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Announcement of the acquisition of marketing approval for transdermal long-acting chronic pain "NORSPAN® TAPE" (development code: BTDS)



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http://www.hisamitsu.co.jp/english/pdf/btds_E_110223.pdf
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- This material is an English translation of the press release announced on February 23,
2011 in Japanese, and the Japanese release is given priority about the content and the
interpretation.


February 23, 2011


Announcement of the acquisition of marketing approval for transdermal long-acting
chronic pain “NORSPAN® TAPE ”(development code: BTDS)


Hisamitsu Pharmaceutical Co., Inc. (HQ: Tosu, Saga, Japan; President/CEO: Hirotaka
Nakatomi; hereinafter referred to as Hisamitsu) is pleased to announce that we were notified
by Mundipharma K.K. that they have received as of today (February 23, 2011) a marketing
approval for “NORSPAN® TAPE” (development code: BTDS), a buprenorphine patch
developed by the company.


“NORSPAN® TAPE” is. a long-acting transdermal patch indicated for analgesia of chronic
pain associated with osteoarthritis and low back pain not being controlled sufficiently with
non-opioid analgesics.


In August 2007, Hisamitsu acquired from Mundipharma the exclusive right to distribution
of the product in Japan, for which Mundipharma K.K. filed an application for marketing
approval in October 2008. We will receive a supply of products from Mundipharma K.K. and
distribute them to customers.


In collaboration with Mundipharma K.K., we will further contribute to improving the
quality of life of patients suffering from chronic pain through providing appropriate
information and establishing the system to promote the proper use of the product.



Product name: NORSPAN® TAPE 5 mg, NORSPAN® TAPE 10 mg, NORSPAN® TAPE
20 mg


Generic name: Buprenorphine
Indication: Relief of chronic pain associated with the following diseases of which the
pain can not be controlled sufficiently with non-opioid analgesics:
- Osteoarthritis
- Low back pain


Dosage and administration:
Usually for adults, apply this product onto prothoracic part, upper part of
back, outside of upper arm or side chest and change it every 7 days.
The initial dose applied is set at 5 mg as buprenorphine, and the subsequent
dose to be applied should be adjusted according to the symptom of patient
as appropriate but should not exceed 20 mg.


Approval requirements
Appropriate actions should be taken at the time of marketing so that
NORSPAN® TAPE will be prescribed/used by physicians who know how
to make a diagnosis of and treat chronic pain accompanying osteoarthritis
and low back pain; NORSPAN® TAPE will be used only at pharmacies and
medical institutions where a physician or supervising pharmacist can
sufficiently control and explain the risks of NORSPAN® TAPE, etc; and
NORSPAN® TAPE will be dispensed at the pharmacies after the concerned
physician/medical institution has confirmed its use.


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