Regulatory Approval (5969B)
22 Fevereiro 2011 - 10:30AM
UK Regulatory
TIDMPSK
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 +44 (0) 1896 664000
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Peter Allen, Chairman & Acting Chief Executive
------------------------------------------------ --------------------
Allan Watson, Chief Financial Officer
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Callum Spreng, Corporate Communications
------------------------------------------------ --------------------
Brunswick Group +44 (0) 20 7404
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
END
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