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PRESS RELEASE.COMMUNIQUE DE PRESSE -  DRAFT 5th March

Frank Baldino, Président-directeur Général of de Cephalon Inc. joins NicOx Board of Directorsrejoint le Conseil d’Administration de NicOx  

 

NicOx’s HCT-3012 moves advances into Phase II Human Clinical Trials for pain and inflammation

 

Company receives US$ 3 million Milestone Payment from AstraZeneca

 

 


Sophia-Antipolis, France. December XXMarchJanuary13183 marsXX, 20001 - NicOx S.A. (Nouveau Marché: NICOX)  announced annonce  lla nomination de Frank Baldinothe appointment of Frank Baldino, Jr., PhD à son Conseil d’Administration à la place de Mr. Denis Lucquin, to its Board of Directors. Dr. Baldino replaces représentant de Sofinnova Partners representative, Mr. Denis Lucquin.

 

Le Dr . Frank Baldino est Président-directeur Général et fondateur de Cephalon, Inc. (Nasdaq : CEPH), une société biopharmaceutique internationale spécialisée dans le développement de nouveaux composés pour le traitement des affections neurologiques et du sommeil, le cancer et la douleur.

Il est administrateur de ViroPharma, Inc., Pharmacopeia, Inc., Adolor Corporation, Biotechnology Industry Organization et The Jackson Laboratory. Il est membre des Conseils Consultatifs de  Benjamin Franklin Barrow Awards, National Venture Capital Association, American Entrepreneurs for Economic Growth, Eastern Technology Council of Greater Philadelphia et Technology Leaders LP. Le Dr. Baldino est également membre des visiting committees   pour l’Université de Pennsylvanie et Muhlenberg College.   

 

Le Dr. Baldino a plus de 16 années d’expérience en neurobiologie, biologie moléculaire et électrophysiologie.  etIl est l’auteur de plus de 100 publications dans des revues telles que Nature, Journal of Neuroscience Research et Brain Research. Il a obtenu un Doctorat de l’Université de Temple en 1979 et a occupé un poste de chercheur postdoctoral à l’Université de Pennsylvanie et UMDNJ – Rutgers Medical School. Il est également Professor Associé Adjoint à l’Université Temple et l’Hôpital Universitaire Université Hospital de Allegheny à Philadelphie.  De 1981 à 1987, le Dr. Baldino était biologiste en recherche dans le Département des Produits Médicaux chez E.I. DuPont de Nemours & Company. Il était responsable du développement des stratégies de recherche pour l’identification de nouveaux agents neuropharmaceutiques.

Dr. Frank Baldino is Chairman, CEO and founder of Cephalon, Inc. (Nasdaq: CEPH), an international biopharmaceutical company focused on the development of novel compounds to treat sleep and neurological disorders, cancer, and pain.  Dr. Baldino currently serves on the boards of ViroPharma, Inc., Pharmacopeia, Inc., Adolor Corporation, Biotechnology Industry Organization and The Jackson Laboratory.  He serves on the advisory boards of the Benjamin Franklin Barrow Awards, National Venture Capital Association, American Entrepreneurs for Economic Growth, Eastern Technology Council of Greater Philadelphia and Technology Leaders LP.  Dr. Baldino is also a member of the visiting committees for the University of Pennsylvania and Muhlenberg College.

Dr. Baldino has more than 16 years’ scientific experience in neurobiology, molecular biology and electrophysiology, and has authored more than 100 publications in peer-reviewed journals such as Nature, Journal of Neuroscience Research and Brain Research.  He received his Ph.D. from Temple University in 1979 and held post-doctorate positions at the University of Pennsylvania and UMDNJ - Rutgers Medical School.  He also holds adjunct academic appointments at Temple University and Allegheny University Hospital in Philadelphia.  From 1981-1987, Dr. Baldino served as senior research biologist in the medical products department at E.I. DuPont de Nemours & Company, where he was responsible for developing research strategies for identifying novel neuropharmaceutical agents.

