of clinical development while
outsourcing routine drug development activities.
CORPORATE INFORMATION
We were incorporated as Discovery Therapeutics, Inc. in Delaware in 1994
and changed our name to Aderis Pharmaceuticals, Inc. in January 2002. Our
principal executive offices are located at 85 Main Street, Hopkinton,
Massachusetts 01748, and our telephone number is (508) 497-2300. References in
this prospectus to "Aderis," "we," "our" and "us" refer to Aderis
Pharmaceuticals, Inc. Our web site is located at www.aderis.com. Information
contained in our web site is not incorporated by reference into and does not
form any part of this prospectus. |
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