European Medicines Agency (EMEA) Approves Relistor(TM) The First-in-Class Treatment of Opioid-Induced Constipation (OIC) in Advanced-Illness Patients

Maidenhead, England (ots/PRNewswire) -

- First-in-Class Treatment set to Provide a New and Important
Targeted Treatment for Distressing and near Universal Side Effect in
Patients Receiving Opioids for Pain Relief as Part of Palliative Care

Wyeth Pharmaceuticals, today 3rd July, announced that it has
received EMEA marketing approval for Relistor(TM) (methylnaltrexone
bromide) subcutaneous injection. This first-in-class treatment is
indicated for opioid-induced constipation (OIC) in patients with
advanced illness who are receiving palliative care, when response to
the usual laxative therapy has not been sufficient.

Relistor is now approved for use across all 27 EU member states
as well as Iceland, Norway, and Liechtenstein. Currently, Relistor is
already approved for use in OIC in the US and Canada, and undergoing
regulatory review in Australia. Commercial launch of Relistor in
Europe will be rolled out on a country-by-country basis, with the
first launch anticipated to occur later this month.

Stevo Knezevic, Chief Medical Officer EMEA for Wyeth Europa said:
"We are delighted with the EMEA's approval of Relistor. Both patients
with advanced illness and their physicians will have the option of an
innovative first-in-class treatment which finally targets the
underlying cause of opioid-induced constipation. We look forward to
launching Relistor throughout Europe."

As Europe's population ages, so the number of patients living
with advanced illness is likely to increase.(1) Pain relief is often
a key part of palliative care and opioids are routinely used.(2)
However, the effective pain relief provided by opioids is often
accompanied with a less welcome side effect of opioid-induced
constipation (OIC). OIC is a near universal occurrence in patients
receiving opioid analgesics as part of palliative care (3,4) and can
be so severe, that it may result in patients choosing to sacrifice
their pain medication to mitigate the problem.

Commenting on the approval for Relistor, Professor Lukas
Radbruch, head of the Department for Palliative Care, University
Hospital Aachen, Germany, and President of the European Association
of Palliative Care, explains the challenges facing physicians in
managing advanced-illness patients with OIC, an often overlooked and
under-diagnosed side effect of pain management: "For the large number
of patients receiving palliative care, opioids provide effective pain
relief and are the routine analgesic treatment for patients with
advanced illness. However, they often cause the unwelcome and
distressing side effect of constipation, so severe that patients can
prefer to reduce their opioid pain medication to minimise their
discomfort. That is why it is so important that there are treatments
available that target the underlying mechanisms of OIC, allowing pain
to be managed while preserving quality of life in these patients"

Relistor (methylnaltrexone bromide) is the first in a new class
of peripherally acting mu-opioid receptor antagonists that reverse
the constipating effects of opioid pain medications in the
gastrointestinal tract without affecting their ability to relieve
pain. It is indicated for the treatment of opioid-induced
constipation in patients with advanced illness who are receiving
palliative care when response to usual laxative therapy has not been
sufficient. It is administered via subcutaneous injection.

Relistor has a novel mechanism of action which has been
clinically shown to directly target the underlying cause of OIC: it
blocks the binding of the opioids to peripheral mu-opioid receptors
within the gastrointestinal tract (GI), thus reversing the slowing
effects of opioids on the GI tract and bowel without reducing their
pain-relieving effect. Traditional options with which to manage OIC
include laxatives and stool softeners given as soon as opioids are
started. In spite of aggressive use of these agents, symptoms often
continue and their clinical efficacy is unpredictable.

We estimate that each year, more than 1.5 million Americans
receive palliative care due to an advanced illness, and other
end-stage diseases such as incurable cancer.(5,6) Similar figures are
not available for Europe as a whole, which may be considered
indicative of the fact that this is an overlooked condition and an
area of unmet medical need.

About Relistor

Relistor is the first in a new class of peripherally acting
mu-opioid receptor antagonist. Relistor targets the underlying cause
of OIC. It blocks the binding of opioids to peripheral mu-opioid
receptors, in the gastrointestinal (GI) tract, reversing the slowing
effects of opioids on the GI tract without diminishing their
analgesic effect via the central nervous system receptors.(7)

In April 2008 the FDA approved Relistor subcutaneous injection
for the treatment of OIC in patients with advanced illness who are
receiving palliative care, when response to laxative therapy has not
been sufficient in the USA. In March, 2008, Relistor received
approval in Canada for the treatment of OIC in patients with advanced
illness receiving palliative care. In August 2007, Wyeth submitted a
marketing application to the Australian Therapeutic Goods
Administration, and a decision is expected around Q3 2008.

About Wyeth

Wyeth Pharmaceuticals, a division of Wyeth, has leading products
in the areas of women's health care, infectious disease,
gastrointestinal health, central nervous system, inflammation,
transplantation, hemophilia, oncology, vaccines and nutritional
products. Wyeth is one of the world's largest research-driven
pharmaceutical and health care products companies. It is a leader in
the discovery, development, manufacturing and marketing of
pharmaceuticals, vaccines, biotechnology products, nutritionals and
non-prescription medicines that improve the quality of life for
people worldwide. The Company's major divisions include Wyeth
Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
Health.

Editor's Notes:

Additional information on Wyeth is available at
http://www.wyeth.eu

References

1. Davies E, Higginson I. Better Palliative Care for Older
People. WHO, 2004. http://www.eapcnet.org/download/forProjects/Elderl
y/BetterPC.Older%20People.p df

2. Gutstein HB, Akil H. Opioid Analgesics. In: Brunton LL, Lazo
JS, Parker KL, eds. Goodman & Gilman's The Pharmacological Basis of
Therapeutics. 11th Ed. New York, NY: McGraw-Hill; 2006: 547-590

3. Fallon MT. Constipation in cancer patients: prevalence,
pathogenesis, and cost-related issues. Eur J Pain. 1999;3(suppl
A):3-7

4. Emanuel EJ, Emanuel LL. Palliative and end-of-life care. In:
Kasper DL, Braunwald E, Fauci AS, et al, eds. Harrison's Principles
of Internal Medicine. 16th ed. New York, NY: McGraw-Hill; 2005:53-66

5. Miniño AM, Heron M, Murphy SL, et al. Deaths: final data for
2004. Health E-Stats. Released November 24, 2006. Available at: http:
//www.cdc.gov/nchs/products/pubs/pubd/hestats/finaldeaths04/finaldeat
hs0 4.htm. Accessed March 9, 2007

6. National Hospice and Palliative Care Organization. NHPCO's
Facts and Figures -

2005 Findings. Available at:
http://www.NHPCO.org/i4a/pages/index.cfm?pageid=3274. Accessed May
30, 2007

7. Thomas J., Karver, S, Cooney GA: Methylnaltrexone for Opioid
Induced Constipation in Advanced Illness. New England Journal of
Medicine, May 29, 2008:22, vol. 358: 2332-2343.

ots Originaltext: Wyeth Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further media information please contact: Gill Markham, Assistant
Vice President, Communications Europe, Middle East and Africa, Wyeth
Europa, UK, Tel: +44(0)1628-692536, Mobile: +44(0)7770-827753,
Emails: markhagl@wyeth.com. Jaimella Espley, Senior Account Manager,
Edelman, UK, Tel: +44-(0)207-3047-2115, Mob: +44(0)-7880-681750,
Email: jaimella.espley@edelman.com