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Nycomed AG

Approval of Instanyl(R) Marks Important Turn in Management of Breakthrough Cancer Pain

Taastrup, Denmark (ots/PRNewswire)

- First Intranasal Treatment for Breakthrough Cancer Pain
Allowing  Patients Fast, Effective and Good Tolerated Pain Relief
Soon to be Available
Nycomed today announced that the European Commission has granted
marketing authorisation for Instanyl, its first-in-class intranasal
fentanyl spray designed to closely match the typical episodes of
breakthrough cancer pain.
"We have had a great unmet need in the management of breakthrough
cancer pain. With Instanyl, however, we now have a treatment designed
to better meet the needs of a patient suffering from breakthrough
cancer pain. Instanyl has a fast onset, a short duration, is well
tolerated and is easy to use allowing the patients effective control
of the pain episodes with minor adverse effects," said Professor
Stein Kaasa from Trondheim University Hospital in Norway and chairman
of the Research Network of the European Association for Palliative
Care (EAPC-RN).
Instanyl is the first fast acting intranasal fentanyl spray
approved for the management of breakthrough cancer pain in adults
already receiving maintenance opioid therapy for chronic cancer pain.
The approval of Instanyl is based on comprehensive data demonstrating
the efficacy and good tolerance of this novel treatment. Phase III
data[i] on Instanyl has shown:
- clinically substantial pain relief at 10 minutes after administration
      in 58% of Instanyl treated pain episodes (P<0.001)
    - all doses of Instanyl were well tolerated during the 10-month follow-up
      phase
"The intranasal drug administration is an innovation within
treatment of breakthrough cancer pain. The rapid uptake via the nose
translates into fast onset of action enabling the patients to be in
control of their pain. Instanyl data presented at the 11th Congress
of the European Association for Palliative Care (EAPC) in May in
Vienna, and fully published soon, demonstrated an onset of pain
relief as early as five minutes underlining the clinical benefit this
treatment represents to the patients," said Professor Kaasa.
Breakthrough pain is a transitory exacerbation of pain occurring
with controlled persistent pain. Up to 95% of patients with cancer
pain experience breakthrough pain[ii] of which two-thirds experience
inadequate pain control[iii]. Untreated breakthrough cancer pain has
a profound impact on patients' quality of life[iv], [v].
Guido Oelkers, Nycomed's Executive Vice President Commercial
Operations added: "Instanyl underlines Nycomed's commitment to
therapies with clear medical utility. We strongly believe that this
product will provide an innovative approach for the half a million
patients with cancer suffering from breakthrough pain in Europe."
Nycomed plans to launch Instanyl in 2009.
About Nycomed
Nycomed is a privately owned global pharmaceutical company with a
differentiated portfolio focused on branded medicines in
gastroenterology, respiratory and inflammatory diseases, pain,
osteoporosis and tissue management. An extensive range of OTC
products completes the portfolio.
Its R&D is built to be open for partnerships as in-licensing is a
cornerstone in the company's growth strategy.
Nycomed employs 12,000 associates worldwide, and its products are
available in more than 100 countries. It has strong platforms in
Europe and in fast-growing markets such as Russia/CIS, and Latin
America. While the US and Japan are commercialised through
best-in-class partners, Nycomed will further strengthen its position
in key Asian markets.
Headquartered in Zurich, Switzerland, the company generated in
2008 total sales of euro 3.4 billion and an adjusted EBITDA of euro
1.2 billion.
For more information please visit http://www.nycomed.com
[i] Kress. H. G. et al. Efficacy and Tolerability of Intranasal
Fentanyl Spray 50 to 200μg for Breakthrough Pain in Patients With
Cancer: A Phase III, Multinational, Double-Blind, Randomized,
Placebo-Controlled, Crossover Trial With a 10/Month, Open-Label
Extension Treatment Period. Clin Ther. 2009;31:
[ii] Zeppetella G. Ribeiro MD. Pharmacotherapy of cancer-related
episodic pain. Expert Opin. Pharmacother. 2003;4:493-502
[iii] Davis MP, Walsh D, Lagman R, LeGrand SB. Controversies in
pharmacotherapy of pain management. Lancent Oncol. 2005;6:696-704.
[iv] Hwang SS, Chang VT, Kasimis B. Cancer breakthrough pain
characteristics and responses to treatment at a VA medical center.
Pain. 2003;101:55-64.
[v] Portenoy RK, Payne D, Jacobsen P. Breakthrough pain:
characteristics and impact in patients with cancer pain. Pain.
1999.;81:129-34.
For further information
Media: Ulf Jonson, Senior International Brand Manager, Nycomed:
+45-46-77-10-78

Contact:

For further information: Media: Ulf Jonson, Senior International
Brand Manager, Nycomed:
+45-46-77-10-78