11th Apr 2007 07:01
AGI Therapeutics plc11 April 2007 AGI Therapeutics plc FDA approval to file IND for Arverapamil Phase III study Dublin, Ireland, 11 April 2007 - AGI Therapeutics plc ("AGI" or the "Company")(AIM, IEX: AGI), a speciality pharmaceutical company focused on gastrointestinaldrug products, today announces that it has concluded a successful pre-IND(Investigational New Drug) meeting with the U.S. Food and Drug Administration(FDA) for arverapamil, (AGI-003), AGI's lead product for irritable bowelsyndrome (IBS). The pre-IND meeting was held to allow the FDA to review the current data packageon arverapamil, to discuss the requirements for an arverapamil IND, and to agreeon the design and scope of the Phase III programme as well as the fulldevelopment programme to support the submission of an NDA (New Drug Application)under FDA's 505(b)(2) regulations. Following a review of the current data package on arverapamil, including thepreviously reported successful Phase II clinical study (conducted in Europeunder the Clinical Trials Directive), the FDA determined that the existingpre-clinical and clinical data would support an IND submission and a Phase IIItrial for arverapamil. The design and scope of the Phase III trial was alsoagreed upon pending a final review of the Phase III protocol and supporting dataduring the statutory 30 days post-IND submission. In addition, the FDA and AGIagreed on the overall manufacturing, pre-clinical, and clinical developmentplans to support the submission of the NDA in diarrhoea predominant IBS (d-IBS)under FDA's 505(b)(2) NDA regulations. The discussions included FDA'sconcurrence that the remaining pre-clinical and supporting clinical studiesrequired for the NDA could be performed in parallel with the Phase IIIprogramme. As a result of the meeting, AGI intends to finalise and submit an IND with aPhase III protocol and, subject to FDA review, would expect to initiate patientenrolment into a Phase III trial in 2H07. Dr. John Devane, CEO of AGI, said: "We are pleased with the outcome of this initial regulatory meeting which marksa positive step forward in the development of our lead product for a common yetunder-treated condition. Consistent with our KMW approach, we are now in aposition to immediately progress from our Phase II clinical trial directly intoPhase III. Our immediate focus for averapamil will now be on filing our IND forfinal agreement before commencing patient enrolment in the second half of thisyear." Contact Information: AGI Therapeutics plc. Tel: +353 1 449 3254David Kelly, Chief Financial Officer Financial Dynamics - UK Tel: +44 (0) 20 7831 3113Anna Keeble Financial Dynamics - Ireland Tel: +353 1 663 3607Aisling Garvey For further information please see www.agitherapeutics.com Note to editors: About 505(b)(2) NDA The FDA 505(b)(2) NDA regulatory process provides a specific regulatory pathwayto seek approval for new and improved uses of drugs which are already approvedin the US and rest of the world. The process allows the sponsor to use existinginformation in the public domain to support their approval. Typically thisprocess would reduce the regulatory requirements to obtain approval and wouldallow for a more condensed timeline compared to new chemical/molecular entities. About arverapamil (AGI-003) and IBS IBS is a functional disorder that comprises a cluster of gastrointestinalsymptoms which are likely to be life long and which affects between 10% and 20%of the population in developed markets. Altered intestinal motility is a majorcomponent of IBS and patients are diagnosed and sub-typed according to theirpredominant symptom of bowel disturbance. Arverapamil is being developed in anoral dosage form for the treatment of diarrhoea-predominant irritable bowelsyndrome ("d-IBS") in both men and women. The d-IBS segment of the IBS market isestimated to account for at least one-third of all IBS patients and there iscurrently an estimated 6 million diagnosed d-IBS patients who could benefit fromsafe and effective drug therapy. D-IBS represents a significant unmet medicalneed as there are currently few or no safe and effective therapeutic optionsavailable to these patients. Arverapamil, AGI-003, has been identified as AGI's lead development programmeand will be the Company's primary focus during 2007. In May 2006 AGI reportedthe initial results of a Phase II clinical study for this product in thetreatment of non-constipation predominant Irritable Bowel Syndrome (IBS). AGIwas extremely encouraged by those results and the potential of this product intreating IBS, and now intends to advance arverapamil into Phase IIIdevelopment. About AGI Therapeutics plc AGI is a speciality pharmaceutical company which is focused on the developmentand commercialisation of differentiated drug products for gastrointestinal (GI)diseases and disorders. AGI's common shares are listed on the AlternativeInvestment Market of the London Stock Exchange (AIM) and on the Irish EnterpriseExchange of the Irish Stock Market (IEX) as AGI. The Company has a portfolio of product candidates derived from its KnownMolecular Entity (KME) approach to drug re-profiling and development. KME is are-profiling methodology used by the Company to identify existing therapeuticdrugs which typically have been marketed for a number of years, have establishedsafety profiles and can be developed for new clinical indications or withimproved profiles in their existing clinical indications. In this way, theCompany seeks to reduce the risk, time and cost of new product development ascompared to the development of new chemical entities. AGI is developing a range of product candidates to treat a variety of prevalentGI diseases and disorders, including irritable bowel syndrome (IBS), dyspepsia,gastroparesis, ulcerative colitis, gastro-esophageal reflux disease (GERD) anddiarrhea-related conditions such as chemotherapy-induced diarrhea (CID). TheCompany is targeting areas of the GI therapeutic drug products market for itsproduct candidates where there are currently unmet medical needs or where theeffectiveness of existing drug therapies can be further improved. The Company has five active clinical stage product candidates which are eitherisomers or new drug delivery formulations of existing approved drugs, and whichhave established safety and tolerability profiles in their currently approvedclinical indications. Statements contained within this press release may contain forward-lookingcomments which involve risks and uncertainties that may cause actual results tovary from those contained in the forward-looking statements. In some cases, youcan identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions andforward-looking references in this press release are subject to the satisfactoryprogress of research which is, by nature, unpredictable. Forward projectionsreflect management's best estimates based on information available at the timeof issue. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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