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ProStrakan Group plc (PSK)

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Monday 17 December, 2007

ProStrakan Group plc

Research Update

ProStrakan Group plc
17 December 2007

ProStrakan Group plc

Positive US Phase III Interim Data on Rapinyl Released by Endo Pharmaceuticals

Galashiels, Scotland, 17th December, 2007 - ProStrakan Group plc (LSE: PSK), the
international specialty pharmaceutical company, announces that Endo
Pharmaceuticals Inc. ("Endo") has today reported positive results from an
interim statistical analysis of its US Phase III, placebo-controlled,
double-blind trial of Rapinyl (announcement attached).

Rapinyl is a fast-dissolving tablet for sub-lingual administration of fentanyl
intended for the treatment of breakthrough cancer pain.  ProStrakan has
in-licensed the exclusive rights to develop and market Rapinyl in Europe from
Orexo AB, while Endo has in-licensed the rights for North America.

Endo has reported that the data from this interim analysis of 61 patients
demonstrated that Rapinyl met its primary endpoint, the Sum of Pain Intensity
Difference from baseline to 30 minutes (SPID 0-30), and the results were highly
statistically significant (p=0.0004). In addition, all the secondary endpoints
for Rapinyl were met.  Statistically significant separation from placebo on mean
pain intensity difference was seen as early as 10 minutes after dosing.

In Europe, Rapinyl is currently being reviewed by the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMEA), where a
majority decision is sufficient to gain pan-EU approval.  ProStrakan expects
that the approval process will complete in 2008.

Commenting on today's development, Dr Wilson Totten, Chief Executive of
ProStrakan, said:

"We welcome the release of this positive interim analysis of Endo's Phase III US
study on Rapinyl. We view the results as further evidence of the efficacy of
this important product and validation of our belief in the clinical and
commercial value of Rapinyl."

Further enquiries:

Dr Wilson Totten, Chief Executive                        Tel: +44 (0) 1896 664000
Paul Garvey, Chief Financial Officer
Callum Spreng, Corporate Comms Director

Financial Dynamics                                       Tel: +44 (0) 20 7831 3113

David Yates/Emma Thomson

Trout Group (for US investor enquiries)                  Tel: (646) 378-2949
Gitanjali Jain

Notes to Editors:


ProStrakan Group plc is a rapidly growing international 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 and development facilities are situated in Galashiels
in Scotland. EU-wide sales and marketing of ProStrakan's portfolio of products
are handled by commercial subsidiaries in the UK, France, Germany, Spain and
other EU countries. ProStrakan has recently announced plans to expand its
operations into the US.


This product is a new formulation of fentanyl, a long-established opioid used
for the management of episodes of severe breakthrough pain experienced by cancer
patients who are already receiving opioid analgesics for their chronic pain.

This product has recently completed the EU Decentralised Procedure (DCP) where a
consensus is required to achieve approval.  Of the 25 Concerned Member States,
21  expressed a positive opinion and the application has therefore been referred
for review by the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMEA), where a majority decision is sufficient to
gain approval. The Company expects that approval will be achieved in 2008. First
launches are likely to commence from the end of 2008.

Endo Pharmaceuticals Inc. Press Release


CHADDS FORD, Pa., Dec. 17, 2007 - Endo Pharmaceuticals Inc., a market leader in
pain management and a wholly owned subsidiary of Endo Pharmaceuticals Holdings
Inc. (NASDAQ: ENDP), today reported positive results from the previously
announced, planned interim statistical analysis of a Phase III,
placebo-controlled, double-blind trial of its development product, RAPINYLTM.
The data from the analysis of 61 patients demonstrated that RAPINYL met its
primary endpoint, the Sum of Pain Intensity Difference from baseline to 30
minutes (SPID 0-30), and the results were highly statistically significant (p=
0.0004). In addition, all the secondary endpoints were met. Statistically
significant separation from placebo on mean pain intensity difference was seen
as early as 10 minutes.

