advances transdermal treatment for global severe

ACRUX ADVANCES TRANSDERMAL
TREATMENT FOR GLOBAL SEVERE
PAIN MARKET
Melbourne, 1 February 2005: Acrux Limited (ASX: ACR), announced today
the successful completion of the Phase 1 human clinical trial program for its
Fentanyl MDTS® transdermal treatment for severe chronic pain.
Acrux CEO and Managing Director Igor Gonda said: “Our Phase 1 work has
confirmed the suitability of Acrux’s transdermal technology for the attractive
commercial opportunity in the global pain market”.
“Our plans on the remaining development and commercialisation strategy will
advance after discussions with the US Food and Drug Administration (FDA) on
the path to approval for the US market,” Dr Gonda said.
“There are millions of patients around the world whose severe pain is not being
treated adequately. Our aim is to provide these patients with a convenient and
effective method to treat their pain with Fentanyl – a well tested drug, especially
for pain associated with cancer,” Dr Gonda said.
The trial was a single centre, randomized study in 12 healthy male volunteers
designed to evaluate if therapeutic levels of fentanyl are achieved safely after
administration of Fentanyl MDTS® at either 12, 24 or 48 hour intervals over a 2
week treatment period. The full results of the study are to be presented at a
major conference in United States later this year.
University of Adelaide Anaesthesia Professor and Principal Investigator
Professor Guy Ludbrook said: “All three dose regimens achieved steady-state
therapeutic levels of fentanyl, without any serious or unexpected adverse events
or any application site reactions. These results suggest Fentanyl MDTS® will be
able to provide effective treatment of pain with greater flexibility.”
CSL Ltd licensed Fentanyl MDTS® for the Australian and New Zealand market
from Acrux in November 2004. Acrux retains rights for the rest of the world and
1.2.05
will be seeking commercial partners for such territories, particularly USA and Europe.
CSL Pharmaceutical’s President Mr Colin Armit said: “We are very pleased with the
encouraging results and the rapid progress being made on the program. The study
reinforces our original view, that this is an attractive product; easy to apply with flexible
dosing allowing patients improved pain control and a lower incidence of side effects”.
Dr. Gonda said “We received much help and encouragement for this work from our
Scientific Advisory Board member and leading global pain management expert, Professor
Michael Cousins at the Royal North Shore Hospital in Sydney. Our clinical team used a
creative trial design and the results mean that we do not need to proceed with an
additional Phase 1 trial that had been planned.”
Background:
Fentanyl is a potent narcotic analgesic used for the treatment of severe pain associated
with cancer and other chronic pain conditions. The global pain market for narcotic
analgesics is valued at US$5.6 billion*, representing an increase of 19% over the previous
year. The existing transdermal fentanyl patch has a 25%* share of this market. (*IMS
Health, IMS Midas, MAT Feb 2004). Transdermal fentanyl offers advantages over other
long-acting oral products which typically cause the patient to suffer from a higher
incidence of side effects such as constipation.
Media Contact: Paula Hannaford, Director
Gavin Anderson & Company
[email protected]: Tel: +61 2 9552 4499
Acrux Contact: Dr Igor Gonda, CEO & Managing Director
www.acrux.com.au; Tel: +61 3 8379 0100
CSL Contact: Dr Rachel David, Director Public Affairs
www.csl.com.au: Tel: +61 (0)401 775 779
About Acrux (ASX: ACR)
Acrux is a specialty pharmaceutical company, developing and commercialising a
range of patented, patient-preferred healthcare products for global markets, using
its innovative technology to administer drugs through the skin.
Acrux’s product pipeline includes treatments of hormonal deficiencies, pain,
central nervous system disorders and urinary incontinence, as well as a
contraceptive.
15 human clinical trials have been completed with 6 different drugs and the lead
product, Evamist™ (Estradiol MDTS®), is currently in a phase 3 clinical trial in the
USA.
Acrux has licensed USA rights for Evamist™ (Estradiol MDTS®) and Testosterone
MDTS® to VIVUS and AUS/NZ distribution rights for Testosterone MDTS® and
Fentanyl MDTS® to CSL Limited. Acrux has also licensed its technology to Eli
Lilly for veterinary healthcare products, and to Connetics for anti-psoriatics and
local anaesthetics.