FDA Issues Approvable Letter for ADEPT® Adhesion Reduction Solution
01 Jun 2006
FDA Issues Approvable Letter for ADEPT® Adhesion Reduction Solution
Nottingham, UK, 1st June 2006 – Innovata plc (LSE: IOV) today announces that the FDA has issued a letter to the company indicating that ADEPT® adhesion reduction solution is approvable for use as an adjunct to good surgical technique for the reduction of post surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.
On March 27th 2006, ADEPT received a unanimous recommendation for marketing approval by the Obstetrics and Gynecology Devices Panel of the US Food and Drug Administration (FDA).
The letter states that the FDA is continuing to review the product labeling and requires Innovata to submit amended label copy for adverse event data and warnings and also to agree proposals for post-approval safety monitoring. Innovata plans to submit this information as quickly as possible.
Kieran Murphy, Chief Executive Officer of Innovata, said: "We are delighted by this news and hope to complete the approval process in the shortest possible time."
Available in Europe since 2000, ADEPT is a 4% icodextrin solution that has been used in adhesion reduction in over 100,000 surgical patients. The Phase III study supporting Innovata's filing submission was conducted in over 400 patients undergoing gynecological laparoscopic adhesiolysis in the USA. The results showed that ADEPT reduced the number of adhesions following surgery while the overall incidence of adverse events in the ADEPT and control groups was similar.
ADEPT is licensed to Baxter International Inc. on a global basis under an agreement formed in January 2006. ADEPT is marketed by Baxter's BioSurgery business, a business unit that is focused on developing and commercializing novel biomaterials and biosurgery products.
Contacts:
Innovata plc
Tel: 0115 974 7474
Kieran Murphy, Chief Executive Officer
Peter Shennan, Finance Director
Financial Dynamics
Tel: 020 7831 3113
David Yates/ Anna Keeble
Notes to Editors
About Adhesions
An adhesion is a band of scar tissue that binds two planes of tissue together which should remain separate. Studies suggest that adhesions may form in over 10% of patients who have never had surgery and in 93% of patients having abdominal or pelvic surgery 1. Pelvic and abdominal adhesions are a significant women’s health issue as they can be associated with infertility, small bowel obstruction and chronic pelvic pain.
The use of anti-adhesion products has been limited by their difficulty in use and lack of clinical efficacy data 2.
About Innovata plc
Innovata plc specialises in the development of pulmonary products for the treatment of respiratory disorders and other serious diseases. Using its proprietary dry powder inhaler and drug formulation technologies, the company has developed a pipeline of revenue-generating/marketed and clinical-stage products. In addition, the Company has a portfolio of non-pulmonary products with growing revenues. Innovata has established development and marketing partnerships with a number of pharmaceutical companies including Baxter, Merck KGaA, UCB and Otsuka.
Innovata was formed in July 2005 when ML Laboratories PLC acquired Quadrant Technologies Limited and the remaining minority interest in Innovata Biomed Limited. The company has over 90 employees of whom of 65 are engaged in research and development, mainly based at Innovata plc’s headquarters in Ruddington.
1 Menzies, D. and Ellis, H. (1990) Intestinal obstruction from adhesions—How big is the problem? Ann. R. Coll. Surg. Engl., 72, 72–60.
2 Frost and Sullivan, March 2005
