Regulatory Approval (5969B)

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RNS Number : 5969B

ProStrakan Group plc

22 February 2011

ProStrakan Group plc

Abstral Approved by Health Canada

Galashiels, UK. 22nd February 2011 - ProStrakan Group plc (LSE: PSK), the international specialty pharmaceutical company announces that its Canadian partner for Abstral(R) , Paladin Labs Inc. (TSX: PLB), has been informed by Health Canada, the Canadian Government Department with responsibility for public health, that it has approved Abstral.

Abstral is a novel, rapidly-disintegrating, sublingual (under the tongue) formulation of fentanyl, a well-established opioid used for the management of episodes of breakthrough pain experienced by cancer patients who are already receiving opioid analgesics for chronic pain.

ProStrakan out-licensed the Canadian rights for Abstral to Paladin in December 2008, having in-licensed the rights for Abstral in Europe and North America from Orexo AB. ProStrakan will receive an undisclosed milestone payment from Paladin on the achievement of a successful pricing outcome, with further milestone payments due on the subsequent achievement of certain sales targets.

Abstral was approved last month by the US Food and Drug Administration, where ProStrakan plans to launch this product in Q1 2011. ProStrakan already markets Abstral across Europe through its own direct sales force.

Peter Allen, Chairman and Acting Chief Executive of ProStrakan, said:

"Abstral will now be made available to clinicians and their patients right across Europe and North America and we look forward to working closely with our partner, Paladin, in introducing this important product for breakthrough cancer pain sufferers in Canada."

For further enquiries, please contact:

 
 ProStrakan                                        [phone] 
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 Peter Allen, Chairman & Acting Chief Executive 
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 Allan Watson, Chief Financial Officer 
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 Callum Spreng, Corporate Communications 
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 Brunswick Group                                   [phone] 
                                                    5959 
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 Jon Coles / Justine McIlroy 
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About ProStrakan:

ProStrakan Group plc is a rapidly growing specialty pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in major markets.

ProStrakan's head office is located in Galashiels in Scotland. The company's development capabilities are centered in Galashiels and Bedminster, New Jersey, USA. Sales and marketing of ProStrakan's portfolio of products are handled by commercial subsidiaries in the UK, US, France, Germany, Spain, Italy and other EU countries.

You can learn more about the business at: www.prostrakan.com

This information is provided by RNS

The company news service from the London Stock Exchange

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