Dublin, Ireland, 11th April 2007
AGI Therapeutics plc FDA approval to file IND for Arverapamil Phase III study
AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused on gastrointestinal drug 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 bowel syndrome (IBS).
The pre-IND meeting was held to allow the FDA to review the current data package on arverapamil, to discuss the requirements for an arverapamil IND, and to agree on the design and scope of the Phase III programme as well as the full development 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 the previously reported successful Phase II clinical study (conducted in Europe under the Clinical Trials Directive), the FDA determined that the existing pre-clinical and clinical data would support an IND submission and a Phase III trial for arverapamil. The design and scope of the Phase III trial was also agreed upon pending a final review of the Phase III protocol and supporting data during the statutory 30 days post-IND submission. In addition, the FDA and AGI agreed on the overall manufacturing, pre-clinical, and clinical development plans 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's concurrence that the remaining pre-clinical and supporting clinical studies required for the NDA could be performed in parallel with the Phase III programme.
As a result of the meeting, AGI intends to finalise and submit an IND with a Phase III protocol and, subject to FDA review, would expect to initiate patient enrolment 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 marks a positive step forward in the development of our lead product for a common yet under-treated condition. Consistent with our KME approach, we are now in a position to immediately progress from our Phase II clinical trial directly into Phase III. Our immediate focus for averapamil will now be on filing our IND for final agreement before commencing patient enrolment in the second half of this year."
Contact Information
AGI Therapeutics
David Kelly, Chief Financial Officer
Tel: +353 1 449 3254
Financial Dynamics - UK
Sarah MacLeod
Tel: +44 (0) 20 7831 3113
Financial Dynamics - Ireland
Aisling Garvey
Tel: +353 1 663 3607
For further information please see www.agitherapeutics.com
Notes to editors
About 505(b)(2) NDA
The FDA 505(b)(2) NDA regulatory process provides a specific regulatory pathway to seek approval for new and improved uses of drugs which are already approved in the US and rest of the world. The process allows the sponsor to use existing information in the public domain to support their approval. Typically this process would reduce the regulatory requirements to obtain approval and would allow 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 gastrointestinal symptoms 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 major component of IBS and patients are diagnosed and sub-typed according to their predominant symptom of bowel disturbance. Arverapamil is being developed in an oral dosage form for the treatment of diarrhoea-predominant irritable bowel syndrome ("d-IBS") in both men and women. The d-IBS segment of the IBS market is estimated to account for at least one-third of all IBS patients and there is currently an estimated 6 million diagnosed d-IBS patients who could benefit from safe and effective drug therapy. D-IBS represents a significant unmet medical need as there are currently few or no safe and effective therapeutic options available to these patients.
Arverapamil, AGI-003, has been identified as AGI's lead development programme and will be the Company's primary focus during 2007. In May 2006 AGI reported the initial results of a Phase II clinical study for this product in the treatment of non-constipation predominant Irritable Bowel Syndrome (IBS). AGI was extremely encouraged by those results and the potential of this product in treating IBS, and now intends to advance arverapamil into Phase III development.
About AGI
AGI is a speciality pharmaceutical company which is focused on the development and commercialisation of differentiated drug products for gastrointestinal (''GI'') diseases and disorders. AGI's common shares are listed on the Alternative Investment Market of the London Stock Exchange ("AIM") and on the Irish Enterprise Exchange of the Irish Stock Market ("IEX") as "AGI".
The Company has a portfolio of product candidates derived from the Known Molecular Entity (''KME'') approach to drug re-profiling and development. KME is a re-profiling methodology used by the Company to identify existing therapeutic drugs which typically have been marketed for a number of years, have established safety profiles and can be developed for new clinical indications or with improved profiles in their existing clinical indications. In this way, the Company seeks to reduce the risk, time and cost of new product development as compared to the development of new chemical entities.
AGI is developing a range of product candidates to treat a variety of prevalent GI diseases and disorders, including irritable bowel syndrome, functional dyspepsia, ulcerative colitis and gastro-esophageal reflux disease. The Company is targeting areas of the GI therapeutic drug products market for its product candidates where there are currently unmet medical needs or where the effectiveness of existing drug therapies can be further improved.
The Company has six clinical stage product candidates which are either isomers or new drug delivery formulations of existing approved drugs, and which have established safety and tolerability profiles in their currently approved clinical indications. These product candidates are all in clinical development, including five Phase II trials.
AGI intends to complete its ongoing clinical trials and, dependent on the results of these trials, the Company will initiate late stage development of a lead product candidate and will also seek to enter into licensing and development agreements with pharmaceutical companies so as to enhance the global market reach for its products and achieve optimal revenue and value opportunities for the Company.
Statements contained within this press release may contain forward-looking comments that involve risks and uncertainties that may cause actual results to vary from those contained in the forward-looking statements. In some cases, you can identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions and forward-looking references in this press release are subject to the satisfactory progress of research, which is, by nature, unpredictable. Forward projections reflect management's best estimates based on information available at the time of issue.