PAI Paion

        
    The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8, London
AIM: PAI) today announces positive results from a meta-analysis of Phase II and Phase III data generated with
morphine-6-glucuronide (M6G). According to PAION, applying the findings should improve the probability of success for
the development program and will facilitate the planning of future studies. Accordingly, PAION is now re-launching the
partnering process for M6G.
    In spring 2007, a Phase III study with M6G was completed which demonstrated that M6G reduced pain as effectively as
morphine, the current standard treatment for post operative pain. This study also showed a significant reduction in
vomiting, a common side effect of morphine. However, while a marked and clinically relevant decrease in nausea was also
shown, statistical significance was narrowly missed.
    M6G was added to PAION's portfolio by way of the acquisition of CeNeS, which was successfully closed in June 2008.
Following the transaction, and as planned, PAION initiated a meta-analysis of the clinical data in order to re-evaluate
the study results obtained so far, and to gain a clearer view of the status of the M6G program.
    A combined data analysis based on 769 patients from two Phase II studies and two Phase III studies has now been
completed. The results confirm the analgesic effect of M6G and also reveal significant reductions in both vomiting and
nausea, the pre-specified parameters of the meta-analysis, compared with patients treated with morphine. The p-values in
this meta-analysis were 0.025 for nausea and 0.010 for vomiting and thus both reached statistical significance.
    In parallel, modelling analyses have been conducted to simulate dose-response relationships and pharmacodynamic
effects. The results support the product profile of M6G, both in terms of its analgesic properties and side-effect
profile, and in addition reproduce the previously observed longer duration of action of M6G compared to morphine. Based
on this model, PAION believes that even at increased doses M6G may be better tolerated than equi-analgesic doses of
morphine.
    Wolfgang S�hngen, CEO of PAION commented: "  As previously shown with Desmoteplase, which is now partnered with
Lundbeck, a thorough analysis of clinical studies is a powerful tool, especially for studies which have failed at first
glance. The result of our current meta-analysis supports our thesis that M6G could make an important contribution to the
improvement of pain management for patients requiring opioid analgesia. These new data allow us to now re-start the
partnering process with a higher probability of success." 
    In summary, these new analyses support PAION's view that M6G has a wider therapeutic margin than morphine, with
lower incidences of post-operative nausea and vomiting at equi-analgesic levels.
     About M6G 
    Morphine-6-glucuronide (M6G) is an active potent metabolite of morphine which may offer therapeutic advantages over
morphine, the current gold standard for the treatment of moderate to severe post-operative pain, in having an equivalent
analgesic effect, but with a reduced tendency to cause side-effects such as nausea and vomiting. The substance was added
to PAION's portfolio by acquiring CeNeS Pharmaceuticals in June 2008. Clinical trials have shown that M6G given
intravenously can induce analgesia equivalent to morphine in the treatment of moderate to severe post-operative pain.
These studies, along with those published in the scientific literature, suggest that M6G also induces less post
operative nausea and vomiting compared with morphine, as well as less sedation and respiratory depression. Two Phase III
trials have now been completed with M6G.
     About PAION 
    PAION is a biopharmaceutical company headquartered in Aachen, Germany. Since the acquisition of CeNeS
Pharmaceuticals, which was completed in June 2008, the company has a second site in Cambridge, UK. The company is
specializing in developing and commercializing innovative drugs for the hospital-based treatment of central nervous
system (CNS) disorders and thrombotic/cardiovascular diseases, indications for which there is a substantial unmet
medical need. PAION intends to further expand its portfolio of drugs by exploiting its core expertise in identifying
high-potential compounds, licensing or otherwise acquiring them and advancing them through the clinical development and
regulatory approval process. Where appropriate, particularly during the late stages of the clinical development and
approval process and the commercialization phase, PAION seeks to collaborate with experienced partners.
 Dr. Peer Nils Schroder, +49 241 4453-152
 Corporate Communications & Investor Relations
 pn.schroeder@paion.com
 www.paion.com
 or
 Teathers Limited
 Nomad and broker
 Shaun Dobson/Claes Spang, +44 20 7426 9000
    
    
    

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