On the basis of these results and in accordance with the predetermined criteria
of the interim analysis, Endo is terminating enrollment in the double-blind
crossover portion of this clinical study. Enrollment is continuing in the safety
portion of this trial and a second Phase III trial to meet the requirements for
additional safety data. RAPINYL is an oral, fast-dissolving tablet of fentanyl
intended for the treatment of breakthrough cancer pain. Endo licensed the
exclusive rights to develop and market RAPINYL in North America from Orexo AB.

"We are extremely pleased by the outcome of this analysis, which we believe
demonstrates that RAPINYL can be an effective treatment for breakthrough pain in
cancer patients," said David A. Lee, M.D., Ph.D., Chief Scientific Officer.  "We
remain confident that RAPINYL's quick dissolution and rapid absorption profile
make it a potentially attractive treatment for breakthrough cancer pain." He
added that Endo will conduct a thorough analysis of the data to determine the
next course of action, including the possibility of filing a New Drug
Application (NDA) based on these results.  It expects to provide further updates
on the status of the RAPINYL clinical development program early in 2008.

The company noted that although this planned interim analysis was only intended
to determine efficacy and not tolerability, those adverse events that were
reported were consistent with what is usually observed with other opioids.

About Endo

A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., Endo
Pharmaceuticals is a fully integrated specialty pharmaceutical company with
market leadership in pain management products. The company researches, develops,
produces and markets a broad product offering of branded and generic
pharmaceuticals, meeting the needs of healthcare professionals and consumers
alike. More information, including this and past press releases of Endo
Pharmaceuticals Holdings Inc., is available online at

Forward-Looking Statements

This press release contains forward-looking statements, within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, as amended, that are based on management's beliefs and
assumptions, current expectations, estimates and projections. Statements that
are not historical facts, including statements which are preceded by, followed
by, or that include, the words "believes," "anticipates," "plans," "expects" or
similar expressions and statements are forward-looking statements. Endo's
estimated or anticipated future results, product performance or other non-
historical facts are forward-looking and reflect Endo's current perspective on
existing trends and information. Many of the factors that will determine the
Company's future results are beyond the ability of the Company to control or
predict. These statements are subject to risks and uncertainties and, therefore,
actual results may differ materially from those expressed or implied by these
forward-looking statements. The reader should not rely on any forward-looking
statement. The Company undertakes no obligation to update any forward-looking
statements whether as a result of new information, future events or otherwise.
Several important factors, in addition to the specific factors discussed in
connection with these forward-looking statements individually, could affect the
future results of Endo and could cause those results to differ materially from
those expressed in the forward-looking statements contained in this press
release. Important factors that may affect future results include, but are not
limited to: market acceptance of the Company's products and the impact of
competitive products and pricing; dependence on sole source suppliers; the
success of the Company's product development activities and the timeliness with
which regulatory authorizations and product launches may be achieved; successful
compliance with extensive, costly, complex and evolving governmental regulations
and restrictions; the availability on commercially reasonable terms of raw
materials and other third party manufactured products; exposure to product
liability and other lawsuits and contingencies; dependence on third party
suppliers, distributors and collaboration partners; the ability to timely and
cost effectively integrate acquisitions; uncertainty associated with pre-
clinical studies and clinical trials and regulatory approval; uncertainty of
market acceptance of new products; the difficulty of predicting FDA approvals;
risks with respect to technology and product development; the effect of
competing products and prices; uncertainties regarding intellectual property
protection; uncertainties as to the outcome of litigation; a determination by a
regulatory agency that we are engaging in inappropriate sales or marketing
activities, including promoting the "off-label" use of our products; changes in
operating results; impact of competitive products and pricing; product
development; changes in laws and regulations; customer demand; possible future
litigation; availability of future financing and reimbursement policies of
government and private health insurers and others; and other risks and
uncertainties detailed in Endo's filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K filed with the SEC on March
1, 2007. Readers should evaluate any statement in light of these important

                      This information is provided by RNS
            The company news service from the London Stock Exchange

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