FDA Fast Track for Myogane
Phytopharm PLC
09 November 2004
Company Contact: U.S. Investor Relations Contact U.K. Investor Relations Contact
Phytopharm, plc Lippert/Heilshorn & Associates, Inc Financial Dynamics
Richard Dixey Kim Sutton Golodetz (Kgolodetz@lhai.com) David Yates/Ben Atwell
+1 44 1480 437 697 +1 212 838 3777 +44 207 831 3113
www.phytopharm.com Bruce Voss (bvoss@lhai.com)
+1 310 691-7100
Phytopharm plc
Fast Track designation granted by the FDA for ALS drug candidate MyoganeTM
GODMANCHESTER, CAMBRIDGESHIRE, UK (November 9th 2004) - Phytopharm plc (PYM:
London Stock Exchange; NASDAQ: PHYOF) ('Phytopharm') announces today that the
U.S. Food and Drug Administration (FDA) has granted Fast Track designation to
its drug candidate PYM50018 (MyoganeTM) for the treatment of amyotrophic lateral
sclerosis (ALS, also known as Lou Gehrig's disease).
The Fast Track program is designed to expedite the review of drug candidates for
the treatment of patients with serious or life-threatening diseases with unmet
medical needs for new therapeutic approaches. The Fast Track designation allows
a company to file a New Drug Application (NDA) on a rolling basis as data become
available and to request the evaluation of studies using surrogate endpoints.
This permits the FDA to review the filing as it is received and can lead to a
decrease in the typical review period.
Myogane is a patented, orally active, neuroprotective and neuroregenerative
compound. In pre-clinical models, Myogane has been observed to protect against
neuronal damage, increase neurite outgrowth, reverse oxidative damage and
reverse neuronal apoptosis in vitro. When administered orally to a transgenic
pre-clinical model of ALS, Myogane delays the loss of muscle strength and
extends survival time.
In April 2004, Phytopharm announced the successful completion of a phase I
clinical study to evaluate the safety, tolerability and pharmacokinetic profile
of Myogane. This study was conducted under an investigational new drug (IND)
application filed with the FDA. A repeat dose phase Ib clinical study to
evaluate the safety, tolerability and pharmacokinetic profile of Myogane in
healthy volunteers is expected to commence in the first half of 2005.
Commenting on today's announcement, Richard Dixey, Chief Executive of
Phytopharm, said: 'This is an important step in the development of Myogane and
may help us bring this potentially promising drug to patients more quickly.'
NOTES TO EDITORS
Phytopharm plc
Phytopharm is a pharmaceutical company specialising in the discovery and
development of novel therapeutic agents in neurodegeneration, obesity,
inflammation and dermatology. It has lead products in development for
Alzheimer's disease, obesity and Amyotrophic Lateral Sclerosis. The Company's
strategy is to develop first-in-class drug products through Phase II testing,
then to secure pharmaceutical partners for late-stage development, sales and
marketing. CoganeTM is in a Phase II trial as a potential therapy to reverse
neurodegeneration in the brain of patients with Alzheimer's disease. MyoganeTM
is in Phase I testing as a neuroregenerative agent for treating ALS, an
always-fatal disease, and has received Orphan Drug designation. Phytopharm is
also developing a product for the dietary control of obesity within the P57
program. The Company has preclinical programs in several other disease areas
including eczema, asthma and metabolic disease. Further, there are two marketed
products: PhytopicaTM for canine skin disorders, and ZanthofenTM for canine
joint disorders.
Amyotrophic Lateral Sclerosis
ALS is the most common motor neurone disease resulting from progressive
degeneration of both upper and lower motor neurones which lead to severe muscle
weakness and wasting, followed by paralysis and death, generally caused by
respiratory failure. It is estimated that as many as 30,000 Americans may have
the disease at any given time with 5,000 new cases diagnosed each year (source:
ALS Association). For the families of ALS patients, the burden of providing
supportive care is exceedingly high and it is estimated that, in the advanced
stage of the disease, supportive care can cost an average of $200,000 per year
(source: International Alliance of ALS Associations). Treatment with the only
drug currently indicated for ALS typically increases the average survival time
by only three months (source Datamonitor). Thus, there is an urgent need for
the development of new and more effective therapies for this devastating
condition.
More information concerning Phytopharm's activities can be found on its web site
at http://www.phytopharm.com
This press release may contain forward-looking statements within the meaning of
Section 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S.
Securities Exchange Act of 1934 with respect to the financial condition, results
and business achievements/performance of Phytopharm and certain of the plans and
objectives of its management. These statements are statements that are not
historical facts. Words such as 'should', 'expects', 'anticipates', 'estimates
', 'believes' or similar expressions, as they relate to Phytopharm, are intended
to identify forward-looking statements. By their nature, forward-looking
statements involve risk and uncertainty because they reflect Phytopharm's
current expectations and assumptions as to future events and circumstances that
may not prove accurate. There is no guarantee that the expected events, trends
or results will actually occur. Any changes in such assumptions or expectations
could cause actual results to differ materially from current expectations.
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