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

TAASTRUP, Denmark -

- 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 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

Source: Nycomed

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