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Abstral® launches in Canada

6/14/2011 8:00 AM EST  -   Orexo
Uppsala, Sweden, June 14 2011 – Through its local partner, Orexo now initiates marketing and sales of the pain treatment Abstral in Canada.
In 2008, ProStrakan, who markets Abstral in Europe and the U.S., licensed its rights in the Canadian market to Paladin Labs Inc., which now launches the treatment of breakthrough pain in cancer patients in the Canadian market.
Paladin Labs is a specialty pharmaceutical...

Abstral® approved in Canada

2/22/2011 8:30 AM EST  -   Orexo
Uppsala, Sweden– February 22, 2010 – Orexo AB (STO: ORX) today announces that ProStrakan’s partner, Paladin Labs Inc. has been informed by Health Canada, the Canadian Government Department with responsibility for public health, that it has approved Abstral®.

Abstral is a rapidly-disintegrating, sublingual (under the tongue) formulation of fentanyl. The product is approved for the treatment of breakthrough pain in...

FDA Approval for Abstral (Fentanyl) Sublingual Tablets - US launch planned for Q...

1/10/2011 2:00 AM EST  -   Orexo
Uppsala, January 10, 2011 - Orexo AB (STO: ORX) announces today that its partner ProStrakan Group plc (LSE: PSK) has received approval from the US Food and Drug Administration (FDA) for Abstral®. Abstral® is licensed for the treatment of breakthrough pain in cancer patients, 18 years of age and older, who are already receiving, and are tolerant to, opioid analgesics for their underlying persistent cancer pain. “This...

Update on the FDA review for Abstral™

9/7/2010 2:15 AM EST  -   Orexo
Uppsala, September 7, 2010 - Orexo AB (STO: ORX) announces that the US Food and Drug Administration (“FDA”) has informed Orexo’s partner, ProStrakan Group plc (LSE: PSK), the international specialty pharmaceutical company, that it will not yet be making a decision under the Prescription Drug User Fee Act (“PDUFA”) for Abstral™.

Discussions between ProStrakan and the FDA on the review of Abstral™ are ongoing and...

Orexo confirms Abstral PDUFA date update

6/2/2010 7:30 AM EST  -   Orexo
Uppsala, Sweden, June 2, 2010 –Orexo AB (STO: ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK) has today announced that the US Food and Drug Administration (“FDA”) has extended the review period under the Prescription Drug User Fee Act (“PDUFA”) for AbstralTM by three months.

The FDA has issued the extension following its earlier request for additional information on the Abstral Risk...

Orexo reports continued strong AbstralTM sales in Europe

5/18/2010 2:15 AM EST  -   Orexo
Uppsala, May 18, 2010 – Orexo AB (STO: ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK) has announced that AbstralTM continues to show strong sales development in 2010.

AbstralTM was launched across Europe during the course of 2009 and ProStrakan reported sales of £5.8 million in its first year on the market. In the first four months of 2010 AbstralTM has already recorded sales of £5.0 million....

Orexo AB (publ) – Interim report, January-March 2010

5/5/2010 2:00 AM EST  -   Orexo
Uppsala, May 5, 2010

Further strong sales development for Abstral
• Net revenues amounted to MSEK 36.4 (114.9). 1)
• Abstral royalty increased to MSEK 8.5 (1.3)
• Abstral approved in Italy and TUER 650 in milestones received
• The loss after tax was MSEK 27.6 (profit: 26.3).
• The loss per share before dilution was SEK 1.18 (profit: 1.20).
• The loss per share after dilution amounted to SEK 1.18 (1.15).
• Cash and...

Orexo AB (publ.) – Year-end Report January-December 2009

2/17/2010 2:00 AM EST  -   Orexo
Uppsala, February 17, 2010

Orexo AB (publ) –
Year-end Report January–December 2009



Key events during the year
• Net revenues totaled MSEK 236.1 (233.3).
• The loss after tax was MSEK 98.1 (loss: 103.1).
• The loss per share amounted to a loss of SEK 4.32 (loss: 4.77).
• Cash and cash equivalents at year-end totaled MSEK 87.4 (188.2).
• Abstral was launched in UK, Germany, France, Spain and Greece.
• In March,...

Orexo confirms Canadian Regulatory Filing of Abstral

2/4/2010 6:00 AM EST  -   Orexo
Uppsala, February 4, 2010 – Orexo AB (STO: ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK) has announced that the New Drug Submission made by their Canadian partner, Paladin Labs Inc., for AbstralTM has been accepted for review by Health Canada, the Canadian Government Department with responsibility for public health.

AbstralTM, developed by Orexo AB is a new, rapidly disintegrating,...

Orexo confirms FDA acceptance of Abstral filing

10/6/2009 2:20 AM EST  -   Orexo
Uppsala, Sweden, 6th October, 2009 - Orexo AB (STO: ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK), has announced that the New Drug Application (NDA) filing for Abstral has been accepted for review by the US Food and Drug Administration (FDA).

Abstral is a new, rapidly disintegrating, sublingual formulation of fentanyl, a long-established opioid used for the management of episodes of...