 

OTHER today that its development partner, AstraZeneca, has initiated a Phase II human clinical trials of with HCT-3012, the lead compound in a series of NO-NSAIDs.  Under the terms of the 1998 agreement, by which this series of compounds was licensed to AstraZeneca for the indications of pain and inflammationThe , the start of this trialphase II human clinical trials triggers a US$3 million dollar milestone payment from AstraZeneca to NicOx.

 

The Phase II clinical trials will be conducted at [XX] centres in Europe and the US, and will encompass a range of clinical indications in the field of pain and inflammation.  The first patients will be recruited in the UK for a trial to evaluate efficacy of HCT 3012 in dental pain and inflammation.  [can we give any more details?  When will this begin?  What is the trial design?  How many patients?  What are the primary end points?]

The decision to advance HCT 3012 into phase II clinical testing follows satisfactory completion of

A double blind, placebo controlled pPhase I human clinical trials in over 60 healthy volunteers was conducted in Sweden earlier this year. The treatment regime which included single escalating doses and multiple doses.  for one week, showed overall safety and tolerability of HCT 3012.  Earlier Published animal studies have showned HCT 3012 to have a more effective anti-inflammatory and analgesic profile than current NSAIDS and to have excellent gastric, renal and cardiovascular safety.

(DELETE THE WORD ALL) SOne of the main THE SENIOR sB. , AT THIS PRECLINICAL STAGESUGGEST THAT NO-NSAIDs COULD BECOME would EXCELLENT DRUGS make of these compounds the drug  FOR SUCH AN APPLICATION

 

“Theis rapid start of phase II clinical trials with HCT 3012 this year is the result of the fast track development plan and the commitment of significant resources to the project by AstraZeneca”, said Michele Garufi, President and Chief Executive ofCEO and Chairman of NicOx. “We are convinced that our NO-NSAIDS compounds will demonstrate improved clinical benefit compared to current therapies for the treatment of pain and inflammationinflammatory arthritic disorders. Today the worldwide pain and inflammation market is estimated at close to US$ 20 billion. In particular, the non-steroidal anti-inflammatory (NSAIDs) segment is in rapid expansion and analysts expect this segment alone will  reach US$ 12 billion  by 2008. If the current profile of HCT 3012 is confirmed in further clinical trials, it will play a major role in this huge market.

 

AstraZeneca has a worldwide exclusive license  (except in Japan) for the development and commercialisation of NicOx ’s selected NO-NSAIDs including HCT 1032 3012 for the treatment of pain and rheumatoid inflammatory arthritic disorders.

 

 

Based in Sophia-Antipolis, France, NicOx is a Public Company listed on the Nouveau Marché of the Paris Stock Exchange. 

NicOx,  société pharmaceutique émergente, développe des médicaments avec des profils de sécurité et d’efficacité améliorés par l’exploitation des propriétés récemment découvertes de l’oxyde nitrique .is an emerging  pharmaceutical company harnessing leader in therecently- discoveryed properties and development of uniqueof nitric oxide-releasing to design and develop safer and more effective  drugs.

NicOx cible plusieurs marchés thérapeutiques majeurs tels que lis targeting for break-through therapy improvement of s several major therapeutic markets diseases such asincluding osteoarthritis, pa douleur et l’inflammation, les maladies cardiovasculaires, l’incontinence urinaire, les entéropathies inflammatoires chroniques et la maladie d’Alzheimer. in and inflammation, cardiovascular diseases,, thrombosis, urinary incontinence, osteoporosis, inflammatory bowel diseases, asthma and Alzheimer’s disease.

NicOx, dont le siège social se situe à Sophia-Antipolis - France, est cotée au Nouveau Marché de la Bourse de Paris.Based in Sophia-Antipolis, France, NicOx is a Public Company listed on the Nouveau Marché of the Paris Stock Exchange.

 

Contacts:  NicOx                                                                     Noonan/Russo Ltd.

      Elizabeth RobinsonCorinne Hoff                                                                  Solène Lebouar/Ashley Tapp

      Executive VP Business DevelopmentCorporate Communication Manager                            Tel: +44 (0) 207 726 44522

      Téel: +33 (0) 4 92 38 70 20                                            

       robinsonhoff@nicox.com