Peripheral Neuropathic Pain Patients in Sweden set to Benefit From First-of-a-Kind Treatment Which Provides Lasting Pain Relief

Decision to Reimburse Qutenza(TM) (capsaicin 8% w/w dermal patch) by Sweden's Dental and Pharmaceutical Benefits Agency (Tand-och Lakemedelsformansverket) Gives new Option to Patients Living With Difficult-to-Treat Condition

STAINES, England, February 28, 2011 - Patients in Sweden living with peripheral neuropathic pain are set to
gain access to a new treatment option which can provide pain relief for up to
three months following a single 30- or 60-minute application. The new
treatment patch uses capsaicin - the substance found in chilli peppers which
gives them their 'heat' - to change the function of pain sensing nerves in
the area of skin affected.[1],[2] The Dental and Pharmaceutical Benefits
Agency (TLV) has confirmed that the capsaicin 8% w/w dermal patch will be
reimbursed for patients who have not tolerated, or who have not achieved
adequate pain relief from, amitriptyline or gabapentin.

Neuropathic pain is caused by damage to nerves and it is estimated that
approximately 1.5% of the Swedish population may require treatment for the
condition.[3] It is a complex and difficult-to-treat disorder that can last
indefinitely and have a detrimental effect on a patient's quality of
life.[4],[5]

"In many patients peripheral neuropathic pain substantially affects
quality of life aspects. With currently used evidence based pharmacological
treatments, frequently with bothersome side effects, we are able to relieve
pain in a useful way in 30-40% of patients only. Hence there is a huge need
for new effective treatments that are minimally side effect prone and that do
not interact with other medicines. With Qutenza we can treat selected
patients with peripheral neuropathic pain in the area where pain is
experienced," says Per Hansson, professor and senior consultant at the Pain
Center, Karolinska University Hospital in Stockholm. "It is now pertinent to
accumulate and communicate treatment related experience on which types of
pain are most susceptible to this type of treatment."

The efficacy and safety of the capsaicin 8% w/w dermal patch have been
investigated in a comprehensive clinical trial programme involving 1,327
patients who received at least one application. The treatment has been shown
to significantly reduce neuropathic pain.[6],[7] Pain relief is rapid in
onset (between one and two weeks to take full effect) and long-lasting
following a single application. Reductions in pain were achieved with high
concentration capsaicin treatment when used alone or in combination with
other treatments for pain. In clinical trials, 44% of patients with
post-herpetic neuralgia, a type of peripheral neuropathic pain, treated with
the patch reported greater than or equal to 30% decrease in pain compared
with 33% of controls.[6] In the same study, twelve weeks post-treatment, 55%
of patients treated with capsaicin 8% w/w still reported improvement in
pain relief compared to 43% of controls.[6] The reported side effects with
the high concentration capsaicin patch are temporary, self-limiting and
mild to moderate in intensity.[6],[7],[8]

Use of conventional therapies for peripheral neuropathic pain can be
restricted by factors such as side effects, drug-drug interactions, slow
onset of action, the need for potentially complex titration and multiple
daily dosing.[6] Since the capsaicin 8% w/w dermal patch acts only on the
affected area, with a minimal amount of capsaicin being absorbed into the
body,[8] application of the patch is not associated with systemic drug-drug
interactions or side effects such as sedation and dizziness that may be
experienced with other treatments currently prescribed for neuropathic
pain.[6]

The capsaicin 8% w/w dermal patch has to be applied by a healthcare
professional. It is already available in a number of European countries and
will become more widely available across Europe in the coming months.

Notes to editors

About the TLV

The Dental and Pharmaceutical Benefits Agency, TLV, is a central
government agency whose remit is to determine whether a pharmaceutical
product or dental care procedure shall be subsidised by the Swedish state and
also to monitor profitability on the reformed pharmacy market.

About the capsaicin 8% w/w dermal patch

The capsaicin 8% w/w dermal patch is approved by the European Medicines
Agency for the treatment of peripheral neuropathic pain in non-diabetic
adults either alone or in combination with other medicinal products for
pain.[8] When applied to the painful area of skin for 30 or 60 minutes and
then removed, the patch can provide relief from the pain for up to three
months.[8] After three months the treatment can be re-applied, if
required.[8]

The patch delivers a high-dose of a synthetic form of capsaicin (the
substance found in chilli peppers which gives them their 'heat') directly to
the hyperactive pain sensing nerves in the skin that are the source of
neuropathic pain. Applied to the area of pain, the high concentration of
capsaicin contained in the treatment is released quickly which overstimulates
the pain sensing nerves in the skin. Overstimulating the pain sensing nerves
makes them become "defunctionalised", effectively making them unresponsive to
stimuli that normally cause pain for patients with peripheral neuropathic
pain.

About Astellas Pharma Europe Ltd.

Astellas Pharma Europe Ltd., located in the UK, is a European subsidiary
of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceutical products. The
organisation is committed to becoming a global company by combining
outstanding R&D and marketing capabilities and continuing to grow in the
world pharmaceutical market. Astellas Pharma Europe Ltd. is responsible for
20 affiliate offices located across Europe, the Middle East and Africa, an
R&D site and three manufacturing plants. The company employs approximately
3,400 staff across these regions.

References

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[1] Knotkova H, et al. Capsaicin (TRPV1 agonist) therapy for pain relief:
Farewell or Revival? Clin J Pain 2008;24 (2):142-154

[2] Qutenza (capsaicin) EPAR summary for the public. Available from:
bit.ly/evoQhp Last accessed: 24th February 2011

[3] Läkemedelsverket. Bakgrundsdokumentation. Farmakologisk behandling av
neuropatisk smerta. Epidemiologi. Information från Läkemedelsverket 6:
2007(2) available at: bit.ly/g1y5km Last accessed: 24th February 2011

[4] Gálvez R et al. Cross-sectional evaluation of patient functioning and
health-related quality of life in patients with neuropathic pain under
standard care conditions. European Journal of Pain 2007;3:244-55

[5] Smith B et al. Health and Quality of Life Associated With Chronic
Pain of

Predominantly Neuropathic Origin in the Community. Clinical Journal of
Pain 2007;23:143-9

[6] Backonja, M et al. NGX-4010, a high-concentration capsaicin patch,
for the treatment of postherpetic neuralgia: a randomised, double-blind
study. Lancet Neurology 2008;7(12):1106-12

[7] Simpson DM, et al. Controlled trial of high-concentration capsaicin
patch for treatment of painful HIV neuropathy. Neurology 2008;70(24):2305-13

[8] Qutenza Summary of Product Characteristics. Available from:
bit.ly/hK6WTk Last accessed: 24th February 2011

For further information please contact: Astellas, Mindy Dooa, Corporate Communications Director, Tel: +44(0)7826-912-339, mindy.dooa at eu.astellas.com; Ketchum Pleon, Philippa Mallaband, Tel: +44(0)207-611-3599, philippa.mallaband at ketchumpleon.com