advance single-dose delivery system DebioClipTM
obtains FDA approval for use with TrelstarTM
to treat advanced stage prostate cancer.
(July 5 2001)
Swiss Drug Developer Debiopharm Announces
FDA Approval Of TRELSTARTM LA
for Therapeutic Use
LAUSANNE, Switzerland, July 5 /PRNewswire/ -- The
Swiss-based pharmaceutical development company Debiopharm S.A.,
part of the Debio group, today announced that the FDA has granted
marketing authorization for Debiopharm's luteinizing hormone releasing
hormone (LHRH) agonist, triptorelin pamoate, TRELSTARTM
LA, to treat advanced stage prostate cancer. TRELSTARTM
LA is a controlled release formulation of triptorelin which delivers
triptorelin continuously over a period of three months after intramuscular
Extensive clinical studies comparing the effectiveness of the already
approved one-month controlled release formulation of triptorelin
(TRELSTARTM DEPOT 3.75mg) and
the new three-month formulation of triptorelin (TRELSTARTM
LA 11.25mg) in men with advanced stage prostate cancer have proven
that three-monthly administrations of triptorelin induce and maintain
castration levels of serum testosterone as effectively as monthly
injections. TRELSTARTM LA is
approved in two different presentations: As a vial alone, containing
triptorelin pamoate to be reconstituted in sterile water for injection,
or as TRELSTARTM LA DebioClipTM
single-dose delivery system, developed by Debiotech, Switzerland,
consisting of a vial containing triptorelin pamoate and a pre-filled
syringe containing 2 ml sterile water for injection. DebioClipTM
is an innovative device for easy and safe lyophilized drug constitution,
and avoids accidental exposure to needlesticks by healthcare workers.
TRELSTARTM LA has optimal patent
life protection in the United States.
During the pivotal clinical trial, which proved that the three-month
formulation of triptorelin pamoate is as effective as the monthly
formulation, secondary objectives included regression of pain, mean
change in Quality of Life scales throughout the treatment period,
and testosterone pharmacodynamics. Patients treated with triptorelin
pamoate used fewer analgesics after the start of treatment and,
overall, patients gained on average 5 kg in body weight. The local
tolerance of the injections was excellent and TRELSTARTM
LA was well tolerated.
"Our three-month injectable formulation of triptorelin, TRELSTARTM
LA, represents a significant benefit to patients in terms of comfort
and quality of life and demonstrates Debiopharm's proven expertise
in bringing drugs to market in the United States and Canada, as
well as in Europe," says Dr. R.-Y. Mauvernay, founder and President
of the Debio Group, which includes Debiopharm, Debio R.P. and Debioclinic.
"Debio's knowledge and expertise in both drug development and
controlled release systems has allowed us to develop this formulation."
"We are very proud of the approval of TRELSTAR LA, which is
manufactured in a state-of-the-art facility in Switzerland using
our proprietary solvent-free process, developed specifically for
this product," comments Dr Piero Orsolini, President and CEO
of Debio R.P. "We are working on new formulations able to release
triptorelin over longer periods, other advanced drug delivery systems
for proteins and peptides, as well as other therapeutic agents."
Prostate cancer is the most common type of cancer found in American
men, other than skin cancer. The American Cancer Society estimates
that there will be about 198,100 new cases of prostate cancer in
the United States in 2001. One hundred and ten men in every 100,000
will develop prostate cancer. Debiopharm has a successful track
record in bringing new chemical entities to the market in Europe
and the United States. The monthly formulation of triptorelin is
currently marketed in over 80 countries for prostate cancer, endometriosis,
fibromyoma, breast cancer and precocious puberty. It is the market
leader in Southern Europe and Brazil. The worldwide LHRH agonist
market is worth approximately US$ 1.4 billion. Debiopharm also has
successfully developed oxaliplatin, the first diamine-cyclohexane
platinum complex and a third generation platinum series, presently
registered and commercialized in major European countries, Latin
America and Asia for the treatment of advanced colorectal cancer.
Debiopharm's vapreotide, a somatostatin analog used in the treatment
of bleeding oesophageal varices, has completed Phase III and is
currently under review for registration in Europe.
Specialized in oncology, hormonal and niche products
for serious medical conditions, Debiopharm is the preferred partner
of research institutions, pharmaceutical and biotech companies who
seek to successfully develop their drug. Debio Recherche Pharmaceutique
(Debio R.P.), Debiopharm's sister company, is a leading world player
in the research, development and manufacturing of polymer-based
controlled-release injectable formulations for peptides and proteins,
including proprietary technologies suitable for other therapeutic
modalities such as soluble polymer drug conjugates for parenteral
administration. Debio R.P. carries out industrial scale up under
current good manufacturing practice (cGMP) and is FDA inspected.
SOURCE Debiopharm S.A.
Web Site: http://www.debio.com