ENACT
PHARMA FILES PATENT ON THE USE OF NEW IMPROVED BREAST CANCER DRUG
...a
purer form of tamoxifen which improves side- effects ...
Tuesday
15 August 2002. Enact
Pharma PLC ("Enact"), the market-driven biopharmaceutical
company, announces that it has filed a patent application on the use of
its purer form of tamoxifen claiming an improved side-effect profile over
existing marketed tamoxifen products. Tamoxifen is the world's largest
selling breast cancer drug. In 2000, worldwide sales of tamoxifen exceeded
$575 million, split predominantly between Barr Laboratories and
AstraZeneca
Tamoxifen,
a potent anti-oestrogen, is a proven breast cancer therapy used in the
first- line treatment of oestrogen-sensitive breast tumours, which
accounts for around 50% of all cases of breast cancer. However, the
E-isomer of tamoxifen is a contaminant and potent oestrogen found in all
currently available tamoxifen formulations that have been evaluated to
date.
Enact's
new synthesis and formulation of tamoxifen contains less than 0.005% of
the E-isomer, compared with current permitted concentrations of up to
0.3%. The Company's patent application provides in
vivo animal data supporting the proposal that this purer form
of tamoxifen will reduce the likelihood of patients developing endometrial
hyperplasia and possible subsequent endometrial (and ovarian) cancer
compared to existing forms of tamoxifen therapy. Enact's new product still
retains the advantageous increase in bone mineral density observed in
current tamoxifen therapy.
Enact
has shown that it can manufacture this formulation of tamoxifen by a
simple process, the costs of which are competitive with current
formulations available in the marketplace. In order to achieve this,
Enact has identified a potential bulk manufacturer which is expert in the
large batch synthesis of tamoxifen. This novel manufacturing process
is covered by two previously filed tamoxifen patents, the first of which
has already been granted in the UK,
USA, Australia, Norway, and Singapore and is proceeding to grant in other
territories. The second patent is in the international examination
phase. Enact has the exclusive rights to the commercial exploitation of
these two manufacturing patents from the University of Bradford and is a
co-applicant of the second patent.
While
Enact recognises that Aramidex particularly (and potentially other
aromatase inhibitors) has been shown to have a significant beneficial
effect in the treatment of breast cancer in post menopausal women, at the
mid-way point in their trial, aromatase inhibitors can only be used in
post menopausal women. Tamoxifen however can be used in both pre and
postmenopausal women. Furthermore Enact is aware that as reported in Scrip
(May 22nd 2002) and Cancer
Watch (June 2002), the Blue Ribbon panel of experts from ASCO,
the American Society of Clinical Oncology, has recommended that tamoxifen
should remain the "Gold Standard of breast cancer therapy". The
basis of this decision is that - a significant survival advantage has not
been demonstrated by aromatase inhibitors over tamoxifen and the long-term
consequences of aromatase inhibitors are not yet known and fractures due
to osteoporosis remain a significant concern - in long-term therapy with
these compounds. ASCO has also updated its recommendations on the
use of tamoxifen for the reduction of breast cancer risk in pre-menopausal
women advocating its use in women over the age of 35 who have an elevated
5 years projected breast cancer risk.
Tony
Atkinson, CEO at
Enact said: "This patent is a very important addition to the
commercial protection around Enact's pure tamoxifen product and its
potential advantages to patients. Tamoxifen is expected to play a
significant role in the treatment of breast cancer for many years. It is
Enact's aim to make a considerable difference to the large number of
patients being treated with tamoxifen by proving in human patients that
which the company has already proven in animal studies. Enact is conscious
that it will be difficult to get this particular product to market without
a major marketing partner already in the oncology market place and is
actively seeking a collaborative partner for Europe and the USA. "
-ends-
For
Further Information
Scott
Learmouth/Mel Choi
WMC Communications ltd
Tel: +44 (0) 2075913999
Email: melissa.choi@wmccommunications.com
Breast
Cancer Facts taken from
Cancer Research UK (www.cancerresearchuk.org )
-
Breast
Cancer is by far the most common cancer for women
-
Every
year there are over 38, 000 new cases in the UK
-
More
than 1 in 4 of all female cancers occurs in the breast.
-
The
lifetime risk for breast cancer is 1 in 9 women
-
Approximately
8 000 women were diagnosed before their menopause in the UK in 1997.
This figure is rising each year.
-
In
the year 2000 there were 12, 770 deaths from female breast cancer in
the UK
About
Enact:
Enact
Pharma is an emerging biopharmaceutical company. An OFEX listed company,
Enact Pharma has focused on the research and development of anti-cancer
therapies and other products for the treatment of neuropathological
diseases. Enact is the result of a merger in April 2000 between Enzacta
and Kymed. The Company is based in the UK, with a small research and
development facility at Porton Down near Salisbury, and offices at
Salisbury and Heyford Park. The combined investment in the merged company
to date is approximately £6.2 million.
Enact's
strengths are a committed management and scientific team, a strong product
portfolio, which has now been developed and validated to enter clinical
trials, and its ability to both identify and create commercial
opportunity. The Company is now in a position to proceed independently to
a Phase I trial of its lead product NQ02. The NQ02 clinical trial will
create the first major step increase in company value and initiate a
significant revenue flow to develop the Company's rich product portfolio.
Mel
Choi
Senior Account Manager
WMC Communications
7 Cheval Place
London SW7 IEW
Ph:
+44 (0)207 591 3999
Fax: +44 (0)207 591 3910
www.wmccommunications.com
