Great news, expecially re Entacapone field studies.

Bob Cowan <[log in to unmask]>

06/18 0903  STUDY SUGGESTS NEW MEDICATION OVERCOMES OBSTACLE ...

VIENNA, Austria, June 18 /PRNewswire/ -- According to results
announced at this week's 4th International Congress of Movement
Disorders, a new  Parkinson's medication called entacapone
reduces fluctuations in motor  performance that commonly occur in
patients being treated with levodopa.
   The SEESAW (Safety and Efficacy of Entacapone Study Assessing
Wearing Off) study found that entacapone managed these
fluctuations, while prolonging the effectiveness of levodopa and
reducing the need for levodopa increases.  The trial was
conducted by the Parkinson's Study Group (PSG), a leading
consortium of Parkinson's disease (PD) researchers.
   Entacapone belongs to a new class of drugs under investigation
known as  catechol-O-methyltransferase or COMT-inhibitors, which
have a novel mechanism of action.  These agents have been shown
to be safe and effective with other adjunctive PD medications and
to prolong the duration of action of levodopa, thus avoiding
problems related to levodopa's "wearing off" phenomenon.
Traditionally the mainstay of PD treatment, chronic levodopa use
leads to motor fluctuations and involuntary movements.
   "Of particular importance, these patients were able to
continue all other anti-Parkinsonian medications including
dopamine agonists and selegiline," said Karl Kieburtz, MD, MPH,
Associate Professor of Neurology, University of Rochester, New
York, USA.  "The introduction of entacapone therefore provided a
significant additional benefit even in the presence of
conventional therapies."
   The study included 205 optimally-treated patients with
levodopa- related motor fluctuations at 18 centers in the US and
Canada.  The participants were randomized to receive either
entacapone (200 mg daily) or placebo with each dose of
carbidopa/levodopa and were followed for 28 weeks.
   At 24 weeks, Unified Parkinson's Disease Rating Scale (UPDRS)
scores had  worsened by three points in the placebo group, who
were taking 20.7 mg more levodopa.  UPDRS scores improved by one
point in the entacapone treatment group, who required 101.9 mg
less levodopa. Entacapone also increased "on" or good time
significantly (p 0.005). UPDRS is a standard international tool
to measure functional ability.
   "This is significant as Parkinson's disease is a chronic
disorder and patients progressively decline over time," added Dr.
Kieburtz.  "A significant improvement in motor scores, as shown
in the SEESAW trial, is therefore very positive."
   Several other presentations at the meeting provided evidence
of entacapone's therapeutic potential.  Among them, Scandinavian
researchers from 16 clinical sites, led by Urpo K. Rinne, MD,
PhD, Professor of Neurology, University of Turku, Finland, found
that "on" time based on home diaries increased significantly in
entacapone- compared with placebo-treated patients.  The results
persisted throughout the six-month study.  The trial included 171
patients who had developed motor fluctuations during optimal
levodopa treatment.
   Entacapone was generally well tolerated, although there was a
slight increase in gastrointestinal side effects including nausea
and abdominal pain.
   Parkinson's disease is a chronic, progressive neurological
disorder that  affects motor function.  Primary symptoms include
muscle rigidity, tremor, a decrease in the range and frequency of
voluntary movements, and abnormalities in posture and gait.
   The studies were sponsored by Orion Pharma of Finland.
Entacapone will be co-marketed internationally by Sandoz Pharma
Ltd.
   -0-                 6/18/96 /CONTACT:  John Quick of Ogilvy
Adams & Rinehart, 212-880-5259/
  CO:  Sandoz Pharma Ltd. ST: IN:  MTC SU:

Copyright 1996




06/18 0853  Discovery Therapeutics' Parkinson's  Treatment ...

VIENNA, AUSTRIA (June 18) BUSINESS WIRE -June 18, 1996--Discovery
Therapeutics, Inc., a privately-held pharmaceutical company
located in  Richmond, Va., today announced the presentation of
the first human data for its N-0923 transdermal patch product for
the treatment of Parkinson's Disease.
   Dr. Vincent P. Calabrese, M.D., Associate Professor of
Neurology, Medical College of Virginia, will present the data in
poster sessions June 19- 21, 1996 at the Fourth International
Congress of Movement Disorders in Vienna.  The data are from
Discovery's recent human pharmacokinetic and safety study of
N-0923, a potent dopamine replacement molecule specifically
designed and optimized for delivery through the skin.
   More than $1 billion dollars (U.S.) are spent worldwide for
therapeutic agents to treat Parkinson's Disease, a debilitating
neurological disorder that afflicts more than 1% of the U.S. and
European population over the age of 50.  Patients experience
rigidity, difficulty in walking,  muscle tremor and slowness of
movement.  The disease is caused by  degeneration of the portion
of the brain that secretes dopamine, a  neurotransmitter signal
molecule used to coordinate voluntary muscle activity.
   "I think this drug is going to become an important treatment
for Parkinson's Disease," said Dr.
Calabrese.  "This study demonstrates that transdermal delivery
can maintain consistent levels of drug in the blood without the
ups and downs associated with oral delivery. Delivery through the
skin avoids the side effects of oral delivery for any patient,
and provides the first practical alternative in the United States
for the patient who cannot take medication by mouth.
   "The N-0923 molecule itself is structurally different from
available  therapies.  In addition to being optimized for
transdermal delivery, it is a very specific non-ergot-based
dopamine agonist that avoids side effects, such as dyskinesia
(jerky movements) and the gastrointestinal distress associated
with less specific and ergot-based compounds."
   The company has just completed a study of the efficacy of the
N-0923 patch in Parkinson's Disease patients.  Preliminary
results are encouraging and the data will be submitted this
summer for publication, probably to appear early next year.  The
company plans to proceed with Phase III within the next few
months and will seek a marketing partner.
   Discovery Therapeutics, Inc. is an independent company founded
to invent,  develop and commercialize pharmaceuticals for
poorly-met medical needs using novel signal molecule technology.
In addition to its transdermal product for treating Parkinson's
Disease, Discovery Therapeutics Inc. is developing new products
for improved diagnosis and treatment of coronary artery disease.
These include an agent designed to selectively dilate coronary
blood vessels to facilitate cardiac imaging diagnostic
procedures.  Use of this agent should result in fewer side
effects and improved imaging than is possible with the current
generation of vasodilating imaging agents.  The company intends
to begin clinical trials with this product in 1996. Another
product is in human trials for the treatment of cardiac rhythm
disorders.
   --30--lmm/sf    dc/sf
   CONTACT: Discovery Therapeutics
   Dr. Donald A. McAfee, 804/358-9468
   or
   EMM Communications
   Ellen M. Martin, 510/832-7604
   KEYWORD: VIRGINIA
   INDUSTRY KEYWORD: MEDICINE PHARMACEUTICAL BIOTECHNOLOGY
REPEATS: New York
212-752-9600 or 800-221-2462; Boston 617-236-4266 or
800-225-2030; SF
415-986-4422 or 800-227-0845; LA 310-820-9473 BW URL:
http://www.businesswire.com

Copyright 1996